Nitazoxanide
Alinia, 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
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)
Nitazoxanide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ALINIA | Romark Laboratories L.c. | N-021497 RX | 2004-07-21 | 1 products, RLD, RS |
| ALINIA | Romark Laboratories L.c. | N-021498 RX | 2002-11-22 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| alinia | New Drug Application | 2024-03-20 |
| nitazoxanide | ANDA | 2022-03-31 |
Indications
FDA
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Agency Specific
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
108 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 | — | — | 1 | 19 | 16 | 2 | 1 | 30 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 2 | 11 | 3 | 2 | — | 14 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | 10 | 3 | 2 | — | 13 |
| Hepatitis c | D006526 | — | B19.2 | 2 | 10 | 3 | 2 | — | 13 |
| Infections | D007239 | EFO_0000544 | — | 2 | 6 | 5 | 3 | — | 11 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | 7 | 2 | 2 | — | 9 |
| Communicable diseases | D003141 | — | — | 2 | 5 | 2 | 2 | — | 7 |
| Chronic hepatitis | D006521 | — | K73.9 | — | 6 | 2 | 1 | — | 7 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 2 | 1 | 2 | — | 5 |
| Helicobacter infections | D016481 | EFO_1000961 | — | — | — | 2 | 2 | — | 4 |
Show 4 more
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 | 2 | — | 2 | 6 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | 5 | 1 | — | — | 5 |
| Human influenza | D007251 | EFO_0007328 | J11.1 | — | 2 | 4 | — | — | 5 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | 2 | 2 | — | 1 | 4 |
| Hepatic encephalopathy | D006501 | — | K72.91 | — | 2 | 2 | — | 1 | 4 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | 2 | 1 | — | 1 | 4 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | 1 | 2 | 2 | — | 1 | 4 |
| Gastroenteritis | D005759 | EFO_1001463 | K52.9 | — | 3 | 1 | — | — | 3 |
| Rotavirus infections | D012400 | — | — | — | 2 | 1 | — | 1 | 3 |
Show 25 more
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 |
| Fibrosis | D005355 | — | — | — | 1 | — | — | 1 | 2 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Hepatitis b | D006509 | — | — | — | 1 | — | — | — | 1 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | 1 | — | — | — | 1 |
| Coinfection | D060085 | — | — | — | 1 | — | — | — | 1 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | 1 | — | — | — | 1 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | 1 | — | — | — | 1 |
| Coronavirus | D017934 | — | — | — | 1 | — | — | — | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 1 | — | — | — | 1 |
Show 14 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | HP_0002910 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Cerebral palsy | D002547 | — | G80 | — | — | — | — | 2 | 2 |
| Diet therapy | D004035 | — | — | — | — | — | — | 1 | 1 |
| Nutrition disorders | D009748 | EFO_0001069 | — | — | — | — | — | 1 | 1 |
| Child nutrition disorders | D015362 | — | — | — | — | — | — | 1 | 1 |
| Probiotics | D019936 | — | — | — | — | — | — | 1 | 1 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| Muscle spasticity | D009128 | HP_0001257 | — | — | — | — | — | 1 | 1 |
| Paralysis | D010243 | HP_0003470 | — | — | — | — | — | 1 | 1 |
| Microsporidiosis | D016881 | EFO_0007366 | B60.8 | — | — | — | — | 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 | — |
| ChEMBL ID | CHEMBL1401 |
| ChEBI ID | — |
| PubChem CID | 41684 |
| DrugBank | DB00507 |
| UNII ID | SOA12P041N (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Nitazoxanide
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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461 adverse events reported
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