Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial
Crossref dates: July 17, 2021. Publisher notice ↗
Citation-backed change ledger
What changed recently?
Follow records added to PeptideScanner separately from revised profiles, corrections, and retractions. Every event keeps its date, before-and-after state, preserved version links, and supporting public sources.
2753Ledger events
2697Record additions
56Version changes
September 15, 2026Latest change date
Source-published notices
Research integrity connected to synthesis
These are Crossref-attributed publisher or Retraction Watch notices, not PeptideScanner corrections. The source-event dates and PeptideScanner review date remain separate.
Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study.
Crossref dates: June 19, 2026 and August 1, 2026. Publisher notice ↗
Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial
Crossref dates: December 17, 2025 and February 1, 2026. Publisher notice ↗
Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a randomized, double-blind, placebo-controlled phase 3 trial.
Crossref dates: August 25, 2026. Publisher notice ↗
Maintenance of response to oral octreotide compared with injectable somatostatin receptor ligands in patients with acromegaly: a phase 3, multicentre, randomised controlled trial
Crossref dates: March 1, 2022. Publisher notice ↗
Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period
Crossref dates: February 1, 2023. Publisher notice ↗
Preserved version history
Profile and record changes
These are the latest routine updates, status changes, corrections, and retractions. Before-and-after fields are derived from adjacent preserved public versions.
Correction
Abaloparatide profile
We refreshed this profile's label citation to the reviewed SPL version 19, published 2026-08-17. Earlier profile versions retain their original label citations. The product-specific label account identifies its reviewed scope.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Cited source records
- Before
- dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v18
- After
- dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v19
Named organizations
- Before
- U.S. National Library of Medicine [sources: dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v18]
- After
- U.S. National Library of Medicine [sources: dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v19]
Claim citations
- Before
- name: dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v18; aliases: dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v18; category: dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v18; status: dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v18; summary: dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v18; evidenceNote: dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v18
- After
- name: dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v19; aliases: dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v19; category: dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v19; status: dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v19; summary: dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v19; evidenceNote: dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v19
Correction
CJC-1295 profile
We clarified that CJC-1295 with DAC is a related, distinct active moiety rather than an interchangeable form. The FDA briefing describes five bulk substances; clinical findings must retain the studied form.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Profile summary
- Before
- A peptide named in FDA compounding-risk and DOJ enforcement records.
- After
- FDA evaluates CJC-1295 and CJC-1295 with drug affinity complex (DAC) as distinct active moieties, with several salt forms.
Evidence note
- Before
- FDA's compounding-risk page describes immunogenicity, impurity, and adverse-event concerns. A separate Justice Department release names CJC 1295 among unapproved new drugs distributed by the cited pharmacy.
- After
- FDA's 2024 briefing distinguishes five bulk substances and reports that none is a component of an FDA-approved drug. Evidence for a DAC-modified substance cannot automatically establish effects for a non-DAC form.
Cited source records
- Before
- fda-bulk-peptide-risks, doj-unapproved-peptide-enforcement
- After
- fda-bulk-peptide-risks, doj-unapproved-peptide-enforcement, fda-cjc-1295-briefing-2024
Claim citations
- Before
- name: doj-unapproved-peptide-enforcement; aliases: fda-bulk-peptide-risks; category: fda-bulk-peptide-risks, doj-unapproved-peptide-enforcement; status: doj-unapproved-peptide-enforcement; summary: fda-bulk-peptide-risks, doj-unapproved-peptide-enforcement; evidenceNote: fda-bulk-peptide-risks, doj-unapproved-peptide-enforcement
- After
- name: doj-unapproved-peptide-enforcement; aliases: fda-bulk-peptide-risks; category: fda-bulk-peptide-risks, doj-unapproved-peptide-enforcement; status: doj-unapproved-peptide-enforcement; summary: fda-cjc-1295-briefing-2024; evidenceNote: fda-cjc-1295-briefing-2024
Correction
Dulaglutide profile
We refreshed this profile's label citation to the reviewed SPL version 62, published 2026-08-10. Earlier profile versions retain their original label citations. The product-specific label account identifies its reviewed scope.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Cited source records
- Before
- dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v60
- After
- dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v62
Named organizations
- Before
- U.S. National Library of Medicine [sources: dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v60]
- After
- U.S. National Library of Medicine [sources: dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v62]
Claim citations
- Before
- name: dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v60; aliases: dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v60; category: dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v60; status: dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v60; summary: dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v60; evidenceNote: dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v60
- After
- name: dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v62; aliases: dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v62; category: dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v62; status: dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v62; summary: dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v62; evidenceNote: dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v62
Correction
Elamipretide profile
The previous profile described elamipretide only as investigational. We added FDA's September 19, 2025 accelerated approval of Forzinity for the specified Barth syndrome population. This correction does not extend that approval to other uses or formulations.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Status
- Before
- Investigational
- After
- U.S. accelerated approval for a specified Barth syndrome population
Status classification
- Before
- investigational
- After
- approved
Profile summary
- Before
- A mitochondria-targeting peptide candidate. This profile cites a recruiting ClinicalTrials.gov study record.
- After
- FDA granted Forzinity (elamipretide) accelerated approval to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg.
Evidence note
- Before
- ClinicalTrials.gov lists the 4TAZPower study as recruiting, updated July 13, 2026.
- After
- FDA's September 19, 2025 approval letter requires a confirmatory trial to verify clinical benefit. The approval concerns this product and specified use; a recruiting trial record does not describe its full regulatory status.
Related names
- Before
- SS-31, MTP-131
- After
- SS-31, MTP-131, Forzinity
Cited source records
- Before
- ctg-nct07531251-v4
- After
- ctg-nct07531251-v4, fda-forzinity-approval-2025
Claim citations
- Before
- name: ctg-nct07531251-v4; aliases: ctg-nct07531251-v4; category: ctg-nct07531251-v4; status: ctg-nct07531251-v4; summary: ctg-nct07531251-v4; evidenceNote: ctg-nct07531251-v4
- After
- name: ctg-nct07531251-v4; aliases: ctg-nct07531251-v4, fda-forzinity-approval-2025; category: ctg-nct07531251-v4; status: fda-forzinity-approval-2025; summary: fda-forzinity-approval-2025; evidenceNote: fda-forzinity-approval-2025
Correction
Elamipretide profile
We added a preserved FDA-hosted product label to support the product-specific label account. Prior profile versions retain their original citations.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Cited source records
- Before
- ctg-nct07531251-v4, fda-forzinity-approval-2025
- After
- ctg-nct07531251-v4, fda-forzinity-approval-2025, fda-forzinity-label-2025
Correction
Emideltide profile
We narrowed the status wording to what the dated FDA briefing establishes. A briefing prepared for an advisory process does not establish the current absence of a later final decision. Related substance identities remain distinct.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Status
- Before
- FDA compounding safety review; final determination pending
- After
- FDA compounding assessment in the cited records
Evidence note
- Before
- FDA's emideltide briefing describes evidence and safety questions presented to the advisory committee. Committee recommendations are nonbinding, and FDA says its final determination will follow completion of the committee process and relevant reviews.
- After
- FDA's July 2026 briefing evaluates Emideltide-related bulk drug substances for pharmacy compounding. The briefing is an advisory-process assessment, not a final regulatory determination.
Claim citations
- Before
- name: fda-emideltide-briefing; aliases: fda-emideltide-briefing; category: fda-emideltide-briefing, fda-pcac-peptide-meeting-2026; status: fda-emideltide-briefing, fda-pcac-peptide-meeting-2026; summary: fda-emideltide-briefing, fda-pcac-peptide-meeting-2026; evidenceNote: fda-emideltide-briefing, fda-pcac-peptide-meeting-2026
- After
- name: fda-emideltide-briefing; aliases: fda-emideltide-briefing; category: fda-emideltide-briefing, fda-pcac-peptide-meeting-2026; status: fda-emideltide-briefing; summary: fda-emideltide-briefing, fda-pcac-peptide-meeting-2026; evidenceNote: fda-emideltide-briefing
Correction
Epitalon profile
We narrowed the status wording to what the dated FDA briefing establishes. A briefing prepared for an advisory process does not establish the current absence of a later final decision. Related substance identities remain distinct.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Status
- Before
- FDA compounding safety review; final determination pending
- After
- FDA compounding assessment in the cited records
Evidence note
- Before
- FDA's Epitalon briefing describes evidence and safety questions presented to the advisory committee. Committee recommendations are nonbinding, and FDA says its final determination will follow completion of the committee process and relevant reviews.
- After
- FDA's July 2026 briefing evaluates epitalon free base and acetate and distinguishes the tetrapeptide from epithalamin, a pineal-gland extract. The briefing is an advisory-process assessment, not a final regulatory determination.
Related names
- Before
- None recorded
- After
- AEDG, Epithalon
Claim citations
- Before
- name: fda-epitalon-briefing; aliases: fda-epitalon-briefing; category: fda-epitalon-briefing, fda-pcac-peptide-meeting-2026; status: fda-epitalon-briefing, fda-pcac-peptide-meeting-2026; summary: fda-epitalon-briefing, fda-pcac-peptide-meeting-2026; evidenceNote: fda-epitalon-briefing, fda-pcac-peptide-meeting-2026
- After
- name: fda-epitalon-briefing; aliases: fda-epitalon-briefing; category: fda-epitalon-briefing, fda-pcac-peptide-meeting-2026; status: fda-epitalon-briefing; summary: fda-epitalon-briefing, fda-pcac-peptide-meeting-2026; evidenceNote: fda-epitalon-briefing
Open the profile version →Compare the preserved prior version →Open machine-readable lineage →Epitalon change history →
Cited source
Correction
Glucagon profile
The previous summary described this only as an emergency-treatment label. We now distinguish Gvoke's severe-hypoglycemia indication from Gvoke VialDx's diagnostic indication in the same cited label.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Profile summary
- Before
- A peptide hormone. This profile cites a U.S. emergency-treatment label.
- After
- A peptide hormone. The cited U.S. label distinguishes Gvoke for severe hypoglycemia from Gvoke VialDx for diagnostic use.
Evidence note
- Before
- The cited DailyMed label identifies Glucagon and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.
- After
- The cited label describes subcutaneous Gvoke for severe hypoglycemia in people with diabetes aged two years and older, and intravenous Gvoke VialDx as a diagnostic aid in adults. The product, route and indication must remain distinct.
Correction
Ipamorelin profile
We added FDA's dated assessment to distinguish substance forms, evaluated uses and the advisory stage of review. Earlier profile versions remain available.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Profile summary
- Before
- A peptide named in FDA compounding-risk and DOJ enforcement records.
- After
- FDA's August 2024 assessment distinguishes ipamorelin free base and acetate and evaluates evidence for growth hormone deficiency and postoperative ileus.
Evidence note
- Before
- FDA's compounding-risk page describes immunogenicity and characterization concerns. A separate Justice Department release names Ipamorelin among unapproved new drugs distributed by the cited pharmacy.
- After
- At the time of its assessment, FDA reported that neither form was a component of an FDA-approved drug and found insufficient evidence for the evaluated uses. The advisory briefing is not a final compounding determination.
Cited source records
- Before
- fda-bulk-peptide-risks, doj-unapproved-peptide-enforcement
- After
- fda-bulk-peptide-risks, doj-unapproved-peptide-enforcement, fda-ipamorelin-briefing-2024
Claim citations
- Before
- name: doj-unapproved-peptide-enforcement; aliases: fda-bulk-peptide-risks; category: fda-bulk-peptide-risks, doj-unapproved-peptide-enforcement; status: doj-unapproved-peptide-enforcement; summary: fda-bulk-peptide-risks, doj-unapproved-peptide-enforcement; evidenceNote: fda-bulk-peptide-risks, doj-unapproved-peptide-enforcement
- After
- name: doj-unapproved-peptide-enforcement; aliases: fda-bulk-peptide-risks; category: fda-bulk-peptide-risks, doj-unapproved-peptide-enforcement; status: doj-unapproved-peptide-enforcement; summary: fda-ipamorelin-briefing-2024; evidenceNote: fda-ipamorelin-briefing-2024
Correction
KPV profile
We narrowed the status wording to what the dated FDA briefing establishes. A briefing prepared for an advisory process does not establish the current absence of a later final decision. Related substance identities remain distinct.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Status
- Before
- FDA compounding safety review; final determination pending
- After
- FDA compounding assessment in the cited records
Evidence note
- Before
- FDA's KPV briefing describes evidence and safety questions presented to the advisory committee. Committee recommendations are nonbinding, and FDA says its final determination will follow completion of the committee process and relevant reviews.
- After
- FDA's July 2026 briefing evaluates KPV-related bulk drug substances for pharmacy compounding. The briefing is an advisory-process assessment, not a final regulatory determination.
Related names
- Before
- None recorded
- After
- Lys-Pro-Val
Claim citations
- Before
- name: fda-kpv-briefing; aliases: fda-kpv-briefing; category: fda-kpv-briefing, fda-pcac-peptide-meeting-2026; status: fda-kpv-briefing, fda-pcac-peptide-meeting-2026; summary: fda-kpv-briefing, fda-pcac-peptide-meeting-2026; evidenceNote: fda-kpv-briefing, fda-pcac-peptide-meeting-2026
- After
- name: fda-kpv-briefing; aliases: fda-kpv-briefing; category: fda-kpv-briefing, fda-pcac-peptide-meeting-2026; status: fda-kpv-briefing; summary: fda-kpv-briefing, fda-pcac-peptide-meeting-2026; evidenceNote: fda-kpv-briefing
Open the profile version →Compare the preserved prior version →Open machine-readable lineage →KPV change history →
Cited source
Correction
Lixisenatide profile
We added a preserved FDA-hosted product label to support the product-specific label account. Prior profile versions retain their original citations.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Cited source records
- Before
- dailymed-lixisenatide-4bba538b-cf7c-4310-ae8f-cb711ed21bcc-v25
- After
- dailymed-lixisenatide-4bba538b-cf7c-4310-ae8f-cb711ed21bcc-v25, fda-adlyxin-label-2024
Correction
Mazdutide profile
The previous profile used an unqualified investigational status. We added dated local-government reports of approval in China while keeping national decision and label verification open. Earlier trial-based versions remain available.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Status
- Before
- Investigational
- After
- China: approval reported by local government sources
Status classification
- Before
- investigational
- After
- approval-reported
Profile summary
- Before
- A metabolic peptide candidate. This profile cites a ClinicalTrials.gov study record that was not yet recruiting.
- After
- A June 2025 Suzhou Industrial Park regulator report describes Chinese approval of mazdutide injection for long-term weight management in adults with obesity or overweight. A December 2025 Suzhou government report describes approved diabetes and weight-management indications in China.
Evidence note
- Before
- ClinicalTrials.gov lists a West China Hospital study as not yet recruiting, updated July 21, 2026.
- After
- These are attributable local-government reports, not the national approval decision or complete prescribing information. The national decision and exact indication conditions remain to be reconciled. This account does not establish approval in the United States or other jurisdictions.
Cited source records
- Before
- ctg-nct07718126-v1
- After
- ctg-nct07718126-v1, sipac-mazdutide-approval-report-2025, suzhou-mazdutide-indications-report-2025
Claim citations
- Before
- name: ctg-nct07718126-v1; aliases: ctg-nct07718126-v1; category: ctg-nct07718126-v1; status: ctg-nct07718126-v1; summary: ctg-nct07718126-v1; evidenceNote: ctg-nct07718126-v1
- After
- name: ctg-nct07718126-v1; aliases: ctg-nct07718126-v1; category: ctg-nct07718126-v1; status: sipac-mazdutide-approval-report-2025, suzhou-mazdutide-indications-report-2025; summary: sipac-mazdutide-approval-report-2025, suzhou-mazdutide-indications-report-2025; evidenceNote: sipac-mazdutide-approval-report-2025, suzhou-mazdutide-indications-report-2025
Correction
MOTS-c profile
We narrowed the status wording to what the dated FDA briefing establishes. A briefing prepared for an advisory process does not establish the current absence of a later final decision. Related substance identities remain distinct.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Status
- Before
- FDA compounding safety review
- After
- FDA compounding assessment in the cited records
Evidence note
- Before
- FDA presented MOTS-c briefing material at its July 2026 pharmacy-compounding advisory-committee meeting. Committee recommendations are nonbinding, and FDA says its final determination will follow completion of the committee process and relevant reviews.
- After
- FDA's July 2026 briefing evaluates MOTS-c-related bulk drug substances for pharmacy compounding. The briefing is an advisory-process assessment, not a final regulatory determination.
Claim citations
- Before
- name: fda-mots-c-briefing; aliases: fda-mots-c-briefing; category: fda-bulk-peptide-risks, fda-mots-c-briefing; status: fda-mots-c-briefing, fda-pcac-peptide-meeting-2026; summary: fda-bulk-peptide-risks, fda-mots-c-briefing, fda-pcac-peptide-meeting-2026; evidenceNote: fda-mots-c-briefing, fda-pcac-peptide-meeting-2026
- After
- name: fda-mots-c-briefing; aliases: fda-mots-c-briefing; category: fda-bulk-peptide-risks, fda-mots-c-briefing; status: fda-mots-c-briefing; summary: fda-bulk-peptide-risks, fda-mots-c-briefing, fda-pcac-peptide-meeting-2026; evidenceNote: fda-mots-c-briefing
Open the profile version →Compare the preserved prior version →Open machine-readable lineage →MOTS-c change history →
Cited source
Correction
Semax profile
We narrowed the status wording to what the dated FDA briefing establishes. A briefing prepared for an advisory process does not establish the current absence of a later final decision. Related substance identities remain distinct.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Status
- Before
- FDA compounding safety review; final determination pending
- After
- FDA compounding assessment in the cited records
Evidence note
- Before
- FDA's Semax briefing describes evidence and safety questions presented to the advisory committee. Committee recommendations are nonbinding, and FDA says its final determination will follow completion of the committee process and relevant reviews.
- After
- FDA's July 2026 briefing evaluates Semax-related bulk drug substances for pharmacy compounding. The briefing is an advisory-process assessment, not a final regulatory determination.
Claim citations
- Before
- name: fda-semax-briefing; aliases: fda-semax-briefing; category: fda-semax-briefing, fda-pcac-peptide-meeting-2026; status: fda-semax-briefing, fda-pcac-peptide-meeting-2026; summary: fda-semax-briefing, fda-pcac-peptide-meeting-2026; evidenceNote: fda-semax-briefing, fda-pcac-peptide-meeting-2026
- After
- name: fda-semax-briefing; aliases: fda-semax-briefing; category: fda-semax-briefing, fda-pcac-peptide-meeting-2026; status: fda-semax-briefing; summary: fda-semax-briefing, fda-pcac-peptide-meeting-2026; evidenceNote: fda-semax-briefing
Open the profile version →Compare the preserved prior version →Open machine-readable lineage →Semax change history →
Cited source
Correction
TB-500 profile
We narrowed the status wording to what the dated FDA briefing establishes. A briefing prepared for an advisory process does not establish the current absence of a later final decision. Related substance identities remain distinct.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Status
- Before
- FDA compounding safety review; final determination pending
- After
- FDA compounding assessment in the cited records
Evidence note
- Before
- FDA's identity record maps TB-500 to a thymosin beta-4 fragment, while FDA's July 2026 briefing addresses its pharmacy-compounding review. Committee recommendations are nonbinding, and FDA's final determination remains pending.
- After
- FDA's July 2026 briefing evaluates TB-500-related bulk drug substances for pharmacy compounding. The briefing is an advisory-process assessment, not a final regulatory determination.
Claim citations
- Before
- name: fda-tb-500-identity, fda-tb-500-briefing; aliases: fda-tb-500-identity, fda-tb-500-briefing; category: fda-tb-500-briefing; status: fda-tb-500-briefing, fda-pcac-peptide-meeting-2026; summary: fda-tb-500-identity, fda-tb-500-briefing; evidenceNote: fda-tb-500-identity, fda-tb-500-briefing, fda-pcac-peptide-meeting-2026
- After
- name: fda-tb-500-identity, fda-tb-500-briefing; aliases: fda-tb-500-identity, fda-tb-500-briefing; category: fda-tb-500-briefing; status: fda-tb-500-briefing; summary: fda-tb-500-identity, fda-tb-500-briefing; evidenceNote: fda-tb-500-briefing
Open the profile version →Compare the preserved prior version →Open machine-readable lineage →TB-500 change history →
Cited source
Correction
Tesamorelin profile
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 change date
- September 15, 2026
- Evidence lane
- Profile
Cited source records
- Before
- dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v8
- After
- dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v9
Named organizations
- Before
- U.S. National Library of Medicine [sources: dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v8]
- After
- U.S. National Library of Medicine [sources: dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v9]
Claim citations
- Before
- name: dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v8; aliases: dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v8; category: dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v8; status: dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v8; summary: dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v8; evidenceNote: dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v8
- After
- name: dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v9; aliases: dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v9; category: dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v9; status: dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v9; summary: dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v9; evidenceNote: dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v9
Correction
Tirzepatide profile
We refreshed this profile's label citation to the reviewed SPL version 40, published 2026-09-02. Earlier profile versions retain their original label citations. The product-specific label account identifies its reviewed scope.
- PeptideScanner change date
- September 15, 2026
- Evidence lane
- Profile
Cited source records
- Before
- dailymed-tirzepatide-487cd7e7-434c-4925-99fa-aa80b1cc776b-v38, fda-tirzepatide-2023, fda-tirzepatide-identity
- After
- dailymed-tirzepatide-487cd7e7-434c-4925-99fa-aa80b1cc776b-v40, fda-tirzepatide-2023, fda-tirzepatide-identity
Named organizations
- Before
- U.S. National Library of Medicine [sources: dailymed-tirzepatide-487cd7e7-434c-4925-99fa-aa80b1cc776b-v38]
- After
- U.S. National Library of Medicine [sources: dailymed-tirzepatide-487cd7e7-434c-4925-99fa-aa80b1cc776b-v40]
Claim citations
- Before
- name: dailymed-tirzepatide-487cd7e7-434c-4925-99fa-aa80b1cc776b-v38; aliases: fda-tirzepatide-identity; category: dailymed-tirzepatide-487cd7e7-434c-4925-99fa-aa80b1cc776b-v38; status: dailymed-tirzepatide-487cd7e7-434c-4925-99fa-aa80b1cc776b-v38; summary: dailymed-tirzepatide-487cd7e7-434c-4925-99fa-aa80b1cc776b-v38, fda-tirzepatide-2023; evidenceNote: dailymed-tirzepatide-487cd7e7-434c-4925-99fa-aa80b1cc776b-v38
- After
- name: dailymed-tirzepatide-487cd7e7-434c-4925-99fa-aa80b1cc776b-v40; aliases: fda-tirzepatide-identity; category: dailymed-tirzepatide-487cd7e7-434c-4925-99fa-aa80b1cc776b-v40; status: dailymed-tirzepatide-487cd7e7-434c-4925-99fa-aa80b1cc776b-v40; summary: dailymed-tirzepatide-487cd7e7-434c-4925-99fa-aa80b1cc776b-v40, fda-tirzepatide-2023; evidenceNote: dailymed-tirzepatide-487cd7e7-434c-4925-99fa-aa80b1cc776b-v40
Profile status changed
TB-500 profile
We added FDA's July 2026 pharmacy-compounding review and changed the display status from identity-only to a pending safety review without implying a final FDA determination.
- PeptideScanner change date
- July 29, 2026
- Evidence lane
- Profile
Status
- Before
- FDA identity record only; approval status not established
- After
- FDA compounding safety review; final determination pending
Status classification
- Before
- identity-only
- After
- safety-review
Topic
- Before
- Identity records
- After
- Safety records
Profile summary
- Before
- A research-peptide name that FDA's substance registry maps to a thymosin beta-4 fragment.
- After
- A thymosin beta-4 fragment represented in FDA identity and pharmacy-compounding review records.
Evidence note
- Before
- FDA's substance registry identifies TB-500 as an N-terminal acetylated 17-23 fragment of thymosin beta-4 and explicitly states that a UNII record does not imply regulatory review or approval.
- After
- FDA's identity record maps TB-500 to a thymosin beta-4 fragment, while FDA's July 2026 briefing addresses its pharmacy-compounding review. Committee recommendations are nonbinding, and FDA's final determination remains pending.
Cited source records
- Before
- fda-tb-500-identity
- After
- fda-tb-500-identity, fda-tb-500-briefing, fda-pcac-peptide-meeting-2026
Named organizations
- Before
- U.S. Food and Drug Administration [sources: fda-tb-500-identity]
- After
- U.S. Food and Drug Administration [sources: fda-tb-500-identity, fda-tb-500-briefing, fda-pcac-peptide-meeting-2026]
Claim citations
- Before
- name: fda-tb-500-identity; aliases: fda-tb-500-identity; category: fda-tb-500-identity; status: fda-tb-500-identity; summary: fda-tb-500-identity; evidenceNote: fda-tb-500-identity
- After
- name: fda-tb-500-identity, fda-tb-500-briefing; aliases: fda-tb-500-identity, fda-tb-500-briefing; category: fda-tb-500-briefing; status: fda-tb-500-briefing, fda-pcac-peptide-meeting-2026; summary: fda-tb-500-identity, fda-tb-500-briefing; evidenceNote: fda-tb-500-identity, fda-tb-500-briefing, fda-pcac-peptide-meeting-2026
Collection activity
Recently added evidence records
These records entered PeptideScanner most recently. Their separately labeled cited source dates may be much older.
Record added
Tirzepatide DailyMed SPL version 40
DailyMed lists Structured Product Labeling version 40 for the reviewed Tirzepatide label family with a published date of 2026-09-02. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
- PeptideScanner change date
- September 15, 2026
- Cited source date
- September 2, 2026
- Evidence lane
- Regulatory
Record added
ClinicalTrials.gov record NCT00206297
PeptideScanner retained ClinicalTrials.gov record NCT00206297 at 2026-07-30T21:36:16.909Z. Its registry update date was 2016-07-14, and PeptideScanner's reviewed identity mapping was pramlintide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- July 14, 2016
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT01364584
PeptideScanner retained ClinicalTrials.gov record NCT01364584 at 2026-07-30T19:10:42.711Z. Its registry update date was 2023-07-12, and PeptideScanner's reviewed identity mapping was exenatide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- July 12, 2023
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT01888120
PeptideScanner retained ClinicalTrials.gov record NCT01888120 at 2026-07-30T21:25:36.852Z. Its registry update date was 2017-03-16, and PeptideScanner's reviewed identity mapping was ziconotide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- March 16, 2017
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT01982240
PeptideScanner retained ClinicalTrials.gov record NCT01982240 at 2026-07-30T20:42:14.439Z. Its registry update date was 2019-12-26, and PeptideScanner's reviewed identity mapping was plecanatide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- December 26, 2019
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT02012556
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.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- December 16, 2013
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT02025179
PeptideScanner retained ClinicalTrials.gov record NCT02025179 at 2026-07-30T19:13:03.751Z. Its registry update date was 2023-05-10, and PeptideScanner's reviewed identity mapping was teriparatide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- May 10, 2023
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT02055157
PeptideScanner retained ClinicalTrials.gov record NCT02055157 at 2026-07-30T20:07:13.490Z. Its registry update date was 2021-01-15, and PeptideScanner's reviewed identity mapping was vosoritide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- January 15, 2021
- Evidence lane
- Clinical trials
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
Record added
ClinicalTrials.gov record NCT02493517
PeptideScanner retained ClinicalTrials.gov record NCT02493517 at 2026-07-30T20:57:18.712Z. Its registry update date was 2019-01-29, and PeptideScanner's reviewed identity mapping was lanreotide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- January 29, 2019
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT02693119
PeptideScanner retained ClinicalTrials.gov record NCT02693119 at 2026-07-30T19:56:31.565Z. Its registry update date was 2021-11-30, and PeptideScanner's reviewed identity mapping was elamipretide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- November 30, 2021
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT02745470
PeptideScanner retained ClinicalTrials.gov record NCT02745470 at 2026-07-30T21:22:00.254Z. Its registry update date was 2017-11-29, and PeptideScanner's reviewed identity mapping was lixisenatide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- November 29, 2017
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT02981069
PeptideScanner retained ClinicalTrials.gov record NCT02981069 at 2026-07-30T19:10:42.759Z. Its registry update date was 2023-07-20, and PeptideScanner's reviewed identity mapping was exenatide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- July 20, 2023
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT03120520
PeptideScanner retained ClinicalTrials.gov record NCT03120520 at 2026-07-30T20:44:36.699Z. Its registry update date was 2019-10-04, and PeptideScanner's reviewed identity mapping was plecanatide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- October 4, 2019
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT03139305
PeptideScanner retained ClinicalTrials.gov record NCT03139305 at 2026-07-30T16:22:22.326Z. Its registry update date was 2026-03-30, and PeptideScanner's reviewed identity mapping was glucagon.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- March 30, 2026
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT03573908
PeptideScanner retained ClinicalTrials.gov record NCT03573908 at 2026-07-30T20:18:37.978Z. Its registry update date was 2020-12-01, and PeptideScanner's reviewed identity mapping was linaclotide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- December 1, 2020
- Evidence lane
- Clinical trials
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 NCT03891875
PeptideScanner retained ClinicalTrials.gov record NCT03891875 at 2026-07-30T18:42:56.626Z. Its registry update date was 2024-07-12, and PeptideScanner's reviewed identity mapping was elamipretide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- July 12, 2024
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT03973047
PeptideScanner retained ClinicalTrials.gov record NCT03973047 at 2026-07-30T19:40:58.916Z. Its registry update date was 2022-04-04, and PeptideScanner's reviewed identity mapping was bremelanotide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- April 4, 2022
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT03989947
PeptideScanner retained ClinicalTrials.gov record NCT03989947 at 2026-07-30T16:22:22.327Z. Its registry update date was 2026-03-13, and PeptideScanner's reviewed identity mapping was vosoritide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- March 13, 2026
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT04179734
PeptideScanner retained ClinicalTrials.gov record NCT04179734 at 2026-07-30T18:41:37.916Z. Its registry update date was 2024-08-09, and PeptideScanner's reviewed identity mapping was bremelanotide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- August 9, 2024
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT04321408
PeptideScanner retained ClinicalTrials.gov record NCT04321408 at 2026-07-30T18:23:09.829Z. Its registry update date was 2025-08-17, and PeptideScanner's reviewed identity mapping was ziconotide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- August 17, 2025
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT04561245
PeptideScanner retained ClinicalTrials.gov record NCT04561245 at 2026-07-30T18:26:04.261Z. Its registry update date was 2025-06-24, and PeptideScanner's reviewed identity mapping was pemvidutide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- June 24, 2025
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT04575844
PeptideScanner retained ClinicalTrials.gov record NCT04575844 at 2026-07-30T16:19:36.923Z. Its registry update date was 2026-05-06, and PeptideScanner's reviewed identity mapping was liraglutide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- May 6, 2026
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT04750460
PeptideScanner retained ClinicalTrials.gov record NCT04750460 at 2026-07-30T19:32:59.860Z. Its registry update date was 2022-11-10, and PeptideScanner's reviewed identity mapping was teriparatide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- November 10, 2022
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT05760313
PeptideScanner retained ClinicalTrials.gov record NCT05760313 at 2026-07-30T16:25:18.002Z. Its registry update date was 2026-01-06, and PeptideScanner's reviewed identity mapping was linaclotide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- January 6, 2026
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT05929066
PeptideScanner retained ClinicalTrials.gov record NCT05929066 at 2026-09-09T19:17:17.407Z. Its registry update date was 2026-08-21, and PeptideScanner's reviewed identity mapping was retatrutide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- August 21, 2026
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT06383390
PeptideScanner retained ClinicalTrials.gov record NCT06383390 at 2026-09-09T19:17:17.103Z. Its registry update date was 2026-08-24, and PeptideScanner's reviewed identity mapping was retatrutide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- August 24, 2026
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT06439277
PeptideScanner retained ClinicalTrials.gov record NCT06439277 at 2026-09-09T19:17:17.406Z. Its registry update date was 2026-09-04, and PeptideScanner's reviewed identity mapping was tirzepatide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- September 4, 2026
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT06588504
PeptideScanner retained ClinicalTrials.gov record NCT06588504 at 2026-07-30T18:18:33.514Z. Its registry update date was 2025-12-05, and PeptideScanner's reviewed identity mapping was glucagon.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- December 5, 2025
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT06760546
PeptideScanner retained ClinicalTrials.gov record NCT06760546 at 2026-07-30T16:23:45.658Z. Its registry update date was 2026-02-12, and PeptideScanner's reviewed identity mapping was setmelanotide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- February 12, 2026
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT06851962
PeptideScanner retained ClinicalTrials.gov record NCT06851962 at 2026-09-09T19:17:17.407Z. Its registry update date was 2026-09-04, and PeptideScanner's reviewed identity mapping was dulaglutide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- September 4, 2026
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT06926842
PeptideScanner retained ClinicalTrials.gov record NCT06926842 at 2026-09-09T19:17:17.080Z. Its registry update date was 2026-09-09, and PeptideScanner's reviewed identity mapping was petrelintide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- September 9, 2026
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT07076030
PeptideScanner retained ClinicalTrials.gov record NCT07076030 at 2026-07-30T16:25:18.009Z. Its registry update date was 2026-01-28, and PeptideScanner's reviewed identity mapping was petrelintide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- January 28, 2026
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT07083154
PeptideScanner retained ClinicalTrials.gov record NCT07083154 at 2026-09-09T19:17:17.091Z. Its registry update date was 2026-09-02, and PeptideScanner's reviewed identity mapping was mazdutide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- September 2, 2026
- Evidence lane
- Clinical trials
Record added
ClinicalTrials.gov record NCT07225829
PeptideScanner retained ClinicalTrials.gov record NCT07225829 at 2026-08-10T18:10:03.940Z. Its registry update date was 2026-07-27, and PeptideScanner's reviewed identity mapping was liraglutide.
- PeptideScanner change date
- September 9, 2026
- Cited source date
- July 27, 2026
- Evidence lane
- Clinical trials