Data updated: May 26, 2026
OXBRYTA (voxelotor)
Trial Activity: Declining 1 active trials
First-in-Class Orphan Drug Breakthrough Therapy Priority Review Fast Track
Rare Disease
Approved 2019-11-25
Development Insights
Pfizer conducting 8 trials (62%)
6 indications explored (Moderate)
→ sickle cell disease (10 trials)
→ sickle cell anemia (2 trials)
→ sickle cell anemia in children (1 trials)
2
Indications
--
Phase 3 Trials
2
Priority Reviews
6
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2019-11-25
- Patent Cliff
- 2037
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, FOR SUSPENSION
OXBRYTA Approval History
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
10 FDA actions from 2019 to 2023 · 1 indication expansions
What OXBRYTA Treats
2 FDA approvalsOriginally approved for its first indication in 2019 . Covers 2 distinct patient populations.
- Other (2)
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Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04218084 HOPE Kids 2 results posted | GBT440-032 2017-000903-26, C5341021 | Ph 3 | terminated | Study to Evaluate the Effect of GBT440 on TCD in Pediatrics With Sickle Cell Disease |
| NCT06023199 | U23-02-4988 | Ph 2 | active not recruiting | Assessing Physical Function in Sickle Cell Patients Taking Voxelotor |
| NCT05018728 VoxSCAN | STUDY00002483 | Ph 2 | terminated | The Effect of Voxelotor on Cerebral Hemodynamic Response in Children With Sickle Cell Anemia |
| NCT03573882 034OLE results posted | GBT440-034 C5341022 | Ph 3 | terminated | Study to Assess the Effect of Long-term Treatment With Voxelotor in Participants Who Have Completed Treatment in Study GBT440-031 |
| NCT04188509 results posted | GBT440-038 2019-003144-76, C5341023 | Ph 3 | terminated | Open-Label Extension of Voxelotor |
| NCT02850406 HOPE-KIDS results posted | GBT440-007 C5341020 | Ph 2 | terminated | Study to Evaluate the Effect of GBT440 in Pediatrics With Sickle Cell Disease |
| NCT04335721 | 2020-0047 | Ph 1, Ph 2 | terminated | A Voxelotor for Sickle Cell Anemia Patients at Highest Risk for Progression of Chronic Kidney Disease |
| NCT05981365 results posted | GBT440-0122 C5341029 | Ph 1 | completed | Voxelotor CYP and Transporter Cocktail Interaction Study |
| NCT05289570 Voxelotor results posted | Pro00109353 | Ph 2 | terminated | Voxelotor for Improving Oxygen Saturation in Adults |
| NCT04247594 results posted | GBT440-029 C5341042 | Ph 2 | terminated | Dose Escalation Study to Evaluate the Safety, Tolerability, PK and PD of Voxelotor in Patients With SCD |
| NCT04400487 ActIVe results posted | GBT440-039 C5341024 | Ph 4 | completed | Actigraphy Improvement With Voxelotor (ActIVe) Study |
| NCT03036813 GBT_HOPE results posted | GBT440-031 C5341043 | Ph 3 | completed | Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE) |
| NCT04581356 | ESR-C006 | Ph 4 | completed | Voxelotor Sickle Cell Exercise Study |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OXBRYTA FDA Label Details
View full patent landscape →
11 OB patents · 6 families ·
255 international docs across 43 countries
OXBRYTA Patents & Exclusivity
Latest Patent: Oct 2037
Exclusivity: Dec 2028
Patents (11 active)
US10493035
Expires Oct 12, 2037
US11020382
Expires Dec 2, 2036
US11944612
Expires Dec 2, 2036
US11452720
Expires Feb 6, 2035
US10722502
Expires Feb 6, 2035
US9447071
Expires Feb 6, 2035
US9248199
Expires Jan 29, 2034
US9018210
Expires Nov 25, 2033
US10806733
Expires Dec 28, 2032
US10017491
Expires Dec 28, 2032
US10034879
Expires Dec 28, 2032
Exclusivity
ODE-281
Until Nov 2026
ODE-394
Until Dec 2028
ODE-394
Until Dec 2028
ODE-281
Until Nov 2026
ODE-394
Until Dec 2028
ODE-394
Until Dec 2028
ODE*
Until Nov 2026
ODE-394
Until Dec 2028
ODE*
Until Nov 2026
ODE-394
Until Dec 2028
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for OXBRYTA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 76 active patents
Trial Analysis
- • 13 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment