secnidazole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antiprotozoals and radiosensitizers, metronidazole derivatives 2427 3366-95-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • solosec
  • secnidazol
  • seknidazol
  • secnidazole
  • flagentyl
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.
  • Molecular weight: 185.18
  • Formula: C7H11N3O3
  • CLOGP: -0.15
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 1
  • TPSA: 81.19
  • ALOGS: -1.58
  • ROTB: 3

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
2 g O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 15, 2017 FDA SYMBIOMIX THERAPEUTICS LLC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Vomiting 103.65 80.50 38 84 460720 50144282

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (acidic/basic)
pKa1 11.13 acidic
pKa2 2.74 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
3-oxoacyl-[acyl-carrier-protein] synthase 3 Enzyme IC50 4.55 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
SOLOSEC HUMAN PRESCRIPTION DRUG LABEL 1 27437-051 GRANULE 2 g ORAL NDA 26 sections