FDA Peptide News - Approvals, Advisory Votes and Updates

Regulatory UpdateOctober 28, 2026 Draft enforcement discretion policy released October 28, 2026; Federal Register publication October 30, 2026 - not an FDA approval

HHS Releases Enforcement Discretion Policy Covering Six Peptides for 503A Compounding

On October 28, 2026, the U.S. Department of Health and Human Services made public a draft enforcement discretion policy for 503A compounding using six peptide bulk drug substances: BPC-157, epitalon, KPV, MOTS-c, semax, and TB-500. The notice of availability was published in the Federal Register on October 30, 2026. The policy is not an FDA approval and does not add any peptide to the 503A bulks list.

Read the full regulatory breakdown →

All FDA Peptide Updates

Clinical TrialsOctober 28, 2026

Retatrutide Meets Phase 3 Endpoints in TRANSCEND-T2D-2, the First Head-to-Head Trial Against Ozempic in Type 2 Diabetes

Eli Lilly reported on October 28, 2026, that retatrutide met the primary and key secondary endpoints in TRANSCEND-T2D-2, a Phase 3 trial in 1,298 adults with type 2 diabetes, with a greater HbA1c reduction and more than double the weight loss of the highest approved dose of Ozempic (semaglutide) at 80 weeks. Retatrutide is investigational and is not approved anywhere.

RetatrutideSemaglutide

Regulatory UpdateOctober 28, 2026

FDA Accepts Bevonescein (ALM-488) New Drug Application for Nerve Visualization During Head and Neck Surgery

Alume Biosciences announced on October 28, 2026, that the FDA has accepted for filing and review its New Drug Application for bevonescein (ALM-488), an investigational fluorescent peptide-dye conjugate intended to help surgeons visualize nerves in real time in adult patients undergoing head and neck surgery. Bevonescein is not FDA approved, and its safety and effectiveness have not been established.

Bevonescein

FDA ApprovalOctober 23, 2026

FDA Expands Awiqli (Insulin Icodec-abae) Approval to Children 10 Years and Older With Type 2 Diabetes

On October 23, 2026, the FDA approved Awiqli (insulin icodec-abae) to improve glycemic control in pediatric patients aged 10 years and older with type 2 diabetes mellitus, stating that it is the first once-weekly insulin approved for children with type 2 diabetes.

Insulin Icodec

FDA ApprovalOctober 16, 2026

FDA Approves Zilbrysq (Zilucoplan) Autoinjector, a New Administration Option for a Macrocyclic Peptide

On October 16, 2026, UCB announced that the FDA approved an autoinjector administration option for Zilbrysq (zilucoplan) for adults with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive. This is a delivery-device approval for an existing drug, not a new drug or a new indication.

Zilucoplan

Regulatory UpdateOctober 14, 2026

HHS and FDA Submit an Interim Access Policy for Compounding Using Certain Peptides to the White House for Review

On October 14, 2026, HHS and the FDA submitted a document titled Interim Access Policy for Compounding Using Certain Peptides (RIN 0910-ZD94) to the Office of Management and Budget for regulatory review. The submission itself authorized nothing and changed no rule.

BPC-157

Clinical TrialsOctober 12, 2026

RYZ101, a DOTATATE Peptide Radiopharmaceutical, Meets Phase 3 Endpoint in ACTION-1 GEP-NET Trial

Bristol Myers Squibb and RayzeBio reported on October 12, 2026 that RYZ101 (225Ac-DOTATATE), an investigational peptide radiopharmaceutical, met the primary progression-free survival endpoint at the planned interim analysis of the Phase 3 ACTION-1 trial in somatostatin receptor-positive GEP-NETs. The candidate is not FDA approved, and the sponsor said it plans to engage the FDA toward a regulatory submission.

DOTATATE

EnforcementOctober 9, 2026

FDA Publishes Major Revision of Import Alert 66-80 on GLP-1 Bulk Drug Substances

On October 9, 2026, the FDA published a major revision of Import Alert 66-80 on detention without physical examination of GLP-1 receptor agonist bulk drug substances, updating Green List guidance and adding orforglipron entries and new product codes.

OrforglipronGLP-1 Receptor Agonists

Clinical TrialsOctober 7, 2026

Survodutide Meets Phase 3 Endpoints in SYNCHRONIZE-2: What the Dual Agonist Readout Means

Boehringer Ingelheim reported that the investigational glucagon/GLP-1 dual agonist survodutide met both co-primary endpoints in the Phase 3 SYNCHRONIZE-2 trial in adults with overweight or obesity and type 2 diabetes. Full results were presented October 1, 2026 at EASD and published in the New England Journal of Medicine.

Survodutide

FDA ApprovalSeptember 23, 2026

FDA Approves Onswik (Insulin Efsitora Alfa-gobe), a Second Once-Weekly Insulin, for Adults With Type 2 Diabetes

The FDA approved Onswik (insulin efsitora alfa-gobe) to improve glycemic control in adults with type 2 diabetes mellitus. The FDA Novel Drug Approvals for 2026 page lists the approval date as September 23, 2026.

Insulin Efsitora Alfa

EnforcementSeptember 19, 2026

FDA Adds Chengdu Shengnuo Biopharm to Import Alert 66-40 Red List

The FDA Import Alert 66-40 Red List includes Chengdu Shengnuo Biopharm Co., Ltd., with the date published of September 19, 2026, for detention without physical examination of drugs from firms that have not met drug GMPs, covering all drugs and drug products.

SemaglutideTirzepatide

EnforcementSeptember 18, 2026

FDA Warning Letter to Empower Pharmacy Says Compounded GLP-1 Combination Products Were Essentially Copies

On September 18, 2026, the FDA issued a warning letter to Empower Pharmacy stating that its tirzepatide/niacinamide and semaglutide/cyanocobalamin products appear to be essentially copies of FDA-approved products and therefore did not meet the conditions of section 503A.

TirzepatideSemaglutide

FDA ApprovalAugust 28, 2026

FDA Approves MIMRYLO (Rusfertide), First Hepcidin Mimetic Peptide for Polycythemia Vera

On August 28, 2026, the FDA approved MIMRYLO (rusfertide), a first-in-class hepcidin mimetic peptide for erythrocytosis in adults with polycythemia vera - the first hepcidin mimetic ever approved.

Rusfertide

FDA ApprovalAugust 28, 2026

FDA Approves Mounjaro (Tirzepatide) to Reduce Cardiovascular Risk in Adults With Type 2 Diabetes

On August 28, 2026, Eli Lilly announced that the FDA had approved Mounjaro (tirzepatide) to lower the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high risk for these events, based on the SURPASS-CVOT trial.

Tirzepatide

EnforcementAugust 24, 2026

FDA Issues Warning Letters to Five Online Peptide Sellers, Including Peptide Partners and Peak Performance Peptides

On August 24, 2026, the FDA issued warning letters to at least five online peptide sellers, stating that products including semaglutide, tirzepatide, retatrutide, SS-31 (elamipretide), tesamorelin, and PT-141 (bremelanotide) are unapproved new drugs.

SemaglutideTirzepatideRetatrutideElamipretide

Regulatory UpdateJuly 28, 2026

FDA Publishes 17 Revised Draft Product-Specific Guidances for Generic Peptide Products

On July 28, 2026, the FDA published 17 revised draft product-specific guidances for peptide products, including semaglutide, tirzepatide, liraglutide, glucagon, teriparatide, pegcetacoplan, and vosoritide. It also withdrew its May 2021 synthetic peptide ANDA guidance.

SemaglutideTirzepatideLiraglutideGlucagon

FDA AdvisoryJuly 24, 2026

FDA Advisory Committee Votes to Recommend Six Peptides for 503A Compounding List

On July 23-24, 2026, the FDA’s Pharmacy Compounding Advisory Committee voted to recommend six peptides - BPC-157, KPV, TB-500, MOTS-c, Semax, and Epitalon - for the 503A bulk drug substances list, over the objection of FDA staff scientists.

BPC-157KPVTB-500MOTS-c

FDA ApprovalJuly 15, 2026

FDA Approves Lipfendra (Enlicitide), the First Oral PCSK9 Inhibitor

The FDA approved Lipfendra (enlicitide), a macrocyclic peptide, to reduce LDL cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, and described it as the first oral PCSK9 inhibitor. The FDA novel approvals list gives the approval date as July 15, 2026.

Enlicitide

EnforcementJune 17, 2026

FDA Warning Letter to Wholesale Peptide Over Unapproved Prostamax and Gonadorelin

On June 17, 2026, the FDA issued a warning letter to Wholesale Peptide stating that Prostamax and Gonadorelin are unapproved new drugs and that research use only statements did not override evidence of intended human use.

ProstamaxGonadorelin

EnforcementJune 16, 2026

FDA Issues 25 More Warning Letters to Telehealth Companies Over Compounded GLP-1 Marketing Claims

On June 16, 2026, the FDA posted a third wave of 25 warning letters to telehealth companies over false or misleading website claims about compounded semaglutide, tirzepatide, and liraglutide products, according to Reuters reporting on the FDA letters.

SemaglutideTirzepatideLiraglutide

FDA ApprovalMay 22, 2026

FDA Approves Hepcludex (Bulevirtide), the First Treatment for Chronic Hepatitis Delta Virus Infection

On May 22, 2026, the FDA approved Hepcludex (bulevirtide-gmod) to treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis, calling it the first FDA-approved treatment for chronic HDV infection.

Bulevirtide

Regulatory UpdateApril 30, 2026

FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide From the 503B Bulks List

On April 30, 2026, the FDA announced it is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances, and invited public comments before a final determination.

SemaglutideTirzepatideLiraglutide

Regulatory UpdateApril 15, 2026

FDA Removes 12 Peptides from Category 2 List, Restoring a Path to Compounding Review

In April 2026, the FDA formally moved 12 peptides from its Category 2 bulk substances list - the tier flagged for safety concerns - reopening the regulatory path toward compounding eligibility.

BPC-157

FDA ApprovalApril 1, 2026

FDA Approves Foundayo (Orforglipron), First Once-Daily Oral GLP-1 Pill for Weight Management

On April 1, 2026, the FDA approved Foundayo (orforglipron), the first oral small-molecule GLP-1 receptor agonist for weight management in adults with obesity or overweight with a weight-related condition.

Orforglipron

Regulatory UpdateApril 1, 2026

FDA Clarifies Compounding Policies as National GLP-1 Supply Stabilizes, Including the Essentially a Copy Standard

On April 1, 2026, the FDA updated its statement clarifying policies for compounders as national GLP-1 supply begins to stabilize, explaining when a compounded product counts as essentially a copy of a commercially available drug and noting that tirzepatide and semaglutide appear on neither the 503B bulks list nor the drug shortage list.

SemaglutideTirzepatide

EnforcementMarch 31, 2026

FDA Issues Warning Letters to Online Research-Peptide Sellers Gram Peptides, Prime Sciences, and Mile High Compounds

On March 31, 2026, the FDA issued warning letters to Gram Peptides, Prime Sciences, and Mile High Compounds, stating that products including retatrutide, tirzepatide, semaglutide, and cagrilintide offered on their websites are unapproved new drugs and that research use only labeling did not change that conclusion.

RetatrutideTirzepatideSemaglutideCagrilintide

FDA ApprovalMarch 26, 2026

FDA Approves Awiqli (Insulin Icodec-Abae), the First Once-Weekly Insulin for Adults With Type 2 Diabetes

On March 26, 2026, the FDA approved Awiqli (insulin icodec-abae) to improve glycemic control in adults with type 2 diabetes mellitus, marking the first once-weekly basal insulin approved in the United States, as listed on the FDA Novel Drug Approvals for 2026 page.

Insulin Icodec

FDA ApprovalMarch 19, 2026

FDA Approves Higher-Dose Wegovy HD (Semaglutide) Under the National Priority Voucher Program

On March 19, 2026, the FDA approved Wegovy HD, a new higher dose of Wegovy (semaglutide) injection, for weight reduction in adults with obesity or overweight with at least one weight-related condition, as the fourth approval under the National Priority Voucher pilot program.

Semaglutide

FDA ApprovalMarch 17, 2026

FDA Approves Icotyde (Icotrokinra), an Oral Peptide, for Plaque Psoriasis

On March 17, 2026, the FDA approved Icotyde (icotrokinra), an oral peptide that targets the IL-23 receptor, to treat moderate-to-severe plaque psoriasis in patients 12 years and older who meet the labeled criteria, as listed on the FDA Novel Drug Approvals for 2026 page.

Icotrokinra

EnforcementMarch 3, 2026

FDA Warns 30 Telehealth Companies Over Illegal Marketing of Compounded GLP-1 Products

On March 3, 2026, the FDA announced it had issued 30 warning letters to telehealth companies for false or misleading claims about compounded GLP-1 products, including claims implying the compounded products were the same as FDA-approved drugs.

GLP-1 Receptor Agonists

FDA ApprovalFebruary 27, 2026

FDA Approves Yuviwel (Navepegritide) for Achondroplasia in Children 2 Years and Older

On February 27, 2026, the FDA approved Yuviwel (navepegritide), a prodrug of C-type natriuretic peptide, to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses, under the accelerated approval pathway.

Navepegritide

Regulatory UpdateFebruary 6, 2026

FDA Announces Intent to Take Action Against Non-FDA-Approved GLP-1 Drugs

On February 6, 2026, the FDA announced its intent to take decisive steps to restrict GLP-1 active pharmaceutical ingredients intended for use in non-FDA-approved compounded drugs mass-marketed as alternatives to FDA-approved drugs, naming Hims & Hers and other compounding pharmacies.

GLP-1 Receptor Agonists

FDA AdvisoryJanuary 13, 2026

FDA Requests Removal of Suicidal Behavior and Ideation Warning From GLP-1 Receptor Agonist Labels

In a Drug Safety Communication dated January 13, 2026, the FDA said its review did not identify an increased risk of suicidal ideation or behavior with GLP-1 receptor agonists and requested that application holders remove that warning language from the labeling of Saxenda, Wegovy, and Zepbound.

LiraglutideSemaglutideTirzepatide

FDA ApprovalDecember 22, 2025

FDA Approves Wegovy Pill, First Oral GLP-1 Peptide for Obesity

On December 22, 2025, the FDA approved the Wegovy pill (oral semaglutide 25 mg), the first once-daily oral GLP-1 peptide medicine for obesity in the United States.

Semaglutide

FDA ApprovalDecember 19, 2025

FDA Expands Mounjaro (Tirzepatide) Approval to Children 10 Years and Older With Type 2 Diabetes

On December 19, 2025, the FDA approved a supplemental application expanding Mounjaro (tirzepatide) for pediatric patients 10 years of age and older with type 2 diabetes mellitus, according to the FDA pediatric labeling record and the agency approval letter for the supplement.

Tirzepatide

How we report FDA news

Every post reports what the FDA actually did - approvals, advisory votes, reclassifications - tied to the specific drug product and indication. We never publish dosing, administration guidance, or usage advice. FDA approval belongs to a labeled product, never to a molecule in general or to compounded or research-grade material.