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Dirloctocogene samoparvovec - Spark Therapeutics

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Drug Profile

Dirloctocogene samoparvovec - Spark Therapeutics

Alternative Names: AAV-Spark 200-hFVIII; RG 6357; SPK-8011

Latest Information Update: 13 Mar 2024

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At a glance

  • Originator Spark Therapeutics
  • Class Antihaemorrhagics; Gene therapies
  • Mechanism of Action Factor VIII 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 A
  • New Molecular Entity No

Highest Development Phases

  • Phase III Haemophilia A

Most Recent Events

  • 29 Feb 2024 Spark Therapeutics plans a phase III KEYSTONE 1 trial for Hemophilia A (Treatment-experienced), in February 2024 (IV, Infusion) (NCT06297486, EudraCT2023-504537-46)
  • 05 Dec 2023 Spark Therapeutics completes a phase I/II trial in Haemophilia A in the US, Australia, Canada, Israel and Thailand (NCT03003533)
  • 12 Dec 2022 Efficacy and adverse events data from a phase I/II trial in Haemophilia A presented at the 64th American Society of Hematology annual meeting (ASH-2022)
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