For patients and healthcare providers in the United States, you can learn more about Oxbryta® by visiting the product website or downloading the U.S. Full Prescribing Information.
P-VOX-US-00181 v3
Our Company
GBT is working to discover, develop and deliver life-changing treatments for people living with grievous blood-based disorders, starting with sickle cell disease
Our goal is to transform the treatment of sickle cell disease (SCD), an overlooked rare condition, and help address the urgent needs of the community. Our mission is driven by the historical lack of understanding and attention given to SCD. Although the fundamental cause of SCD has been understood for decades, therapeutic innovation and access to care has significantly lagged.
GBT’s medicine is the first treatment approved by the FDA to target an underlying cause of SCD. We are developing additional investigational treatments that have the potential to better the lives of patients.
Our history: we’re proud of all we have accomplished alongside the SCD community in our first 10 years and remain committed to our goal of changing the treatment paradigm in SCD.
DEC 2021
Oxbryta® (voxelotor) Approved by the U.S. FDA for SCD Patients as Young as 4 Years of Age
The approval of GBT’s medicine for SCD was expanded to treat children ages 4 years to less than 12 years. The FDA also approved Oxbryta tablets for oral suspension, a new dispersible tablet dosage form.
OCT 2021
GBT Wins Prestigious Prix Galien USA Award for Oxbryta
Considered the equivalent of the Nobel Prize in biopharmaceutical research, Prix Galien USA honored Oxbryta as the Best Biotechnology Product for 2021.
SEP 2021
GBT Establishes The GBT Foundation
The GBT Foundation is a community-focused, charitable entity that seeks to improve the health and well-being of underserved patient communities around the world, particularly for people living with SCD.
APR 2021
Complete Analysis of Phase 3 HOPE Study of Oxbryta Published in The Lancet Haematology
Complete 72-week results from the Phase 3 HOPE Study were published in The Lancet Haematology.
JAN 2021
European Medicines Agency (EMA) Accepts Marketing Authorization Application (MAA) for Oxbryta
GBT is seeking full marketing approval from the EMA for Oxbryta to treat hemolytic anemia in patients with SCD who are 12 years of age and older.
DEC 2019
GBT Partners with Syros Pharmaceuticals to Develop Novel Therapies for SCD and Beta Thalassemia
GBT is collaborating with Syros to discover new medicines that induce fetal hemoglobin to treat SCD and beta thalassemia.
NOV 2019
Oxbryta Approved by the U.S. FDA
GBT’s first medicine for SCD received accelerated approval in the U.S. three months prior to our PDUFA date.
SEPT 2019
Voxelotor NDA Seeking Accelerated Approval Accepted by the U.S. FDA Under Priority Review
Priority Review is granted to therapies that the FDA determines have the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious condition.
JUN 2019
GBT’s Phase 3 HOPE Study of Voxelotor in SCD Published in The New England Journal of Medicine and Presented at the 24th European Hematology Association Congress
Topline results for all patients enrolled in the Phase 3 HOPE Study were published in The New England Journal of Medicine.
FEB 2019
GBT Launches Access to Excellent Care for Sickle Cell Patients (ACCEL) Grants Program
The ACCEL Grants Program provides funding to support the development of sustainable access to care programs for people with SCD in the U.S.
Jan 2018
GBT Receives Breakthrough Therapy Designation for Voxelotor from U.S. FDA for SCD
Breakthrough Therapy designation expedites the development and review of drugs that have demonstrated preliminary clinical evidence indicating the potential for substantial improvement over available therapy.
Jun 2017
Voxelotor Gets PRIME Designation from EMA for SCD
Voxelotor became the first potential treatment for SCD to be accepted for the EU’s new Priority Medicines (PRIME) designation, enabling frequent and early interactions with the EMA to accelerate evaluation and potential marketing approval.
JAN 2017
First Patient Enrolled in GBT’s SCD HOPE Study
The HOPE (Hemoglobin Oxygen Affinity Modulation to Inhibit HbS
PolymErization) Study was designed to assess the efficacy of voxelotor
in producing meaningful clinical improvements in anemia.
AUG 2015
GBT Completes a Successful Initial Public Offering (IPO)
GBT became a public company.
JAN 2015
First Cohort Dosed in Phase 1/2 Trial of Voxelotor
Within 15 months of voxelotor being identified as a potential clinical candidate, the first 8 patients were dosed in a Phase 1/2 clinical trial in SCD.
AUG 2012
Voxelotor (GBT440) Discovered
GBT began testing GBT440 in 2012 to understand its mechanism of action. This molecule would later be named voxelotor.
FEB 2011
Global Blood Therapeutics, Inc. (GBT), Is Founded
The company was founded to develop medicines that could make a transformative impact, and SCD was our first focus.