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Etranacogene dezaparvovec - CSL Behring

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Drug Profile

Etranacogene dezaparvovec - CSL Behring

Alternative Names: AAV5-FIX-Padua; AAV5-hFIXco-Padua; AMT 061; CSL-222; Etranacogene dezaparvovec - CSL Behring/uniQure; Etranacogene dezaparvovec-drlb; EtranaDez; HEMGENIX; Lanacogene vosiparvovec

Latest Information Update: 29 Aug 2025

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At a glance

  • Originator uniQure
  • Developer CSL Behring
  • Class Antihaemorrhagics; Gene therapies
  • Mechanism of Action Factor IX replacements; Gene transference
  • Orphan Drug Status

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

    Yes - Haemophilia B
  • New Molecular Entity No

Highest Development Phases

  • Marketed Haemophilia B

Most Recent Events

  • 28 Jul 2025 Phase-III clinical trials in Haemophilia B (In adolescents) in USA (IV) (NCT07080905)
  • 15 Jul 2025 CSL Behring plans phase III IX-TEND 3004 trial for Haemophilia B (In adolescents)(IV, Infusion) in July 2025 (NCT07080905)(EudraCT2023-505805-18-00)
  • 19 Mar 2025 CSL Behring completes a phase III trial in Haemophilia B in USA, Belgium, Denmark, Germany, Ireland, Sweden, United Kingdom, Netherlands (IV) (NCT03569891)

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