{ "dataset": { "id": "peptideschool-research-change-timeline", "version": "1.0.0", "canonicalPage": "https://www.peptideschool.org/research-change-timeline", "license": { "spdx": "CC-BY-4.0", "url": "https://creativecommons.org/licenses/by/4.0/" }, "publisher": "PeptideSchool", "author": "PeptideSchool Editorial Desk", "language": "en-US", "publicationDate": "2026-08-11", "reviewDate": "2026-08-11", "coverageEndDate": "2026-08-11", "citation": "PeptideSchool Editorial Desk. PeptideSchool Research and Regulatory Change Timeline, version 1.0.0. https://www.peptideschool.org/research-change-timeline" }, "scope": { "purpose": "Provide a selected, dated, source-backed record of scientific publications, trial-registry changes, and United States regulatory actions that are frequently collapsed into one undifferentiated peptide narrative.", "selectionRule": "Include an event only when an official regulator, official trial registry, or primary-paper record provides an exact date, stable identity, relevant scope, and a boundary that prevents overstatement.", "included": "Selected preclinical and human research publications, a trial-registry posting, named-product approvals, a named-product label expansion, and an advisory-committee meeting from 2015 through August 11, 2026.", "excluded": "Vendor announcements, product promotion, compounded-product claims, social posts, unverified legal conclusions, exhaustive global status, protocols, dosage recommendations, personal advice, and predictions about pending decisions.", "interpretation": "An event date identifies a change in the public evidence or regulatory record. It does not make different evidence classes interchangeable, transfer a status across products or jurisdictions, or establish an outcome for a person." }, "summary": { "eventCount": 12, "scientificRecordCount": 8, "regulatoryRecordCount": 4, "eventTypeCounts": { "advisory_committee_meeting": 1, "long_term_extension_publication": 1, "preclinical_publication": 1, "randomized_trial_publication": 5, "regulatory_approval": 2, "regulatory_label_expansion": 1, "trial_registry_posting": 1 }, "uniqueSubjectCount": 10, "uniqueSourceUrlCount": 12, "earliestDate": "2015-03-03", "latestDate": "2026-07-24" }, "records": [ { "id": "mots-c-primary-paper-2015", "date": "2015-03-03", "lane": "scientific_record", "eventType": "preclinical_publication", "subject": "MOTS-c", "jurisdiction": "International scientific record", "evidenceScope": "Cellular experiments and mouse models", "title": "The first MOTS-c metabolic-homeostasis paper entered the peer-reviewed record.", "whatChanged": "Cell Metabolism published a primary paper describing MOTS-c as a mitochondrial-derived peptide and reporting metabolic findings in cellular and mouse experiments.", "whyItMatters": "The paper established a traceable starting point for the molecule's identity and early biological hypothesis, which later research and public claims can be compared against.", "boundary": "This was preclinical work. It did not establish human efficacy, human safety, a clinical protocol, or regulatory approval.", "source": { "title": "The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance", "publisher": "National Library of Medicine (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/25738459/", "sourceClass": "primary_research_record", "recordId": "PMID 25738459", "accessedAt": "2026-08-11" }, "relatedPaths": [ "/research/peptides/mots-c", "/research/preclinical-vs-clinical-evidence", "/news/mots-c-the-peptide-written-inside-your-mitochondria" ] }, { "id": "elamipretide-tazpower-publication-2020", "date": "2020-10-20", "lane": "scientific_record", "eventType": "randomized_trial_publication", "subject": "Elamipretide", "jurisdiction": "United States study record", "evidenceScope": "Randomized crossover trial in 12 people with Barth syndrome plus an open-label extension", "title": "TAZPOWER results were published online with randomized and extension findings kept distinct.", "whatChanged": "A peer-reviewed report made the small randomized crossover study and its subsequent open-label extension publicly inspectable in one research record.", "whyItMatters": "The publication created a primary source for separating the randomized comparison, where neither primary endpoint was met, from later non-randomized extension observations.", "boundary": "Open-label improvement after the randomized period is not equivalent to a positive randomized primary endpoint, and publication did not itself create an approval.", "source": { "title": "A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome", "publisher": "National Library of Medicine (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/33077895/", "sourceClass": "primary_research_record", "recordId": "PMID 33077895", "accessedAt": "2026-08-11" }, "relatedPaths": [ "/research/peptides/ss-31", "/research/how-to-read-randomized-controlled-trials", "/research/methods/primary-secondary-and-exploratory-endpoints" ] }, { "id": "semaglutide-step-1-publication-2021", "date": "2021-02-10", "lane": "scientific_record", "eventType": "randomized_trial_publication", "subject": "Semaglutide", "jurisdiction": "Multinational scientific record", "evidenceScope": "Randomized phase 3 trial in 1,961 adults with overweight or obesity and without diabetes", "title": "STEP 1 was published online as a large randomized semaglutide trial.", "whatChanged": "The New England Journal of Medicine published the prespecified 68-week comparison of once-weekly semaglutide and placebo, both alongside lifestyle intervention.", "whyItMatters": "The article supplied a primary human comparison with defined population, intervention, endpoints, follow-up, adverse-event reporting, and funding disclosure.", "boundary": "The result belongs to the studied population, formulation, follow-up, and trial design. A paper is evidence, not a universal claim or a substitute for the applicable label.", "source": { "title": "Once-Weekly Semaglutide in Adults with Overweight or Obesity", "publisher": "National Library of Medicine (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/33567185/", "sourceClass": "primary_research_record", "recordId": "PMID 33567185", "accessedAt": "2026-08-11" }, "relatedPaths": [ "/research/peptides/semaglutide", "/research/how-to-read-randomized-controlled-trials", "/research/confidence-intervals-and-effect-sizes" ] }, { "id": "tirzepatide-surmount-1-publication-2022", "date": "2022-06-04", "lane": "scientific_record", "eventType": "randomized_trial_publication", "subject": "Tirzepatide", "jurisdiction": "Multinational scientific record", "evidenceScope": "Randomized phase 3 trial in adults with obesity or overweight and at least one related condition", "title": "SURMOUNT-1 was published online as a randomized tirzepatide trial.", "whatChanged": "A peer-reviewed primary report made the trial design, 72-week outcomes, adverse events, analysis, and sponsor involvement available for direct review.", "whyItMatters": "The publication became a central primary source for interpreting later tirzepatide weight-management claims and regulatory decisions.", "boundary": "Trial publication did not itself approve a product, expand a label, or establish that the findings apply outside the studied population and formulation.", "source": { "title": "Tirzepatide Once Weekly for the Treatment of Obesity", "publisher": "National Library of Medicine (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/35658024/", "sourceClass": "primary_research_record", "recordId": "PMID 35658024", "accessedAt": "2026-08-11" }, "relatedPaths": [ "/research/peptides/tirzepatide", "/research/how-to-read-randomized-controlled-trials", "/research/relative-risk-absolute-risk-and-odds-ratios" ] }, { "id": "retatrutide-triumph-3-registry-2023", "date": "2023-05-31", "lane": "scientific_record", "eventType": "trial_registry_posting", "subject": "Retatrutide", "jurisdiction": "United States trial registry", "evidenceScope": "Phase 3 randomized trial record for participants with obesity and established cardiovascular disease", "title": "The TRIUMPH-3 phase 3 record was first posted on ClinicalTrials.gov.", "whatChanged": "ClinicalTrials.gov publicly posted the study identity, phase, randomized design, planned population, outcomes framework, sponsor, and record history.", "whyItMatters": "A dated registry record lets readers distinguish a planned or ongoing experiment from a completed study with posted results and compare later changes across versions.", "boundary": "Registration is not a result, a favorable finding, or a regulatory approval. The current record must be checked for recruitment status, amendments, and results postings.", "source": { "title": "Record History: A Study of Retatrutide in Participants With Obesity and Cardiovascular Disease (TRIUMPH-3)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT05882045?tab=history", "sourceClass": "official_trial_registry", "recordId": "NCT05882045", "accessedAt": "2026-08-11" }, "relatedPaths": [ "/research/peptides/retatrutide", "/research/glossary/clinical-trial-phases-explained", "/research/methods/how-to-read-clinicaltrials-gov" ] }, { "id": "retatrutide-phase-2-publication-2023", "date": "2023-06-26", "lane": "scientific_record", "eventType": "randomized_trial_publication", "subject": "Retatrutide", "jurisdiction": "United States scientific record", "evidenceScope": "Randomized phase 2 trial in 338 adults with obesity or overweight plus a related condition", "title": "The retatrutide phase 2 obesity trial was published online.", "whatChanged": "A peer-reviewed report disclosed the randomized dose-ranging design, 24- and 48-week outcomes, adverse events, heart-rate observations, funding, and trial identifier.", "whyItMatters": "The paper moved public discussion from mechanism and early development claims to an inspectable randomized human study while the later program remained under investigation.", "boundary": "This was a phase 2 study. Its publication did not constitute an FDA approval, establish a current product label, or resolve phase 3 benefit-risk questions.", "source": { "title": "Triple-Hormone-Receptor Agonist Retatrutide for Obesity: A Phase 2 Trial", "publisher": "National Library of Medicine (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/37366315/", "sourceClass": "primary_research_record", "recordId": "PMID 37366315", "accessedAt": "2026-08-11" }, "relatedPaths": [ "/research/peptides/retatrutide", "/research/glossary/clinical-trial-phases-explained", "/research/how-to-read-randomized-controlled-trials" ] }, { "id": "zepbound-fda-approval-2023", "date": "2023-11-08", "lane": "regulatory_record", "eventType": "regulatory_approval", "subject": "Tirzepatide / Zepbound", "jurisdiction": "United States", "evidenceScope": "FDA approval of a named tirzepatide product for a defined chronic weight-management indication", "title": "FDA approved Zepbound for a defined chronic weight-management indication.", "whatChanged": "FDA approved the branded tirzepatide injection for chronic weight management in specified adults, alongside reduced-calorie diet and increased physical activity.", "whyItMatters": "The action created a dated United States regulatory status for one named product, formulation, population, and indication that can be checked independently of trial headlines.", "boundary": "The approval does not extend to every tirzepatide use, every formulation, compounded products, other jurisdictions, or peptide products as a category.", "source": { "title": "FDA Approves New Medication for Chronic Weight Management", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management", "sourceClass": "official_regulatory_record", "recordId": "FDA news release 2023-11-08", "accessedAt": "2026-08-11" }, "relatedPaths": [ "/research/peptides/tirzepatide", "/research/topics/peptide-therapeutics-development", "/research/methods/peptide-claim-checklist" ] }, { "id": "mazdutide-phase-2-publication-2023", "date": "2023-12-14", "lane": "scientific_record", "eventType": "randomized_trial_publication", "subject": "Mazdutide", "jurisdiction": "China scientific record", "evidenceScope": "Randomized phase 2 interim analysis in 248 Chinese adults with overweight or obesity", "title": "A randomized mazdutide phase 2 interim analysis was published.", "whatChanged": "Nature Communications published the 24-week interim analysis with the randomized design, study population, prespecified primary endpoint, safety reporting, and ClinicalTrials.gov identifier.", "whyItMatters": "The paper provides a primary source for checking claims about this dual-receptor research program rather than relying on conference, company, or secondary summaries.", "boundary": "An interim phase 2 publication in a defined Chinese population is not a United States approval, a complete phase 3 record, or proof of generalizability to other populations.", "source": { "title": "A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity", "publisher": "National Library of Medicine (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/38092790/", "sourceClass": "primary_research_record", "recordId": "PMID 38092790", "accessedAt": "2026-08-11" }, "relatedPaths": [ "/research/peptides/mazdutide", "/research/preclinical-vs-clinical-evidence", "/research/reading-data-tables-and-logarithmic-axes" ] }, { "id": "wegovy-cardiovascular-indication-2024", "date": "2024-03-08", "lane": "regulatory_record", "eventType": "regulatory_label_expansion", "subject": "Semaglutide / Wegovy", "jurisdiction": "United States", "evidenceScope": "FDA approval of an additional cardiovascular-risk-reduction indication for a named semaglutide product", "title": "FDA approved a new cardiovascular-risk-reduction indication for Wegovy.", "whatChanged": "FDA approved use of the named semaglutide injection to reduce cardiovascular death, heart attack, and stroke risk in adults with cardiovascular disease and obesity or overweight.", "whyItMatters": "The action was a label change tied to a specific product and population, not merely a new interpretation of an older weight-management study.", "boundary": "The indication is limited to the FDA-described population, product, and United States jurisdiction. It does not generalize to all semaglutide formulations or all people with obesity or overweight.", "source": { "title": "FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or", "sourceClass": "official_regulatory_record", "recordId": "FDA news release 2024-03-08", "accessedAt": "2026-08-11" }, "relatedPaths": [ "/research/peptides/semaglutide", "/research/topics/peptide-therapeutics-development", "/research/methods/peptide-claim-checklist" ] }, { "id": "elamipretide-long-term-extension-publication-2024", "date": "2024-04-08", "lane": "scientific_record", "eventType": "long_term_extension_publication", "subject": "Elamipretide", "jurisdiction": "United States study record", "evidenceScope": "168-week open-label extension of the TAZPOWER program", "title": "Long-term TAZPOWER extension results were published online.", "whatChanged": "A peer-reviewed report described longer follow-up for the open-label extension, including safety, functional, cardiac, biomarker, attrition, and conflict-of-interest information.", "whyItMatters": "The record added duration and follow-up detail that was absent from the initial randomized-period report and later formed part of the broader evidence history.", "boundary": "Ten people entered the open-label extension and eight reached week 168. Without a concurrent randomized comparator, duration does not remove selection, attrition, or causal-inference limits.", "source": { "title": "Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER", "publisher": "National Library of Medicine (PubMed)", "url": "https://pubmed.ncbi.nlm.nih.gov/38602181/", "sourceClass": "primary_research_record", "recordId": "PMID 38602181", "accessedAt": "2026-08-11" }, "relatedPaths": [ "/research/peptides/ss-31", "/research/methods/missing-data-attrition-and-censoring", "/research/methods/bias-confounding-and-effect-modification" ] }, { "id": "forzinity-accelerated-approval-2025", "date": "2025-09-19", "lane": "regulatory_record", "eventType": "regulatory_approval", "subject": "Elamipretide / Forzinity", "jurisdiction": "United States", "evidenceScope": "FDA accelerated approval for a named elamipretide product and a narrow Barth syndrome indication", "title": "FDA granted accelerated approval to Forzinity for a defined Barth syndrome indication.", "whatChanged": "FDA granted accelerated approval to Forzinity injection to improve muscle strength in adults and pediatric patients with Barth syndrome who weigh at least 30 kilograms.", "whyItMatters": "The action created the first United States approval in this timeline for the named product while explicitly retaining a post-approval evidence obligation.", "boundary": "This is a narrow product, indication, weight threshold, and jurisdiction. Accelerated approval requires a confirmatory trial and is not approval of elamipretide for other conditions or products.", "source": { "title": "FDA Grants Accelerated Approval to First Treatment for Barth Syndrome", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-first-treatment-barth-syndrome", "sourceClass": "official_regulatory_record", "recordId": "NDA 215244", "accessedAt": "2026-08-11" }, "relatedPaths": [ "/research/peptides/ss-31", "/research/topics/peptide-therapeutics-development", "/research/methods/peptide-claim-checklist" ] }, { "id": "fda-pcac-peptide-bulks-meeting-2026", "date": "2026-07-23", "endDate": "2026-07-24", "lane": "regulatory_record", "eventType": "advisory_committee_meeting", "subject": "Seven peptide-related bulk drug substance nominations", "jurisdiction": "United States", "evidenceScope": "FDA Pharmacy Compounding Advisory Committee public meeting on possible Section 503A Bulks List inclusion", "title": "FDA's Pharmacy Compounding Advisory Committee held a two-day public meeting on seven peptide-related nominations.", "whatChanged": "FDA convened a public advisory meeting with briefing materials for BPC-157-, KPV-, TB-500-, MOTS-c-, emideltide-, Semax-, and Epitalon-related bulk drug substances.", "whyItMatters": "The meeting created an official, dated record of the questions, evidence reviews, public process, and advisory discussion surrounding possible 503A Bulks List inclusion.", "boundary": "Advisory committee recommendations are non-binding. The meeting was not a drug approval, did not establish clinical efficacy, and did not by itself complete a final FDA Bulks List action.", "source": { "title": "July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026", "sourceClass": "official_regulatory_record", "recordId": "FDA-2025-N-6895", "accessedAt": "2026-08-11" }, "relatedPaths": [ "/news/fda-pcac-six-peptides-503a-bulks-list-july-2026", "/research/topics/peptide-therapeutics-development", "/research/methods/peptide-claim-checklist" ] } ] }