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Drug ReportsVoxelotor
Oxbryta(voxelotor)
Oxbryta (voxelotor) is a small molecule pharmaceutical. Voxelotor was first approved as Oxbryta on 2019-11-25. It is used to treat sickle cell anemia in the USA. It has been approved in Europe to treat anemia, hemolytic anemia, and sickle cell anemia. It is known to target cytochrome P450 2C8, cytochrome P450 3A4, and cytochrome P450 2C9.
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FDA Novel Drug Approvals 2019
Events Timeline
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Clinical
Drug
Target
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Financial
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Events Timeline
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1Y
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FDA approval date
EMA approval date
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Study first post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Voxelotor
Tradename
Company
Number
Date
Products
OXBRYTAGlobal Blood TherapeuticsN-213137 DISCN2019-11-25
2 products, RLD
OXBRYTAGlobal Blood TherapeuticsN-216157 DISCN2021-12-17
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
oxbrytaNew Drug Application2023-12-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sickle cell anemiaEFO_0000697D000755D57
Agency Specific
FDA
EMA
Expiration
Code
VOXELOTOR, OXBRYTA, GLOBAL BLOOD THERAPS
2028-12-17ODE-394
2026-11-25ODE-281
2024-11-25NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Voxelotor, Oxbryta, Global Blood Theraps
104930352037-10-12DP
110203822036-12-02U-3133, U-3134
94470712035-02-06DS, DP
107225022035-02-06DP
114527202035-02-06U-3459
92481992034-01-29U-2676, U-2715
90182102033-11-25DS, DP
100174912032-12-28DP
100348792032-12-28DS, DP
108067332032-12-28DP
ATC Codes
B: Blood and blood forming organ drugs
— B06: Other hematological agents in atc
— B06A: Other hematological agents in atc
— B06AX: Other hematological agents in atc
— B06AX03: Voxelotor
HCPCS
No data
Clinical
Clinical Trials
31 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sickle cell anemiaD000755EFO_0000697D576763425
AnemiaD000740HP_0001903D64.9—1—1—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
UlcerD014456MPATH_579———1——1
Leg ulcerD007871————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypoxiaD000860HP_0012418R09.0212———3
FibrosisD005355———2———2
Idiopathic pulmonary fibrosisD054990—J84.112—2———2
Pulmonary fibrosisD011658———2———2
Chronic renal insufficiencyD051436—N1811———1
Kidney diseasesD007674EFO_0003086N0811———1
Lung diseasesD008171HP_0002088J98.4—1———1
Acute lung injuryD055371EFO_0004610——1———1
Lung injuryD055370—S27.30—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N191————1
Liver diseasesD008107HP_0002910K70-K771————1
Hepatic insufficiencyD048550——1————1
Healthy volunteers/patients———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVoxelotor
INNvoxelotor
Description
Voxelotor, sold under the brand name Oxbryta, is a medication used for the treatment of sickle cell disease. Voxelotor is the first hemoglobin oxygen-affinity modulator. Voxelotor has been shown to have disease-modifying potential by increasing hemoglobin levels and decreasing hemolysis indicators in sickle cell patients. It has a safe profile in sickle cell patients and healthy volunteers, without any dose-limiting toxicity. It was developed by Global Blood Therapeutics, a subsidiary of Pfizer.
Classification
Small molecule
Drug class—
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Structure (InChI/SMILES or Protein Sequence)
CC(C)n1nccc1-c1ncccc1COc1cccc(O)c1C=O
Identifiers
PDB—
CAS-ID1175852-30-8
RxCUI—
ChEMBL IDCHEMBL4101807
ChEBI ID—
PubChem CID71602803
DrugBankDB14975
UNII ID3ZO554A4Q8 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CYP2C8
CYP2C8
CYP3A4
CYP3A4
CYP2C9
CYP2C9
Organism
Homo sapiens
Gene name
CYP2C8
Gene synonyms
NCBI Gene ID
1558
Protein name
cytochrome P450 2C8
Protein synonyms
CYPIIC8, Cytochrome P450 form 1, Cytochrome P450 IIC2, Cytochrome P450 MP-12, Cytochrome P450 MP-20, cytochrome P450, family 2, subfamily C, polypeptide 8, cytochrome P450, subfamily IIC (mephenytoin 4-hydroxylase), polypeptide 8, flavoprotein-linked monooxygenase, microsomal monooxygenase, P450 form 1, S-mephenytoin 4-hydroxylase, xenobiotic monooxygenase
Uniprot ID
Q9UCZ9
Mouse ortholog
—
—
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Oxbryta – Pfizer
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 670 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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20,955 adverse events reported
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