News

AP reports HHS posted a policy under which FDA would not act against pharmacies that compound six peptides, under conditions

The Associated Press reported on October 28, 2026 that Kennedy's HHS posted a document directing FDA not to take action against specialty pharmacies that compound a half-dozen wellness peptides. The FDA Law Blog (Hyman, Phelps & McNamara), also October 28, lists them as BPC-157 acetate (injected, oral or topical), TB-500 acetate and MOTS-c acetate (injected), Epitalon acetate (injected in intermittent courses), Semax free base (nasal) and KPV acetate (topical or oral). The conditions it describes: a state-licensed pharmacy, federal facility or licensed physician; bulk material from an FDA-registered manufacturer with a certificate of analysis that meets testing requirements; one active ingredient per product, no peptide blends; an FDA-cleared syringe; and reporting of adverse events and quality problems. What it is not: this is enforcement discretion, not a rule, not placement on the 503A Bulks List and not drug approval, it is framed as an HHS policy rather than an FDA position, and it can be revised. Emideltide (DSIP), the one peptide the panel rejected, is not on the list those sources give. AP also reported, from six unnamed people, that most FDA scientific staff opposed the approach and had little say in drafting it; those people are not named and FDA has not commented in anything we found. We have not opened the policy text itself; the FDA Law Blog cites Federal Register document 2026-22192, which we could not retrieve. None of this is evidence that any of the six works, so no grade here moves.

Regulatory, done. Source: FDA Law Blog, Hyman, Phelps & McNamara

Partnership for Safe Medicines petitions FDA not to allow compounding of six peptides

The Partnership for Safe Medicines page, headlined October 26, 2026, says it filed a citizen petition on October 16 asking FDA not to allow compounding of BPC-157, KPV, TB-500, MOTS-c, Semax and emideltide. The page gives no docket number, and its list differs from the panel's favorable six (it names emideltide where the panel's list has Epitalon), so we cannot say which version FDA received. This is an advocacy group's filing, not an FDA finding. Awaiting FDA's response; we found none.

Regulatory, awaiting results. Source: Partnership for Safe Medicines

FDA classes a compounded tirzepatide recall over sterility as Class II

A Fox-affiliate report dated October 21, 2026 says Apothecary Pharma of North Carolina is recalling 22 vials of compounded tirzepatide (18 mg/mL, 4 mL multidose) and one vial of NAD+ injection because sterility cannot be assured. The recall began September 24; FDA classed it Class II on October 8, a category meaning serious health problems are unlikely. No illnesses were reported. We did not reach FDA's own recall notice, so lot numbers should be checked there.

Safety, done. Source: FOX 9, FDA recall report

Kennedy says the goal is a regulated peptide marketplace

Reuters reported that on October 20, 2026, in a Fox News interview, Health Secretary Robert F. Kennedy Jr. said "our objective was to make sure that there is a regulated marketplace" for peptides and that Americans will buy them anyway. It is a statement of intent by an official who has said he uses BPC-157, not evidence about any compound.

Regulatory, done. Source: Reuters, via GV Wire

HHS and FDA send an 'Interim Access Policy' for peptide compounding to the White House for review

Holland & Knight reports that on October 14, 2026 HHS and FDA submitted an 'Interim Access Policy for Compounding Using Certain Peptides' to the Office of Management and Budget. AP, citing two unnamed sources, said it would let pharmacies temporarily compound some popular peptides, including BPC-157, through enforcement discretion and not through rulemaking. Outcome: a policy was posted on October 28; see the entry above.

Regulatory, done. Source: Holland & Knight

Eleven weeks after the peptide vote, FDA still had no rule and no date for the next panel

We rechecked on October 12, 2026. A Federal Register search of FDA documents through October 8 showed no proposed rule adding BPC-157, KPV, TB-500, MOTS-c, Semax or Epitalon to the 503A Bulks List, and that is still true on October 28: no proposed rule has been published. FDA's meeting page for the second tranche (LL-37, GHK-Cu, Dihexa acetate, Melanotan II and PEG-MGF) still says only 'before the end of February 2027', with no date, notice or docket; that was unchanged on October 28. The public docket for the July meeting (FDA-2025-N-6895) closed on July 22. FDA has posted no vote tallies, so every number is press-reported, and the Epitalon no count is reported as 4 or 5. The 503B side is also open: FDA's April 30 proposal to keep semaglutide, tirzepatide and liraglutide off the outsourcing-facility bulks list closed for comment on July 30, 2026 after a June 26 Federal Register extension, and we found no final decision as of October 28. Update: the October 12 statement that nothing about what a pharmacy may lawfully compound had changed was true that day; see the October 28 entry on HHS's enforcement-discretion policy.

Regulatory, delayed. Source: FDA, Pharmacy Compounding Advisory Committee meeting page

New PubMed systematic review scrutinizes human BPC-157 evidence in orthopaedics

A PRISMA-compliant, PROSPERO-registered systematic review in Acta Orthopaedica Belgica searched Embase, PubMed, Cochrane and ClinicalTrials.gov through June 2026 to evaluate BPC-157's human efficacy and safety evidence for orthopaedic/regenerative use.

Trial. Source: PubMed / Acta Orthop Belg. Checked automatically against the source.

FDA says retatrutide cannot be compounded under federal law and counts nearly 1,000 compounded semaglutide reports

FDA's page on unapproved GLP-1 drugs, current as of October 1, 2026, states that retatrutide and cagrilintide cannot be used in compounding under federal law. It says FDA has warned telehealth companies, distributors and outsourcing facilities over retatrutide, and sellers who labeled semaglutide, tirzepatide, retatrutide, survodutide or mazdutide 'not for human consumption'. As of May 31, 2026 FDA had received more than 990 adverse-event reports for compounded semaglutide and more than 730 for compounded tirzepatide, which it says are likely underreported.

Regulatory. Source: FDA, concerns with unapproved GLP-1 drugs

Lilly's tirzepatide + eloralintide combo beats tirzepatide alone in Phase 2

A mid-stage trial found Lilly's experimental tirzepatide/amylin-agonist combo produced greater weight loss than high-dose tirzepatide alone in obesity/T2D patients; Lilly plans Phase 3 trials by end of 2026, including a co-formulated single injection.

Trial. Source: CNBC. Checked automatically against the source.

Retatrutide's TRIUMPH-1 and TRIUMPH-2 are now peer reviewed: 25.0% weight loss at 80 weeks

TRIUMPH-1 (2,339 adults) appeared in the New England Journal of Medicine and TRIUMPH-2 (1,152 adults with type 2 diabetes) in The Lancet on September 29, 2026. In TRIUMPH-1 the 12 mg dose averaged 25.0% weight loss at 80 weeks against 3.9% on placebo counting everyone randomized; the 28.3% Lilly led with in May is the figure if everyone stayed on drug. Dysesthesia, an abnormal skin sensation, was more common on retatrutide than placebo in every phase 3 trial reported, and dropouts for side effects rose with dose. Lilly says it will file with FDA in the first quarter of 2027. Until approval, retatrutide is investigational and anything sold under its name is not Lilly's drug.

Trial. Source: PubMed, TRIUMPH-1 (NEJM)

Tirzepatide: SURMOUNT-1 3-year analysis shows most patients keep weight off

A new 3-year analysis of SURMOUNT-1 found 70% of participants with prediabetes who hit their lowest weight on tirzepatide had regained less than 5% of baseline weight by year three, with glycemic benefits largely intact.

Trial. Source: Medscape. Checked automatically against the source.

FDA warns Empower Pharmacy that adding a vitamin to compounded GLP-1s does not make them a different drug

FDA's warning letter to Empower Clinic Services (Empower Pharmacy) found its tirzepatide-plus-niacinamide and semaglutide-plus-B12 products were essentially copies of the approved drugs under section 503A, and said the volume it was producing made the claimed differences look pretextual. This matters because 'it has B12 in it' has been one of the main ways compounded GLP-1s stayed on the market after the shortages ended. It is a letter, not a court ruling, but it tells you where FDA thinks the line is.

Regulatory. Source: FDA, warning letter 738238

WADA approves its 2027 Prohibited List: a broader peptide warning, and GLP-1 drugs stay off

WADA's Executive Committee approved the 2027 List on September 10, 2026, effective January 1, 2027. The peptide change is a caution, not a new named ban: WADA says named peptides are examples only and that an unnamed peptide may still be prohibited. Semaglutide and tirzepatide stay unlisted pending a second study of athletes. For context, the 2026 List already names BPC-157 under S0 and TB-500 under S2. We did not reach WADA's own summary of changes, so this rests on national anti-doping and Paralympic reports.

Regulatory. Source: International Paralympic Committee

FDA posts warning letters to five 'research use only' peptide sellers

Dated August 24, 2026 and posted September 1, the letters went to Peptide Partners, Peak Performance Peptides, Royal Peptides, NuScience Peptides and TXP Innovations (Tex Peptides). Products named in the Peptide Partners letter, the one we read in full, include semaglutide, tirzepatide, retatrutide, tesamorelin, SS-31 and PT-141, and other letters name tesamorelin-ipamorelin blends. FDA's reasoning is the part to remember: dosing information, injection instructions, dose calculators and bundled bacteriostatic water showed the products were meant for people, so the 'not for human use' label did not protect them. None of the six peptides from the July PCAC vote appears in the letter we read in full, but the logic applies to anyone selling any peptide this way.

Regulatory. Source: FDA, warning letter to Peptide Partners LLC

Lilly sues six sellers of 'research' retatrutide and refers more than 200 more

Eli Lilly announced six lawsuits against U.S. businesses it says sell unapproved retatrutide: Aesthetic Envy Cosmetic Centers, Astra, Legendary Peptides, Striker Pharmacy, Texas Peptides and Lone Star Peptide. It also reported more than 200 individuals and entities to FDA, the Justice Department, state attorneys general and licensing boards. Retatrutide is still investigational, so anything sold under the name is not Lilly's drug. FDA's August 24 warning letters to five other sellers followed within two weeks.

Market. Source: Healio

Paradigm Peptides owner sentenced to 70 months for selling unapproved drugs

A federal judge in the Northern District of Indiana sentenced Matthew Kawa to 70 months in prison and $5 million in forfeiture for selling unapproved drugs, imported from abroad and represented as domestically made, under a research-chemical label. His sister received 16 months. It is the clearest sign yet that 'research use only' is a legal risk for the seller, not a loophole, and a reminder for buyers that the label tells you nothing about what is in the vial.

Regulatory. Source: CBS News

FDA advisory panel backs six of seven peptides for compounding, against its own agency's scientists

The Pharmacy Compounding Advisory Committee voted to recommend adding BPC-157 (8-6, one abstention), KPV (8-6), TB-500 (8-6) and MOTS-c (7-5, two abstentions) on July 23, then Semax (8-5, one abstention) and Epitalon (7 in favor; published reports differ on the no count, 4 or 5, and FDA has not posted a tally) on July 24. Emideltide (DSIP) was the lone rejection (6-7, one abstention), on evidence the committee called especially weak: one case report for narcolepsy, two small uncontrolled studies for opioid withdrawal, and human data collected intravenously for a product proposed as a subcutaneous injection. FDA has posted no tallies, so these numbers are press-reported. Four things to hold onto, because most coverage dropped at least one. First, the vote itself changed nothing about what was legal (the separate October 28 enforcement-discretion policy is covered in its own entry). The vote is advisory, and FDA now has to run notice-and-comment rulemaking that can take a year, and it can still say no. Second, FDA's own briefing documents recommended against all seven, citing poor characterization, little or no human efficacy evidence for the proposed routes, and unassessed immunogenicity; the panel overrode them. Third, this panel is not a neutral referee: it was reconstituted with recent appointees, and several work at or operate clinics that sell peptide treatments, which is exactly the kind of conflict this site flags on everyone else. Fourth, and most important for anyone reading a grade here: a compounding-eligibility vote is not evidence that a compound works, so not one grade on this site moves because of it. The margins are the story. Six votes against on the flagship compound, from a committee reconstituted in favor, is not a mandate.

Regulatory. Source: FDA, PCAC meeting, July 23-24 2026

Retatrutide clears two more Phase 3 trials; Lilly plans to file with FDA in early 2027

Lilly reported topline TRIUMPH-2 (type 2 diabetes with obesity) and TRIUMPH-3 (severe obesity with established cardiovascular disease) results, with average weight loss up to 22.6% at 80 weeks in TRIUMPH-3, below the 28.3% from TRIUMPH-1. Lilly says it will submit to FDA in the first quarter of 2027. Until then retatrutide is investigational, and anything sold under its name is not Lilly's drug.

Trial, awaiting results. Source: Eli Lilly

Thymulin, not thymosin alpha-1, links the aging thymus to inflammation in Nature Communications

USC's Ito lab reports that thymulin, a zinc-dependent thymic nonapeptide, falls with age while inflammatory cytokines rise. Using heterochronic parabiosis in aged mice plus human blood analysis, restoring thymulin improved survival and anti-PD-L1 immunotherapy response. Worth being precise about two things. This is mouse data with no human trial, so it does not move a grade. And thymulin is a different molecule from thymosin alpha-1 (Zadaxin/thymalfasin), the thymic peptide people actually buy. The two are routinely conflated because both come from the thymus. Nothing here validates thymosin alpha-1.

Trial. Source: Keck School of Medicine of USC

A phase 3 stroke trial of GHRP-6 plus EGF misses its primary endpoint

COURAGE-2, a randomized open-label phase 3 trial of intravenous EGF plus GHRP-6 against standard care in 188 people with acute ischemic stroke, found no difference in disability at 3 or 6 months. A post hoc subgroup of 27 people with severe strokes looked better, which is a hypothesis, not a result. It is a combination, given intravenously, for a different condition, so it says nothing about the wellness uses people buy GHRP-6 for and moves no grade here.

Trial. Source: PubMed, J Clin Neurosci 2026

A viral thread reintroduces the Koniver Huberman episode, and gets his name wrong

A 78K-view 'Peptide Daily' thread recapping Dr. Craig Koniver's Oct 2024 Huberman episode calls him 'Craig Conover' and the 'pioneer' of NAD infusion therapy. Both are wrong: the guest is Dr. Craig Koniver, and clinical IV NAD dates to 1961 (O'Hollaren), not to him. The substance mostly holds up, PDA as the BPC-157 successor and GLP-1 microdosing to spare muscle, so we added his full, evidence-graded track record to the authorities page.

Culture. Source: Peptide Daily (X)

FDA sends a third wave of warning letters in under a year over compounded GLP-1 marketing

The FDA issued 25 warning letters to telehealth companies over allegedly misleading claims about compounded semaglutide and tirzepatide, after ~80 letters in Sept 2025 and 30 in March 2026.

Regulatory. Source: National Law Review

Survodutide cuts liver fat 63% in Phase 3 SYNCHRONIZE-MASLD

Boehringer Ingelheim's glucagon/GLP-1 dual agonist reduced liver fat by 63% vs placebo in adults with obesity and MASLD, presented at ADA 2026 and published in Nature Medicine.

Trial. Source: Boehringer Ingelheim

Retatrutide delivers up to 28.3% weight loss at 80 weeks (TRIUMPH-1)

Eli Lilly's GIP/GLP-1/glucagon triple agonist averaged 28.3% (70.3 lb) weight loss on the 12 mg dose over 80 weeks, rising to 30.3% at 104 weeks in higher-BMI participants.

Trial. Source: Eli Lilly

Ibutamoren, as LUM-201, enters a pediatric phase 3 trial

A randomized, placebo-controlled phase 3 trial of oral LUM-201 (identified as ibutamoren mesylate in a registry record) began on May 20, 2026 in prepubertal children with growth hormone deficiency, with annualized height velocity as the primary endpoint. It is a company trial in children, not a route for adults buying MK-677. FDA still keeps ibutamoren on its Category 2 list.

Trial. Source: ClinicalTrials.gov, NCT06948214

FDA proposes removing semaglutide, tirzepatide and liraglutide from the 503B bulks list

Citing resolved shortages and the end of clinical need, the FDA proposed pulling the major GLP-1s from 503B outsourcing-facility compounding, narrowing the legal path for compounded GLP-1s.

Regulatory, awaiting results. Source: Polsinelli

How the peptides left Category 2: the nominators withdrew them, and FDA did not clear them

FDA's Category 2 page, current as of April 22, 2026, now lists BPC-157, TB-500, MOTS-c, Semax, Epitalon, KPV, DSIP, injectable GHK-Cu and others in a 'nominated but withdrawn' table, noting they were withdrawn by the nominators. Removal was not a safety finding and did not move anything to Category 1. Ipamorelin, GHRP-2, GHRP-6, ibutamoren and kisspeptin-10 are still on Category 2.

Regulatory. Source: FDA, bulk drug substances that may present significant safety risks

FDA removes 12 peptides from the Category 2 'do not compound' list after their nominators withdraw

FDA removed 12 peptide bulk substances, including BPC-157, TB-500, MOTS-c, Semax, Epitalon, injectable GHK-Cu and Melanotan II, from 503A Category 2 by April 22, 2026, after their nominators withdrew them. Removal is not eligibility to compound, and it is not a safety finding.

Regulatory. Source: Frier Levitt

FDA schedules a July 23-24 PCAC meeting to weigh 7 peptides for 503A compounding

The Pharmacy Compounding Advisory Committee met on July 23-24 and voted on whether BPC-157, KPV, TB-500, MOTS-c, DSIP, Semax and Epitalon should be eligible for 503A compounding, a non-binding step that still needs formal rulemaking.

Regulatory, done. Source: FDA Law Blog

FDA approves Wegovy HD, a 7.2 mg semaglutide injection

Novo Nordisk announced approval of a 7.2 mg weekly dose for adults who tolerated 2.4 mg for at least four weeks. In the 72-week STEP UP trial (1,407 adults), 7.2 mg produced 20.7% weight loss against 17.5% on 2.4 mg and 2.4% on placebo if everyone stayed on drug (18.8%, 15.5% and 3.9% counting everyone). The label reports dysesthesia, an altered skin sensation, in 22% on 7.2 mg against 6% on 2.4 mg, and it rises with dose.

Regulatory. Source: Novo Nordisk

UK MHRA updates semaglutide information over rare NAION vision-loss risk

The MHRA revised semaglutide (Wegovy, Ozempic, Rybelsus) information to reflect very rare reports of non-arteritic anterior ischemic optic neuropathy, sudden vision loss, advising urgent referral if suspected.

Safety. Source: MHRA Drug Safety Update

FDA approves the Wegovy pill, the first oral GLP-1 for weight loss

Novo Nordisk announced approval of oral semaglutide 25 mg (Wegovy tablets). In the 64-week OASIS 4 trial (307 adults without diabetes), weight loss was 13.6% against 2.4% on placebo counting everyone, and 16.6% against 2.7% if everyone stayed on drug. The pill is approved in the US only. It is a finished, regulated product, which is not the same thing as the semaglutide powders sold online.

Regulatory. Source: Novo Nordisk

Novo files for FDA approval of CagriSema; a decision is guided for the fourth quarter of 2026

Novo Nordisk submitted a new drug application for CagriSema, cagrilintide 2.4 mg plus semaglutide 2.4 mg, for chronic weight management. The basis is REDEFINE 1 (3,417 adults, 68 weeks): 20.4% weight loss against 3.0% on placebo counting everyone. No FDA decision date has been disclosed; Novo guided to the fourth quarter of 2026, and we found no decision as of October 28. The filing is for the combination, not cagrilintide alone, and FDA says cagrilintide cannot be used in compounding.

Regulatory, awaiting results. Source: Pharmaceutical Executive