Research and regulatory timeline

A dated timeline that keeps research events and regulatory actions separate.

Selected peptide-related milestones from 2015 through August 11, 2026 are linked to an official regulator, official trial registry, or primary-paper record. Every entry states what changed, why it matters, and what the event does not prove.

Educational content only. Not medical advice.

Published by PeptideSchool Editorial Desk · Published and reviewed August 11, 2026

What every entry keeps visible

Evidence in context

Exact dates
12 selected events
Separate lanes
Scientific and regulatory
Direct sources
12 source records
Clear limits
What each event does not prove

Reading rule

Date the record, name the evidence class, preserve the boundary.

A biological finding, a trial registration, a randomized publication, a named-product approval, a label expansion, and an advisory meeting are different events. This timeline places them on one axis without treating them as interchangeable evidence.

Scientific record

8 selected events

Primary-paper or official trial-registry event. Each entry links to the source record and keeps its population, jurisdiction, and inference limits visible.

Regulatory record

4 selected events

Named FDA action or public advisory process. Each entry links to the source record and keeps its population, jurisdiction, and inference limits visible.

Selection is intentionally limited rather than exhaustive. Absence from this page does not mean that an event, study, jurisdiction, safety update, label revision, withdrawal, or enforcement action does not exist. Always open the cited record and check its current version.

Newest first

Twelve events, each with a source and a stopping point.

The date is the public-record event date: online publication, first registry posting, FDA action, or meeting date. It is not necessarily the date a molecule was first conceived, a trial began, or a later interpretation appeared.

  1. United States

    Regulatory recordSeven peptide-related bulk drug substance nominations

    FDA's Pharmacy Compounding Advisory Committee held a two-day public meeting on seven peptide-related nominations.

    Evidence scope: FDA Pharmacy Compounding Advisory Committee public meeting on possible Section 503A Bulks List inclusion

    What changed

    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.

    Why it matters

    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.

    July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee

    U.S. Food and Drug Administration · FDA-2025-N-6895 · checked 2026-08-11

    Open source
  2. United States

    Regulatory recordElamipretide / Forzinity

    FDA granted accelerated approval to Forzinity for a defined Barth syndrome indication.

    Evidence scope: FDA accelerated approval for a named elamipretide product and a narrow Barth syndrome indication

    What changed

    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.

    Why it matters

    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.

    FDA Grants Accelerated Approval to First Treatment for Barth Syndrome

    U.S. Food and Drug Administration · NDA 215244 · checked 2026-08-11

    Open source
  3. United States study record

    Scientific recordElamipretide

    Long-term TAZPOWER extension results were published online.

    Evidence scope: 168-week open-label extension of the TAZPOWER program

    What changed

    A peer-reviewed report described longer follow-up for the open-label extension, including safety, functional, cardiac, biomarker, attrition, and conflict-of-interest information.

    Why it matters

    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.

    Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER

    National Library of Medicine (PubMed) · PMID 38602181 · checked 2026-08-11

    Open source
  4. United States

    Regulatory recordSemaglutide / Wegovy

    FDA approved a new cardiovascular-risk-reduction indication for Wegovy.

    Evidence scope: FDA approval of an additional cardiovascular-risk-reduction indication for a named semaglutide product

    What changed

    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.

    Why it matters

    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.

    FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight

    U.S. Food and Drug Administration · FDA news release 2024-03-08 · checked 2026-08-11

    Open source
  5. China scientific record

    Scientific recordMazdutide

    A randomized mazdutide phase 2 interim analysis was published.

    Evidence scope: Randomized phase 2 interim analysis in 248 Chinese adults with overweight or obesity

    What changed

    Nature Communications published the 24-week interim analysis with the randomized design, study population, prespecified primary endpoint, safety reporting, and ClinicalTrials.gov identifier.

    Why it matters

    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.

    A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity

    National Library of Medicine (PubMed) · PMID 38092790 · checked 2026-08-11

    Open source
  6. United States

    Regulatory recordTirzepatide / Zepbound

    FDA approved Zepbound for a defined chronic weight-management indication.

    Evidence scope: FDA approval of a named tirzepatide product for a defined chronic weight-management indication

    What changed

    FDA approved the branded tirzepatide injection for chronic weight management in specified adults, alongside reduced-calorie diet and increased physical activity.

    Why it matters

    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.

    FDA Approves New Medication for Chronic Weight Management

    U.S. Food and Drug Administration · FDA news release 2023-11-08 · checked 2026-08-11

    Open source
  7. United States scientific record

    Scientific recordRetatrutide

    The retatrutide phase 2 obesity trial was published online.

    Evidence scope: Randomized phase 2 trial in 338 adults with obesity or overweight plus a related condition

    What changed

    A peer-reviewed report disclosed the randomized dose-ranging design, 24- and 48-week outcomes, adverse events, heart-rate observations, funding, and trial identifier.

    Why it matters

    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.

    Triple-Hormone-Receptor Agonist Retatrutide for Obesity: A Phase 2 Trial

    National Library of Medicine (PubMed) · PMID 37366315 · checked 2026-08-11

    Open source
  8. United States trial registry

    Scientific recordRetatrutide

    The TRIUMPH-3 phase 3 record was first posted on ClinicalTrials.gov.

    Evidence scope: Phase 3 randomized trial record for participants with obesity and established cardiovascular disease

    What changed

    ClinicalTrials.gov publicly posted the study identity, phase, randomized design, planned population, outcomes framework, sponsor, and record history.

    Why it matters

    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.

    Record History: A Study of Retatrutide in Participants With Obesity and Cardiovascular Disease (TRIUMPH-3)

    ClinicalTrials.gov · NCT05882045 · checked 2026-08-11

    Open source
  9. Multinational scientific record

    Scientific recordTirzepatide

    SURMOUNT-1 was published online as a randomized tirzepatide trial.

    Evidence scope: Randomized phase 3 trial in adults with obesity or overweight and at least one related condition

    What changed

    A peer-reviewed primary report made the trial design, 72-week outcomes, adverse events, analysis, and sponsor involvement available for direct review.

    Why it matters

    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.

    Tirzepatide Once Weekly for the Treatment of Obesity

    National Library of Medicine (PubMed) · PMID 35658024 · checked 2026-08-11

    Open source
  10. Multinational scientific record

    Scientific recordSemaglutide

    STEP 1 was published online as a large randomized semaglutide trial.

    Evidence scope: Randomized phase 3 trial in 1,961 adults with overweight or obesity and without diabetes

    What changed

    The New England Journal of Medicine published the prespecified 68-week comparison of once-weekly semaglutide and placebo, both alongside lifestyle intervention.

    Why it matters

    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.

    Once-Weekly Semaglutide in Adults with Overweight or Obesity

    National Library of Medicine (PubMed) · PMID 33567185 · checked 2026-08-11

    Open source
  11. United States study record

    Scientific recordElamipretide

    TAZPOWER results were published online with randomized and extension findings kept distinct.

    Evidence scope: Randomized crossover trial in 12 people with Barth syndrome plus an open-label extension

    What changed

    A peer-reviewed report made the small randomized crossover study and its subsequent open-label extension publicly inspectable in one research record.

    Why it matters

    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.

    A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome

    National Library of Medicine (PubMed) · PMID 33077895 · checked 2026-08-11

    Open source
  12. International scientific record

    Scientific recordMOTS-c

    The first MOTS-c metabolic-homeostasis paper entered the peer-reviewed record.

    Evidence scope: Cellular experiments and mouse models

    What changed

    Cell Metabolism published a primary paper describing MOTS-c as a mitochondrial-derived peptide and reporting metabolic findings in cellular and mouse experiments.

    Why it matters

    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.

    The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance

    National Library of Medicine (PubMed) · PMID 25738459 · checked 2026-08-11

    Open source

Method and maintenance

The timeline fails closed when identity, date, scope, or status is unclear.

Source gate

Use an official regulator, official trial registry, or primary-paper record. A company release, vendor page, social post, or search snippet cannot be the event source.

Date gate

Record the specific publication, first-posted, action, or meeting date shown by the source. If only a year or inferred date is available, omit the event until it can be resolved.

Status gate

Name product, indication, population, jurisdiction, evidence class, and unresolved obligation. Never promote a trial, advisory vote, or mechanism into an approval claim.

Coverage is reviewed at the dataset level and when a cited source changes materially. Corrections follow the public Corrections Policy. Historical wording remains scoped to the date shown; the current legal or regulatory state must be verified from the responsible authority.

Technical files for researchers and developers

Most visitors do not need these files. They are available for structured review, citation, and reproducibility.

Dataset structure, event selection, original summaries, and boundaries are CC BY 4.0. Third-party publications, regulator records, trial-registry records, titles, and trademarks remain with their respective owners. Retain each event's source, date, jurisdiction, evidence scope, and boundary when reusing the data.

Continue the audit trail

Read the underlying evidence before interpreting the change.

Use the research guides for study-design context, the News record for dated reporting, and Sources & Methodology for PeptideSchool's claim-to-source rules.