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A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor Administered Orally to Patients With Sickle Cell Disease

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Trial Profile

A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor Administered Orally to Patients With Sickle Cell Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2023

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At a glance

  • Drugs Voxelotor (Primary)
  • Indications Sickle cell anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms GBT-HOPE; HOPE
  • Sponsors Global Blood Therapeutics; Pfizer

Most Recent Events

  • 26 Jul 2022 According to a Global Blood Therapeutics media release, Medicines and Healthcare products Regulatory Agency (MHRA) has granted Great Britain marketing authorization for Oxbryta (voxelotor) for the treatment of hemolytic anemia due to sickle cell disease (SCD) in adult and pediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide (hydroxyurea). The marketing authorization by the MHRA is based on results.
  • 16 Feb 2022 According to a Global Blood Therapeutics media release, the European Commission (EC) has granted Marketing Authorization for Oxbryta (voxelotor) for the treatment of hemolytic anemia due to sickle cell disease (SCD) in adult and pediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide (hydroxyurea) following a positive opinion by CHMP based on results from this study.
  • 17 Dec 2021 According to a Global Blood Therapeutics media release, based on this CHMP opinion, a decision by the European Commission (EC), which authorizes marketing approval in the European Union, is expected in the first quarter of 2022.

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