U.S. label recordMetabolic

Semaglutide

Related names in cited records: Wegovy, Ozempic, Rybelsus

A GLP-1 receptor agonist. This profile cites a Wegovy label and an FDA notice.

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

Profile update · July 29, 2026

We added search aliases that the cited FDA substance-identity record maps to this active ingredient. The profile's status did not change. 3

This version supersedes public version 2.

Start here

The evidence at a glance

What is its status in the cited records?

U.S. label record. The cited DailyMed label identifies Semaglutide 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 18, 2026 · Review version 1.

Review source snapshots checked August 18, 2026 · Integrity checked August 19, 2026.

A bounded review of two sponsor-funded randomized trials: STEP 1 for weight change and SELECT for cardiovascular outcomes.

What the reviewed sources report

In the reviewed trials, semaglutide was associated with greater weight reduction than placebo in adults without diabetes, and fewer major cardiovascular events in adults with established cardiovascular disease and overweight or obesity without diabetes. The findings apply to those studied populations and trial conditions.

What remains unresolved?

  • How do benefits and harms change after discontinuation, across populations excluded from these trials, and over longer follow-up?

Read study designs, results, limitations, and sources →

What does the U.S. product label say?

Wegovy injection and tablets · Read September 15, 2026 · Preserved label summary 1

Which population and use does the label cover?

For adults with established cardiovascular disease and obesity or overweight, the label covers cardiovascular-risk reduction with injection or tablets. Both formulations cover weight management in adults with obesity, or overweight with a weight-related condition. Injection additionally covers weight management in children aged twelve years and older with obesity, and noncirrhotic MASH with F2–F3 fibrosis in adults. The MASH indication has accelerated approval requiring confirmation of clinical benefit; it does not apply to the tablets. Label: 1 ↗

Which safety limits matter?

The boxed warning reports thyroid C-cell tumors in rodents, with uncertain human relevance. Contraindications include personal or family medullary thyroid carcinoma, MEN 2 and hypersensitivity. Warnings address pancreatitis, gallbladder disease, hypoglycemia with insulin or insulin secretagogues, kidney injury from volume depletion, severe gastrointestinal reactions, retinopathy complications, increased heart rate and aspiration during anesthesia or deep sedation. Label: boxed warning, 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.

WEGOVY (semaglutide) injection and tablet · SPL version 19 · published 2026-06-30

Label ZIP SHA-256: a8c57f3e8cf2c89501ac3b6077dd7480fb4bf72bb0b42135078f0d3a1f20f8f8. Extracted XML SHA-256: 2f2c51a1fdf57a3a2459f340abfbe1e0283e5c8849d3a844db8c28ede302f6b3.

Open versioned label context data →

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

Official-source update

Reviewed 2026-09-16 · Preserved version 1

FDA revisited the psychiatric-safety warning

On January 13, 2026, FDA requested removal of the suicidal-behavior and ideation warning from Wegovy labeling after its review found no increased risk. This records the agency’s request, not a claim that every label version has changed. FDA PDF pp. 1 ↗

More findings and the sources behind them

Selected FDA safety communications, read alongside the separately preserved product-label account and human evidence review.

What supported that finding

FDA combined 91 placebo-controlled trials involving 107,910 participants and examined a separate Sentinel claims cohort. These are class-wide analyses, not a dedicated trial of this peptide or a finding about every possible adverse effect. FDA PDF pp. 2, 3 ↗

The chemical form matters

FDA distinguishes semaglutide sodium and acetate from the active ingredient in approved drugs; it lacks information establishing the same chemical and pharmacologic properties. Evidence about an approved product should not be transferred automatically to those salts. FDA source ↗

What remains to be checked

  • Reconcile each current product and formulation label with subsequent safety and indication changes.
  • Appraise remaining eligible trial reports and follow-up studies; this update does not complete the literature review.
Source dates and review coverage

PDF citations use file page numbers. Named webpage sections and registry fields identify the portions read. These are selected readings, not complete source coverage.

  • FDA January 2026 GLP-1 psychiatric-safety communication ↗

    Source dated 2026-01-13; retrieved 2026-09-16.

    • What Is FDA Doing? · PDF pp. 1 of 3
    • What Did FDA Find? · PDF pp. 2, 3 of 3

    SHA-256: d2cc0d43605a9300646146c86f0fd4b84611ada2272de7e65425f33fb7aae53c

  • FDA concerns with unapproved GLP-1 drugs ↗

    Source dated 2026-09-01; retrieved 2026-09-16.

    • Concerns with compounded versions of these drugs
    • Salt forms should not be used to compound semaglutide
    • Adverse events related to compounded versions of semaglutide and tirzepatide
    • Retatrutide and cagrilintide cannot be used in compounding

    SHA-256: bfb6cd2a11e3f8e20bedfeed0e0d554205c76dd83f473956deb82afc186e51cc

Open versioned findings and source records →

European medicine records · 5 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.

5586 retrieved · 2 included · 0 excluded · 5584 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Semaglutide"[Title/Abstract] OR "Wegovy"[Title/Abstract] OR "Ozempic"[Title/Abstract] OR "Rybelsus"[Title/Abstract]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:09:33.424853+00:00 · HTTP 200 · SHA-256 3b62ca5201d3e1967887a0b741a8d33bb9edc649b8dccab137d26118c8211e7f.

  • 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.

Showing 25 of 5586 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. PubMed 37952131 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT03574597.
    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 dabd7cd9d6c08b9c07da39a19d0b48266bfb7ddbbaacefe2e11025d105708245.

  2. PubMed 33567185 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT03548935.
    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 b3cf6a18c3906c27475c4a49d31f5741bf40fa056afc62f07d07fa54dbff28c4.

  3. PubMed 42738873 — not screened: Name-query match awaiting clinical eligibility screening.
  4. PubMed 42737751 — not screened: Name-query match awaiting clinical eligibility screening.
  5. PubMed 42736522 — not screened: Name-query match awaiting clinical eligibility screening.
  6. PubMed 42736040 — not screened: Name-query match awaiting clinical eligibility screening.
  7. PubMed 42736027 — not screened: Name-query match awaiting clinical eligibility screening.
  8. PubMed 42735880 — not screened: Name-query match awaiting clinical eligibility screening.
  9. PubMed 42735804 — not screened: Name-query match awaiting clinical eligibility screening.
  10. PubMed 42735799 — not screened: Name-query match awaiting clinical eligibility screening.
  11. PubMed 42734721 — not screened: Name-query match awaiting clinical eligibility screening.
  12. PubMed 42734711 — not screened: Name-query match awaiting clinical eligibility screening.
  13. PubMed 42733032 — not screened: Name-query match awaiting clinical eligibility screening.
  14. PubMed 42732962 — not screened: Name-query match awaiting clinical eligibility screening.
  15. PubMed 42732434 — not screened: Name-query match awaiting clinical eligibility screening.
  16. PubMed 42732089 — not screened: Name-query match awaiting clinical eligibility screening.
  17. PubMed 42730869 — not screened: Name-query match awaiting clinical eligibility screening.
  18. PubMed 42730175 — not screened: Name-query match awaiting clinical eligibility screening.
  19. PubMed 42730115 — not screened: Name-query match awaiting clinical eligibility screening.
  20. PubMed 42730051 — not screened: Name-query match awaiting clinical eligibility screening.
  21. PubMed 42729958 — not screened: Name-query match awaiting clinical eligibility screening.
  22. PubMed 42729808 — not screened: Name-query match awaiting clinical eligibility screening.
  23. PubMed 42729683 — not screened: Name-query match awaiting clinical eligibility screening.
  24. PubMed 42728029 — not screened: Name-query match awaiting clinical eligibility screening.
  25. PubMed 42727920 — 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.

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

Search terms, record decisions and remaining work

products.active_ingredients.name:"SEMAGLUTIDE"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:26.438298+00:00 · HTTP 200 · SHA-256 c50ccc5ef8704bc1134f7618bfec70c41a9a5c6bd64fede7a52ab00dde77ae30.

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

  1. FDA NDA209637 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: SEMAGLUTIDE.
  2. FDA ANDA220314 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: SEMAGLUTIDE.
  3. FDA NDA213182 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: SEMAGLUTIDE.
  4. FDA NDA215256 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: SEMAGLUTIDE.
  5. FDA NDA218316 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: SEMAGLUTIDE.
  6. FDA NDA213051 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: SEMAGLUTIDE.

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.

5 retrieved · 5 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Semaglutide", "Wegovy", "Ozempic", "Rybelsus"]

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 5 of 5 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/005422 — include: EMA feed product Wegovy; reported status: Authorised. Exact indication and decision documents remain unappraised.
  2. EMA EMEA/H/C/004174 — include: EMA feed product Ozempic; reported status: Authorised. Exact indication and decision documents remain unappraised.
  3. EMA EMEA/H/C/004953 — include: EMA feed product Rybelsus; reported status: Authorised. Exact indication and decision documents remain unappraised.
  4. EMA EMEA/H/C/006426 — include: EMA feed product Kayshild; reported status: Authorised. Exact indication and decision documents remain unappraised.
  5. EMA EMEA/H/C/006279 — include: EMA feed product Kyinsu; reported status: Authorised. 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.

78 retrieved · 45 included · 0 excluded · 33 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Semaglutide", "Wegovy", "Ozempic", "Rybelsus"]

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 25 of 78 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA 14075 — include: Document linked by EMA product number; content unappraised. Ozempic : EPAR - Public assessment report
  2. EMA 29427 — include: Document linked by EMA product number; content unappraised. Ozempic : EPAR - Summary for the public
  3. EMA 47367 — include: Document linked by EMA product number; content unappraised. Ozempic-H-C-PSUSA-00010671-201905 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  4. EMA 47769 — include: Document linked by EMA product number; content unappraised. Rybelsus : EPAR - Public assessment report
  5. EMA 49769 — include: Document linked by EMA product number; content unappraised. Ozempic-H-C-PSUSA-00010671-201911 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  6. EMA 50994 — include: Document linked by EMA product number; content unappraised. Ozempic-H-C-PSUSA-00010671-202005 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  7. EMA 53437 — include: Document linked by EMA product number; content unappraised. Rybelsus-EMEA-H-C-PSUSA-00010671-202005 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  8. EMA 54265 — include: Document linked by EMA product number; content unappraised. Ozempic-H-C-004174-X-0021 : EPAR - Assessment report - Variation
  9. EMA 54415 — include: Document linked by EMA product number; content unappraised. Wegovy : EPAR - Public Assessment Report
  10. EMA 58573 — include: Document linked by EMA product number; content unappraised. Ozempic-H-C-PSUSA-00010671-202205 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  11. EMA 58575 — include: Document linked by EMA product number; content unappraised. Rybelsus-EMEA-H-C-PSUSA-00010671-202205 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  12. EMA 58910 — include: Document linked by EMA product number; content unappraised. Wegovy-H-C-PSUSA-00010671-202205 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
  13. EMA 60713 — include: Document linked by EMA product number; content unappraised. Wegovy-H-C-5422-II-0009 : EPAR - Assessment Report - Variation
  14. EMA 61952 — include: Document linked by EMA product number; content unappraised. Wegovy-H-C-005422-II-0009 : EPAR - Assessment report - Variation
  15. EMA 64756 — include: Document linked by EMA product number; content unappraised. Wegovy-H-C-005422-II-0017 : EPAR - Assessment report - Variation
  16. EMA 47766 — include: Document linked by EMA product number; content unappraised. Rybelsus : EPAR - All Authorised presentations
  17. EMA 47768 — include: Document linked by EMA product number; content unappraised. Rybelsus : EPAR - Risk management plan
  18. EMA 13667 — include: Document linked by EMA product number; content unappraised. Ozempic : EPAR - Procedural steps taken and scientific information after authorisation (archive)
  19. EMA 47939 — include: Document linked by EMA product number; content unappraised. Rybelsus : EPAR - Procedural steps taken and scientific information after authorisation (archive)
  20. EMA 7027 — include: Document linked by EMA product number; content unappraised. Ozempic : EPAR - All Authorised presentations
  21. EMA 69828 — include: Document linked by EMA product number; content unappraised. Rybelsus : EPAR - Medicine overview
  22. EMA 72528 — include: Document linked by EMA product number; content unappraised. Kyinsu : EPAR - Medicine overview
  23. EMA 72529 — include: Document linked by EMA product number; content unappraised. Kyinsu : EPAR - Risk management plan
  24. EMA 72531 — include: Document linked by EMA product number; content unappraised. Kyinsu : EPAR - All authorised presentations
  25. EMA 72532 — include: Document linked by EMA product number; content unappraised. Kyinsu : EPAR - Public assessment report

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.

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

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Semaglutide", "Wegovy", "Ozempic", "Rybelsus"]

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 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

    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.

    783 retrieved · 0 included · 0 excluded · 783 awaiting a decision · 0 full-text appraisals

    Search terms, record decisions and remaining work

    "Semaglutide" OR "Wegovy" OR "Ozempic" OR "Rybelsus" OR "Kayshild" OR "Kyinsu"

    Source retrievals and payload pins
    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:26:52.609684+00:00 · HTTP 200 · SHA-256 814aea84b1cbf86daa3494307142be5d4fbc028bd00333ab7f8f4530c2dae712.

    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:26:54.277422+00:00 · HTTP 200 · SHA-256 972ec5f11faeafdf6e0ec110461396ec17d32998920bc9c1f476f55611810084.

    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:26:55.664476+00:00 · HTTP 200 · SHA-256 b3d8895ed88045fa9c8c0b07a64459fea5d9344d881f6a50a550d300b8b66dce.

    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:26:57.168807+00:00 · HTTP 200 · SHA-256 2f0200b949109ac5e9c1b291a65d5f144cd3c121edf5e49945e603ff5e9ddc83.

    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:26:58.412904+00:00 · HTTP 200 · SHA-256 e0fa80f23d7633ac60dca61538f4f677f477841b1d929e6870199da7b7e6ea5f.

    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:26:59.821049+00:00 · HTTP 200 · SHA-256 430bcd2086343c8762b33d8279536cda404c1e3c5fc8b26c126cd89d69d516fc.

    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:27:01.860109+00:00 · HTTP 200 · SHA-256 10ea128ce764cecba3d428e0f40b48b7a766e9ca2fbf02ef473cdc8925c9f2b4.

    • Open the source endpoint ↗

      Retrieved 2026-09-15T11:27:03.409534+00:00 · HTTP 200 · SHA-256 f1ac058df0d6369131b680a310a842d943711cddeb9e649ec281262b71371273.

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

    1. ClinicalTrials.gov NCT00833716 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    2. ClinicalTrials.gov NCT06546384 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    3. ClinicalTrials.gov NCT06500143 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    4. ClinicalTrials.gov NCT06015893 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    5. ClinicalTrials.gov NCT06977438 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    6. ClinicalTrials.gov NCT07169136 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    7. ClinicalTrials.gov NCT07711548 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    8. ClinicalTrials.gov NCT07627191 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    9. ClinicalTrials.gov NCT05616013 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    10. ClinicalTrials.gov NCT07194317 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    11. ClinicalTrials.gov NCT06065540 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    12. ClinicalTrials.gov NCT02863419 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    13. ClinicalTrials.gov NCT05920889 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    14. ClinicalTrials.gov NCT07770282 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    15. ClinicalTrials.gov NCT01272973 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    16. ClinicalTrials.gov NCT03548935 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    17. ClinicalTrials.gov NCT05227196 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    18. ClinicalTrials.gov NCT07064486 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    19. ClinicalTrials.gov NCT06807970 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    20. ClinicalTrials.gov NCT03631186 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    21. ClinicalTrials.gov NCT07478653 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    22. ClinicalTrials.gov NCT05441267 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    23. ClinicalTrials.gov NCT05700877 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    24. ClinicalTrials.gov NCT07720466 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
    25. ClinicalTrials.gov NCT04447859 — 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 Semaglutide?

    Manually reviewed August 18, 2026 · version 1

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

    A bounded review of two sponsor-funded randomized trials: STEP 1 for weight change and SELECT for cardiovascular outcomes.12

    Bottom line from this bounded source set

    In the reviewed trials, semaglutide was associated with greater weight reduction than placebo in adults without diabetes, and fewer major cardiovascular events in adults with established cardiovascular disease and overweight or obesity without diabetes. The findings apply to those studied populations and trial conditions.12

    Reviewed study record

    STEP 1 weight-management trial

    Design

    A double-blind, randomized, placebo-controlled trial followed participants for 68 weeks alongside a lifestyle intervention.1

    Population

    The trial enrolled 1,961 adults with obesity, or overweight plus at least one weight-related condition, who did not have diabetes.1

    Outcomes reported

    Mean body-weight change at 68 weeks was -14.9% in the semaglutide group and -2.4% with placebo. Gastrointestinal events were common, and treatment discontinuation for gastrointestinal events was more frequent with semaglutide.1

    Limitations

    The sponsor-funded trial combined treatment with lifestyle intervention, excluded people with diabetes, and does not by itself establish outcomes after treatment stops.1

    Reviewed study record

    SELECT cardiovascular-outcomes trial

    Design

    A multicenter, double-blind, randomized, placebo-controlled, event-driven superiority trial assessed a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.2

    Population

    The trial enrolled 17,604 adults age 45 or older with established cardiovascular disease and overweight or obesity, but no history of diabetes.2

    Outcomes reported

    A primary cardiovascular event occurred in 6.5% of the semaglutide group and 8.0% of the placebo group; the reported hazard ratio was 0.80. Permanent discontinuation because of adverse events occurred in 16.6% and 8.2%, respectively.2

    Limitations

    The sponsor-funded findings apply to people with preexisting cardiovascular disease and without diabetes; they do not answer primary prevention for lower-risk populations.2

    Reviewed source set

    1. PubMed · 33567185Once-Weekly Semaglutide in Adults with Overweight or Obesity ↗PubMed PMID 33567185 · EFetch XML reviewed 2026-08-18 · payload SHA-256 b3cf6a18c3906c27475c4a49d31f5741bf40fa056afc62f07d07fa54dbff28c4
      No registered Crossref update in the reviewed snapshotChecked August 19, 2026 for DOI 10.1056/nejmoa2032183. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
    2. PubMed · 37952131Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes ↗PubMed PMID 37952131 · EFetch XML reviewed 2026-08-18 · payload SHA-256 dabd7cd9d6c08b9c07da39a19d0b48266bfb7ddbbaacefe2e11025d105708245
      No registered Crossref update in the reviewed snapshotChecked August 19, 2026 for DOI 10.1056/nejmoa2307563. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
    Explore status sources, recent additions, and coverage gaps

    Living status brief

    What is the current status of Semaglutide?

    U.S. label record. The cited DailyMed label identifies Semaglutide 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.

    Evidence present

    What records are connected here?

    Evidence lanes
    4
    Source years
    10
    Drugs@FDA applications
    5

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

    Latest source-dated record

    What changed most recently at a cited source?

    Clinical trials · source date September 9, 2026

    ClinicalTrials.gov record NCT03811561Added to PeptideScanner September 9, 2026

    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.

    Explore the Evidence Map and record counts

    Evidence Map v1

    What kinds of records connect to Semaglutide?

    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.

    237Selected dated records
    239Connected citations
    10Populated source years2017–2026
    4/4Record lanes present

    Registered human studies

    Trial composition

    26 of 98 selected trial records include at least one phase value; 28 of 98 include a status value in the retained structured contract.

    1,966 public history versions connect to 96 of these trial records across 13 submitted years. Open the record-history collection →

    3 exact source-declared trial-publication links connect selected NCT and PMID records. Open the exact graph →

    PhasesPhase 1 8Phase 3 8Phase 2 6Phase 4 3Not applicable 2
    Status at observationCompleted 13Recruiting 8Active, not recruiting 5Enrolling by invitation 1Not yet recruiting 1

    A phase value is unavailable here for 72 selected records; this is not counted as “no phase.”

    A status value is unavailable here for 70 selected records; this is not counted as a trial status.

    PubMed bibliography

    Publication composition

    41 of 97 selected PubMed records include attributed title, venue, publication date, and publication-type fields.

    Publication typesJournal Article 36Letter 4Observational Study 3Randomized Controlled Trial 2Research Support, Non-U.S. Gov't 2Case Reports 1Clinical Trial, Phase II 1Editorial 1Multicenter Study 1Review 1

    Bibliography fields unavailable here for 56 selected records; the records remain visible as metadata observations.

    Regulatory and publication surfaces

    What is structurally connected?

    Drugs@FDA applications
    5
    FDA Federal Register documents
    13
    DailyMed SPL versions
    19
    Canonical profile
    Published
    Profile structured data
    Published
    Linked dated records
    237

    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

    Exact identifier graph

    3 trial-publication links for Semaglutide

    Open the full graph →

    These links come only from structured NCT and PMID identifiers declared by PubMed or ClinicalTrials.gov. They do not summarize the publications or establish findings.

    Research hub

    Explore the Semaglutide evidence record

    Open all 237 records →
    237Dated records
    4Evidence types
    237Cited public sources
    10Source years

    Change ledger

    Recently changed for Semaglutide

    Open all 239 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 NCT03811561

    PeptideScanner retained ClinicalTrials.gov record NCT03811561 at 2026-09-09T19:17:17.089Z. Its registry update date was 2026-09-09, and PeptideScanner's reviewed identity mapping was semaglutide.

    PeptideScanner change date
    September 9, 2026
    Cited source date
    September 9, 2026
    Evidence lane
    Clinical trials
    Record added

    ClinicalTrials.gov record NCT07662213

    PeptideScanner retained ClinicalTrials.gov record NCT07662213 at 2026-09-09T19:17:17.121Z. Its registry update date was 2026-09-09, and PeptideScanner's reviewed identity mapping was semaglutide.

    PeptideScanner change date
    September 9, 2026
    Cited source date
    September 9, 2026
    Evidence lane
    Clinical trials
    Record added

    "I Believe in Santa Claus" and Ozempic: A Foucauldian Discourse Analysis of Holiday Health Advertising.

    PubMed lists PMID 40536021 in Qualitative health research as Journal Article, with publication-date metadata of 2025-06-19 (day precision). PeptideScanner associated the retained record with the identity slug semaglutide. 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

    Official-source collections

    Source records for Semaglutide

    Open the full research atlas →
    PubMed97

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

    1. Validation of a Pharmacist-Led Semaglutide Prescribing Algorithm for Type 2 Diabetes and Chronic Kidney Disease: Research Letter.Canadian journal of kidney health and disease · 2026 08 13
    2. Off-label semaglutide: A call for monitoring protocols in non-obese populations.JPMA. The Journal of the Pakistan Medical Association · 2026 Aug
    3. Ozempic and thin line between therapy and dependence.JPMA. The Journal of the Pakistan Medical Association · 2026 Aug
    Explore all selected literature →
    ClinicalTrials.gov98

    1,966 public history versions across these dated registry records; status labels apply only to each cited observation.

    1. NCT03811561Registry update September 9, 2026 · current at observation
    2. NCT07662213Registry update September 9, 2026 · current at observation
    3. NCT07087795Registry update August 13, 2026 · current at observation
    Explore all selected trial records →Explore all public record history →
    Drugs@FDA5

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

    1. NDA218316Full FDA chronology · original submission status AP 2025-12-22
    2. NDA215256Full FDA chronology · original submission status AP 2021-06-04
    3. NDA213182Full FDA chronology · original submission status AP 2020-01-16
    4. NDA213051Full FDA chronology · original submission status AP 2019-09-20
    5. NDA209637Full FDA chronology · original submission status AP 2017-12-05
    Explore all selected FDA applications →Explore 50 dated submissions and 109 documents for Semaglutide →
    FDA enforcement reports1

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

    1. D-0536-2021Class II · report date 2021-06-02
    Explore all exact FDA enforcement reports →
    DailyMed SPL history19

    Version metadata and exact historical ZIP receipts for the reviewed label family, without reproducing or interpreting label text.

    1. SPL version 19Published 2026-06-30 · ZIP SHA-256 a8c57f3e8cf2…
    2. SPL version 18Published 2026-05-22 · ZIP SHA-256 42a72412a3cb…
    3. SPL version 17Published 2026-04-02 · ZIP SHA-256 32ff68a3805c…
    4. SPL version 16Published 2026-03-05 · ZIP SHA-256 121930978afd…
    5. SPL version 15Published 2026-02-12 · ZIP SHA-256 521dffd6648a…
    Explore all DailyMed label versions →

    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 April 4, 2017 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.

    Glucagon10 shared source years308 dated records · 4 evidence typesLeuprolide10 shared source years215 dated records · 4 evidence typesLiraglutide10 shared source years167 dated records · 4 evidence typesOctreotide10 shared source years160 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 Semaglutide 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. Clinical trials

      ClinicalTrials.gov record NCT03811561

      PeptideScanner retained ClinicalTrials.gov record NCT03811561 at 2026-09-09T19:17:17.089Z. Its registry update date was 2026-09-09, and PeptideScanner's reviewed identity mapping was semaglutide.

    2. Clinical trials

      ClinicalTrials.gov record NCT07662213

      PeptideScanner retained ClinicalTrials.gov record NCT07662213 at 2026-09-09T19:17:17.121Z. Its registry update date was 2026-09-09, and PeptideScanner's reviewed identity mapping was semaglutide.

    3. Literature metadata

      "I Believe in Santa Claus" and Ozempic: A Foucauldian Discourse Analysis of Holiday Health Advertising.

      PubMed lists PMID 40536021 in Qualitative health research as Journal Article, with publication-date metadata of 2025-06-19 (day precision). PeptideScanner associated the retained record with the identity slug semaglutide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

    4. Literature metadata

      Ozempic and thin line between therapy and dependence.

      PubMed lists PMID 42703141 in JPMA. The Journal of the Pakistan Medical Association as Journal Article, with publication-date metadata of 2026-08 (month precision). PeptideScanner associated the retained record with the identity slug semaglutide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

    5. Literature metadata

      Off-label semaglutide: A call for monitoring protocols in non-obese populations.

      PubMed lists PMID 42703150 in JPMA. The Journal of the Pakistan Medical Association as Journal Article, with publication-date metadata of 2026-08 (month precision). PeptideScanner associated the retained record with the identity slug semaglutide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

    6. Literature metadata

      Validation of a Pharmacist-Led Semaglutide Prescribing Algorithm for Type 2 Diabetes and Chronic Kidney Disease: Research Letter.

      PubMed lists PMID 42602345 in Canadian journal of kidney health and disease as Journal Article, with publication-date metadata of 2026-08-13 (day precision). PeptideScanner associated the retained record with the identity slug semaglutide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

    7. Clinical trials

      ClinicalTrials.gov record NCT07087795

      PeptideScanner retained ClinicalTrials.gov record NCT07087795 at 2026-08-13T16:32:13.881Z. Its registry update date was 2026-08-13, and PeptideScanner's reviewed identity mapping was semaglutide.

    8. Literature metadata

      Semaglutide and Non-arteritic Anterior Ischemic Optic Neuropathy: A Systematic Review and Narrative Synthesis.

      PubMed lists PMID 41938304 in AACE endocrinology and diabetes as Journal Article, Review, with publication-date metadata of 2026-01-17 (day precision). PeptideScanner associated the retained record with the identity slug semaglutide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

    9. Literature metadata

      Quality by Design-Based Formulation Development of an Oral Semaglutide Tablet.

      PubMed lists PMID 42076092 in Pharmaceutics as Journal Article, with publication-date metadata of 2026-04-01 (day precision). PeptideScanner associated the retained record with the identity slug semaglutide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

    10. Literature metadata

      Is Oral Semaglutide a Good Fit for Patients After Metabolic Bariatric Surgery? A Biopharmaceutical Mechanistic Perspective.

      PubMed lists PMID 42076118 in Pharmaceutics as Journal Article, with publication-date metadata of 2026-04-10 (day precision). PeptideScanner associated the retained record with the identity slug semaglutide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

    11. Literature metadata

      Semaglutide use for hypothalamic obesity and type 2 diabetes mellitus after suprasellar germinoma treatment.

      PubMed lists PMID 42158165 in JCEM case reports as Case Reports, Journal Article, with publication-date metadata of 2026-05-18 (day precision). PeptideScanner associated the retained record with the identity slug semaglutide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

    12. Literature metadata

      Optimization of nursing strategies for semaglutide treatment in overweight type 2 diabetes based on gene polymorphism.

      PubMed lists PMID 42232304 in Frontiers in clinical diabetes and healthcare as Journal Article, with publication-date metadata of 2026-05-18 (day precision). PeptideScanner associated the retained record with the identity slug semaglutide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.