PeptideScanner
U.S. label record↗Endocrine↗

Octreotide↗

Related names in cited records: Octreotide acetate↗

A somatostatin analogue. This profile cites a U.S. label record.↗

Citation markers ↗ open the public records supporting the adjacent statements.

Profile update · July 27, 2026

We rewrote the profile summary to describe the cited public record more directly. The cited sources and status did not change. 1

This version supersedes public version 1.

Start here

The evidence at a glance

What is its status in the cited records?

U.S. label record. The cited DailyMed label identifies Octreotide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗

Status sources checked through July 22, 2026. See status sources and coverage →

What do the reviewed human studies say?

Human evidence reviewed August 19, 2026 · Review version 1.

Review source snapshots checked August 19, 2026 · Integrity checked August 19, 2026.

Publisher notices are registered for this reviewed source set. Inspect the notices and their scope →

A bounded review of two randomized acromegaly trials: a short placebo-controlled study and a Phase 3 maintenance comparison in patients already responsive to somatostatin receptor ligands.↗↗

What the reviewed sources report

The short trial reported reduced growth-hormone and insulin-like growth factor I levels with octreotide. In the selected-responder Phase 3 trial, oral octreotide met the prespecified noninferiority criterion against injectable therapy for maintaining biochemical response.↗↗

What remains unresolved?

  • How do long-term symptoms, clinical outcomes, treatment burden, and harms compare in broader acromegaly populations not selected through a responder run-in?↗↗

Read study designs, results, limitations, and sources →

What does the U.S. product label say?

Octreotide acetate injection · Read September 15, 2026 · Preserved label summary 1

Which population and use does the label cover?

The label covers reduction of growth hormone and IGF-1 in specified acromegaly settings, diarrhea and flushing with metastatic carcinoid tumors, and diarrhea with VIP-secreting tumors. It says the cited injection trials did not establish reduction in tumor size or growth; this is separate from evidence for other formulations. Label: 1 ↗

Which safety limits matter?

The label contraindicates hypersensitivity and warns about cardiac conduction abnormalities, gallstones and complications, altered glucose control, hypothyroidism, and impaired fat absorption. Intravenous administration has a distinct warning about higher-degree heart block. Label: 4, 5 ↗

Label edition and source pins

U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.

Octreotide acetate injection, solution · SPL version 2 · published 2026-02-02

Label ZIP SHA-256: ef983a96082e22365e0421c84727fd1f1c4edba8f562651f80efe7222ff70491. Extracted XML SHA-256: 14384962a14328e523de4f1f393ab757985c463cef9f2e690b3b8491076f76d7.

Open versioned label context data →

Reviews summarize selected studies; their scope and limitations are shown above.

Inside the official reviews

Reviewed 2026-09-19 · Preserved version 1

The oral formulation was tested for maintenance

FDA’s 2020 review evaluated oral octreotide in people whose acromegaly was already controlled with injectable octreotide or lanreotide. The randomized placebo-controlled study tested maintenance of biochemical control over 36 weeks. FDA PDF pp. 3, 4 ↗

More findings, study links and document coverage

The endpoint was biochemical control

More participants maintained the specified IGF-1 threshold with oral octreotide than placebo. IGF-1 and growth-hormone measures are distinct from directly measuring survival or every symptom in this trial. FDA PDF pp. 3, 5 ↗

Prior response defined who was studied

The review restricted its conclusion to people who had responded to and tolerated octreotide or lanreotide. No participants previously controlled with pasireotide were enrolled, leaving that switch unanswered. FDA PDF pp. 4, 5 ↗

Oral administration did not remove class-related harms

Gastrointestinal, gallbladder and glucose abnormalities were reported. FDA found the safety pattern consistent with the somatostatin-analogue class; that does not mean the oral formulation was free of adverse effects. FDA PDF pp. 4, 6 ↗

Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.

Document coverage

Selected sections read in 1 of 1 inventoried documents; 0 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.

One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading. EMA inventory source ↗

Inspect documents, application identities and source pins

Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.

  • Mycapssa: FDA selected application review ↗

    Selected sections reviewed · fda-octreotide-review-2020 · Document/feed date: 2020-06-23

    Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.

    Verified: Mycapssa · NDA 208232 · Document dated 2020-06-23. Identity checked on PDF pp. 2.

    Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal.

    Retrieved 2026-09-19. Read PDF pages: 2, 3, 4, 5, 6 of 32. SHA-256: 5d3d903a45a1716927050991fc46b70790be4a156694e41988ce9e15b9b5c94c.

Remaining work

  • Review the injectable octreotide programs separately from oral maintenance therapy.
  • Appraise oral extension reports and later comparative studies with prior-response selection preserved.

Open versioned document coverage and study pins →

European medicine records · 2 products or applications

EMA medicine metadata checked 2026-09-15. These are product-specific centralized records; national European authorizations and full product-information assessments require separate coverage.

Application withdrawal and refusal are distinct from marketing authorization. A withdrawal status alone does not establish why it occurred. These metadata entries do not substitute for indication, population or safety details in the relevant product information.

Open versioned records and source-feed pins →

Research coverage and study families

Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.

Open machine-readable coverage and record decisions →

PubMed search

Catalog-name and calibrated alias discovery for human evidence review. Complete query retrieval is separate from clinical eligibility, study-family linkage and appraisal.

9344 retrieved · 2 included · 0 excluded · 9342 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Octreotide"[Title/Abstract] OR "Octreotide acetate"[Title/Abstract]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:09:40.946557+00:00 · HTTP 200 · SHA-256 8690dd3325a5f47534517cac4a2c9480ae9d1573920a3a0723a428f4f1cc145b.

  • Retrieved IDs completely represent this query response, not all relevant literature. Additional aliases, references and non-PubMed sources require separate searches.
  • Unscreened records may include animal or cell experiments, reviews, secondary analyses, mixtures, protocols and unrelated name matches.
  • Study-family mappings use available declared registry IDs; unresolved mappings do not create independent trial counts. Full-text, corrections and registry comparison remain separate work.
  • Linked correction notices require comparison with the selected reports: PMID35202590 for PMID34953531. Their presence does not establish what changed.

Showing 25 of 9344 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. PubMed 34953531 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT02685709.
    Bibliographic record recheck · 2026-09-15

    The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗

    SHA-256 0068237c2e45fcb3b2ac793ece8483c74712c685d220b01da778fe9fdd42f731.

  2. PubMed 2229278 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: octreotide-PMID2229278-registry-linkage-unresolved.
    Bibliographic record recheck · 2026-09-15

    The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗

    SHA-256 337a6252d870e7b130910baa2e7c29989ff70a50754871c1c5322b43962a0b80.

  3. PubMed 42728814 — not screened: Name-query match awaiting clinical eligibility screening.
  4. PubMed 42723843 — not screened: Name-query match awaiting clinical eligibility screening.
  5. PubMed 42722485 — not screened: Name-query match awaiting clinical eligibility screening.
  6. PubMed 42719453 — not screened: Name-query match awaiting clinical eligibility screening.
  7. PubMed 42719266 — not screened: Name-query match awaiting clinical eligibility screening.
  8. PubMed 42712757 — not screened: Name-query match awaiting clinical eligibility screening.
  9. PubMed 42703785 — not screened: Name-query match awaiting clinical eligibility screening.
  10. PubMed 42696271 — not screened: Name-query match awaiting clinical eligibility screening.
  11. PubMed 42695680 — not screened: Name-query match awaiting clinical eligibility screening.
  12. PubMed 42687079 — not screened: Name-query match awaiting clinical eligibility screening.
  13. PubMed 42676050 — not screened: Name-query match awaiting clinical eligibility screening.
  14. PubMed 42675372 — not screened: Name-query match awaiting clinical eligibility screening.
  15. PubMed 42665197 — not screened: Name-query match awaiting clinical eligibility screening.
  16. PubMed 42662504 — not screened: Name-query match awaiting clinical eligibility screening.
  17. PubMed 42661447 — not screened: Name-query match awaiting clinical eligibility screening.
  18. PubMed 42640470 — not screened: Name-query match awaiting clinical eligibility screening.
  19. PubMed 42639465 — not screened: Name-query match awaiting clinical eligibility screening.
  20. PubMed 42638641 — not screened: Name-query match awaiting clinical eligibility screening.
  21. PubMed 42632511 — not screened: Name-query match awaiting clinical eligibility screening.
  22. PubMed 42626938 — not screened: Name-query match awaiting clinical eligibility screening.
  23. PubMed 42621540 — not screened: Name-query match awaiting clinical eligibility screening.
  24. PubMed 42621460 — not screened: Name-query match awaiting clinical eligibility screening.
  25. PubMed 42619456 — not screened: Name-query match awaiting clinical eligibility screening.

FDA search

Active-ingredient name query in openFDA Drugs@FDA. Returned application identities include salt forms and combination products; exact indications, approval conditions, supplements and marketing status require document-level review.

27 retrieved · 27 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

products.active_ingredients.name:"OCTREOTIDE"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:23.238131+00:00 · HTTP 200 · SHA-256 e59956507c2a1e2b13f5ece6bb99cb98f10a5804ab7c2a4dc3fdf8e77d672aff.

  • Zero results describe this query response only, not absence of FDA approval or worldwide nonapproval.
  • This endpoint does not inventory every label, advisory proceeding, safety communication or regulatory document. Application inclusion does not establish current marketing or approval of every use.

Showing 25 of 27 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. FDA ANDA077373 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  2. FDA ANDA077372 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  3. FDA ANDA077330 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  4. FDA ANDA077329 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  5. FDA ANDA077331 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  6. FDA ANDA210317 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  7. FDA NDA208232 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  8. FDA ANDA216807 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  9. FDA ANDA079198 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  10. FDA ANDA090834 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  11. FDA ANDA077450 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  12. FDA ANDA077457 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  13. FDA NDA213224 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  14. FDA ANDA076313 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  15. FDA ANDA076330 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  16. FDA ANDA203765 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  17. FDA ANDA216839 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  18. FDA ANDA216589 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  19. FDA ANDA217860 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  20. FDA ANDA090986 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  21. FDA ANDA090985 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  22. FDA ANDA075957 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  23. FDA ANDA075959 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  24. FDA NDA019667 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.
  25. FDA ANDA091041 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: OCTREOTIDE ACETATE.

EMA search

Local matching in the pinned EMA medicines feed; document matches also use identified EMA product numbers. This is not every national European record.

2 retrieved · 2 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Octreotide", "Octreotide acetate"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:22.905972+00:00 · HTTP 200 · SHA-256 a947c2b8a56ac2b92ec96156843f262f5e516f83b375d6791d67a8f6dc695729.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 2 of 2 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA EMEA/H/C/006322 — include: EMA feed product Oczyesa; reported status: Authorised. Exact indication and decision documents remain unappraised.
  2. EMA EMEA/H/C/005826 — include: EMA feed product Mycapssa; reported status: Withdrawn. Exact indication and decision documents remain unappraised.

EMA search

Local matching in the pinned EMA documents feed; document matches also use identified EMA product numbers. This is not every national European record.

24 retrieved · 13 included · 0 excluded · 11 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Octreotide", "Octreotide acetate"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:29.167460+00:00 · HTTP 200 · SHA-256 c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 24 of 24 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA 57139 — include: Document linked by EMA product number; content unappraised. Mycapssa: EPAR - Medicine overview
  2. EMA 57142 — include: Document linked by EMA product number; content unappraised. Mycapssa: EPAR - Risk-management-plan
  3. EMA 57141 — include: Document linked by EMA product number; content unappraised. Mycapssa: EPAR - All authorised presentations
  4. EMA 57143 — include: Document linked by EMA product number; content unappraised. Mycapssa: EPAR - Public assessment report
  5. EMA 57144 — include: Document linked by EMA product number; content unappraised. Mycapssa: EPAR - Orphan maintenance assessment report (initial authorisation)
  6. EMA 69109 — include: Document linked by EMA product number; content unappraised. Oczyesa : EPAR - Public assessment report
  7. EMA 69110 — include: Document linked by EMA product number; content unappraised. Oczyesa : Orphan designation withdrawal assessment report (initial-authorisation)
  8. EMA 69114 — include: Document linked by EMA product number; content unappraised. Oczyesa : EPAR - Medicine overview
  9. EMA 71467 — include: Document linked by EMA product number; content unappraised. Oczyesa : EPAR - Procedural steps taken and scientific information after authorisation
  10. EMA 69108 — include: Document linked by EMA product number; content unappraised. Oczyesa : EPAR - All authorised presentations
  11. EMA 69842 — include: Document linked by EMA product number; content unappraised. Oczyesa : EPAR - Risk management plan
  12. EMA 57140 — include: Document linked by EMA product number; content unappraised. Mycapssa: EPAR - Product information
  13. EMA 69107 — include: Document linked by EMA product number; content unappraised. Oczyesa : EPAR - Product information
  14. EMA 26145 — not screened: Title-name match awaiting identity and document review. Octreotide : List of nationally authorised medicinal products - PSUSA/00002201/201706
  15. EMA 28829 — not screened: Title-name match awaiting identity and document review. EU/3/13/1170: Public summary of opinion on orphan designation: Octreotide acetate (oral use) for treatment of acromegaly
  16. EMA 34008 — not screened: Title-name match awaiting identity and document review. Questions and answers on Sandostatin LAR and associated names (octreotide, 10, 20 and 30 mg powder and solvent for suspension for injection)
  17. EMA 39531 — not screened: Title-name match awaiting identity and document review. Questions and answers on Sandostatin and associated names (octreotide, 0.05 mg/1 ml, 0.1 mg/1 ml, 0.5 mg/1 ml and 1 mg/5 ml, solution for injection or infusion)
  18. EMA 43673 — not screened: Title-name match awaiting identity and document review. Octreotide acetate depot powder and solvent for suspension for injection 10 mg, 20 mg and 30 mg product-specific bioequivalence guidance
  19. EMA 43674 — not screened: Title-name match awaiting identity and document review. Overview of comments received on 'Octreotide acetate depot powder and solvent for suspension for injection 10 mg, 20 mg and 30 mg product-specific bioequivalence guidance' (EMA/CHMP/291571/2018)
  20. EMA 50856 — not screened: Title-name match awaiting identity and document review. Octreotide: List of nationally authorised medicinal products - PSUSA/00002201/202006
  21. EMA 50857 — not screened: Title-name match awaiting identity and document review. Octreotide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002201/202006
  22. EMA 40611 — not screened: Title-name match awaiting identity and document review. Draft octreotide acetate depot powder and solvent for suspension for injection 10 mg, 20 mg or 30 mg product-specific bioequivalence guidance
  23. EMA 62307 — not screened: Title-name match awaiting identity and document review. Octreotide : List of nationally authorised medicinal products - PSUSA/00002201/202306
  24. EMA 15134 — not screened: Title-name match awaiting identity and document review. EU/3/09/645: Public summary of positive opinion for orphan designation of octreotide hydrochloride (lipid depot solution) for the treatment of acromegaly

EMA search

Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.

6 retrieved · 6 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Octreotide", "Octreotide acetate"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:31.262344+00:00 · HTTP 200 · SHA-256 7448bf4e77e3345b3f3fbb7062c335d2302d8ea458a246bbe8256ce48aad2806.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 6 of 6 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA EU/3/25/3093 — include: EMA orphan feed identifies octreotide hydrochloride; designation status: Positive. Orphan designation is not marketing authorization.
  2. EMA EU/3/09/645 — include: EMA orphan feed identifies octreotide hydrochloride; designation status: Withdrawn. Orphan designation is not marketing authorization.
  3. EMA EU/3/13/1170 — include: EMA orphan feed identifies octreotide acetate; designation status: Withdrawn. Orphan designation is not marketing authorization.
  4. EMA EU/3/24/2984 — include: EMA orphan feed identifies octreotide hydrochloride; designation status: Positive. Orphan designation is not marketing authorization.
  5. EMA EU/3/22/2738 — include: EMA orphan feed identifies octreotide acetate; designation status: Withdrawn. Orphan designation is not marketing authorization.
  6. EMA EU/3/21/2554 — include: EMA orphan feed identifies octreotide acetate; designation status: Positive. Orphan designation is not marketing authorization.

ClinicalTrials.gov search

ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.

378 retrieved · 0 included · 0 excluded · 378 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Octreotide" OR "Octreotide acetate" OR "Oczyesa" OR "Mycapssa"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:42.222130+00:00 · HTTP 200 · SHA-256 64de9c201c1feb3eb76bff8dd87dc364e78303f41f755f492aa3ac309c4a791d.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:43.493501+00:00 · HTTP 200 · SHA-256 c12935b1d3e3c9136ca06ee75008a66cded9e5efbc512d1fafea002022fa1499.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:44.973900+00:00 · HTTP 200 · SHA-256 d8f5348f99a740353fca8c186e0adbab0c80fc89173c15f29ec021a4db7c77d8.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:46.334053+00:00 · HTTP 200 · SHA-256 1f5a1f7b375f43aebc34603905a55576977c0ff38d0ffda04f1402f70d21c958.

  • Registration is not evidence that a study succeeded, that results were published, or that a use is approved.
  • Other registries, unregistered studies and additional aliases remain outside this query.

Showing 25 of 378 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. ClinicalTrials.gov NCT02119052 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  2. ClinicalTrials.gov NCT04917484 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  3. ClinicalTrials.gov NCT00248157 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  4. ClinicalTrials.gov NCT02384122 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  5. ClinicalTrials.gov NCT00595140 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  6. ClinicalTrials.gov NCT04281680 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  7. ClinicalTrials.gov NCT00543179 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  8. ClinicalTrials.gov NCT00002779 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  9. ClinicalTrials.gov NCT00332969 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  10. ClinicalTrials.gov NCT02359500 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  11. ClinicalTrials.gov NCT03031535 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  12. ClinicalTrials.gov NCT01137682 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  13. ClinicalTrials.gov NCT04076462 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  14. ClinicalTrials.gov NCT02311608 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  15. ClinicalTrials.gov NCT06085976 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  16. ClinicalTrials.gov NCT03624517 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  17. ClinicalTrials.gov NCT06668090 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  18. ClinicalTrials.gov NCT00582426 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  19. ClinicalTrials.gov NCT06558422 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  20. ClinicalTrials.gov NCT03289741 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  21. ClinicalTrials.gov NCT00789841 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  22. ClinicalTrials.gov NCT02621541 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  23. ClinicalTrials.gov NCT04353193 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  24. ClinicalTrials.gov NCT02474914 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  25. ClinicalTrials.gov NCT00765323 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
Read the full Human Evidence Review

Supervised synthesis

What do selected human studies report about Octreotide?

Manually reviewed August 19, 2026 · version 1

Browse all Human Evidence Reviews · Open preserved synthesis version 1 →

A bounded review of two randomized acromegaly trials: a short placebo-controlled study and a Phase 3 maintenance comparison in patients already responsive to somatostatin receptor ligands.12

Bottom line from this bounded source set

The short trial reported reduced growth-hormone and insulin-like growth factor I levels with octreotide. In the selected-responder Phase 3 trial, oral octreotide met the prespecified noninferiority criterion against injectable therapy for maintaining biochemical response.12

Reviewed study record

Short placebo-controlled acromegaly trial

Design

A double-blind randomized placebo-controlled trial assessed biochemical measures during 14 days of treatment.1

Population

The trial included 20 patients with acromegaly, with ten assigned to octreotide and ten to placebo.1

Outcomes reported

Mean growth-hormone and insulin-like growth factor I levels were significantly reduced during octreotide treatment, although response varied and two treated participants had no significant growth-hormone reduction.1

Limitations

The study was very small and lasted only 14 days, so it cannot establish long-term symptom control, clinical outcomes, or uncommon harms.1

Reviewed study record

MPOWERED maintenance trial

Design

A sponsor-funded, open-label randomized Phase 3 trial compared oral octreotide with injectable somatostatin receptor ligands after an oral run-in selected biochemical responders.2

Population

Ninety-two adults with acromegaly who had previously responded to injectable therapy and then completed the oral run-in as responders were randomized.2

Outcomes reported

Biochemical response was maintained by 91% of participants assigned to oral octreotide and 100% assigned to injectable therapy; the adjusted comparison met the prespecified noninferiority criterion.2

Limitations

The open-label trial randomized only oral-run-in responders, limiting generalizability to people who had not already tolerated and responded to both treatment forms.2

Reviewed source set

  1. PubMed · 2229278Short term treatment of acromegaly with the somatostatin analog octreotide: the first double-blind randomized placebo-controlled study on its effects ↗PubMed PMID 2229278 · EFetch XML reviewed 2026-08-19 · payload SHA-256 337a6252d870e7b130910baa2e7c29989ff70a50754871c1c5322b43962a0b80
    No registered Crossref update in the reviewed snapshotChecked August 19, 2026 for DOI 10.1210/jcem-71-5-1189. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  2. PubMed · 34953531Maintenance of response to oral octreotide compared with injectable somatostatin receptor ligands in patients with acromegaly: a phase 3, multicentre, randomised controlled trial ↗PubMed PMID 34953531 · EFetch XML reviewed 2026-08-19 · payload SHA-256 0068237c2e45fcb3b2ac793ece8483c74712c685d220b01da778fe9fdd42f731
    Publication update registered by CrossrefErratum ↗ · publisher metadata · March 1, 2022. Crossref metadata identifies the notice but does not by itself explain what wording changed.
Explore status sources, recent additions, and coverage gaps

Living status brief

What is the current status of Octreotide?

U.S. label record. The cited DailyMed label identifies Octreotide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗

The cited status sources were checked through July 22, 2026. This answer changes only through the profile’s visible version and correction history.

160Dated records59PubMed records57Trial records39Regulatory records

Evidence present

What records are connected here?

Evidence lanes
4
Source years
25
Drugs@FDA applications
27

These are counts in PeptideScanner’s selected public collection, not measures of research quality, medical relevance, safety, or effectiveness.

Collection changes

What did PeptideScanner add most recently?

  1. Literature metadata · added September 9, 2026

    A long-acting octreotide analog formed by conjugation with a peptide linker modified with two fatty acids.↗Source date September 9, 2026

  2. Clinical trials · added September 9, 2026

    ClinicalTrials.gov record NCT02217800↗Source date February 15, 2018

  3. Literature metadata · added September 9, 2026

    [Pharmacological treatment of gastroenteropancreatic apudomas with an analog of somatostatin, SMS 201-995 (octreotide)].↗Source date November 21, 2013

Coverage gaps

What remains unknown or unsupported?

All four evidence lanes appear in this selected collection, but their presence does not establish completeness, agreement, research quality, safety, effectiveness, approval, availability, or suitability.

PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.

Open the complete timeline →Browse all connected recordsFollow via RSS
Explore the Evidence Map and record counts

Evidence Map v1

What kinds of records connect to Octreotide?

Compare collection coverage →

This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.

160Selected dated records
161Connected citations
25Populated source years1988–2026
4/4Record lanes present
Clinical trials57Open matching records →Literature metadata59Open matching records →Regulatory39Open matching records →Safety5Open matching records →

Registered human studies

Trial composition

4 of 57 selected trial records include at least one phase value; 4 of 57 include a status value in the retained structured contract.

1,637 public history versions connect to 56 of these trial records across 22 submitted years. Open the record-history collection →

PhasesPhase 2 2Phase 3 1Phase 4 1
Status at observationCompleted 3Active, not recruiting 1

A phase value is unavailable here for 53 selected records; this is not counted as “no phase.”

A status value is unavailable here for 53 selected records; this is not counted as a trial status.

PubMed bibliography

Publication composition

32 of 59 selected PubMed records include attributed title, venue, publication date, and publication-type fields.

Publication typesJournal Article 29Review 8Case Reports 5Clinical Trial 3Letter 3Comparative Study 2Randomized Controlled Trial 2Comment 1English Abstract 1Meta-Analysis 1Research Support, U.S. Gov't, P.H.S. 1Systematic Review 1

Bibliography fields unavailable here for 27 selected records; the records remain visible as metadata observations.

Regulatory and publication surfaces

What is structurally connected?

Drugs@FDA applications
27
FDA Federal Register documents
10
DailyMed SPL versions
2
Canonical profile
Published
Profile structured data
Published
Linked dated records
160

Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.

Profile publication history and record counts

Research hub

Explore the Octreotide evidence record

Open all 160 records →
160Dated records
4Evidence types
160Cited public sources
25Source years

Change ledger

Recently changed for Octreotide

Open all 161 events →

PeptideScanner change dates and cited source dates stay separate. These entries report collection or version activity, not a ranking of importance.

Record added

ClinicalTrials.gov record NCT02217800

PeptideScanner retained ClinicalTrials.gov record NCT02217800 at 2026-07-30T21:12:47.415Z. Its registry update date was 2018-02-15, and PeptideScanner's reviewed identity mapping was octreotide.

PeptideScanner change date
September 9, 2026
Cited source date
February 15, 2018
Evidence lane
Clinical trials
Open the cited record →
Cited source
Record added

[Pharmacological treatment of gastroenteropancreatic apudomas with an analog of somatostatin, SMS 201-995 (octreotide)].

PubMed lists PMID 2059523 in Revista espanola de enfermedades digestivas as English Abstract, Journal Article, with publication-date metadata of 1991-02 (month precision). PeptideScanner associated the retained record with the identity slug octreotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

PeptideScanner change date
September 9, 2026
Cited source date
November 21, 2013
Evidence lane
Literature metadata
Open the cited record →
Cited source
Record added

A long-acting octreotide analog formed by conjugation with a peptide linker modified with two fatty acids.

PubMed lists PMID 42712757 in Frontiers in endocrinology as Journal Article, Randomized Controlled Trial, Clinical Trial, with publication-date metadata of 2026-08-25 (day precision). PeptideScanner associated the retained record with the identity slug octreotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

PeptideScanner change date
September 9, 2026
Cited source date
September 9, 2026
Evidence lane
Literature metadata
Open the cited record →
Cited source

Official-source collections

Source records for Octreotide

Open the full research atlas →
PubMed59

32 with attributed title, venue, publication-date, and type metadata.

Journal Article (29)Review (8)Case Reports (5)
  1. A long-acting octreotide analog formed by conjugation with a peptide linker modified with two fatty acids.Frontiers in endocrinology · 2026 08 25
  2. Octreotide in the Management of Chyle Leaks After Head and Neck Surgery: A Systematic Review of Cohort Studies.The Journal of laryngology and otology · 2026 07 21
  3. Combined SSTR2-targeted Analogue with 177Lu-DOTATATE radionuclide and octreotide therapy for refractory meningioma: a case report.Frontiers in oncology · 2026 06 11
Explore all selected literature →
ClinicalTrials.gov57

1,637 public history versions across these dated registry records; status labels apply only to each cited observation.

Recruiting history (873)Active Not Recruiting history (556)Completed history (132)
Current at observation (5)Completed at observation (52)
Acromegaly (1)Colorectal Neuroendocrine Tumor G1 (1)Gastric Neuroendocrine Tumor G1 (1)Phase 2 (2)Phase 3 (1)Completed (3)Active, not recruiting (1)
octreotide · Drug (2)Octreotide · Drug (1)Octreotide Acetate · Drug (1)
  1. NCT00569127Registry update July 29, 2026 · current at observation
  2. NCT07460908Registry update March 10, 2026 · completed at observation
  3. NCT03879694Registry update February 6, 2026 · completed at observation
Explore all selected trial records →Explore all public record history →
Drugs@FDA27

Original-submission application metadata connected by exact reviewed active-ingredient names.

  1. ANDA216589Full FDA chronology · original submission status AP 2025-12-12
  2. NDA213224Full FDA chronology · original submission status AP 2024-09-27
  3. ANDA217860Full FDA chronology · original submission status AP 2024-05-02
  4. ANDA210317Full FDA chronology · original submission status AP 2023-12-05
  5. ANDA216839Full FDA chronology · original submission status AP 2023-06-22
Explore all selected FDA applications →Explore 180 dated submissions and 72 documents for Octreotide →
FDA enforcement reports5

Recall-enforcement metadata connected only through exact application numbers already mapped to this reviewed profile.

  1. D-0519-2026Class II · report date 2026-05-13
  2. D-0404-2026Class II · report date 2026-04-01
  3. D-0405-2026Class II · report date 2026-04-01
  4. D-0406-2026Class II · report date 2026-04-01
  5. D-0058-2023Class I · report date 2022-11-16
Explore all exact FDA enforcement reports →

Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.

Evidence types

Coverage by source year

Selected records span October 21, 1988 to September 9, 2026.

Continue exploring

Profiles with overlapping source-year coverage

Open the research atlas →

These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.

Leuprolide22 shared source years215 dated records · 4 evidence typesTeriparatide21 shared source years149 dated records · 3 evidence typesExenatide20 shared source years119 dated records · 3 evidence typesGlucagon19 shared source years308 dated records · 4 evidence types

These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.

Evidence summary

What the cited records say

The cited DailyMed label identifies Octreotide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗

This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.

Cited context

Related records

Organizations named in cited records

  • U.S. National Library of Medicine↗

Dated source history

Updates connected to this profile

Open the full cross-source timeline →

  1. Literature metadata

    A long-acting octreotide analog formed by conjugation with a peptide linker modified with two fatty acids.↗

    PubMed lists PMID 42712757 in Frontiers in endocrinology as Journal Article, Randomized Controlled Trial, Clinical Trial, with publication-date metadata of 2026-08-25 (day precision). PeptideScanner associated the retained record with the identity slug octreotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗

  2. Literature metadata

    Real-World Indirect Treatment Comparison of Terlipressin vs Midodrine Plus Octreotide in Hepatorenal Syndrome-Acute Kidney Injury.↗

    PubMed lists PMID 41472624 in Clinical and translational gastroenterology as Journal Article, Comparative Study, with publication-date metadata of 2026-02-01 (day precision). PeptideScanner associated the retained record with the identity slug octreotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗

  3. Literature metadata

    Uptake of 18F-AlF-NOTA-octreotide PET/CT in gastrointestinal stromal tumors.↗

    PubMed lists PMID 42026400 in EJNMMI reports as Journal Article, with publication-date metadata of 2026-04-24 (day precision). PeptideScanner associated the retained record with the identity slug octreotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗

  4. Literature metadata

    Transarterial embolization combined with octreotide long-acting release in treating rectal neuroendocrine tumor liver metastases: a single-institutional experience.↗

    PubMed lists PMID 42169939 in Journal of gastrointestinal oncology as Journal Article, with publication-date metadata of 2026-04-28 (day precision). PeptideScanner associated the retained record with the identity slug octreotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗

  5. Literature metadata

    Combined SSTR2-targeted Analogue with 177Lu-DOTATATE radionuclide and octreotide therapy for refractory meningioma: a case report.↗

    PubMed lists PMID 42370133 in Frontiers in oncology as Case Reports, Journal Article, with publication-date metadata of 2026-06-11 (day precision). PeptideScanner associated the retained record with the identity slug octreotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗

  6. Literature metadata

    PubMed record PMID 39631560↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 39631560 at 2026-08-10T10:49:06.913Z. PubMed recorded a metadata revision date of 2026-08-09 and an Entrez history date of 2024-12-04. PeptideScanner associated this retained record with the identity slug octreotide. These dates describe PubMed metadata history, not the article's original publication date.↗

  7. Literature metadata

    PubMed record PMID 37951584↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 37951584 at 2026-08-10T10:49:06.851Z. PubMed recorded a metadata revision date of 2026-08-04 and an Entrez history date of 2023-11-11. PeptideScanner associated this retained record with the identity slug octreotide. These dates describe PubMed metadata history, not the article's original publication date.↗

  8. Literature metadata

    PubMed record PMID 38407358↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 38407358 at 2026-08-10T10:49:06.879Z. PubMed recorded a metadata revision date of 2026-08-04 and an Entrez history date of 2024-02-26. PeptideScanner associated this retained record with the identity slug octreotide. These dates describe PubMed metadata history, not the article's original publication date.↗

  9. Literature metadata

    PubMed record PMID 42029102↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 42029102 at 2026-08-10T10:49:08.854Z. PubMed recorded a metadata revision date of 2026-08-03 and an Entrez history date of 2026-04-24. PeptideScanner associated this retained record with the identity slug octreotide. These dates describe PubMed metadata history, not the article's original publication date.↗

  10. Literature metadata

    PubMed record PMID 42333429↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 42333429 at 2026-08-10T10:49:10.713Z. PubMed recorded a metadata revision date of 2026-08-03 and an Entrez history date of 2026-06-23. PeptideScanner associated this retained record with the identity slug octreotide. These dates describe PubMed metadata history, not the article's original publication date.↗

  11. Literature metadata

    PubMed record PMID 42515664↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 42515664 at 2026-08-10T10:49:12.892Z. PubMed recorded a metadata revision date of 2026-07-31 and an Entrez history date of 2026-07-28. PeptideScanner associated this retained record with the identity slug octreotide. These dates describe PubMed metadata history, not the article's original publication date.↗

  12. Clinical trials

    ClinicalTrials.gov record NCT00569127↗

    PeptideScanner retained ClinicalTrials.gov record NCT00569127 at 2026-08-10T18:10:03.946Z. Its registry update date was 2026-07-29, and PeptideScanner's reviewed identity mapping was octreotide.↗

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