ontunisertib

Ontunisertib is an investigational, oral, gastrointestinal‑restricted small‑molecule inhibitor of activin receptor‑like kinase 5 (ALK5), also known as transforming growth factor beta receptor 1 (TGFβR1), being developed by Agomab Therapeutics for the treatment of fibrostenosing Crohn’s disease (FSCD).[1][2][3][5][12] By locally inhibiting TGF‑β–driven fibrotic and inflammatory signaling in the intestinal mucosa while undergoing rapid first‑pass metabolism in the liver, ontunisertib is designed to achieve high exposure in the gut with minimal systemic levels, potentially improving safety relative to systemic ALK5 inhibitors and enabling dual anti‑fibrotic and anti‑inflammatory effects on ileal strictures.[1][2][5] The drug has completed Phase 1 studies in healthy volunteers and a Phase 2a STENOVA trial in FSCD, has shown favorable safety and pharmacokinetics consistent with a gut‑restricted profile, and has received U.S. FDA Fast Track designation for FSCD.[1][2][5][7][9][13]

Other names

ORG-129ORG129ORG 129AGMB-129AGMB129AGMB 129