Medroxyprogesterone acetate
Lunelle, Medroxyprogesterone, Premphase, Prempro, Provera (medroxyprogesterone acetate) is a small molecule pharmaceutical. Medroxyprogesterone acetate was first approved as Provera on 1982-01-01. It is used to treat amenorrhea, breast neoplasms, endometrial hyperplasia, endometrial neoplasms, and hypoventilation amongst others in the USA. The pharmaceutical is active against progesterone receptor.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Trade Name
FDA
EMA
Depo-provera, Depo-subq provera, Medroxyprogesterone, Provera (discontinued: Amen, Curretab, Depo-provera, Medroxyprogesterone)
CombinationsPrempro (discontinued: Lunelle, Premphase (premarin;cycrin ))
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Medroxyprogesterone acetate
Estradiol cypionate
+
Medroxyprogesterone acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LUNELLE | Pharmacia & Upjohn | N-020874 DISCN | 2000-10-05 | 1 products, RLD |
Hide discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| depo-provera | New Drug Application | 2026-08-25 |
| depo-subq provera | New Drug Application | 2025-12-18 |
| depo-subq provera 104 | 2006-05-23 | |
| medroxyprogesterone acetate | NDA authorized generic | 2026-07-21 |
| medroxyprogesterone acetate injectable suspension | ANDA | 2025-01-08 |
| premphase | ANDA | 2012-11-26 |
| premphase prempro | New Drug Application | 2026-04-28 |
| prempro | New Drug Application | 2021-02-05 |
| provera | New Drug Application | 2026-06-29 |
Indications
FDA
EMA
Show 3 more
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03A: Hormonal contraceptives for systemic use
— G03AA: Progestogens and estrogen systemic contraceptives, fixed combinations
— G03AA08: Medroxyprogesterone and ethinylestradiol
— G03AA17: Medroxyprogesterone and estradiol
— G03AC: Progestogen systemic hormonal contraceptives
— G03AC06: Medroxyprogesterone
— G03D: Progestogen sex hormones and modulators of the genital system
— G03DA: Pregnen (4) derivatives, progestogens
— G03DA02: Medroxyprogesterone
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA12: Medroxyprogesterone and estrogen
— G03FB: Progestogens and estrogens, sequential preparations
— G03FB06: Medroxyprogesterone and estrogen
L: Antineoplastic and immunomodulating agents
— L02: Endocrine therapy antineoplastic and immunomodulating agents
— L02A: Hormones and related agents
— L02AB: Progestogens, endocrine therapy drugs
— L02AB02: Medroxyprogesterone
HCPCS
Code | Description |
|---|---|
| J1050 | Injection, medroxyprogesterone acetate, 1 mg |
Clinical
Clinical Trials
243 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception | D003267 | — | — | 14 | 4 | 1 | 13 | 20 | 49 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | 18 | 5 | 2 | 4 | 26 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | 3 | — | 2 | 9 | 17 |
| Endometrial hyperplasia | D004714 | — | N85.0 | 1 | 7 | 3 | 3 | — | 12 |
| Infertility | D007246 | EFO_0000545 | — | 1 | 1 | 2 | 4 | 4 | 11 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 2 | 4 | 2 | 2 | 9 |
| Hiv | D006678 | — | O98.7 | — | 1 | — | 3 | 4 | 8 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | 1 | — | 3 | 2 | — | 6 |
| Menopause | D008593 | EFO_0003922 | N95 | — | 3 | 2 | 1 | — | 6 |
| Endometriosis | D004715 | EFO_0001065 | N80 | 1 | 3 | 1 | 2 | — | 6 |
Show 36 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postmenopause | D017698 | — | — | 3 | 1 | 4 | — | 1 | 9 |
| Uterine hemorrhage | D014592 | — | — | 1 | 1 | 2 | — | 4 | 7 |
| Endometrioid carcinoma | D018269 | — | — | 1 | 3 | 1 | — | 3 | 7 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 1 | — | 5 | 6 |
| Syndrome | D013577 | — | — | — | 1 | 1 | — | 4 | 6 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | 4 | — | 2 | 6 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | 6 | — | — | 6 |
| Coronary disease | D003327 | — | — | — | 1 | 5 | — | — | 5 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | 1 | 5 | — | — | 5 |
| Carcinoma | D002277 | — | C80.0 | — | 3 | 1 | — | — | 4 |
Show 31 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | — | 1 | — | — | 1 | 2 |
| Depression | D003863 | — | F33.9 | — | 1 | — | — | 1 | 2 |
| Premature birth | D047928 | EFO_0003917 | O60 | 1 | 1 | — | — | — | 2 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 1 | — | — | — | 1 |
| Menstruation disturbances | D008599 | — | N91.5 | 1 | 1 | — | — | — | 1 |
| Prehypertension | D058246 | — | — | — | 1 | — | — | — | 1 |
| Persistent fetal circulation syndrome | D010547 | EFO_1001103 | P29.3 | — | 1 | — | — | — | 1 |
| Adenosquamous carcinoma | D018196 | — | — | — | 1 | — | — | — | 1 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | 1 | — | — | — | 1 |
| Seizures | D012640 | — | G40.4 | — | 1 | — | — | — | 1 |
Show 5 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception behavior | D003268 | — | — | 1 | — | — | — | 5 | 6 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 2 | — | — | — | 1 | 3 |
| Postcoital contraception | D044363 | — | — | 1 | — | — | — | 1 | 2 |
| Kidney transplantation | D016030 | — | — | 1 | — | — | — | — | 1 |
| Immunosuppression therapy | D007165 | — | — | 1 | — | — | — | — | 1 |
| Pregnancy rate | D018873 | — | — | 1 | — | — | — | — | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | — | — | 1 |
| Estrogen replacement therapy | D015914 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female infertility | D007247 | EFO_0008560 | N97 | — | — | — | — | 3 | 3 |
| Tissue adhesions | D000267 | — | — | — | — | — | — | 2 | 2 |
| Septate uterus | D000093665 | — | — | — | — | — | — | 2 | 2 |
| Body weight changes | D001836 | — | — | — | — | — | — | 2 | 2 |
| Body weight | D001835 | EFO_0004338 | — | — | — | — | — | 2 | 2 |
| Weight loss | D015431 | — | — | — | — | — | — | 2 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 2 | 2 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 2 | 2 |
| Fertility preservation | D059247 | — | — | — | — | — | — | 2 | 2 |
| Premenstrual dysphoric disorder | D065446 | — | F32.81 | — | — | — | — | 1 | 1 |
Show 42 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Medroxyprogesterone acetate |
| INN | medroxyprogesterone |
| Description | Medroxyprogesterone acetate is an acetate ester resulting from the formal condensation of the 17alpha-hydroxy group of medroxyprogesterone with the carboxy group of acetic acid. A widely used progestin in menopausal hormone therapy and in progestogen-only birth control. It has a role as a progestin, an androgen, a female contraceptive drug, a synthetic oral contraceptive, an adjuvant, an inhibitor, an antioxidant and an antineoplastic agent. It is a steroid ester, an acetate ester, a 20-oxo steroid, a 3-oxo-Delta(4) steroid and a corticosteroid. It is functionally related to a medroxyprogesterone. |
| Classification | Small molecule |
| Drug class | progestins; steroids (androgens, anabolics); antiandrogens |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)O[C@]1(C(C)=O)CC[C@H]2[C@@H]3C[C@H](C)C4=CC(=O)CC[C@]4(C)[C@H]3CC[C@@]21C |
Identifiers
| PDB | — |
| CAS-ID | 71-58-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL717 |
| ChEBI ID | 6716 |
| PubChem CID | 6279 |
| DrugBank | DB00603 |
| UNII ID | HSU1C9YRES (ChemIDplus, GSRS) |
Target
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Medroxyprogesterone – Amphastar Pharmaceuticals
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Provera – Pfizer
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
Medroxyprogesterone acetate
+
Estradiol
+
Medroxyprogesterone
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Medroxyprogesterone acetate
+
Medroxyprogesterone
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
No data
Safety
Black-box Warning
Black-box warning for: Depo-provera, Depo-subq provera, Depo-subq provera 104, Medroxyprogesterone acetate, Medroxyprogesterone acetate injectable suspension, Premphase, Premphase prempro, Prempro, Provera
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
67,304 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use