Peptide News Digest

EU Panel Backs Foundayo and Yuviwel, Mold at Chinese GLP-1 Ingredient Plants, Hormone Therapy and Semaglutide

EU regulators back Lilly's Foundayo pill and the CNP drug Yuviwel, FDA inspectors find mold at two Chinese GLP-1 plants, and a radioligand pairing disappoints.

8 stories · Covering regulatory, research, clinical-trials

Editor's Note

The European Medicines Agency's drug committee recommended two peptide-pathway medicines at its October meeting: Lilly's daily GLP-1 pill Foundayo, for weight management and type 2 diabetes, and Ascendis's weekly CNP prodrug Yuviwel, for children with achondroplasia. Both still need a European Commission decision. In the U.S., inspection reports obtained by Bloomberg described black mold, insects, and discarded samples at a Chinese plant that makes semaglutide and tirzepatide ingredients for compounding; FDA's import-alert list shows both firms named in the reports were added in September and October. A Mayo Clinic records study presented at The Menopause Society linked hormone therapy to more weight loss on semaglutide, though the authors called it too early for firm conclusions. Outside obesity, a UCSF pilot found that adding pembrolizumab to Lutathera did not clearly help and caused more severe side effects than expected, and three lab papers tested peptides in mouse models of colitis, Parkinson's disease, and FAP-positive tumors.

Regulatory

EMA's CHMP Recommends EU Approval of Lilly's Foundayo, a Once-Daily GLP-1 Pill, for Weight Management and Type 2 Diabetes

The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion on October 15, 2026, announced October 16, recommending marketing authorization for Eli Lilly's Foundayo (orforglipron), a once-daily oral GLP-1 receptor agonist, in film-coated tablets from 0.8 mg to 17.2 mg. The recommended indications cover weight management in adults with a BMI of 30 or more, or 27 to under 30 with at least one weight-related condition, and adults with insufficiently controlled type 2 diabetes, alone when metformin is unsuitable or with other diabetes drugs. The most common side effects are nausea, vomiting, and diarrhea; the European Commission normally decides within 67 days of the opinion.

#foundayo #orforglipron #eli-lilly #ema #oral-glp-1
Regulatory

EMA's CHMP Backs Ascendis's Yuviwel (Navepegritide), a Weekly CNP Prodrug, for Children With Achondroplasia

The CHMP adopted a positive opinion on October 15, 2026 recommending EU marketing authorization for Ascendis Pharma's Yuviwel (navepegritide), a prodrug that releases C-type natriuretic peptide to stimulate bone growth, for achondroplasia in children 2 and older whose growth plates have not closed, with the diagnosis confirmed by genetic testing. In a 52-week randomized, double-blind, placebo-controlled trial, it raised annualized growth velocity by 1.49 cm compared with placebo; the most common side effects were injection-site reactions and excess hair growth. The FDA approved Yuviwel in February 2026, and BioMarin's daily CNP analog Voxzogo (vosoritide) is already approved in the EU.

#yuviwel #transcon-cnp #ascendis-pharma #achondroplasia #ema
Regulatory

FDA Inspectors Found Black Mold, Insects, and Discarded Samples at a Chinese Plant Making Semaglutide and Tirzepatide Ingredients for Compounding

FDA inspection reports obtained by Bloomberg through a Freedom of Information Act request describe black mold on equipment, "gross contamination" on floors, and "significant insect activity" in ceilings at Chengdu Shengnuo Biopharm in southwest China, inspected in August, where staff moved documents to lockers and poured product samples into sinks. A September inspection found that Nanjing Chengong Pharmaceutical had bought active ingredients from other factories and applied its own seal without reviewing their test data. FDA's Import Alert 66-40 lists Chengdu Shengnuo as of September 19, 2026 and Nanjing Chengong as of October 1, so their products can be detained at the U.S. border; the companies made semaglutide and tirzepatide ingredients used in compounded drugs.

#compounded-glp-1 #compounding #china #fda #import-alert
Research

Mayo Clinic Records Study Links Menopause Hormone Therapy to More Weight Loss on Semaglutide, With No Significant Difference on Tirzepatide

Mayo Clinic Florida researchers led by Dr. Regina Castaneda presented a retrospective study at The Menopause Society's 2026 annual meeting in San Diego (October 20-24) of women over 45 with a BMI above 27, nearly 2,400 taking semaglutide and nearly 1,500 taking tirzepatide. Among semaglutide users, menopause hormone therapy was associated with significantly greater and sustained weight loss; among tirzepatide users, those on hormone therapy initially lost more, but the difference did not reach statistical significance. The release gives no effect sizes, the study is observational and not yet peer reviewed, and Castaneda said it is "too early to draw firm conclusions" and that weight loss is not an indication for hormone therapy.

#semaglutide #tirzepatide #menopause #real-world-evidence
Clinical Trials

UCSF Pilot of Pembrolizumab Plus Lutathera in High-Risk Neuroendocrine Tumors Finds a 35% Response Rate but More Severe Side Effects Than Expected

University of California, San Francisco researchers reported in Clinical Cancer Research on October 21, 2026 a single-arm pilot of the PD-1 inhibitor pembrolizumab given with 177Lu-DOTATATE (Lutathera), a radioactive somatostatin-analog peptide, in 26 adults with grade 2 or 3 well-differentiated metastatic neuroendocrine tumors and a Ki-67 index above 10%, 20 of them grade 3. The objective response rate was 35%, median progression-free survival 13.3 months, and median overall survival 24.1 months, while severe adverse events occurred in 14 patients (54%). The authors concluded that the added benefit of the immunotherapy remains unclear and that the severe side-effect rate was higher than expected for Lutathera alone.

#lutathera #prrt #neuroendocrine-tumors #radioligand #immunotherapy
Research

Shandong University Peptide Nanoparticle Based on the Macrophage Protein TIMD4 Eases Colitis in Mice

Shandong University researchers reported in PLOS Biology on October 21, 2026 that mice lacking TIMD4, a macrophage protein elevated in colon tissue from people with ulcerative colitis, developed worse chemically induced colitis with more monocytes entering the colon. They designed a peptide from TIMD4's intracellular region, T4(365-378), and packaged it in macrophage-targeted nanoparticles, which reduced inflammatory signaling and eased colitis, performed similarly to a CCR2-blocking drug, and worked better combined with anti-α4β7 or anti-TNF antibodies than either treatment alone. The results are from mice and cells.

#inflammatory-bowel-disease #peptide-nanoparticles #drug-delivery #preclinical
Research

Rouen Team's Analog of the Brain Neuropeptide ODN Protects Dopamine Neurons in a Mouse Model of Parkinson's Disease

Researchers at the University of Rouen Normandy and Inserm reported in Frontiers in Pharmacology on October 21, 2026 that a single 10-nanogram injection into the brain's ventricles of OP, an analog of octadecaneuropeptide (ODN), a peptide made by astrocytes, prevented the loss of dopamine-producing neurons in mice given the toxin MPTP. The peptide reduced oxidative damage, lowered the inflammatory marker TNF-α while raising IL-10, and preserved tight-junction proteins of the blood-brain barrier, assessed seven days after the toxin. The work is in an acute mouse model, and the peptide was delivered directly into the brain.

#parkinsons #neuroprotection #neurodegeneration #preclinical
Research

Chinese Team's Sugar-Modified FAP-Targeting Peptide Tracer Shows About Five Times the Tumor Uptake of FAP-2286 in Mice

Researchers from the Chinese Academy of Sciences and Southern Medical University reported in the Journal of Medicinal Chemistry on October 20, 2026 FAP-Man, a mannose-modified version of the FAP-2286 peptide scaffold that targets fibroblast activation protein, which is abundant in tumor-associated fibroblasts. In mice with U87MG tumors, the gallium-68 version reached 16.9% of the injected dose per gram of tumor at one hour versus 3.2% for gallium-68 FAP-2286, with better tumor-to-liver contrast, and lutetium-177 and actinium-225 versions slowed tumor growth compared with saline. The authors describe preliminary clinical PET scans as supportive but give no patient numbers in the abstract.

#peptide-imaging #radioligand #fap #preclinical

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