Peptide News Digest

Safiglipron Phase 3 in Nature Medicine, Elamipretide Restores Fertility in Aged Mice, Lancet Papers on GLP-1s in Women

Safiglipron's Phase 3 trial against dapagliflozin is published, elamipretide restores fertility in aged mice, and Lancet papers examine GLP-1s in women.

7 stories · Covering clinical-trials, research, regulatory

Editor's Note

Monday's news came mostly from journals, and the evidence varied a lot in strength. Nature Medicine published the full OUTSTAND-2 trial of Hengrui's oral GLP-1 pill safiglipron, a randomized, double-blind comparison with dapagliflozin, while Novo's liver-fat finding for Wegovy came from a post hoc look at a 55-person MRI subgroup. The Lancet's papers on GLP-1s in women show how thin pregnancy data remain: most outcomes showed no clear signal, but the one higher figure, for early pregnancy loss, lumped miscarriages and terminations together. Outside metabolism, a mitochondria-targeting peptide already approved for a rare disease restored fertility in aged mice, Japanese chemists described a cleaner way to make peptides, and stem cell entrepreneurs told STAT they hope to follow compounded peptides into the FDA's good graces. Novo also said the FDA's review of its hemophilia drug denecimig will run past the third quarter because of manufacturing-site fixes.

Clinical Trials

Nature Medicine Publishes Phase 3 OUTSTAND-2: Hengrui's Oral GLP-1 Pill Safiglipron Matches Dapagliflozin on HbA1c, and Its Top Dose Beats It

Full results of OUTSTAND-2, published in Nature Medicine on Monday, October 5, 2026, come from 810 adults in China with type 2 diabetes not controlled on metformin, randomized to once-daily safiglipron (HRS-7535) 30, 60, or 90 mg or the SGLT2 inhibitor dapagliflozin 10 mg for 32 weeks. HbA1c fell 0.22 to 0.40 percentage points more on safiglipron, meeting the non-inferiority goal at every dose, and the 90 mg dose also passed the superiority test; weight loss was similar (2.35% to 4.17% on safiglipron versus 3.60% on dapagliflozin). Gastrointestinal side effects were more common on safiglipron, 3.9% to 4.0% stopped for adverse events versus 1.5% on dapagliflozin, Hengrui funded the trial, whose topline results were announced in July.

#safiglipron #hrs-7535 #hengrui #oral-glp-1 #type-2-diabetes
Clinical Trials

Novo Post Hoc Analysis at EASD: Liver Fat Fell Below the Fatty-Liver Threshold in 23 of 26 Wegovy Users in a Small MRI Subgroup

Novo Nordisk reported on Thursday, October 1, 2026, at EASD in Milan, a post hoc, exploratory analysis pooling 1,919 adults from its STEP UP and STEP UP T2D trials who took Wegovy 7.2 mg, Wegovy 2.4 mg, or placebo. In a 55-person subgroup whose liver fat was measured by MRI, average liver fat fell from 8.8% at baseline to 3.1% at week 72, and 23 of the 26 participants who started above the 5% threshold for fatty liver ended below it. Liver fat was not a prespecified endpoint of either trial, and Novo pooled the two Wegovy doses for the MRI result.

#wegovy #semaglutide #masld #novo-nordisk #easd-2026
Research

Lancet Women's Health Papers Find No Clear Rise in Most Pregnancy Risks After GLP-1 Exposure, but Flag Early Pregnancy Loss and Evidence Gaps

The Lancet Obstetrics, Gynaecology & Women's Health published two papers on GLP-1 drugs in women on Tuesday, September 29, 2026. A systematic review, meta-analysis, and international consensus statement led by Sarah Dib pooled seven studies covering more than 43,000 exposed women with diabetes and found no clear link to congenital anomalies, preterm birth, stillbirth, or preeclampsia; early pregnancy loss, which counted miscarriages and terminations together, was 31% more common among exposed women in two studies, a result the authors said needs caution. A companion review led by Claire Meek of the Leicester Diabetes Research Centre said the drugs' global rollout has outpaced guidance for women and cited studies in which most long-term users fell short on vitamin D, iron, and other nutrients.

#glp-1 #pregnancy #womens-health #type-2-diabetes
Research

Mitochondria-Targeting Peptide Elamipretide Restores Fertility and Egg Quality in Aged Mice, Aging Cell Study Reports

Researchers at Nanjing Agricultural University reported in Aging Cell, published online Friday, October 2, 2026, that elamipretide increased litter size in aged female mice and improved the quality and maturation of their eggs, an effect they traced to a vitamin B6 and VEGF signaling pathway. In lab experiments, the peptide also improved the maturation, fertilization, and early cell division of eggs from older women. Elamipretide received FDA accelerated approval as Forzinity for the rare mitochondrial disease Barth syndrome in September 2025, and it has not been tested as a fertility treatment in people.

#elamipretide #fertility #mitochondria #preclinical
Regulatory

FDA Extends Review of Novo Nordisk's Hemophilia A Drug Denecimig Over Manufacturing-Site Fixes; U.S. Launch Now Aimed for First Half of 2027

Novo Nordisk said on Friday, October 2, 2026 that the FDA's review of its biologics license application for denecimig, a bispecific antibody that mimics activated clotting factor VIII in hemophilia A, is still ongoing with no new action date because of remediation work at a manufacturing facility. Novo filed in September 2025 and had expected a decision in the third quarter of 2026; the FDA has not identified deficiencies in the clinical efficacy or safety data, and Novo now aims to launch in the U.S. in the first half of 2027. The company said the delay does not change its 2026 financial outlook.

#denecimig #novo-nordisk #hemophilia-a #fda
Regulatory

Stem Cell Advocates at the PepMed 2026 Peptide Conference Seek the FDA Openness That Compounded Peptides Have Gained

STAT reported on Monday, October 5, 2026 from PepMed 2026, a conference for regenerative health businesses held by the American Academy of Peptide Medicine, that stem cell entrepreneurs see the FDA's recent openness to compounded peptides as a model for bringing unapproved stem cell therapies out of the gray market. Entrepreneur Chuck Meeker predicted a series of FDA roundtables on stem cells before the end of the year; the FDA declined to say whether any were planned. Commercially sold, unapproved stem cell therapies have remained out of favor with the agency.

#peptide-compounding #stem-cells #regenerative-medicine #fda
Research

Tokyo Chemists Report Filtration-Free Liquid-Phase Peptide Synthesis Using Magnetic Nanoparticles

Researchers at Tokyo University of Agriculture and Technology described in Bioscience, Biotechnology, and Biochemistry, published online Monday, October 5, 2026, a liquid-phase peptide synthesis method that pulls tagged peptides out of solution with hydrophobic magnetic nanoparticles after each coupling and deprotection step, replacing the slow filtration step of conventional tag-assisted synthesis. Liquid-phase synthesis uses fewer reagents and solvents than the standard solid-phase method. The team made the model peptide leucine-enkephalin in high yield and purity without chromatography; the abstract reports results only for that model peptide.

#peptide-synthesis #peptide-manufacturing #green-chemistry

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