Peptide research, quality, and regulatory news.
A 2026 review in Separation Science Plus surveys peptide analysis methods and names LC–MS/MS the gold standard for quantification. How chromatographic purity, mass-spectrometric identity and stability testing answer different questions.
Boehringer Ingelheim says its investigational GLP-1/GIP/NPY2 triple receptor agonist BI 3034701 has entered Phase II development for obesity. What the company announced, and what a Phase II start does and does not mean.
USP and the European Pharmacopoeia now formally recognise recombinant Factor C for bacterial endotoxin testing, and why endotoxin is a separate result on a COA.
Novo Nordisk filed CagriSema with the FDA in December 2025 and says a decision is anticipated by late 2026. What the REDEFINE trials showed, and what REDEFINE 4 did not.
A June 2026 Nature feature weighs the science behind the peptide craze, contrasting roughly 100 approved peptide drugs with under-studied “research use only” compounds.
The FDA’s compounding advisory committee is expected to weigh five more peptides — LL-37, GHK-Cu, Dihexa, Melanotan II and PEG-MGF — for the 503A list by early 2027.
Lilly reported that investigational retatrutide met endpoints in the TRIUMPH-2 and TRIUMPH-3 Phase 3 trials, with a BLA submission planned for Q1 2027.
503A and 503B are two distinct legal compounding pathways under the FD&C Act. Here is how they differ and where research peptides and GLP-1s currently stand.
The FDA published 17 revised draft product-specific guidances for generic peptide products on July 28, 2026, updating impurity, endotoxin and structure recommendations.
An FDA advisory committee recommended six of seven peptides, including BPC-157 and TB-500, for the 503A compounding bulks list at its July 2026 meeting.
