A growth-hormone-releasing factor analogue. This profile cites a U.S. label record.↗
Citation markers ↗ open the public records supporting the adjacent statements.
Correction · September 15, 2026
We refreshed this profile's label citation to the reviewed SPL version 9, published 2026-07-31. Earlier profile versions retain their original label citations. The product-specific label account identifies its reviewed scope. 1
U.S. label record. The cited DailyMed label identifies Tesamorelin and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗
Review source snapshots checked August 19, 2026 · Integrity checked August 19, 2026.
A bounded review of two randomized placebo-controlled trials in adults living with HIV and abdominal fat accumulation.↗↗
What the reviewed sources report
The reviewed trials reported reductions in visceral adipose tissue, and the smaller trial also reported a modest reduction in liver fat. These studies do not establish long-term clinical outcomes or effects outside the studied HIV populations.↗↗
What remains unresolved?
Do the imaging changes translate into durable clinical benefits, and what are the longer-term effects in the studied population?↗↗
The label covers reduction of excess abdominal fat in adults with HIV and lipodystrophy. It explicitly excludes weight-loss management and says long-term cardiovascular safety has not been established. Label: 1 ↗
Which safety limits matter?
Contraindications include disruption of the hypothalamic-pituitary axis, active malignancy, hypersensitivity and pregnancy. Warnings address neoplasms, elevated IGF-1, fluid retention, glucose intolerance or diabetes, hypersensitivity and acute critical illness. The label says effects of prolonged IGF-1 elevation are unknown. 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.
Label ZIP SHA-256: 2208a57e39a937407fe40c3d00ff1f8547a7a33e87685d40205cfaba9137cc6c. Extracted XML SHA-256: 280dc13506741337de1fe23ec2d53b3c65241abd9501425611ff106932ca714d.
Reviews summarize selected studies; their scope and limitations are shown above.
European medicine records · 1 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.
Active substance as listed: tesamorelin. EMA record ↗
Application withdrawal: 2012-06-21. EMA metadata last updated 2012-07-18. EMA metadata ↗
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.
Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.
Catalog-name and calibrated alias discovery for human evidence review. Complete query retrieval is separate from clinical eligibility, study-family linkage and appraisal.
104 retrieved · 2 included · 0 excluded · 102 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"Tesamorelin"[Title/Abstract] OR "TH9507"[Title/Abstract] OR "Egrifta"[Title/Abstract]
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 104 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 25038357 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT01263717.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 ↗
PubMed 18057338 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT00123253.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 ↗
PubMed 42538058 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42419889 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42395176 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42382101 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42160466 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42139091 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42123471 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42018810 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 41966639 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 41598480 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 41545261 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 41490200 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 41476424 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 41138283 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 40510111 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 40397552 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 39813152 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 39746672 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 38905488 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 38416754 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 38197510 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 37806509 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 36845310 — 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.
1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
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 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
FDA BLA022505 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: TESAMORELIN 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.
1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA EMEA/H/C/002427 — include: EMA feed product Egrifta; reported status: Application 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.
5 retrieved · 0 included · 0 excluded · 5 awaiting a decision · 0 full-text appraisals
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.
EMA 13891 — not screened: Title-name match awaiting identity and document review. Questions and answers on the withdrawal of the marketing authorisation application for Egrifta (tesamorelin)
EMA 32433 — not screened: Title-name match awaiting identity and document review. Ferrer Internacional, S.A. withdraws its marketing authorisation application for Egrifta (tesamorelin)
EMA 32484 — not screened: Title-name match awaiting identity and document review. Withdrawal assessment report for Egrifta
EMA 7574 — not screened: Title-name match awaiting identity and document review. Withdrawal letter: Egrifta (tesamorelin)
EMA 37720 — not screened: Title-name match awaiting identity and document review. P/23/2011: EMA decision of 25 January 2011 on the granting of a product specific waiver for tesamorelin (EMEA-001029-PIP01-10) in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Counci...
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
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.
25 retrieved · 0 included · 0 excluded · 25 awaiting a decision · 0 full-text appraisals
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 25 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov NCT01579695 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00850564 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07481734 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02012556 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02572323 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00123253 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00608023 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01788462 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01632592 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06554717 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT05383456 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03150511 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02553603 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02931474 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00795210 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01264497 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03826160 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01388920 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00257712 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00675506 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03226821 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01263717 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02196831 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01591902 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03375788 — 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 Tesamorelin?
A bounded review of two randomized placebo-controlled trials in adults living with HIV and abdominal fat accumulation.12
Bottom line from this bounded source set
The reviewed trials reported reductions in visceral adipose tissue, and the smaller trial also reported a modest reduction in liver fat. These studies do not establish long-term clinical outcomes or effects outside the studied HIV populations.12
Reviewed study record
Twenty-six-week visceral-fat trial
Design
A randomized, placebo-controlled trial assessed computed-tomography visceral adipose tissue and metabolic measures over 26 weeks.1
Population
The trial randomized 412 adults living with HIV who had abdominal fat accumulation during antiretroviral therapy; 86% were men.1
Outcomes reported
Visceral adipose tissue reportedly decreased by 15.2% with tesamorelin and increased by 5.0% with placebo. More participants receiving tesamorelin withdrew because of an adverse event, while the groups did not differ significantly in the reported glycemic measures.1
Limitations
The 26-week trial was limited to adults living with HIV and treatment-associated abdominal fat accumulation and did not establish longer-term clinical outcomes.1
Reviewed study record
Six-month visceral- and liver-fat trial
Design
A double-blind, randomized, placebo-controlled preliminary trial assessed visceral adipose tissue, liver fat, and metabolic measures over six months.2
Population
The single-center trial enrolled 50 antiretroviral-treated adults living with HIV and abdominal fat accumulation; 48 received study treatment.2
Outcomes reported
The reported treatment difference was -42 square centimeters for visceral adipose tissue and -2.9 percentage points for liver fat. The six-month glucose changes were not statistically significant.2
Limitations
The preliminary study was small, single-center, and six months long; the authors stated that further study was needed to determine clinical importance and long-term consequences.2
No registered Crossref update in the reviewed snapshotChecked August 19, 2026 for DOI 10.1056/nejmoa072375. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked August 19, 2026 for DOI 10.1001/jama.2014.8334. 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 Tesamorelin?
U.S. label record. The cited DailyMed label identifies Tesamorelin 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 September 15, 2026. This answer changes only through the profile’s visible version and correction history.
PeptideScanner currently has no selected safety records connected to this profile. That is a collection gap, not evidence that no such records exist.
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.
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.
Bibliography fields unavailable here for 20 selected records; the records remain visible as metadata observations.
Regulatory and publication surfaces
What is structurally connected?
Drugs@FDA applications
1
FDA Federal Register documents
3
DailyMed SPL versions
9
Canonical profile
Published
Profile structured data
Published
Linked dated records
45
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.
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.
We refreshed this profile's label citation to the reviewed SPL version 9, published 2026-07-31. Earlier profile versions retain their original label citations. The product-specific label account identifies its reviewed scope.
PeptideScanner retained ClinicalTrials.gov record NCT02012556 at 2026-07-30T21:55:56.632Z. Its registry update date was 2013-12-16, and PeptideScanner's reviewed identity mapping was tesamorelin.
DailyMed lists Structured Product Labeling version 1 for the reviewed Tesamorelin label family with a published date of 2019-11-05. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
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.
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 Tesamorelin 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.
PeptideScanner retained PubMed bibliographic metadata for PMID 41545261 at 2026-08-10T10:49:08.747Z. PubMed recorded a metadata revision date of 2026-08-02 and an Entrez history date of 2026-01-16. PeptideScanner associated this retained record with the identity slug tesamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
DailyMed lists Structured Product Labeling version 9 for the reviewed Tesamorelin label family with a published date of 2026-07-31. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42419889 at 2026-08-10T10:49:10.753Z. PubMed recorded a metadata revision date of 2026-07-30 and an Entrez history date of 2026-07-08. PeptideScanner associated this retained record with the identity slug tesamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 22495074 at 2026-08-10T18:13:32.273Z. PubMed recorded a metadata revision date of 2026-07-26 and an Entrez history date of 2012-04-13. PeptideScanner associated this retained record with the identity slug tesamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained ClinicalTrials.gov record NCT06554717 at 2026-07-30T16:19:36.918Z. Its registry update date was 2026-05-19, and PeptideScanner's reviewed identity mapping was tesamorelin.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 34006921 at 2026-07-30T16:22:11.959Z. PubMed recorded a metadata revision date of 2026-04-07 and an Entrez history date of 2021-05-19. PeptideScanner associated this retained record with the identity slug tesamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 38905488 at 2026-07-30T16:22:12.148Z. PubMed recorded a metadata revision date of 2026-04-01 and an Entrez history date of 2024-06-21. PeptideScanner associated this retained record with the identity slug tesamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained ClinicalTrials.gov record NCT07481734 at 2026-07-30T16:22:22.324Z. Its registry update date was 2026-03-19, and PeptideScanner's reviewed identity mapping was tesamorelin.↗
PeptideScanner retained ClinicalTrials.gov record NCT02572323 at 2026-07-30T16:22:22.328Z. Its registry update date was 2026-03-12, and PeptideScanner's reviewed identity mapping was tesamorelin.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 17571443 at 2026-07-30T16:30:45.652Z. PubMed recorded a metadata revision date of 2026-01-28 and an Entrez history date of 2007-06-19. PeptideScanner associated this retained record with the identity slug tesamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 21115997 at 2026-07-30T16:30:48.398Z. PubMed recorded a metadata revision date of 2026-01-28 and an Entrez history date of 2010-12-01. PeptideScanner associated this retained record with the identity slug tesamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 21591600 at 2026-07-30T16:30:48.420Z. PubMed recorded a metadata revision date of 2026-01-28 and an Entrez history date of 2011-05-20. PeptideScanner associated this retained record with the identity slug tesamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗