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

Stem definition	Drug id	CAS RN
androgens/anabolic steroids	2607	58-22-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: testosterone 17beta-Testosterone	A potent androgenic steroid and major product secreted by the LEYDIG CELLS of the TESTIS. Its production is stimulated by LUTEINIZING HORMONE from the PITUITARY GLAND. In turn, testosterone exerts feedback control of the pituitary LH and FSH secretion. Depending on the tissues, testosterone can be further converted to DIHYDROTESTOSTERONE or ESTRADIOL. Molecular weight: 288.43 Formula: C19H28O2 CLOGP: 3.41 LIPINSKI: 0 HAC: 2 HDO: 1 TPSA: 37.30 ALOGS: -3.94 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

testosterone
17beta-Testosterone

A potent androgenic steroid and major product secreted by the LEYDIG CELLS of the TESTIS. Its production is stimulated by LUTEINIZING HORMONE from the PITUITARY GLAND. In turn, testosterone exerts feedback control of the pituitary LH and FSH secretion. Depending on the tissues, testosterone can be further converted to DIHYDROTESTOSTERONE or ESTRADIOL.

Molecular weight: 288.43
Formula: C19H28O2
CLOGP: 3.41
LIPINSKI: 0
HAC: 2
HDO: 1
TPSA: 37.30
ALOGS: -3.94
ROTB: 0

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.12	g	O
18	mg	P
0.12	g	R
60	mg	SL
50	mg	TD
3	mg	TD

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	4 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance)	24.50 mL/min/kg	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	2.97 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	0.35 L/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.17 hours	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.06 %	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.02 mg/mL	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
July 13, 1972	FDA	ACTIENT PHARMS

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
Blood testosterone increased	299.60	19.16	42	4586	128	63484266
Idiopathic intracranial hypertension	256.40	19.16	56	4572	2875	63481519
Metaplasia	197.07	19.16	34	4594	490	63483904
Accidental exposure to product	188.63	19.16	72	4556	27333	63457061
Prostatic disorder	179.01	19.16	24	4604	46	63484348
Virilism	156.22	19.16	20	4608	21	63484373
Expulsion of medication	137.76	19.16	17	4611	9	63484385
Enlarged clitoris	136.74	19.16	21	4607	137	63484257
Off label use	129.44	19.16	198	4430	674264	62810130
Precocious puberty	114.85	19.16	19	4609	209	63484185

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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
Blood testosterone decreased	654.20	11.64	225	36902	4132	34915672
Blood testosterone increased	515.86	11.64	141	36986	1132	34918672
Polycythaemia	391.71	11.64	126	37001	1859	34917945
Product deposit	369.52	11.64	86	37041	322	34919482
Product administered at inappropriate site	243.26	11.64	91	37036	2145	34917659
Application site rash	239.31	11.64	71	37056	786	34919018
Poor quality product administered	231.02	11.64	84	37043	1823	34917981
Deep vein thrombosis	189.36	11.64	286	36841	64962	34854842
Expulsion of medication	175.01	11.64	33	37094	24	34919780
Blood testosterone abnormal	161.23	11.64	45	37082	393	34919411

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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
Blood testosterone increased	554.33	11.21	118	30039	934	79713297
Polycythaemia	414.54	11.21	108	30049	2176	79712055
Idiopathic intracranial hypertension	350.98	11.21	102	30055	3120	79711111
Blood testosterone decreased	330.22	11.21	91	30066	2286	79711945
Expulsion of medication	238.62	11.21	37	30120	20	79714211
Deep vein thrombosis	200.94	11.21	238	29919	120681	79593550
Metaplasia	196.24	11.21	45	30112	517	79713714
Precocious puberty	196.12	11.21	41	30116	294	79713937
Virilism	148.61	11.21	23	30134	12	79714219
Pulmonary embolism	144.53	11.21	244	29913	171410	79542821

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	G03BA03	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM ANDROGENS 3-oxoandrosten (4) derivatives
ATC	G03EA02	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM ANDROGENS AND FEMALE SEX HORMONES IN COMBINATION Androgens and estrogens
CHEBI has role	CHEBI:50113	androgene
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
CHEBI has role	CHEBI:83056	Daphnia magna metabolites
FDA CS	M0001109	Androstanes
FDA EPC	N0000175824	Androgen
FDA MoA	N0000000146	Androgen Receptor Agonists
MeSH PA	D000728	Androgens

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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
Hypogonadotropic hypogonadism	indication	33927004
Deficiency of testosterone biosynthesis	indication	38825009
Inhibition of lactation procedure	indication	43141007
Male hypogonadism	indication	48723006
Hypopituitarism	indication	74728003	DOID:9406
Menopausal flushing	indication	198436008
Undescended testicle	indication	204878001	DOID:11383
Bilateral orchidectomy	indication	386634006
Delayed puberty	indication	400003000
Klinefelter's syndrome, XXY	indication	405769009

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🐶 Veterinary Drug Use

Species	Use	Relation
Cattle	To increase rate of weight gain	Indication
Cattle	To improve feed efficiency	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Component E-H with Tylan	Elanco US Inc.	3

Acid dissociation constants calculated using MoKa v3.0.0

None

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
1.62% (20.25MG/1.25GM ACTUATION)	ANDROGEL	BESINS HLTHCARE	N022309	April 29, 2011	RX	GEL, METERED	TRANSDERMAL	8466137	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM ACTUATION)	ANDROGEL	BESINS HLTHCARE	N022309	April 29, 2011	RX	GEL, METERED	TRANSDERMAL	8466138	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM ACTUATION)	ANDROGEL	BESINS HLTHCARE	N022309	April 29, 2011	RX	GEL, METERED	TRANSDERMAL	8741881	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ANDROGEL	BESINS HLTHCARE	N022309	Sept. 7, 2012	DISCN	GEL	TRANSDERMAL	8466137	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ANDROGEL	BESINS HLTHCARE	N022309	Sept. 7, 2012	DISCN	GEL	TRANSDERMAL	8466138	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ANDROGEL	BESINS HLTHCARE	N022309	Sept. 7, 2012	DISCN	GEL	TRANSDERMAL	8741881	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ANDROGEL	BESINS HLTHCARE	N022309	Sept. 7, 2012	DISCN	GEL	TRANSDERMAL	8466137	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ANDROGEL	BESINS HLTHCARE	N022309	Sept. 7, 2012	DISCN	GEL	TRANSDERMAL	8466138	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ANDROGEL	BESINS HLTHCARE	N022309	Sept. 7, 2012	DISCN	GEL	TRANSDERMAL	8741881	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
12.5MG/1.25GM ACTUATION	VOGELXO	UPSHER SMITH LABS	N204399	June 4, 2014	RX	GEL, METERED	TRANSDERMAL	8785426	Feb. 11, 2034	METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE

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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
Androgen receptor	Nuclear hormone receptor	P10275	ANDR_HUMAN	AGONIST	EC50	9.20	WOMBAT-PK	CHEMBL
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN		Ki	5.84	DRUG MATRIX
Aromatase	Enzyme	P11511	CP19A_HUMAN		Ki	6.22	CHEMBL
Corticosteroid-binding globulin	Secreted	P08185	CBG_HUMAN		Ki	6.72	CHEMBL
Sex hormone-binding globulin	Secreted	P04278	SHBG_HUMAN		Kd	9.20	CHEMBL
Lanosterol 14-alpha demethylase	Enzyme	Q16850	CP51A_HUMAN		IC50	4.30	CHEMBL
Sigma non-opioid intracellular receptor 1	Membrane receptor	Q99720	SGMR1_HUMAN		Ki	5.92	CHEMBL
Alpha-synuclein	Transporter	P37840	SYUA_HUMAN		IC50	4.01	CHEMBL
Androgen receptor	Transcription factor		ANDR_RAT		Ki	8.85	CHEMBL
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	6.60	DRUG MATRIX

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External reference:

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ID	Source
TES	PDB_CHEM_ID
001245	NDDF
10379	RXNORM
109033004	SNOMEDCT_US
1900	INN_ID
2858	IUPHAR_LIGAND_ID
2966	MMSL
3XMK78S47O	UNII
4017484	VUID
4017484	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Androderm	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5990	PATCH	2 mg	TRANSDERMAL	NDA	36 sections
Androderm	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5990	PATCH	2 mg	TRANSDERMAL	NDA	36 sections
Androderm	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5990	PATCH	2 mg	TRANSDERMAL	NDA	36 sections
Androderm	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5992	PATCH	4 mg	TRANSDERMAL	NDA	36 sections
Androderm	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5992	PATCH	4 mg	TRANSDERMAL	NDA	36 sections
Androderm	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5992	PATCH	4 mg	TRANSDERMAL	NDA	36 sections
Androgel	HUMAN PRESCRIPTION DRUG LABEL	1	0051-8425	GEL	10 mg	TRANSDERMAL	NDA	37 sections
Androgel	HUMAN PRESCRIPTION DRUG LABEL	1	0051-8450	GEL	10 mg	TRANSDERMAL	NDA	37 sections
Androgel	HUMAN PRESCRIPTION DRUG LABEL	1	0051-8462	GEL	16.20 mg	TRANSDERMAL	NDA	37 sections
Androgel	HUMAN PRESCRIPTION DRUG LABEL	1	0051-8462	GEL	16.20 mg	TRANSDERMAL	NDA	37 sections

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