SPK 8011

Drug Profile

SPK 8011

Alternative Names: SPK-8011

Latest Information Update: 07 Jan 2017

Price : $50

At a glance

  • Originator Spark Therapeutics
  • Class Antihaemorrhagics; Gene therapies
  • Mechanism of Action Gene transference
  • Orphan Drug Status

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

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II Haemophilia A

Most Recent Events

  • 06 Jan 2017 Spark therapeutics announces intention to file IND in 2H 2016
  • 01 Dec 2016 Phase-I/II clinical trials in Haemophilia A in USA (IV) (NCT03003533)
  • 13 Jun 2016 Spark Therapeutics plans a phase I/II trial in Haemophilia A in H2 of 2016
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