Policy
Six peptides, ten conditions: HHS notice reaches the Federal Register
The October 30 notice resolves publication status, not drug approval. The HHS policy remains conditional, nonbinding and subject to change.
A year in context.
What changed, what the source establishes, and what a practice still cannot conclude.
39 dated news records13 month windowsOpen completeness audit
A targeted one-year review, not a comprehensive industry archive. New primary-source reporting expands BPC-157 and non-GLP-1 enforcement coverage. A ten-query trial-register snapshot now preserves 44 returned records and screening decisions. Independent trial verification, court outcomes, PCAC votes and full-paper reviews remain gaps. Explore the annual evidence audit ↗
2026-10
Market
Hims signals a peptide expansion. A plan is not a launch.
The company’s October 29 communication describes a planned Peptides+ specialty and contingent future access.
Clinical
The comparator belongs in a retatrutide headline
Lilly reported TRANSCEND-T2D-2 topline results comparing retatrutide with Ozempic in adults with type 2 diabetes over 80 weeks.
Safety
NSW reports 1,180 peptide-associated emergency presentations
The Australian surveillance release covers July 2025 through September 2026. Association is not causation.
Market
The EU Foundayo opinion awaits the final steps
EMA recommended EU authorization for Foundayo and described orforglipron as a small non-peptide molecule.
Safety
Packaging is not evidence of authorization
MHRA reported an October 14 raid involving over 12,000 pens it characterized as fake retatrutide and tirzepatide products; the release was published October 15.
Policy
An import alert is not a blanket import ban
FDA’s GLP-1 active-ingredient alert carries an October 9 revision and describes detention and Green List provisions.
Clinical
Thirty participants are not a treatment standard
An October systematic review found three small human studies and very-low-certainty evidence. The useful story is the design—not the promise.
2026-09
Clinical
TRIUMPH-2: promise and investigational status
Lilly reported phase 3 retatrutide results over 80 weeks in adults with obesity and type 2 diabetes; it said results were presented at EASD and published in The Lancet.
Clinical
Retatrutide: why 28.3% and 25.0% can both be correct
TRIUMPH-1 moved from a May sponsor topline to a September peer-reviewed report. The analysis behind a percentage changes what it means.
Market
Generic GLP-1 development is a quality question
FDA’s workshop page scheduled a September 23–24 program on generic GLP-1 characterization, manufacturing quality, bioequivalence and drug-device issues.
Policy
Empower letter: read the allegations precisely
FDA’s Empower Pharmacy letter describes inspection findings and alleged statutory violations involving compounded products.
Evidence
The BPC-157 rotator-cuff registration is a plan, with unresolved conflicts
The record says not yet recruiting, estimates a 2027 start and disagrees internally about enrollment and the comparator.
2026-08
Policy
The whole offer matters more than a research-use footer
Two August FDA letters connect product claims, blends and injection-related tools. They are product-specific enforcement records, not verdicts about every peptide.
Market
Lilly asks platforms to act on investigational sellers
Lilly announced legal and platform-related actions against online sellers marketing investigational compounds, including retatrutide.
Market
Orforglipron’s UK move is market-adjacent news
MHRA authorized Foundayo for specified weight-management and type 2 diabetes uses in the UK.
Evidence
Completed is not published: the BPC-157 gummy registry record
A commercial-product record was first posted after its recorded conduct. It has no posted results module in this snapshot.
2026-07
Policy
Seven peptide families, fourteen substances, and a nonbinding process
The July PCAC briefing distinguishes free bases, acetate salts and proposed uses. FDA staff proposals are documented; committee vote outcomes remain unverified here.
Policy
MASH: conditional belongs in the headline
MHRA granted semaglutide conditional authorization for MASH in adults with moderate-to-advanced liver fibrosis.
2026-06
Policy
The peptide enforcement story extends beyond weight loss
FDA’s June letter to Wholesale Peptide names Prostamax and Gonadorelin. It is a useful counterweight to a GLP-1-heavy annual archive.
Policy
The UK authorizes oral Wegovy
MHRA announced approval of oral semaglutide as a Wegovy tablet for adults meeting specified weight-management conditions.
Clinical
CagriSema in type 2 diabetes: read the HbA1c result first
The peer-reviewed trial found a 0.16-percentage-point HbA1c advantage over semaglutide 2.4 mg under the efficacy estimand—not proof of every downstream benefit.
2026-05
Policy
Europe’s oral Wegovy recommendation is intermediate
EMA described a CHMP recommendation for oral Wegovy in adult weight management, citing a 307-participant, 64-week phase 3 study.
2026-04
Policy
The 503B proposal is not a universal compounding ban
FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, citing no identified clinical need for bulk compounding by outsourcing facilities.
Policy
GLP-1 compounding after shortages: the distinctions that matter
The end of a shortage changes the legal framework for copies. It does not answer every patient-specific compounding question.
Market
Foundayo expands GLP-1 competition, not peptide counts
FDA approved Foundayo, orforglipron, for the stated weight-management indication. It is an oral non-peptide GLP-1 agonist.
2026-03
Policy
A research-use label does not end FDA’s inquiry
FDA’s Gram Peptides warning letter describes website review and alleges that offered products were unapproved new drugs.
Evidence
A recruiting badge can coexist with a fictional-study disclaimer
Two primary registry records call themselves fictional or mock. That changes how a peptide pipeline should be counted.
Policy
Wegovy HD: a product-specific approval, a higher-dose safety signal
FDA approved semaglutide 7.2-mg injection for specified adults on March 19. The decision is not a blanket approval of compounded or investigational products.
Policy
Thirty letters put product identity in focus
FDA announced 30 warning letters about compounded GLP-1 marketing, identifying sameness claims and branding that obscured the compounder.
2026-02
Clinical
CagriSema: substantial weight loss, a missed primary endpoint
REDEFINE 4 reported 23% weight loss under its efficacy estimand but did not establish non-inferiority to tirzepatide.
Policy
FDA signals action on mass-marketed unapproved GLP-1s
FDA announced intent to act against non-FDA-approved GLP-1 products and active ingredients used in mass-marketed compounded products.
Safety
NAION: preserve the regulator’s uncertainty
MHRA updated semaglutide guidance about the very rare eye condition NAION and evidence of a potential association.
2026-01
Safety
Pancreatitis warnings without an incidence estimate
MHRA strengthened pancreatitis information for GLP-1 and dual GLP-1/GIP medicines, including rare necrotising and fatal cases.
Policy
A UK authorization is not a U.S. practice change
MHRA authorized a higher maximum Wegovy dose for adults with obesity on January 6; its explanatory story was published January 16.
2025-12
Policy
Oral Wegovy: an approval date, not a class-wide permission
Drugs@FDA records the tablet application’s original approval on 22 December 2025. Product, route and later labeling changes stay distinct.
2025-11
Clinical
Amycretin advances; evidence remains a sponsor readout
Novo Nordisk reported positive phase 2 headline results in 448 people with type 2 diabetes. The randomized dose-finding study compared oral and subcutaneous amycretin with placebo over up to 36 weeks.
Clinical
Post hoc is not prospective proof
Novo Nordisk presented four OASIS 4 analyses, including post hoc analyses and an indirect comparison. The underlying study included 307 adults without diabetes over 64 weeks.
2025-10
Clinical
Real-world evidence needs its own label
A claims-database SEPRA emulation used 1,144 propensity-matched pairs of adults with type 2 diabetes and found better glycemic control among semaglutide initiators.