Secnidazole
Solosec (secnidazole) is a small molecule pharmaceutical. Secnidazole was first approved as Solosec on 2017-09-15. It is used to treat bacterial vaginosis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
Trade Name
FDA
EMA
Solosec
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Secnidazole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SOLOSEC | Evofem Biosciences | N-209363 RX | 2017-09-15 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| solosec | New Drug Application | 2022-07-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bacterial vaginosis | EFO_0003932 | D016585 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SECNIDAZOLE, SOLOSEC, LUPIN | |||
| 2027-09-15 | GAIN | ||
| 2025-01-26 | NPP | ||
| 2024-06-30 | I-866 | ||
| 2022-09-15 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Secnidazole, Solosec, Lupin | |||
| 11684607 | 2035-09-16 | DP | U-2583, U-3169, U-3270, U-3302 |
| 10335390 | 2035-09-04 | DP | U-2583, U-3270 |
| 10682338 | 2035-09-04 | DP | U-2583, U-3270 |
| 10849884 | 2035-09-04 | DP | U-2583, U-3169, U-3270, U-3302 |
| 10857133 | 2035-09-04 | DP | U-2583, U-3270 |
| 11000507 | 2035-09-04 | DP | U-2583, U-3169, U-3270, U-3302 |
| 11000508 | 2035-09-04 | DP | U-2583, U-3169, U-3270, U-3302 |
| 11020377 | 2035-09-04 | DP | U-2583, U-3169, U-3270, U-3302 |
| 11324721 | 2035-09-04 | DP | U-2583, U-3169, U-3270, U-3302 |
| 11602522 | 2035-09-04 | DP | U-3169, U-3302 |
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01R: Combinations of antibacterials
— J01RA: Combinations of antibacterials
— J01RA07: Azithromycin, fluconazole and secnidazole
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
— P01AB07: Secnidazole
HCPCS
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Clinical
Clinical Trials
11 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial vaginosis | D016585 | EFO_0003932 | — | — | 2 | 3 | 1 | — | 5 |
| Vaginal diseases | D014623 | — | — | — | 2 | 3 | 1 | — | 5 |
| Trichomonas infections | D014245 | DOID_1947 | A59 | — | — | 1 | 1 | — | 2 |
| Vaginitis | D014627 | EFO_0005757 | N76 | — | — | — | 1 | — | 1 |
| Trichomonas vaginitis | D014247 | EFO_0007521 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vaginal discharge | D019522 | — | — | — | — | 1 | — | — | 1 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | — | 1 | — | — | 1 |
| Recurrence | D012008 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Typhoid fever | D014435 | EFO_0006789 | A01.0 | 1 | 1 | — | — | — | 1 |
| Cholera | D002771 | — | A00 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Giardiasis | D005873 | DOID_10718 | A07.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Secnidazole |
| INN | secnidazole |
| Description | Secnidazole is a C-nitro compound that is 5-nitroimidazole in which the hydrogens at positions 1 and 2 are replaced by 2-hydroxypropyl and methyl groups, respectively. It has a role as an epitope. It is a C-nitro compound, a member of imidazoles and a secondary alcohol. |
| Classification | Small molecule |
| Drug class | antiprotozoal substances (metronidazole type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1ncc([N+](=O)[O-])n1CC(C)O |
Identifiers
| PDB | — |
| CAS-ID | 3366-95-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL498847 |
| ChEBI ID | — |
| PubChem CID | 71815 |
| DrugBank | DB12834 |
| UNII ID | R3459K699K (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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247 adverse events reported
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