Progesterone
Bijuva, Crinone, Endometrin, Progesterone, 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 short transient receptor potential channel 5, cation channel sperm-associated protein 1, cation channel sperm-associated protein 4, mineralocorticoid receptor, cation channel sperm-associated protein 2, and cation channel sperm-associated protein 3.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Crinone, Endometrin, Progesterone, Prometrium (discontinued: Milprosa, Progestasert, Progesterone, Prometrium)
CombinationsBijuva (discontinued: Estradiol progesterone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Progesterone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CRINONE | AbbVie | N-020701 RX | 1997-07-31 | 2 products, RLD, RS |
| ENDOMETRIN | Ferring Pharmaceuticals | N-022057 RX | 2007-06-21 | 1 products, RLD, RS |
| PROMETRIUM | Virtus Pharmaceuticals | N-019781 RX | 1998-05-14 | 2 products, RLD |
Show 5 discontinued
Estradiol
+
Progesterone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BIJUVA | Mayne Group | N-210132 RX | 2018-10-28 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| advanced formula progesto-life | unapproved drug other | 2022-03-31 |
| bijuva | New Drug Application | 2025-01-28 |
| crinone | New Drug Application | 2024-05-21 |
| endometrin | New Drug Application | 2022-08-16 |
| estradiol and progesterone | ANDA | 2024-06-07 |
| fluocinolone acetonide 0.01% / minoxidil 7% / progesterone 0.1% | unapproved drug other | 2019-05-08 |
| minoxidil 5% / progesterone 0.1% / tretinoin 0.025% | unapproved drug other | 2019-05-06 |
| minoxidil 7% / progesterone 0.1% | unapproved drug other | 2019-04-24 |
| minoxidil 7% / progesterone 0.1% / tretinoin 0.025% | unapproved drug other | 2019-05-06 |
| p25 progesterone cream | unapproved drug other | 2021-06-21 |
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Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PROGESTERONE, MILPROSA, FERRING PHARMS INC | |||
| 2023-04-29 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Estradiol / Progesterone, Bijuva, Mayne Pharma | |||
| 8633178 | 2032-11-21 | DP | |
| 8846648 | 2032-11-21 | U-2439 | |
| 8846649 | 2032-11-21 | DP | U-2439 |
| 8933059 | 2032-11-21 | DP | U-2439 |
| 8987237 | 2032-11-21 | DP | |
| 8993548 | 2032-11-21 | DP | |
| 8993549 | 2032-11-21 | DP | |
| 9006222 | 2032-11-21 | DP | U-2439 |
| 9114145 | 2032-11-21 | U-2439 | |
| 9114146 | 2032-11-21 | DP | U-2439 |
| 9301920 | 2032-11-21 | DP | U-2439 |
| 10052386 | 2032-11-21 | DP | |
| 10206932 | 2032-11-21 | U-2439 | |
| 10639375 | 2032-11-21 | DP | |
| 10675288 | 2032-11-21 | U-2439 | |
| 10806740 | 2032-11-21 | DP | U-2439 |
| 11033626 | 2032-11-21 | DP | U-2439 |
| 11103513 | 2032-11-21 | U-2439 | |
| 11103516 | 2032-11-21 | DP | |
| 11110099 | 2032-11-21 | DP | |
| 11166963 | 2032-11-21 | DP | |
| 11529360 | 2032-11-21 | DP | |
| Progesterone, Milprosa, Ferring Pharms Inc | |||
| 8580293 | 2030-01-21 | U-2810 | |
| 10537584 | 2029-02-03 | DP | |
| 10548904 | 2029-02-03 | U-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
Clinical Trials
1320 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | EFO_0000545 | — | 14 | 23 | 36 | 54 | 122 | 242 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 19 | 75 | 33 | 1 | 45 | 160 |
| Premature birth | D047928 | EFO_0003917 | O60 | 5 | 17 | 32 | 17 | 44 | 105 |
| Contraception | D003267 | — | — | 10 | 15 | 14 | 16 | 30 | 83 |
| Female infertility | D007247 | EFO_0008560 | N97 | 7 | 5 | 10 | 9 | 39 | 67 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 7 | 5 | 11 | 7 | 21 | 49 |
| Endometriosis | D004715 | EFO_0001065 | N80 | 1 | 12 | 8 | 6 | 18 | 40 |
| Menopause | D008593 | EFO_0003922 | N95 | 3 | 9 | 7 | 17 | 5 | 37 |
| Syndrome | D013577 | — | — | 2 | 9 | 7 | 7 | 13 | 36 |
| Premature obstetric labor | D007752 | — | O60 | 2 | 4 | 4 | 11 | 15 | 35 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 3 | 5 | 1 | — | 5 | 13 |
| Triple negative breast neoplasms | D064726 | — | — | 7 | 6 | 1 | — | 3 | 12 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | 7 | — | 4 | 12 |
| Coronary disease | D003327 | — | — | — | — | 7 | — | 3 | 10 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 3 | 2 | — | 4 | 7 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 6 | — | 1 | 7 |
| Anorexia | D000855 | — | R63.0 | 1 | 4 | 3 | — | — | 6 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | 1 | 4 | 3 | — | — | 6 |
| Eclampsia | D004461 | — | O15 | — | — | 1 | — | 4 | 5 |
| Atrophy | D001284 | — | — | 2 | 2 | 2 | — | — | 5 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperandrogenism | D017588 | — | — | 3 | 1 | — | — | 7 | 11 |
| Carcinoma | D002277 | — | C80.0 | 2 | 6 | — | — | 2 | 9 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | 2 | — | — | 3 | 5 |
| Inflammation | D007249 | MP_0001845 | — | — | 2 | — | — | 3 | 5 |
| Endometrioid carcinoma | D018269 | — | — | — | 1 | — | — | 4 | 5 |
| Carcinoma in situ | D002278 | — | D09.9 | 1 | 2 | — | — | 2 | 5 |
| Placenta previa | D010923 | EFO_0007442 | O44 | — | 2 | — | — | 3 | 5 |
| Covid-19 | D000086382 | — | U07.1 | 1 | 1 | — | — | 2 | 4 |
| Infections | D007239 | EFO_0000544 | — | 1 | 1 | — | — | 2 | 4 |
| Male breast neoplasms | D018567 | — | — | 1 | 2 | — | — | 2 | 4 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Puberty | D011627 | EFO_0001382 | — | 4 | — | — | — | 1 | 5 |
| Pharmacokinetics | D010599 | — | — | 4 | — | — | — | 1 | 5 |
| Diabetes insipidus | D003919 | — | E23.2 | 1 | — | — | — | 1 | 2 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | 1 | — | — | — | 1 | 2 |
| Headache | D006261 | — | R51 | 1 | — | — | — | 1 | 2 |
| Intracytoplasmic sperm injections | D020554 | — | — | 1 | — | — | — | 1 | 2 |
| Hemophilia b | D002836 | — | D67 | 1 | — | — | — | 1 | 2 |
| Urogenital abnormalities | D014564 | — | — | 1 | — | — | — | — | 1 |
| Inflammatory breast neoplasms | D058922 | — | — | 1 | — | — | — | — | 1 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Menstrual cycle | D008597 | — | — | — | — | — | — | 8 | 8 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | — | 4 | 4 |
| Corpus luteum maintenance | D003340 | — | — | — | — | — | — | 3 | 3 |
| Oocyte donation | D018587 | — | — | — | — | — | — | 3 | 3 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | — | — | — | 3 | 3 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | — | 3 | 3 |
| Thromboembolism | D013923 | — | — | — | — | — | — | 3 | 3 |
| Infarction | D007238 | EFO_0009463 | — | — | — | — | — | 3 | 3 |
| Body weight | D001835 | EFO_0004338 | — | — | — | — | — | 3 | 3 |
| Body weight changes | D001836 | — | — | — | — | — | — | 3 | 3 |
Show 110 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Progesterone |
| INN | progesterone |
| 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 class | progestins; 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
| PDB | — |
| CAS-ID | 57-83-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL103 |
| ChEBI ID | 17026 |
| PubChem CID | 5994 |
| DrugBank | DB00396 |
| UNII ID | 4G7DS2Q64Y (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
NR3C2
NR3C2
CATSPER2
CATSPER2
NCOA2
NCOA2
Organism
Homo sapiens
Gene name
NR3C2
Gene synonyms
MCR, MLR
NCBI Gene ID
Protein name
mineralocorticoid receptor
Protein synonyms
aldosterone receptor, mineralocorticoid receptor 1, mineralocorticoid receptor 2, mineralocorticoid receptor delta, Nuclear receptor subfamily 3 group C member 2
Uniprot ID
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII8)
Variants
No data
Financial
Revenue by drug
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£
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Bijuva – TherapeuticsMD
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Crinone – Juniper Pharmaceuticals
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Estimated US medical usage
Progesterone
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Bijuva, Estradiol and progesterone, Progesterone, Prometrium
Adverse Events
Top Adverse Reactions
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51,214 adverse events reported
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