secnidazole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antiprotozoals and radiosensitizers, metronidazole derivatives | 2427 | 3366-95-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Secnidazole is a 5-nitroimidazole antimicrobial. 5-nitroimidazoles enter the bacterial cell as an inactive prodrug where the nitro group is reduced by bacterial enzymes to radical anions. It is believed that these radical anions interfere with bacterial DNA synthesis of susceptible isolates.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 2 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 40 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 15, 2017 | FDA | SYMBIOMIX THERAPEUTICS LLC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Vomiting | 103.79 | 86.17 | 38 | 87 | 559579 | 62929318 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J01RA07 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE COMBINATIONS OF ANTIBACTERIALS Combinations of antibacterials |
| ATC | P01AB07 | ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS ANTIPROTOZOALS AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES Nitroimidazole derivatives |
| FDA CS | M0014907 | Nitroimidazoles |
| FDA EPC | N0000175435 | Nitroimidazole Antimicrobial |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000977 | Antiparasitic Agents |
| MeSH PA | D000981 | Antiprotozoal Agents |
| CHEBI has role | CHEBI:53000 | epitope role |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Infection by Trichomonas | indication | 56335008 | DOID:1947 |
| Giardiasis | indication | 58265007 | DOID:10718 |
| Bacterial vaginosis | indication | 419760006 | DOID:3385 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.13 | acidic |
| pKa2 | 2.74 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 10335390 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 10335390 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 10682338 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 10682338 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 10849884 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 10849884 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 10849884 | Sept. 4, 2035 | TREATMENT OF TRICHOMONIASIS IN ADULTS |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 10849884 | Sept. 4, 2035 | TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 10857133 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 10857133 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11000507 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11000507 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11000507 | Sept. 4, 2035 | TREATMENT OF TRICHOMONIASIS IN ADULTS |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11000507 | Sept. 4, 2035 | TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11000508 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11000508 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11000508 | Sept. 4, 2035 | TREATMENT OF TRICHOMONIASIS IN ADULTS |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11000508 | Sept. 4, 2035 | TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11020377 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11020377 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11020377 | Sept. 4, 2035 | TREATMENT OF TRICHOMONIASIS IN ADULTS |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11020377 | Sept. 4, 2035 | TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11324721 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11324721 | Sept. 4, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11324721 | Sept. 4, 2035 | TREATMENT OF TRICHOMONIASIS IN ADULTS |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11324721 | Sept. 4, 2035 | TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11602522 | Sept. 4, 2035 | TREATMENT OF TRICHOMONIASIS IN ADULTS |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11602522 | Sept. 4, 2035 | TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11684607 | Sept. 16, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11684607 | Sept. 16, 2035 | TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11684607 | Sept. 16, 2035 | TREATMENT OF TRICHOMONIASIS IN ADULTS |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | 11684607 | Sept. 16, 2035 | TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | Sept. 15, 2022 | NEW CHEMICAL ENTITY |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | June 30, 2024 | FOR THE TREATMENT OF TRICHOMONIASIS CAUSED BY TRICHOMONAS VAGINALIS IN ADULTS |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | Jan. 26, 2025 | NEW PATIENT POPULATION |
| 2GM/PACKET | SOLOSEC | LUPIN | N209363 | Sept. 15, 2017 | RX | GRANULE | ORAL | Sept. 15, 2027 | GENERATING ANTIBIOTIC INCENTIVES NOW |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| 3-oxoacyl-[acyl-carrier-protein] synthase 3 | Enzyme | IC50 | 4.55 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D07353 | KEGG_DRUG |
| 4037208 | VANDF |
| C0074246 | UMLSCUI |
| CHEBI:140628 | CHEBI |
| CHEMBL498847 | ChEMBL_ID |
| DB12834 | DRUGBANK_ID |
| 71815 | PUBCHEM_CID |
| 3506 | INN_ID |
| C016724 | MESH_SUPPLEMENTAL_RECORD_UI |
| R3459K699K | UNII |
| 1946693 | RXNORM |
| 23281 | MMSL |
| 262144 | MMSL |
| d06604 | MMSL |
| 005775 | NDDF |
| 713462001 | SNOMEDCT_US |
| 763524000 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| SOLOSEC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 27437-051 | GRANULE | 2 g | ORAL | NDA | 26 sections |
| SOLOSEC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 27437-051 | GRANULE | 2 g | ORAL | NDA | 26 sections |