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

Stem definition	Drug id	CAS RN
testosterone reductase inhibitors	1171	98319-26-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: finasteride finastid prosteride prostide propecia	An orally active 3-OXO-5-ALPHA-STEROID 4-DEHYDROGENASE inhibitor. It is used as a surgical alternative for treatment of benign PROSTATIC HYPERPLASIA. Molecular weight: 372.55 Formula: C23H36N2O2 CLOGP: 3.01 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 58.20 ALOGS: -5.27 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

finasteride
finastid
prosteride
prostide
propecia

An orally active 3-OXO-5-ALPHA-STEROID 4-DEHYDROGENASE inhibitor. It is used as a surgical alternative for treatment of benign PROSTATIC HYPERPLASIA.

Molecular weight: 372.55
Formula: C23H36N2O2
CLOGP: 3.01
LIPINSKI: 0
HAC: 4
HDO: 2
TPSA: 58.20
ALOGS: -5.27
ROTB: 2

Status: OFP

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

Drug dosage:

Dose	Unit	Route
1	mg	O
5	mg	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	63 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
t_half (Half-life)	6 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2.40 mL/min/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Bocci G, Oprea TI, Benet LZ
Vd (Volume of distribution)	1.10 L/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.19 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
fu (Fraction unbound in plasma)	0.10 %	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.01 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
June 19, 1992	FDA	MERCK

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
Exposure via body fluid	312.91	24.64	44	1339	572	63487067
Exposure during pregnancy	125.83	24.64	63	1320	155484	63332155
Abortion spontaneous	89.92	24.64	35	1348	47160	63440479
Product administration error	70.19	24.64	24	1359	22373	63465266
Abortion induced	56.99	24.64	17	1366	10225	63477414
Paternal drugs affecting foetus	53.01	24.64	7	1376	54	63487585
Exposure via father	42.55	24.64	7	1376	265	63487374
Hypertrichosis	38.15	24.64	8	1375	1146	63486493
Trans-sexualism	36.71	24.64	4	1379	3	63487636
Temporal lobe epilepsy	33.07	24.64	6	1377	405	63487234

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FDA Adverse Event Reporting System (Male)

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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
Sexual dysfunction	2882.85	10.68	919	82271	5384	34868357
Erectile dysfunction	2517.04	10.68	1145	82045	19492	34854249
Libido decreased	1504.99	10.68	524	82666	4172	34869569
Loss of libido	1240.24	10.68	390	82800	2162	34871579
Semen volume decreased	937.80	10.68	208	82982	148	34873593
Ejaculation disorder	886.33	10.68	244	82946	765	34872976
Depression	773.11	10.68	1049	82141	96049	34777692
Cognitive disorder	709.33	10.68	570	82620	28123	34845618
Penile size reduced	552.74	10.68	121	83069	74	34873667
Anxiety	551.07	10.68	907	82283	98521	34775220

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FDA Adverse Event Reporting System (Geriatric)

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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
Erectile dysfunction	666.01	10.66	281	54305	14383	79675419
Post 5-alpha-reductase inhibitor syndrome	477.38	10.66	79	54507	22	79689780
Libido decreased	363.76	10.66	137	54449	5184	79684618
Loss of libido	301.58	10.66	100	54486	2585	79687217
Testicular pain	264.69	10.66	85	54501	1980	79687822
Penile size reduced	229.15	10.66	40	54546	30	79689772
Gynaecomastia	199.89	10.66	100	54486	7581	79682221
Right atrial hypertrophy	160.06	10.66	46	54540	725	79689077
Depression	157.75	10.66	412	54174	216378	79473424
Semen volume decreased	156.41	10.66	29	54557	42	79689760

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	D11AX10	DERMATOLOGICALS OTHER DERMATOLOGICAL PREPARATIONS OTHER DERMATOLOGICAL PREPARATIONS Other dermatologicals
ATC	G04CA51	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY Alpha-adrenoreceptor antagonists
ATC	G04CA55	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY Alpha-adrenoreceptor antagonists
ATC	G04CB01	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY Testosterone-5-alpha reductase inhibitors
ATC	G04CB51	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY Testosterone-5-alpha reductase inhibitors
CHEBI has role	CHEBI:35497	antiandrogen
CHEBI has role	CHEBI:50781	5alpha-reductase inhibitors
CHEBI has role	CHEBI:59844	antihyperplasia drugs
FDA EPC	N0000175836	5-alpha Reductase Inhibitor
FDA MoA	N0000000126	5-alpha Reductase Inhibitors

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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
Benign prostatic hyperplasia	indication	266569009
Male Patterned Baldness	indication
Hidradenitis suppurativa	off-label use	59393003	DOID:2280
Disease of liver	contraindication	235856003	DOID:409
Pregnancy, function	contraindication	289908002
Breastfeeding (mother)	contraindication	413712001
High-Grade Prostate Cancer	contraindication
Breast Carcinoma in Males	contraindication

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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	13.26	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
3-oxo-5-alpha-steroid 4-dehydrogenase 2	Enzyme	P31213	S5A2_HUMAN	INHIBITOR	IC50	8.26	WOMBAT-PK	DRUG LABEL
3-oxo-5-alpha-steroid 4-dehydrogenase 1	Enzyme	P18405	S5A1_HUMAN	INHIBITOR	IC50	7.58	WOMBAT-PK	DRUG LABEL
3 beta-hydroxysteroid dehydrogenase/Delta 5-->4-isomerase type 1	Enzyme	P14060	3BHS1_HUMAN		Ki	4.96	CHEMBL
Cytochrome P450 2C9	Enzyme	P11712	CP2C9_HUMAN		IC50	5.70	DRUG MATRIX
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN		IC50	6	DRUG MATRIX
3-oxo-5-alpha-steroid 4-dehydrogenase 1	Enzyme		S5A1_RAT		Ki	8.17	CHEMBL
Steroid 5-alpha-reductase	Enzyme		S5A1_RAT S5A2_RAT		Ki	7.26	CHEMBL
3-oxo-5-alpha-steroid 4-dehydrogenase 2	Enzyme		S5A2_RAT		IC50	9.55	CHEMBL

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External reference:

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ID	Source
FIT	PDB_CHEM_ID
003665	NDDF
109035006	SNOMEDCT_US
11509	MMSL
219462	RXNORM
386963006	SNOMEDCT_US
4020167	VUID
4020167	VANDF
4728	MMSL
57363	PUBCHEM_CID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Finasteride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7355	TABLET, FILM COATED	5 mg	ORAL	ANDA	27 sections
Finasteride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7355	TABLET, FILM COATED	5 mg	ORAL	ANDA	27 sections
Finasteride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6830	TABLET, FILM COATED	5 mg	ORAL	ANDA	26 sections
Finasteride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6830	TABLET, FILM COATED	5 mg	ORAL	ANDA	26 sections
Finasteride	HUMAN PRESCRIPTION DRUG LABEL	1	16729-089	TABLET, FILM COATED	1 mg	ORAL	ANDA	28 sections
Finasteride	HUMAN PRESCRIPTION DRUG LABEL	1	16729-089	TABLET, FILM COATED	1 mg	ORAL	ANDA	28 sections
Finasteride	HUMAN PRESCRIPTION DRUG LABEL	1	16729-089	TABLET, FILM COATED	1 mg	ORAL	ANDA	28 sections
Finasteride	HUMAN PRESCRIPTION DRUG LABEL	1	16729-090	TABLET, FILM COATED	5 mg	ORAL	ANDA	27 sections
Finasteride	HUMAN PRESCRIPTION DRUG LABEL	1	16729-090	TABLET, FILM COATED	5 mg	ORAL	ANDA	27 sections
Finasteride	HUMAN PRESCRIPTION DRUG LABEL	1	16729-090	TABLET, FILM COATED	5 mg	ORAL	ANDA	27 sections

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