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

Molecule

Description

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: OFP

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

Drug dosage:

Dose	Unit	Route
2	g	O

ADMET properties:

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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

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Approvals:

Date	Agency	Company	Orphan
Sept. 15, 2017	FDA	SYMBIOMIX THERAPEUTICS LLC

FDA Adverse Event Reporting System (Female)

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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

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FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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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
CHEBI has role	CHEBI:53000	epitope role
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

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Infection by Trichomonas	indication	56335008	DOID:1947
Giardiasis	indication	58265007	DOID:10718
Bacterial vaginosis	indication	419760006	DOID:3385

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🐶 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)

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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

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Orange Book exclusivity data (new drug applications)

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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