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

Stem definition	Drug id	CAS RN
androgens/anabolic steroids	795	53-43-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: intrarosa 5,6-didehydroepiandrosterone androstenolone dehydroandrosterone dehydroepiandrosterone dehydroisoandrosterone prasterone	A major C19 steroid produced by the ADRENAL CORTEX. It is also produced in small quantities in the TESTIS and the OVARY. Dehydroepiandrosterone (DHEA) can be converted to TESTOSTERONE; ANDROSTENEDIONE; ESTRADIOL; and ESTRONE. Most of DHEA is sulfated (DEHYDROEPIANDROSTERONE SULFATE) before secretion. Molecular weight: 288.43 Formula: C19H28O2 CLOGP: 3.07 LIPINSKI: 0 HAC: 2 HDO: 1 TPSA: 37.30 ALOGS: -3.82 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

intrarosa
5,6-didehydroepiandrosterone
androstenolone
dehydroandrosterone
dehydroepiandrosterone
dehydroisoandrosterone
prasterone

A major C19 steroid produced by the ADRENAL CORTEX. It is also produced in small quantities in the TESTIS and the OVARY. Dehydroepiandrosterone (DHEA) can be converted to TESTOSTERONE; ANDROSTENEDIONE; ESTRADIOL; and ESTRONE. Most of DHEA is sulfated (DEHYDROEPIANDROSTERONE SULFATE) before secretion.

Molecular weight: 288.43
Formula: C19H28O2
CLOGP: 3.07
LIPINSKI: 0
HAC: 2
HDO: 1
TPSA: 37.30
ALOGS: -3.82
ROTB: 0

Status: OFP

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

Drug dosage:

Dose	Unit	Route
6.50	mg	V

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
None	FDA

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
Butterfly rash	132.78	20.40	28	3213	1745	63484036
Periorbital oedema	100.36	20.40	28	3213	5656	63480125
Photosensitivity reaction	80.95	20.40	30	3211	14964	63470817
Off label use	70.58	20.40	124	3117	674338	62811443
Head discomfort	69.34	20.40	26	3215	13389	63472392
Swelling face	58.98	20.40	38	3203	63437	63422344
Tinnitus	56.03	20.40	30	3211	35598	63450183
Feeling hot	51.40	20.40	32	3209	50322	63435459
Application site discharge	46.31	20.40	8	3233	169	63485612
Cellulitis	33.39	20.40	30	3211	81928	63403853

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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
Tendon calcification	52.65	29.68	7	646	68	34956210
Progesterone increased	34.85	29.68	4	649	9	34956269
Blood parathyroid hormone increased	31.65	29.68	7	646	1507	34954771

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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
Butterfly rash	144.80	21.88	28	2741	1668	79739951
Periorbital oedema	100.23	21.88	28	2741	8374	79733245
Photosensitivity reaction	78.51	21.88	29	2740	21098	79720521
Head discomfort	77.17	21.88	26	2743	14476	79727143
Tinnitus	66.81	21.88	32	2737	44301	79697318
Swelling face	57.77	21.88	34	2735	71178	79670441
Feeling hot	55.06	21.88	31	2738	59703	79681916
Tendon calcification	43.16	21.88	7	2762	149	79741470
Cellulitis	42.39	21.88	33	2736	109027	79632592
Off label use	39.88	21.88	93	2676	907122	78834497

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A14AA07	ALIMENTARY TRACT AND METABOLISM ANABOLIC AGENTS FOR SYSTEMIC USE ANABOLIC STEROIDS Androstan derivatives
ATC	G03EA03	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM ANDROGENS AND FEMALE SEX HORMONES IN COMBINATION Androgens and estrogens
ATC	G03XX01	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM Other sex hormones and modulators of the genital system
CHEBI has role	CHEBI:50113	androgene
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
MeSH PA	D000276	Adjuvants, Immunologic
MeSH PA	D007155	Immunologic Factors

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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
Systemic lupus erythematosus	indication	55464009	DOID:9074
Dyspareunia	indication	71315007

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
6.5MG	INTRAROSA	MILLICENT	N208470	Nov. 16, 2016	RX	INSERT	VAGINAL	8957054	Jan. 8, 2030	INTRAVAGINAL PRASTERONE (DEHYDROEPIANDROSTERONE) AT A DAILY DOSE OF 6.5MG FOR THE TREATMENT OF DYSPAREUNIA, A SYMPTOM OF VULVAR AND VAGINAL ATROPHY, DUE TO MENOPAUSE

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Type	Activity value (-log[M])	Bioact source
Corticosteroid-binding globulin	Secreted	P08185	CBG_HUMAN	Ki	5	CHEMBL
Sex hormone-binding globulin	Secreted	P04278	SHBG_HUMAN	Kd	7.84	CHEMBL
Glucose-6-phosphate 1-dehydrogenase	Enzyme	P11413	G6PD_HUMAN	Ki	5.21	CHEMBL
Beta-glucuronidase	Enzyme	P08236	BGLR_HUMAN	IC50	4.11	CHEMBL
Glucose-6-phosphate 1-dehydrogenase	Enzyme		Q9GRG7_9TRYP	Ki	5.96	CHEMBL

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External reference:

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ID	Source
004609	NDDF
131731	MMSL
1927689	RXNORM
20676	MMSL
2370	IUPHAR_LIGAND_ID
247058	MMSL
2869	INN_ID
32118	MMSL
4021360	VUID
4021360	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Debaochun	HUMAN OTC DRUG LABEL	7	82570-016	POWDER	10 g	TOPICAL	unapproved drug other	8 sections
Intrarosa	HUMAN PRESCRIPTION DRUG LABEL	1	64011-601	INSERT	6.50 mg	VAGINAL	NDA	17 sections
Intrarosa	HUMAN PRESCRIPTION DRUG LABEL	1	72495-401	INSERT	6.50 mg	VAGINAL	NDA	17 sections
Intrarosa	HUMAN PRESCRIPTION DRUG LABEL	1	72495-401	INSERT	6.50 mg	VAGINAL	NDA	17 sections
Intrarosa	HUMAN PRESCRIPTION DRUG LABEL	1	72495-501	INSERT	6.50 mg	VAGINAL	NDA	17 sections
Intrarosa	HUMAN PRESCRIPTION DRUG LABEL	1	72495-501	INSERT	6.50 mg	VAGINAL	NDA	17 sections

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