June 2019

GBT’s Phase 3 HOPE Study for Voxelotor in SCD Published in the New England Journal of Medicine

24-week efficacy and safety data from the 274 patients enrolled in the Phase 3 HOPE Study were published in The New England Journal of Medicine. The study met the primary endpoint and voxelotor provided a significant and sustained improvement in hemoglobin levels. The data were also presented at the 24th European Hematology Association (EHA) Congress.

Dec 2018

GBT and FDA Agree on Proposal Relating to an Accelerated Approval Pathway for Voxelotor for the Treatment of SCD

The FDA grants accelerated approval under subpart H for new drugs that address serious or life-threatening illnesses and appear to provide meaningful therapeutic benefit to patients over existing treatments. GBT plans to submit a New Drug Application for voxelotor for the treatment of SCD under this pathway.

Jun 2018

GBT Reports Positive Top-line Data from Part A of the Phase 3 HOPE Study

Patients treated with voxelotor achieved a statistically significant increase in hemoglobin compared to baseline, the primary endpoint, at 12 weeks.

Jan 2018

GBT Receives Breakthrough Therapy Designation for Voxelotor from 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.

Sep 2017

GBT Receives Rare Pediatric Disease Designation from FDA for Voxelotor in SCD

This designation demonstrated the FDA’s recognition that the SCD community faces a critical need for new treatments and further endorsed the potential of GBT’s voxelotor program.

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 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 enrollment was launched with plans to conduct the study at approximately 80 leading SCD sites globally. The study is expected to enroll up to approximately 400 adults and adolescents with SCD.

Nov 2016

European Medicines Agency (EMA) Grants Orphan Drug Designation for Voxelotor

In growing recognition of the current limitations in treatment for SCD among the global regulatory community, the EMA designated voxelotor as an orphan medicinal product, qualifying GBT for a range of development and commercial incentives in the European Union (EU).

Sep 2016

GBT Announces Agreement with FDA to Begin Phase 3 HOPE Study in SCD

The FDA approved the first of its kind pivotal trial design for SCD that combines a Phase 2b dose escalation phase with a Phase 3 efficacy phase, to accelerate voxelotor’s development and completion of this registrational study.

Dec 2015

FDA Grants Orphan Drug Designation for Voxelotor

With orphan drug designation, GBT qualified for various incentives for voxelotor, including tax credits for qualified clinical trials and market exclusivity upon U.S. marketing approval.

Oct 2015

U.S. Food and Drug Administration (FDA) Grants Voxelotor Fast Track Designation

Acknowledging that SCD is a serious health problem that needs new treatment options, the FDA granted voxelotor Fast Track designation which has the potential to accelerate drug approval and access by patients.

Aug 2015

GBT Completes a Successful Initial Public Offering (IPO)

GBT raised $120 million in the initial public offering to fund further clinical trials of voxelotor. Since its IPO, GBT has successfully completed multiple follow-on offerings, most recently in March 2018.

Jan 2015

First Cohort Dosed in Phase 1/2 Trial of Voxelotor

Within 15 months of identifying voxelotor as a potential clinical candidate, the first eight patients were dosed in a Phase 1/2 clinical trial for SCD.

Dec 2014

Proof-of-Concept Achieved in Sickle Cell Disease (SCD)

Experiments run in collaboration with Emory University provided pre-clinical proof-of-concept for voxelotor as a polymerization inhibitor.

Jun 2014

Dr. Ted Love Joins GBT as Chief Executive Officer (CEO)

Inspired by the promise of GBT’s science and the plight of SCD patients, board member Ted Love came out of retirement to become CEO.

Sep 2013

Voxelotor Named Clinical Candidate

Based on promising pre-clinical data, voxelotor was nominated as the first clinical candidate of GBT.

Dec 2012

GBT440 Disclosed in a U.S. Patent Application

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 initially undertook a traditional medicinal chemistry approach for drug discovery to identify promising molecules.