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AFTX 201

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Drug Profile

AFTX 201

Alternative Names: AFTX-201

Latest Information Update: 11 Mar 2026

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At a glance

  • Originator AFFINIA THERAPEUTICS
  • Class Cardiovascular therapies; Gene therapies
  • Mechanism of Action BAG3 protein replacements; Gene transference
  • Orphan Drug Status

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

    Yes - Dilated cardiomyopathy
  • New Molecular Entity No

Highest Development Phases

  • Preclinical Dilated cardiomyopathy

Most Recent Events

  • 04 Mar 2026 AFTX 201 receives Fast Track designation for Dilated cardiomyopathy [IV] in USA
  • 18 Feb 2026 AFTX 201 receives Orphan Drug status for Dilated cardiomyopathy in European Union
  • 04 Feb 2026 Affinia Therapeutics plans phase I/II UPBEAT trial for Dilated cardiomyopathy in USA (IV) in March 2026 (NCT07426419)

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