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 | Lupin Research | N-209363 RX | 2017-09-15 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| solosec | New Drug Application | 2021-01-08 |
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 | |||
| 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
No data
Clinical
Clinical Trials
361 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 | — | 4 | 1 | 1 | — | 5 | |
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | — | 1 | 1 | 1 | 1 | 4 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | C95 | 8 | 31 | 7 | — | 2 | 46 | |
| Lymphoma | D008223 | C85.9 | 8 | 31 | 4 | — | 1 | 43 | |
| Melanoma | D008545 | 8 | 29 | 3 | — | 1 | 39 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 17 | 20 | 2 | — | — | 33 |
| Neuroblastoma | D009447 | EFO_0000621 | 5 | 13 | 5 | — | 2 | 23 | |
| Myelodysplastic syndromes | D009190 | D46 | 8 | 13 | 1 | — | 1 | 22 | |
| Plasma cell neoplasms | D054219 | 5 | 12 | 1 | — | — | 17 | ||
| Hiv infections | D015658 | EFO_0000764 | B20 | 8 | 1 | 2 | — | 4 | 15 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 3 | 7 | 1 | — | — | 10 |
| Sarcoma | D012509 | 2 | 5 | 2 | — | — | 9 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 7 | 16 | — | — | — | 21 | |
| Prostatic neoplasms | D011471 | C61 | 7 | 11 | — | — | — | 16 | |
| Lung neoplasms | D008175 | C34.90 | 6 | 8 | — | — | — | 14 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 6 | 7 | — | — | — | 12 |
| Colorectal neoplasms | D015179 | 4 | 10 | — | — | — | 11 | ||
| Myeloid leukemia acute | D015470 | C92.0 | 3 | 7 | — | — | — | 9 | |
| Multiple myeloma | D009101 | C90.0 | 3 | 5 | — | — | 1 | 9 | |
| Central nervous system neoplasms | D016543 | 3 | 6 | — | — | — | 9 | ||
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 3 | 7 | — | — | — | 8 |
| Fallopian tube neoplasms | D005185 | 4 | 3 | — | — | — | 7 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | 3 | — | — | — | — | 3 |
| Colonic neoplasms | D003110 | C18 | 2 | — | — | — | — | 2 | |
| Rectal neoplasms | D012004 | 2 | — | — | — | — | 2 | ||
| Kaposi sarcoma | D012514 | C46 | 2 | — | — | — | — | 2 | |
| Glioma | D005910 | EFO_0000520 | 2 | — | — | — | — | 2 | |
| Astrocytoma | D001254 | EFO_0000271 | 2 | — | — | — | — | 2 | |
| Oligodendroglioma | D009837 | EFO_0000631 | 2 | — | — | — | — | 2 | |
| Hepatocellular carcinoma | D006528 | C22.0 | 2 | — | — | — | — | 2 | |
| Small cell lung carcinoma | D055752 | 1 | — | — | — | — | 1 | ||
| Plasma cell leukemia | D007952 | C90.1 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Residual neoplasm | D018365 | — | — | — | — | 1 | 1 | ||
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | — | 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 | 36314 |
| ChEMBL ID | CHEMBL498847 |
| ChEBI ID | — |
| PubChem CID | 71815 |
| DrugBank | DB12834 |
| UNII ID | R3459K699K (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,524 adverse events reported
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