Nitazoxanide
Alinia (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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COVID-19
Commercial
Trade Name
FDA
EMA
Alinia (generic drugs available since 2020-11-27)
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 |
|---|---|---|
| alinia | New Drug Application | 2021-01-06 |
| nitazoxanide | ANDA | 2022-03-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cryptosporidiosis | — | D003457 | A07.2 |
| diarrhea | HP_0002014 | D003967 | R19.7 |
| giardiasis | DOID_10718 | D005873 | A07.1 |
| protozoan infections | — | D011528 | B50-B64 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
92 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | U07.1 | 1 | 17 | 15 | 2 | 1 | 28 | |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | 7 | 2 | 1 | — | 8 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | — | 2 | — | 2 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | 1 | 1 | — | 1 | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | 5 | 1 | — | 1 | 8 |
| Cryptosporidiosis | D003457 | A07.2 | 1 | 2 | 1 | — | 2 | 5 | |
| Human influenza | D007251 | EFO_0007328 | J11.1 | — | 2 | 4 | — | — | 5 |
| Hepatic encephalopathy | D006501 | K72.91 | — | 2 | 2 | — | 1 | 4 | |
| Rotavirus infections | D012400 | — | 2 | 1 | — | 1 | 3 | ||
| Enterovirus | D004770 | — | — | 2 | — | — | 2 | ||
| Rhinovirus | D012229 | — | — | 2 | — | — | 2 | ||
| Gastroenteritis | D005759 | EFO_1001463 | K52.9 | — | 2 | 1 | — | — | 2 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | — | 1 | — | 1 | 2 |
| Hepatitis c | D006526 | B19.2 | 1 | 1 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | — | 1 | 2 |
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | — | 1 | — | — | — | 1 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | 1 | — | — | — | 1 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | 1 | — | — | — | 1 |
| Coronavirus | D017934 | — | 1 | — | — | — | 1 | ||
| Fatty liver | D005234 | — | 1 | — | — | — | 1 | ||
| Alcoholic fatty liver | D005235 | K70.0 | — | 1 | — | — | — | 1 | |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | 1 | — | — | — | 1 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | 1 | — | — | — | 1 |
| Protozoan infections | D011528 | B50-B64 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 | ||
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | — | — | 1 | 1 |
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 | 31819 |
| ChEMBL ID | CHEMBL1401 |
| ChEBI ID | — |
| PubChem CID | 41684 |
| DrugBank | DB00507 |
| UNII ID | SOA12P041N (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
No data
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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11,302 adverse events reported
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