Nitazoxanide
Nitazoxanide (nitazoxanide) is a small molecule pharmaceutical. Nitazoxanide was first approved as Alinia on 2002-11-22. It is used to treat cryptosporidiosis, diarrhea, giardiasis, and protozoan infections in the USA.
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Commercial
Therapeutic Areas
Trade Name
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Nitazoxanide (discontinued: Alinia)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nitazoxanide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ALINIA | Romark Laboratories L.c. | N-021497 DISCN | 2004-07-21 | 1 products, RLD |
| ALINIA | Romark Laboratories L.c. | N-021498 DISCN | 2002-11-22 | 1 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| alinia | New Drug Application | 2024-03-20 |
| nitazoxanide | ANDA | 2026-06-18 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| diarrhea | — | D003967 | R19.7 |
| giardiasis | DOID_10718 | D005873 | A07.1 |
| cryptosporidiosis | — | D003457 | A07.2 |
| protozoan infections | — | D011528 | B50-B64 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
118 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis | D006505 | — | K75.9 | — | 7 | 1 | — | — | 7 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | — | 7 | 1 | — | — | 7 |
| Hepatitis c | D006526 | — | B19.2 | — | 6 | 1 | — | — | 6 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | 6 | 1 | — | — | 6 |
| Chronic hepatitis | D006521 | — | K73.9 | — | 5 | 1 | — | — | 5 |
| Covid-19 | D000086382 | — | U07.1 | — | — | 5 | — | — | 5 |
| Human influenza | D007251 | EFO_0007328 | J11.1 | — | 2 | 4 | — | — | 5 |
| Enterovirus | D004770 | — | — | — | — | 2 | — | — | 2 |
| Rhinovirus | D012229 | — | — | — | — | 2 | — | — | 2 |
| Enterovirus infections | D004769 | EFO_0007255 | B34.1 | — | — | 2 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis b | D006509 | — | — | — | 1 | — | — | — | 1 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | 1 | — | — | — | 1 |
| Gastroenteritis | D005759 | EFO_1001463 | K52.9 | — | 1 | — | — | — | 1 |
| Clostridioides difficile | D016360 | NCBITaxon_1496 | — | — | 1 | — | — | — | 1 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 1 | — | — | — | 1 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nitazoxanide |
| INN | nitazoxanide |
| Description | Acetic acid [2-[[(5-nitro-2-thiazolyl)amino]-oxomethyl]phenyl] ester is a carboxylic ester and a member of benzamides. It is functionally related to a salicylamide. |
| Classification | Small molecule |
| Drug class | antiparasitics (salicylanilide derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)Oc1ccccc1C(=O)Nc1ncc([N+](=O)[O-])s1 |
Identifiers
| PDB | — |
| CAS-ID | 55981-09-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1401 |
| ChEBI ID | — |
| PubChem CID | 41684 |
| DrugBank | DB00507 |
| UNII ID | SOA12P041N (ChemIDplus, GSRS) |
Target
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Financial
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Estimated US medical usage
Nitazoxanide
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Trends
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Safety
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563 adverse events reported
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