Oxbryta

(Voxelotor)

ApprovedSmall molecule

Oxbryta is a small molecule that works as a Hemoglobin Hba Positive Modulator.[2] It is being used across 4 indications, with its most advanced program in Approved.[1]

Oxbryta is one of 144 small molecule programs targeting Anemia (phenotype). It is currently in Approved.

Indications

Total Trials

Active Trials

143

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Anemia (phenotype)Active, not recruiting

Liver DiseaseApproved

Kidney DiseaseApproved

Acute Lung InjuryApproved

Anemia (phenotype)Approved

Active, not recruiting

Liver DiseaseApproved

Approved

Kidney DiseaseApproved

Approved

Acute Lung InjuryApproved

Approved

Competition

Competitive Landscape

105 competitors in Kidney Disease

#DrugCompanyPhaseTrials

Sensipar

Amgen

Approved

2 2

Kerendia

Bayer

Approved

1 3

Oxbryta

GGlobal Blood Therapeutics

Approved

19 4

Medrol

Nexavar

Zyloprim

Veozah

Fosrenol

Dayvigo

Scemblix

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Sickle Cell Disease6 trials

Expanded Access to Voxelotor for Patients With Sickle Cell Disease Who Have No Alternative Treatment Options

No longer available· Pfizer logo

Pfizer··NCT03943615

Expanded Access Protocol for Adults and Pediatric Patients With Sickle Cell Disease Who Have No Alternative Treatment Options

No longer available· Pfizer logo

Pfizer··NCT04724421

Study to Evaluate the Effect of GBT440 on TCD in Pediatrics With Sickle Cell Disease

Terminated· Pfizer logo

Pfizer·Phase 3·NCT04218084·236 enrolled

Show 3 more trials

Study to Evaluate the Effect of GBT440 in Pediatrics With Sickle Cell Disease

Terminated· Pfizer logo

Pfizer·Phase 2·NCT02850406·147 enrolled

Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE)

Completed· Pfizer logo

Pfizer·Phase 3·NCT03036813·449 enrolled

Assessing Functional Capacity in Sickle Cell Patients Receiving Voxelotor

Completed·IInova Health Care Services·Phase 2·NCT06023199·6 enrolled

Chronic Kidney Disease1 trial

A Voxelotor for Sickle Cell Anemia Patients at Highest Risk for Progression of Chronic Kidney Disease

Terminated·UUniversity of Illinois at Chicago·Phase 1/2·NCT04335721·12 enrolled

Oxygenation1 trial

Voxelotor Brain Oxygenation and Neurocognitive Study

Withdrawn· Pfizer logo

Pfizer·Phase 4·NCT05228821

Adult1 trial

Voxelotor for Improving Oxygen Saturation in Adults

Terminated·—·Phase 2·NCT05289570·3 enrolled

MPR1 trial

Actigraphy Improvement With Voxelotor (ActIVe) Study

Completed· Pfizer logo

Pfizer·Phase 4·NCT04400487·25 enrolled

8 more indications

Neurocognitive Function1 trial

Voxelotor Neurocognitive Function Study

Terminated· Pfizer logo

Pfizer·Phase 3·NCT05228834·1 enrolled

Complication1 trial

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT05199766·30 enrolled

Leg Ulcer1 trial

Resolution of Sickle Cell Leg Ulcers With Voxelotor

Terminated· Pfizer logo

Pfizer·Phase 3·NCT05561140·88 enrolled

Anemia1 trial

The Effect of Voxelotor on Cerebral Hemodynamic Response in Children With Sickle Cell Anemia

Terminated·EEmory University·Phase 2·NCT05018728·22 enrolled

Treatment1 trial

Study to Assess the Effect of Long-term Treatment With Voxelotor in Participants Who Have Completed Treatment in Study GBT440-031

Terminated· Pfizer logo

Pfizer·Phase 3·NCT03573882·179 enrolled

Exercise1 trial

Voxelotor Sickle Cell Exercise Study

Completed·—·Phase 4·NCT04581356·14 enrolled

Interaction1 trial

Voxelotor CYP and Transporter Cocktail Interaction Study

Completed· Pfizer logo

Pfizer·Phase 1·NCT05981365·44 enrolled

Unspecified2 trials

Open-Label Extension of Voxelotor

Terminated· Pfizer logo

Pfizer·Phase 3·NCT04188509·162 enrolled

Dose Escalation Study to Evaluate the Safety, Tolerability, PK and PD of Voxelotor in Patients With SCD

Terminated· Pfizer logo

Pfizer·Phase 2·NCT04247594·6 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 17, 2021

OXBRYTA

NDA NDA216157

Oct 14, 2022

OXBRYTA

NDA NDA213137

Sources

References

[1]
ClinicalTrials.gov — 19 trial records for Voxelotor. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Voxelotor compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Voxelotor. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA213137). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Oxbryta. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Global Blood Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Hemoglobin Hba Positive Modulator[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: GGlobal Blood Therapeutics

Patent Landscape[5]

Patent Cliff

Dec 28, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10034879Dec 28, 2032

10017491Dec 28, 2032

10806733Dec 28, 2032

9018210Nov 25, 2033

9248199Jan 29, 2034

6 more patents

11452720Feb 6, 2035

10722502Feb 6, 2035

9447071Feb 6, 2035

11944612Dec 2, 2036

11020382Dec 2, 2036

10493035Oct 12, 2037

Oxbryta

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Sickle Cell Disease6 trials

Chronic Kidney Disease1 trial

Oxygenation1 trial

Adult1 trial

MPR1 trial

Neurocognitive Function1 trial

Complication1 trial

Leg Ulcer1 trial

Anemia1 trial

Treatment1 trial

Exercise1 trial

Interaction1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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