RFK Jr. moves to reverse FDA peptide ban amid safety pushback; Lilly retatrutide hits Phase 3 endpoints; oral semaglutide may outperform orforglipron.
10 stories · Covering regulatory, clinical-trials, research, industry
Today's peptide landscape is dominated by a seismic regulatory fight: ProPublica published a major investigative report revealing that RFK Jr. is poised to reverse the FDA's 2023 ban on 19 injectable peptides from compounding pharmacies, with former FDA officials pushing back hard. Meanwhile, the clinical pipeline keeps delivering — Eli Lilly reported positive Phase 3 results for retatrutide in type 2 diabetes, and a new indirect analysis suggests oral semaglutide may outperform the just-approved orforglipron (Foundayo) on weight loss. A Medscape analysis of the FAERS database found different risk profiles across GLP-1 drugs, adding nuance to the safety conversation. Across 14 stories today, the tension between regulatory caution and consumer demand for peptides has never been sharper.
ProPublica reveals the potential reversal of the FDA's 2023 ban on 19 compounded peptides. Three former FDA officials, including former acting commissioner Janet Woodcock, say RFK Jr. mischaracterized their work and that documented safety concerns supported the ban.
Eli Lilly's triple agonist (GIP/GLP-1/glucagon) retatrutide met its primary A1C reduction endpoint and all key secondary endpoints at 40 weeks in the TRANSCEND-T2D-1 trial.
Published the day after Foundayo's FDA approval, a new indirect comparison found oral semaglutide may produce greater weight loss than orforglipron with fewer GI discontinuations.
Analysis of the FAERS database (2012–2025) examining exenatide, liraglutide, dulaglutide, semaglutide, and tirzepatide reveals distinct risk profiles, suggesting not all GLP-1 agents carry the same safety concerns.
A physician essays about a patient who stopped her statin despite high coronary calcium yet continues injecting BPC-157 ordered online, highlighting the growing trust gap between consumer-hyped peptides and evidence-backed medications.
Takeda/Protagonist Therapeutics' rusfertide, a first-in-class hepcidin mimetic peptide, received NDA acceptance and priority review. The Phase 3 VERIFY study showed it more than doubled clinical response rates.
Managed Healthcare Executive compares Foundayo (orforglipron) vs oral Wegovy (semaglutide). ACHIEVE-3 trial data showed Foundayo superior on HbA1c, but oral Wegovy may edge ahead on weight loss.
Several peptide-loaded hydrogels are already in Phase 3 clinical trials for chronic and acute wound care, signaling an accelerating transition from bench to pharmacy shelf.
With one in ten American adults already on GLP-1 drugs, next-generation medications including Foundayo and retatrutide could reach the ~25% of patients who don't respond to current GLP-1 monotherapies.
Researchers engineered PLGA nanocomplexes functionalized with iRGD tumor-penetrating peptides to deliver paclitaxel combined with medicinal fungus extract, targeting the PDCD4 gene to overcome drug resistance.