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For a broader survey of published preclinical findings and study design considerations, the BPC-157 research overview consolidates the current experimental landscape
The closest performing GLP-1 medicine in terms of average weight loss is Novo Nordisks CagriSema, an Amylin/GLP-1 dual agonist, which had an average weight loss of 22.7% after 68 weeks in Phase 3 trials
Indeed, CDER Acting Director Michael Davis reinforced the policy point publicly on X, emphasizing that compounded GLP1 products are not FDAapproved and have not undergone the rigorous review for safety, efficacy, and manufacturing quality that is required for drugs approved through the new drug application (NDA) or abbreviated new drug application (ANDA) pathways.[3] This is now the third major set of warning letters in less than a year with the majority aimed at telehealth marketing of compounded GLP-1 products: September 2025: roughly 80 warning letters and 40 untitled letters March 2026: 30 warning letters June 2026: 25 warning letters The Claims FDA Is Targeting As in earlier rounds, the June 2026 letters appear highly standardized and focus on consumerfacing promotion of compounded GLP-1 products
This is unusual for a peptide-based therapy
Eli Lilly expects to complete phase 3 studies by late 2025, with potential regulatory submissions following in 2026
N Engl J Med (2020) 383(15):141324
