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

Stem definition	Drug id	CAS RN
steroids, progestogens	2279	57-83-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: progesterone gestone gestormone glanducorpin lugesteron lugesterone progestan progeston progestone progestron progesterol syngesterone	The major progestational steroid that is secreted primarily by the CORPUS LUTEUM and the PLACENTA. Progesterone acts on the UTERUS, the MAMMARY GLANDS and the BRAIN. It is required in EMBRYO IMPLANTATION; PREGNANCY maintenance, and the development of mammary tissue for MILK production. Progesterone, converted from PREGNENOLONE, also serves as an intermediate in the biosynthesis of GONADAL STEROID HORMONES and adrenal CORTICOSTEROIDS. Molecular weight: 314.47 Formula: C21H30O2 CLOGP: 3.96 LIPINSKI: 0 HAC: 2 HDO: 0 TPSA: 34.14 ALOGS: -4.76 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

progesterone
gestone
gestormone
glanducorpin
lugesteron
lugesterone
progestan
progeston
progestone
progestron
progesterol
syngesterone

The major progestational steroid that is secreted primarily by the CORPUS LUTEUM and the PLACENTA. Progesterone acts on the UTERUS, the MAMMARY GLANDS and the BRAIN. It is required in EMBRYO IMPLANTATION; PREGNANCY maintenance, and the development of mammary tissue for MILK production. Progesterone, converted from PREGNENOLONE, also serves as an intermediate in the biosynthesis of GONADAL STEROID HORMONES and adrenal CORTICOSTEROIDS.

Molecular weight: 314.47
Formula: C21H30O2
CLOGP: 3.96
LIPINSKI: 0
HAC: 2
HDO: 0
TPSA: 34.14
ALOGS: -4.76
ROTB: 1

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.30	g	O
5	mg	P
0.20	g	R
90	mg	V

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	25 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	21.20 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.01 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
Feb. 4, 1976	FDA	ALZA
Sept. 27, 2021	PMDA	FUJI PHARMA CO., LTD.

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
Ovarian hyperstimulation syndrome	960.36	12.65	246	28954	3768	63456054
Temperature regulation disorder	501.54	12.65	163	29037	5969	63453853
Food allergy	413.21	12.65	166	29034	11235	63448587
Coeliac disease	391.34	12.65	165	29035	12632	63447190
Exposure during pregnancy	319.38	12.65	375	28825	155172	63304650
Immunodeficiency	318.99	12.65	165	29035	20089	63439733
Bursitis	245.46	12.65	173	29027	36868	63422954
Rash erythematous	235.14	12.65	178	29022	42332	63417490
Premature labour	208.82	12.65	106	29094	12398	63447424
Foetal exposure during pregnancy	204.18	12.65	146	29054	31816	63428006

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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
Foetal exposure during pregnancy	701.50	85.14	173	933	37928	34917897
Premature baby	362.17	85.14	90	1016	19543	34936282
Atrial septal defect	151.22	85.14	37	1069	7355	34948470
Low birth weight baby	133.79	85.14	34	1072	7871	34947954
Hypospadias	107.59	85.14	24	1082	3177	34952648
Congenital hydronephrosis	101.95	85.14	18	1088	715	34955110
Human herpesvirus 6 infection	88.86	85.14	19	1087	2062	34953763

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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
Ovarian hyperstimulation syndrome	1015.01	14.18	228	21815	3343	79719002
Temperature regulation disorder	545.18	14.18	153	21890	5700	79716645
Food allergy	464.34	14.18	156	21887	10668	79711677
Coeliac disease	453.15	14.18	155	21888	11196	79711149
Immunodeficiency	361.61	14.18	157	21886	21611	79700734
Exposure during pregnancy	322.40	14.18	248	21795	100884	79621461
Bursitis	303.91	14.18	163	21880	35681	79686664
Maternal exposure during pregnancy	257.65	14.18	248	21795	136290	79586055
Rash erythematous	246.22	14.18	169	21874	57600	79664745
Fluid retention	224.09	14.18	172	21871	69637	79652708

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FDA Adverse Event Reporting System (Pediatric)

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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
Human herpesvirus 6 infection	46.81	37.71	15	363	45	89369
Congestive cardiomyopathy	40.41	37.71	14	364	57	89357

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Pharmacologic Action:

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Source	Code	Description
ATC	G03DA04	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM PROGESTOGENS Pregnen (4) derivatives
ATC	G03FA04	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM PROGESTOGENS AND ESTROGENS IN COMBINATION Progestogens and estrogens, fixed combinations
CHEBI has role	CHEBI:49323	contraceptive drugs
CHEBI has role	CHEBI:59826	progestins
CHEBI has role	CHEBI:70709	progesterone receptor agonists
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
FDA CS	M0017672	Progesterone
FDA EPC	N0000175601	Progesterone
MeSH PA	D009465	Neuromuscular 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
Contraception	indication	13197004
Dysfunctional uterine bleeding	indication	19155002
Atrophic vaginitis	indication	52441000
Secondary physiologic amenorrhea	indication	86030004
Secondary malignant neoplasm of kidney	indication	94360002
Postmenopausal osteoporosis	indication	102447009
Endometriosis	indication	129103003
Menopausal flushing	indication	198436008
Endometrial carcinoma	indication	254878006	DOID:2871
Infertility Secondary to Progesterone Deficiency	indication

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🐶 Veterinary Drug Use

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Species	Use	Relation
Cattle	Estrus synchronization	Indication
Cattle	Induction of estrous cycles	Indication
Cattle	Synchronization of the return to estrus	Indication
Cattle	Advancement of first postpartum estrus	Indication
Cattle	Advancement of first pubertal estrus	Indication
Cattle	To increase rate of weight gain	Indication
Cattle	To improve feed efficiency	Indication
Sheep	Estrus induction	Indication

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🐶 Veterinary products

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Product	Applicant	Ingredients
Component E-C with Tylan, Component E-S with Tylan	Elanco US Inc.	3
EAZI-BREED CIDR Cattle Insert	Zoetis Inc.	1
EAZI-BREED CIDR Sheep Insert	Zoetis Inc.	1
Synovex C, Synovex S	Zoetis Inc.	2

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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
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	10206932	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	10675288	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	11033626	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	8846648	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	8846649	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	8933059	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	9114145	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	9114146	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	9301920	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1.78GM	MILPROSA	FERRING PHARMS INC	N201110	April 29, 2020	DISCN	SYSTEM	VAGINAL	10548904	Feb. 3, 2029	METHOD OF SUPPORTING EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED REPRODUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN

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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
1.78GM	MILPROSA	FERRING PHARMS INC	N201110	April 29, 2020	DISCN	SYSTEM	VAGINAL	April 29, 2023	NEW PRODUCT

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Progesterone receptor	Nuclear hormone receptor	P06401	PRGR_HUMAN	AGONIST	ED50	9.88	WOMBAT-PK	CHEMBL
Sigma non-opioid intracellular receptor 1	Membrane receptor	Q99720	SGMR1_HUMAN		Ki	6.59	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		IC50	4.32	CHEMBL
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN		Ki	7.52	CHEMBL
Mineralocorticoid receptor	Nuclear hormone receptor	P08235	MCR_HUMAN		EC50	11	WOMBAT-PK
Estrogen receptor	Nuclear hormone receptor	P03372	ESR1_HUMAN				WOMBAT-PK
Androgen receptor	Nuclear hormone receptor	P10275	ANDR_HUMAN		Ki	8.07	CHEMBL
Corticosteroid-binding globulin	Secreted	P08185	CBG_HUMAN		Ki	7.38	CHEMBL
Sex hormone-binding globulin	Secreted	P04278	SHBG_HUMAN		Kd	6.94	CHEMBL
Sterol O-acyltransferase 1	Enzyme	P35610	SOAT1_HUMAN		IC50	4.77	CHEMBL

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External reference:

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ID	Source
STR	PDB_CHEM_ID
001290	NDDF
16683002	SNOMEDCT_US
2110	MMSL
2377	IUPHAR_LIGAND_ID
4017453	VUID
4017453	VANDF
417	INN_ID
4G7DS2Q64Y	UNII
50318003	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Bijuva	HUMAN PRESCRIPTION DRUG LABEL	2	50261-211	CAPSULE	100 mg	ORAL	NDA	33 sections
Bijuva	HUMAN PRESCRIPTION DRUG LABEL	2	50261-211	CAPSULE	100 mg	ORAL	NDA	33 sections
Bijuva	HUMAN PRESCRIPTION DRUG LABEL	2	50261-251	CAPSULE	100 mg	ORAL	NDA	33 sections
Crinone	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6150	GEL	45 mg	VAGINAL	NDA	24 sections
Crinone	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6150	GEL	45 mg	VAGINAL	NDA	24 sections
Crinone	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6151	GEL	90 mg	VAGINAL	NDA	24 sections
Crinone	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6151	GEL	90 mg	VAGINAL	NDA	24 sections
Crinone	HUMAN PRESCRIPTION DRUG LABEL	1	55056-0806	GEL	90 mg	VAGINAL	NDA	24 sections
Prochieve	HUMAN PRESCRIPTION DRUG LABEL	1	55056-0406	GEL	45 mg	VAGINAL	NDA	24 sections
Progesterone	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9725	INJECTION	50 mg	INTRAMUSCULAR	ANDA	13 sections

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