Peptide industry news.
FDA regulatory action, clinical trial readouts, and peptide pipeline developments — paraphrased from primary sources by the Grey Peptides News Desk. Every post links to its original source.
CagriSema Against Tirzepatide in Type 2 Diabetes: What REIMAGINE 5 Shows
Novo Nordisk reports that CagriSema beat tirzepatide 5 mg on weight loss in people with type 2 diabetes, 12.4% against 9.1% over 60 weeks, with similar HbA1c falls. The results are the company's and not yet published.
Vosoritide's Phase 3 Hypochondroplasia Trial: 2.33 cm a Year Faster Growth Than Placebo
In a 52-week phase 3 trial in 81 children with hypochondroplasia, vosoritide raised yearly growth by 2.33 cm more than placebo. Vosoritide is approved for achondroplasia, not for hypochondroplasia.
Saxenda Is Being Discontinued, and Rybelsus Tablets Are Being Replaced
Two Novo Nordisk GLP-1 products are leaving the US market according to FDA notices: Saxenda (liraglutide for weight) by January 2027, and the original Rybelsus tablets, which are being replaced by Ozempic tablets.
EloraTZP Phase 2b: 23.3% Weight Loss in Type 2 Diabetes, and Up to 27% Stopped for Side Effects
In 367 adults with type 2 diabetes, the top EloraTZP dose cut weight 23.3% and HbA1c 2.9 points at 48 weeks, against 14.8% and 2.4 on tirzepatide 15 mg. Up to 27% stopped for side effects.
Petrelintide's Phase 2 Paper Is Out: Weight Loss Levelled Off Above 5 mg. What Else EASD 2026 Showed
The ZUPREME-1 paper puts petrelintide's 28-week weight loss at 7.9% to 9.8% against 1.7% on placebo, with doses above 5 mg adding nothing. Other peptide data from EASD 2026 came from Hengrui, Kailera and AbbVie.
FDA Approves Rusfertide (Mimrylo), the First Hepcidin Mimetic for Polycythemia Vera
FDA approved rusfertide, sold as Mimrylo, for adults with polycythemia vera on August 28. It is a weekly injected peptide that copies the iron-regulating hormone hepcidin, and in its phase 3 trial it spared far more patients from blood removal than placebo did.
SYNCHRONIZE-2: Survodutide Reaches 13.1% Weight Loss in Type 2 Diabetes, and 18% Stopped for Side Effects
Survodutide produced up to 13.1% weight loss at 76 weeks in adults with type 2 diabetes, versus 3.1% on placebo, by Boehringer's figures. 18% on the drug stopped because of gastrointestinal side effects.
The Gray Market Passed $100 Million On-Chain. Spending on Testing Fell to $8 a Buyer
Crypto to gray-market peptide vendors reached $32 million in Q1 2026, a 159% rise on the quarter. Independent testing spend per buyer fell about 88%, to an estimated $8.
CagriSema's Diabetes Trials Read Out: What REIMAGINE 1, 2 and 3 Found
CagriSema's type 2 diabetes programme has published. In the largest trial it beat semaglutide 2.4 mg on HbA1c by 0.16 percentage points; the two smaller trials cut HbA1c by 1.8 and 2.3 points against placebo.
Two Peptides in Tablet Form: FDA's 2026 Approvals of Icotyde and Lipfendra
Two engineered peptides that work when swallowed won FDA approval this year: Icotyde for plaque psoriasis in March and Lipfendra for high LDL cholesterol in July. Both are daily tablets taken on an empty stomach.
FDA Approves a Second Once-Weekly Insulin: Lilly's Onswik Joins Novo's Awiqli
FDA approved Onswik, Lilly's once-weekly basal insulin, on September 23 for adults with type 2 diabetes. It follows Novo Nordisk's Awiqli, approved in March; neither is for type 1 diabetes.
Retatrutide: Lilly Plans to File in Early 2027, and Offers Single-Patient Access Before Then
Lilly plans to file retatrutide with FDA in the first quarter of 2027. Its pre-approval expanded-access program, listed since June, admits only adults with refractory severe obesity and serious complications.
FDA to Five Online Peptide Sellers: A 'Research Use Only' Label Does Not Decide What You Are Selling
Five letters dated August 24 call retatrutide, semaglutide, tirzepatide and other research peptides unapproved new drugs, despite the sellers' research-use-only labels.
WADA's 2027 Prohibited List Writes 'Peptides' Into Its Catch-All Ban
From January 1, 2027, S0 names 'peptides' among its examples of unapproved substances. WADA says an unnamed peptide can still be prohibited under S0, S2 or S4.
FDA: Adding a Vitamin Does Not Stop a Compounded GLP-1 From Being a Copy
FDA told Empower Pharmacy its tirzepatide-niacinamide and semaglutide-B12 products appear to be essentially copies of approved GLP-1s, made in volumes that suggest the differences are pretextual.
PCAC Backed Six of Seven Peptides in July. Two Months Later, FDA Has Not Acted
The compounding committee recommended BPC-157, KPV, TB-500, MOTS-c, semax and epitalon for the 503A Bulks List and rejected emideltide. As of September 25, none of the six is on the list or in Category 1.
The FDA Comment Window on Compounded GLP-1s Closes July 30 — Not June 29
A two-page notice quietly moved the deadline thirty days and most coverage never updated. Comments closed at 11:59 p.m. ET on July 30.
FDA Staff Propose Rejecting All Seven Peptides Before Next Week's Compounding Committee
Briefing documents released ahead of the July 23-24 PCAC meeting show FDA staff proposing against all fourteen substances, including BPC-157, TB-500 and semax.
ADA 2026 Preview: The Incretin Readouts to Watch in New Orleans
The American Diabetes Association's 86th Scientific Sessions open June 5 in New Orleans. Retatrutide, CagriSema, survodutide, and oral orforglipron headline a packed incretin agenda.
TRIUMPH-1: Retatrutide Posts Bariatric-Level Weight Loss in Phase 3
On May 21, Eli Lilly reported topline TRIUMPH-1 results: retatrutide drove up to 28.3% mean weight loss at 80 weeks — the largest pharmacological obesity readout to date.
A Single Peptide That Hits Five Receptors: The Quintuple Agonist
A Nature paper describes GLP-1-GIP-lanifibranor, one molecule that activates five metabolic receptors at once. It corrects obesity and diabetes in mice — emphasis on mice.
Ozempic Pill Reaches US Pharmacies: First Oral Peptide GLP-1 for Type 2 Diabetes
Starting May 4, Novo Nordisk's Ozempic tablets reached US pharmacies — the first oral peptide GLP-1 approved for type 2 diabetes, with cardiovascular risk reduction on label.
REDEFINE-1 Body Composition Data: How CagriSema Affects Muscle Mass
New post-hoc DXA findings from Novo Nordisk's pivotal CagriSema trial, presented at the European Congress on Obesity 2026, examine the muscle-mass and lean-tissue picture behind 20%+ weight loss.
The FDA Just Proposed Ending Mass GLP-1 Compounding — Here's What It Actually Means
On April 30, the FDA published a proposed rule that would permanently exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. The compounding workaround is closing — but slower than the headlines suggest.
SYNCHRONIZE-1: Survodutide Hits 16.6% Weight Loss in Phase 3
Boehringer Ingelheim and Zealand Pharma reported that survodutide, a glucagon/GLP-1 dual agonist, produced 16.6% mean weight loss at 76 weeks in its first Phase 3 obesity trial.
PIONEER TEENS: Oral Semaglutide Posts Positive Phase 3 Results in Pediatric Type 2 Diabetes
Novo Nordisk reported topline results from a phase 3a trial of oral semaglutide in patients aged 10 to 17 with type 2 diabetes — the first oral GLP-1 RA to clear a pivotal study in this group.
FDA Pulls 12 Peptides Off Its "Do Not Compound" List — What Changes, and What Doesn't
On April 15, the FDA quietly removed twelve peptide bulk substances from Category 2 of the 503A interim policy. A July advisory-committee vote will decide whether they actually become compoundable.
Wegovy HD Cleared in 54 Days: What the FDA's New Voucher Pathway Means for Peptide Drugs
The FDA approved semaglutide 7.2 mg on March 19 — fifty-four days after filing — using the Commissioner's National Priority Voucher pathway. Faster reviews are great. The precedent is more complicated.
Foundayo (Orforglipron) Approved: The First Oral Small-Molecule GLP-1 for Weight Loss
On April 1, the FDA approved Eli Lilly's orforglipron under the brand Foundayo. Unlike oral Wegovy, it's a small-molecule pill that doesn't require an empty stomach — and pricing is undercutting injectables.
All news posts are paraphrased from primary sources. Each post links to its original publication. Read more about how the News Desk operates or subscribe via RSS.