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SAR441566 (balinatunfib) is an orally available small molecule inhibitor of tumor necrosis factor (TNF) signaling, developed for the treatment of autoimmune diseases such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, and plaque psoriasis. It works by stabilizing an asymmetrical form of the soluble TNF trimer and blocking its interaction with tumor necrosis factor receptor superfamily member 1A (TNFR1), thereby inhibiting downstream proinflammatory signaling without affecting membrane-bound TNF activity. This mechanism aims to deliver biologic-like efficacy in a convenient oral formulation for patients with chronic inflammatory conditions. The drug is being developed by Sanofi and has reached Phase 2 clinical trials for several autoimmune indications.
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