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
No data
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 | 2023-10-26 |
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
119 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 2 | 3 | 3 | 1 | — | 7 |
| Plasma cell neoplasms | D054219 | — | — | 2 | 3 | 3 | 1 | — | 7 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | 2 | — | 2 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 1 | — | 1 | — | 2 |
| Systemic lupus erythematosus | D008180 | HP_0002725 | M32 | — | 1 | — | 1 | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | 1 | — | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | 1 | — | 1 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | — | 1 | — | 1 |
| Ulcer | D014456 | MPATH_579 | — | — | — | — | 1 | — | 1 |
| Fibrosis | D005355 | — | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 3 | 21 | 28 | — | 1 | 50 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 3 | 22 | 23 | — | 2 | 47 |
| Lymphoid leukemia | D007945 | — | C91 | 3 | 21 | 21 | — | 2 | 44 |
| Lymphoma | D008223 | — | C85.9 | 1 | 6 | 6 | — | — | 11 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | 5 | 4 | — | — | 9 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | 1 | 3 | 4 | — | — | 7 |
| Philadelphia chromosome | D010677 | — | — | — | 3 | 3 | — | — | 6 |
| Promyelocytic leukemia acute | D015473 | — | C92.4 | — | — | 4 | — | — | 4 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | 2 | 2 | — | — | 4 |
| Syndrome | D013577 | — | — | — | 2 | 1 | — | 1 | 4 |
Show 15 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 2 | 1 | — | — | 1 | 4 |
| Recurrence | D012008 | — | — | 1 | 3 | — | — | — | 3 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 1 | — | — | 2 | 3 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | — | — | 2 | 3 |
| Anemia | D000740 | HP_0001903 | D64.9 | 1 | 2 | — | — | — | 2 |
| Fanconi anemia | D005199 | Orphanet_84 | D61.09 | 1 | 2 | — | — | — | 2 |
| Eye diseases | D005128 | EFO_0003966 | H44 | — | 1 | — | — | 1 | 2 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | — | 1 |
| Precursor b-cell lymphoblastic leukemia-lymphoma | D015452 | — | — | — | 1 | — | — | — | 1 |
| Hermanski-pudlak syndrome | D022861 | — | E70.331 | — | 1 | — | — | — | 1 |
Show 22 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | 1 | — | — | — | 1 | 2 |
| Stargardt disease | D000080362 | — | H35.53 | 1 | — | — | — | — | 1 |
| Hereditary corneal dystrophies | D003317 | HP_0007802 | H18.5 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | — | 3 | 3 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | — | — | 3 | 3 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 1 | 1 |
| Mycoplasma infections | D009175 | — | — | — | — | — | — | 1 | 1 |
| Pleuropneumonia | D011001 | — | — | — | — | — | — | 1 | 1 |
| Choroidal neovascularization | D020256 | — | — | — | — | — | — | 1 | 1 |
| Pathologic neovascularization | D009389 | — | — | — | — | — | — | 1 | 1 |
| Anesthesia | D000758 | — | — | — | — | — | — | 1 | 1 |
Show 35 more
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 | — |
| ChEMBL ID | CHEMBL1308 |
| ChEBI ID | 5141 |
| PubChem CID | 3406 |
| DrugBank | DB01213 |
| UNII ID | 83LCM6L2BY (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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124 adverse events reported
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