Tinidazole
Tindamax, Tinidazole (tinidazole) is a small molecule pharmaceutical. Tinidazole was first approved as Tindamax on 2004-05-17. It is used to treat amebiasis, bacterial infections, bacterial vaginosis, giardiasis, and protozoan infections in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| digestive system diseases | D004066 |
| urogenital diseases | D000091642 |
Trade Name
FDA
EMA
Tindamax, Tinidazole (discontinued: Tinidazole)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tinidazole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TINDAMAX | Mission Pharmacal | N-021618 RX | 2004-05-17 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tindamax | New Drug Application | 2021-12-27 |
| tindazole | ANDA | 2024-09-04 |
| tinidazole | ANDA | 2024-07-17 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD09: Lansoprazole, clarithromycin and tinidazole
G: Genito urinary system and sex hormones
— G01: Gynecological antiinfectives and antiseptics
— G01A: Antiinfectives and antiseptics, excl. combinations with corticosteroids
— G01AF: Imidazole derivatives, gyncological antiinfectives
— G01AF21: Tinidazole
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01R: Combinations of antibacterials
— J01RA: Combinations of antibacterials
— J01RA11: Ciprofloxacin and tinidazole
— J01RA13: Norfloxacin and tinidazole
— J01X: Other antibacterials in atc
— J01XD: Imidazole derivatives, antibacterial for systemic use
— J01XD02: Tinidazole
P: Antiparasitic products, insecticides and repellents
— P01: Antiprotozoals
— P01A: Agents against amoebiasis and other protozoal diseases
— P01AB: Nitroimidazole derivatives, antiprotozoal agents against amoebiasis and other protozoal diseases
— P01AB02: Tinidazole
HCPCS
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Clinical
Clinical Trials
43 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | 1 | 5 | 12 | 2 | 19 |
| Helicobacter infections | D016481 | EFO_1000961 | — | — | 1 | 4 | 5 | 2 | 11 |
| Disease susceptibility | D004198 | — | — | — | — | 1 | 6 | 1 | 8 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | 1 | 1 | 3 | 2 | — | 7 |
| Vaginal diseases | D014623 | — | — | 1 | 1 | 3 | 2 | — | 7 |
| Communicable diseases | D003141 | — | — | — | — | 2 | 3 | 1 | 6 |
| Vaginitis | D014627 | EFO_0005757 | N76 | — | — | 2 | 1 | 1 | 4 |
| Trichomonas vaginitis | D014247 | EFO_0007521 | — | — | — | 1 | 1 | 1 | 3 |
| Gastritis | D005756 | EFO_0000217 | K29.7 | — | — | 1 | 1 | — | 2 |
| Vulvovaginal candidiasis | D002181 | EFO_0007543 | B37.3 | — | — | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Esophageal neoplasms | D004938 | — | C15 | — | — | 1 | — | 1 | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | 1 | — | — | 1 |
| Candidiasis | D002177 | — | B37 | — | — | 1 | — | — | 1 |
| Vaginal discharge | D019522 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urethritis | D014526 | EFO_0003878 | N34 | — | 1 | — | — | — | 1 |
| Malaria | D008288 | EFO_0001068 | B54 | — | 1 | — | — | — | 1 |
| Vivax malaria | D016780 | EFO_0007445 | B51 | — | 1 | — | — | — | 1 |
| Recurrence | D012008 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Trichomonas infections | D014245 | DOID_1947 | A59 | 1 | — | — | — | 1 | 2 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endometritis | D004716 | EFO_1001312 | — | — | — | — | — | 1 | 1 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | — | — | — | 1 | 1 |
| Abdominal pain | D015746 | HP_0002027 | R10.9 | — | — | — | — | 1 | 1 |
| Hysterectomy | D007044 | EFO_0003881 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tinidazole |
| INN | tinidazole |
| Description | Tinidazole is 1H-imidazole substituted at C-1 by a (2-ethylsulfonyl)ethyl group, at C-2 by a methyl group and at C-5 by a nitro group. It is used as an antiprotozoal, antibacterial agent. It has a role as an antiprotozoal drug, an antibacterial drug, an antiparasitic agent and an antiamoebic agent. |
| Classification | Small molecule |
| Drug class | antiprotozoal substances (metronidazole type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCS(=O)(=O)CCn1c([N+](=O)[O-])cnc1C |
Identifiers
| PDB | — |
| CAS-ID | 1216767-04-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1220 |
| ChEBI ID | 63627 |
| PubChem CID | 5479 |
| DrugBank | DB00911 |
| UNII ID | 033KF7V46H (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Tinidazole
Total medical expenditures per year (USD, in millions)
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Trends
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Safety
Black-box Warning
Black-box warning for: Tindamax, Tindazole, Tinidazole
Adverse Events
Top Adverse Reactions
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247 adverse events reported
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