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
Commercial
Trade Name
FDA
EMA
Oxbryta
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
oxbryta | New Drug Application | 2021-01-20 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
sickle cell anemia | EFO_0000697 | D000755 | D57 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
VOXELOTOR, OXBRYTA, GLOBAL BLOOD THERAPS | |||
2028-12-17 | ODE-394 | ||
2026-11-25 | ODE-281 | ||
2024-11-25 | NCE |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Voxelotor, Oxbryta, Global Blood Theraps | |||
10493035 | 2037-10-12 | DP | |
11020382 | 2036-12-02 | U-3133, U-3134 | |
9447071 | 2035-02-06 | DS, DP | |
10722502 | 2035-02-06 | DP | |
11452720 | 2035-02-06 | U-3459 | |
9248199 | 2034-01-29 | U-2676, U-2715 | |
9018210 | 2033-11-25 | DS, DP | |
10017491 | 2032-12-28 | DP | |
10034879 | 2032-12-28 | DS, DP | |
10806733 | 2032-12-28 | DP |
HCPCS
No data
Clinical
Clinical Trials
29 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 anemia | D000755 | EFO_0000697 | D57 | 5 | 6 | 6 | 3 | 4 | 23 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Leg ulcer | D007871 | — | — | 1 | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Hepatic insufficiency | D048550 | 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 name | VOXELOTOR |
INN | voxelotor |
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 | — |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CC(C)n1nccc1-c1ncccc1COc1cccc(O)c1C=O |
Identifiers
PDB | — |
CAS-ID | 1446321-46-5 |
RxCUI | — |
ChEMBL ID | CHEMBL4101807 |
ChEBI ID | — |
PubChem CID | 71602803 |
DrugBank | DB14975 |
UNII ID | 3ZO554A4Q8 (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
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
Mouse ortholog
—
—
Variants
Clinical Variant
No data
Financial
Oxbryta - Pfizer
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 406 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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661 adverse events reported
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