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Progesterone
Bijuva, Crinone, Endometrin, Prometrium (progesterone) is a small molecule pharmaceutical. Progesterone was first approved as Progesterone on 1982-01-01. It is used to treat amenorrhea, endometrial hyperplasia, female infertility, and uterine hemorrhage in the USA. The pharmaceutical is active against progesterone receptor. In addition, it is known to target cation channel sperm-associated protein 2, cation channel sperm-associated protein 4, short transient receptor potential channel 5, cation channel sperm-associated protein 3, mineralocorticoid receptor, cation channel sperm-associated protein 1, and nuclear receptor coactivator 2.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Crinone, Endometrin, Prometrium (generic drugs available since 2001-04-25, discontinued: Milprosa, Progestasert)
Combinations
Bijuva (generic drugs available since 2001-04-25)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Estradiol
+
Progesterone
Tradename
Company
Number
Date
Products
BIJUVAMayne GroupN-210132 RX2018-10-28
2 products, RLD, RS
Progesterone
Tradename
Company
Number
Date
Products
CRINONEAllerganN-020701 RX1997-07-31
2 products, RLD, RS
ENDOMETRINFerring PharmaceuticalsN-022057 RX2007-06-21
1 products, RLD, RS
PROMETRIUMVirtus PharmaceuticalsN-019781 RX1998-05-14
2 products, RLD
Show 5 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
bijuvaNew Drug Application2021-06-30
crinoneNew Drug Application2019-01-16
endometrinNew Drug Application2020-11-25
progesteroneANDA2023-06-15
prometriumNew Drug Application2022-10-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
amenorrheaD000568N91.2
endometrial hyperplasiaD004714N85.0
female infertilityEFO_0008560D007247N97
uterine hemorrhageD014592
Agency Specific
FDA
EMA
Expiration
Code
PROGESTERONE, MILPROSA, FERRING PHARMS INC
2023-04-29NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Estradiol / Progesterone, Bijuva, Mayne Pharma
86331782032-11-21DP
88466482032-11-21U-2439
88466492032-11-21DPU-2439
89330592032-11-21DPU-2439
89872372032-11-21DP
89935482032-11-21DP
89935492032-11-21DP
90062222032-11-21DPU-2439
91141452032-11-21U-2439
91141462032-11-21DPU-2439
93019202032-11-21DPU-2439
100523862032-11-21DP
102069322032-11-21U-2439
106393752032-11-21DP
106752882032-11-21U-2439
108067402032-11-21DPU-2439
110336262032-11-21DPU-2439
111035132032-11-21U-2439
111035162032-11-21DP
111100992032-11-21DP
111669632032-11-21DP
115293602032-11-21DP
Progesterone, Milprosa, Ferring Pharms Inc
85802932030-01-21U-2810
105375842029-02-03DP
105489042029-02-03U-2810
ATC Codes
G: Genito urinary system and sex hormones
G03: Sex hormones and modulators of the genital system
G03D: Progestogen sex hormones and modulators of the genital system
G03DA: Pregnen (4) derivatives, progestogens
G03DA04: Progesterone
G03F: Progestogens and estrogens in combination
G03FA: Progestogens and estrogens, fixed combinations
G03FA04: Progesterone and estrogen
G03X: Other sex hormones and modulators of the genital system in atc
G03XB: Progesterone receptor modulators, sex hormones and modulators of the genital system
HCPCS
Code
Description
J1050
Injection, medroxyprogesterone acetate, 1 mg
J1726
Injection, hydroxyprogesterone caproate, (makena), 10 mg
J1729
Injection, hydroxyprogesterone caproate, not otherwise specified, 10 mg
J2675
Injection, progesterone, per 50 mg
S3620
Newborn metabolic screening panel, includes test kit, postage and the laboratory tests specified by the state for inclusion in this panel (e.g., galactose; hemoglobin, electrophoresis; hydroxyprogesterone, 17-d; phenylalanine (pku); and thyroxine, total)
Clinical
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePROGESTERONE
INNprogesterone
Description
Progesterone is a C21-steroid hormone in which a pregnane skeleton carries oxo substituents at positions 3 and 20 and is unsaturated at C(4)-C(5). As a hormone, it is involved in the female menstrual cycle, pregnancy and embryogenesis of humans and other species. It has a role as a contraceptive drug, a progestin, a progesterone receptor agonist, a human metabolite and a mouse metabolite. It is a 20-oxo steroid, a 3-oxo-Delta(4) steroid and a C21-steroid hormone. It derives from a hydride of a pregnane.
Classification
Small molecule
Drug classprogestins; steroids (androgens, anabolics); antiandrogens
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(=O)[C@H]1CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@H]3CC[C@]12C
Identifiers
PDB7RAF
CAS-ID57-83-0
RxCUI8727
ChEMBL IDCHEMBL103
ChEBI ID17026
PubChem CID5994
DrugBankDB00396
UNII ID4G7DS2Q64Y (ChemIDplus, GSRS)
Target
Agency Approved
PGR
PGR
Organism
Homo sapiens
Gene name
PGR
Gene synonyms
NR3C3
NCBI Gene ID
Protein name
progesterone receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 3
Uniprot ID
Mouse ortholog
Pgr (18667)
progesterone receptor (Q00175)
Alternate
CATSPER2
CATSPER2
CATSPER4
CATSPER4
TRPC5
TRPC5
CATSPER3
CATSPER3
NR3C2
NR3C2
CATSPER1
CATSPER1
NCOA2
NCOA2
Organism
Homo sapiens
Gene name
CATSPER2
Gene synonyms
NCBI Gene ID
Protein name
cation channel sperm-associated protein 2
Protein synonyms
sperm ion channel
Uniprot ID
Mouse ortholog
Catsper2 (212670)
cation channel sperm-associated protein 2 (A2ARP9)
Variants
Clinical Variant
No data
Financial
Bijuva - TherapeuticsMD
$
£
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Crinone - Juniper Pharmaceuticals
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 148,527 documents
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Safety
Black-box Warning
Black-box warning for: Bijuva, Progesterone, Prometrium
Adverse Events
Top Adverse Reactions
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673 adverse events reported
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