Global Blood Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Global Blood Therapeutics (GBT).
Over the past two years, Global Blood Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Inclacumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Inclacumab + GBT601 FDA Regulatory Events
Inclacumab + GBT601 is a drug developed by Global Blood Therapeutics for the following indication: Sickle Cell Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Inclacumab + GBT601
- Announced Date:
- August 15, 2025
- Indication:
- Sickle Cell Disease
Announcement
Pfizer Inc announced results from the Phase 3 THRIVE-131 study evaluating inclacumab, an investigational P-selectin inhibitor, in patients 16 years of age and older with sickle cell disease (SCD).
Read Announcement
Global Blood Therapeutics FDA Events - Frequently Asked Questions
As of now, Global Blood Therapeutics (GBT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Global Blood Therapeutics (GBT) has reported FDA regulatory activity for Inclacumab + GBT601.
The most recent FDA-related event for Global Blood Therapeutics occurred on August 15, 2025, involving Inclacumab + GBT601. The update was categorized as "Results," with the company reporting: "Pfizer Inc announced results from the Phase 3 THRIVE-131 study evaluating inclacumab, an investigational P-selectin inhibitor, in patients 16 years of age and older with sickle cell disease (SCD)."
Currently, Global Blood Therapeutics has one therapy (Inclacumab + GBT601) targeting the following condition: Sickle Cell Disease.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:GBT) was last updated on 8/22/2025 by MarketBeat.com Staff
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