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Balinatunfib - Sanofi

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Drug Profile

Balinatunfib - Sanofi

Alternative Names: SAR-441566

Latest Information Update: 03 Nov 2025

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At a glance

  • Originator Sanofi
  • Class Amines; Anti-inflammatories; Antipsoriatics; Antirheumatics; Azabicyclo compounds; Benzimidazoles; Cyclobutanes; Fluorinated hydrocarbons; Heterocyclic compounds with 4 or more rings; Ketones; Phenyl ethers; Pyrimidines; Small molecules
  • Mechanism of Action Tumour necrosis factor alpha inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Crohn's disease; Psoriasis; Rheumatoid arthritis; Ulcerative colitis
  • No development reported Inflammation

Most Recent Events

  • 29 Oct 2025 Sanofi plans a phase II SPECIFI-IBD-LTS trial for Crohn's Disease or Ulcerative Colitis ( Treatment-experienced) in unknown location (PO, Tablet) in December 2025 (NCT07222189)
  • 16 Sep 2025 Chemical structure information added.
  • 01 Aug 2025 Sanofi completes a phase I trial in Healthy volunteers in Belgium (PO) (CTIS2024-519860-41-00)

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