16 September 2026 editorial review · Item
Icovamenib (BMF-219) — oral menin inhibitor: review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the item evidence page →Preventing and curing evidence review — 16 September 2026
- Disposition: corrected/updated. Current item
lastReviewed: 2026-09-16. - Claim check: COVALENT-112 is now completed (28 August registry; 37 actual participants), not terminated. Sponsor Week-12 n=5 C-peptide and Week-52 historical comparison remain uncontrolled and not peer-reviewed. Removed “largest regeneration signal” superlatives; C-peptide is not direct proof of new cell growth. Prior liver-related clinical hold remains relevant.
- Registry NCT06152042: COMPLETED; updated 2026-08-28; enrollment 37 (ACTUAL); primary completion 2025-05-20 (ACTUAL); results not posted in retrieved record.
- Programme/sponsor/conference source boundary: Biomea Fusion Announces Positive 52-Week Results from Phase 2 COVALENT-112 Trial in Type 1 Diabetes (manufacturer); Biomea Fusion Presents New Clinical and Translational Data for Icovamenib at the ADA 86th Scientific Sessions (manufacturer); Biomea Fusion Announces BMF-219 in Diabetes Placed on Clinical Hold (manufacturer); FDA Lifts Clinical Hold on BMF-219 in Type 2 and Type 1 Diabetes Trials (manufacturer).