Fomepizole
Antizol (fomepizole) is a small molecule pharmaceutical. Fomepizole was first approved as Antizol on 1997-12-04. It is used to treat poisoning in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| chemically-induced disorders | D064419 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fomepizole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ANTIZOL | Par Pharmaceutical | N-020696 DISCN | 1997-12-04 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| antizol | New Drug Application | 2009-07-27 |
| fomepizole | ANDA | 2023-02-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| poisoning | EFO_0008546 | D011041 | T65.91 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Fomepizole, Antizol, Par Pharm Inc | |||
| 7553863 | 2027-06-30 | DS, DP | |
HCPCS
Code | Description |
|---|---|
| J1451 | Injection, fomepizole, 15 mg |
Clinical
Clinical Trials
56 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | 3 | 4 | — | — | 6 | ||
| Bone neoplasms | D001859 | EFO_0003820 | D16 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 2 | 1 | — | — | 3 | 6 |
| Castration-resistant prostatic neoplasms | D064129 | — | 1 | — | — | — | 1 | ||
| Infertility | D007246 | EFO_0000545 | — | 1 | — | — | — | 1 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperandrogenism | D017588 | — | — | — | — | 1 | 1 | ||
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | — | 1 | 1 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FOMEPIZOLE |
| INN | fomepizole |
| Description | Fomepizole is a member of the class of pyrazoles that is 1H-pyrazole substituted by a methyl group at position 4. It has a role as an antidote, a protective agent and an EC 1.1.1.1 (alcohol dehydrogenase) inhibitor. It derives from a hydride of a 1H-pyrazole. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Cc1cn[nH]c1 |
Identifiers
| PDB | — |
| CAS-ID | 7554-65-6 |
| RxCUI | 15226 |
| ChEMBL ID | CHEMBL1308 |
| ChEBI ID | 5141 |
| PubChem CID | 3406 |
| DrugBank | DB01213 |
| UNII ID | 83LCM6L2BY (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 516 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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434 adverse events reported
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