Megestrol acetate
Megace (megestrol acetate) is a small molecule pharmaceutical. Megestrol acetate was first approved as Megace on 1982-01-01. It is used to treat anorexia, breast neoplasms, cachexia, and endometrial neoplasms in the USA.
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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| urogenital diseases | D000091642 |
| skin and connective tissue diseases | D017437 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Megace (generic drugs available since 1988-08-08)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Megestrol acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MEGACE ES | Endo | N-021778 RX | 2005-07-05 | 1 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| megace es | New Drug Application | 2014-03-18 |
| megestrol acetate | ANDA | 2023-06-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| anorexia | HP_0002039 | D000855 | R63.0 |
| breast neoplasms | EFO_0003869 | D001943 | C50 |
| cachexia | HP_0004326 | D002100 | R64 |
| endometrial neoplasms | EFO_0004230 | D016889 | — |
Agency Specific
FDA
EMA
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
— G03AA04: Megestrol and ethinylestradiol
— G03AB: Progestogens and estrogens systemic contraceptives, sequential preparations
— G03AB01: Megestrol and ethinylestradiol
— G03AC: Progestogen systemic hormonal contraceptives
— G03AC05: Megestrol
— G03D: Progestogen sex hormones and modulators of the genital system
— G03DB: Pregnadien derivatives, progestogens
— G03DB02: Megestrol
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA08: Megestrol and estrogen
— G03FB: Progestogens and estrogens, sequential preparations
— G03FB04: Megestrol and estrogen
L: Antineoplastic and immunomodulating agents
— L02: Endocrine therapy antineoplastic and immunomodulating agents
— L02A: Hormones and related agents
— L02AB: Progestogens, endocrine therapy drugs
— L02AB01: Megestrol
HCPCS
Code | Description |
|---|---|
| S0179 | Megestrol acetate, oral, 20 mg |
Clinical
Clinical Trials
119 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception | D003267 | 8 | 3 | 1 | 9 | 8 | 27 | ||
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 8 | 2 | 1 | — | 10 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 3 | — | 1 | 3 | 8 |
| Postmenopause | D017698 | 2 | 1 | 3 | 1 | — | 7 | ||
| Endometrial hyperplasia | D004714 | N85.0 | — | 2 | 1 | 2 | — | 5 | |
| Hot flashes | D019584 | — | 2 | 2 | 1 | — | 5 | ||
| Hiv | D006678 | O98.7 | — | 1 | — | 3 | 1 | 5 | |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | — | 3 | 1 | — | 4 |
| Metrorrhagia | D008796 | HP_0100608 | N92.1 | — | — | 1 | 2 | 1 | 4 |
| Infertility | D007246 | EFO_0000545 | — | — | 1 | 2 | — | 3 |
Show 6 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 1 | 4 | — | 1 | 5 |
| Coronary disease | D003327 | — | 1 | 5 | — | — | 5 | ||
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | 5 | — | — | 5 |
| Menopause | D008593 | EFO_0003922 | N95 | — | 2 | 2 | — | — | 4 |
| Healthy volunteers/patients | — | 3 | 1 | 1 | — | — | 4 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | 2 | — | — | 3 |
| Menorrhagia | D008595 | N92.0 | — | — | 2 | — | 1 | 3 | |
| Uterine hemorrhage | D014592 | — | — | 1 | — | 2 | 3 | ||
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 3 | — | — | 3 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | 1 | — | — | 2 |
Show 13 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endometrioid carcinoma | D018269 | — | 2 | — | — | — | 2 | ||
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 1 | — | — | — | 1 |
| Prehypertension | D058246 | — | 1 | — | — | — | 1 | ||
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | — | 1 | — | — | — | 1 |
| Persistent fetal circulation syndrome | D010547 | EFO_1001103 | P29.3 | — | 1 | — | — | — | 1 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | 1 | — | — | — | 1 |
| Myelodysplastic syndromes | D009190 | D46 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postcoital contraception | D044363 | 1 | — | — | — | 1 | 2 | ||
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | — | — | 1 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | 1 | — | — | — | — | 1 | |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | — | — | — | 1 | 1 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | — | 1 | 1 |
| Cognitive dysfunction | D060825 | G31.84 | — | — | — | — | 1 | 1 | |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | — | 1 | 1 |
| Body weight changes | D001836 | — | — | — | — | 1 | 1 | ||
| Contraception behavior | D003268 | — | — | — | — | 1 | 1 | ||
| Hormonal contraception | D000080282 | — | — | — | — | 1 | 1 | ||
| Breast feeding | D001942 | — | — | — | — | 1 | 1 | ||
| Chlamydia infections | D002690 | EFO_0007205 | A74.9 | — | — | — | — | 1 | 1 |
| Neisseriaceae infections | D016870 | EFO_1001377 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | MEGESTROL ACETATE |
| INN | megestrol |
| Description | Megestrol acetate is a steroid ester resulting from the formal condensation of the hydroxy group of megestrol with the carboxy group of acetic acid. It is an appetite stimulant used for the treatment of anorexia and cachexia. Also used for birth control and for the treatment of breast cancer. It has a role as an antineoplastic agent, an appetite enhancer, a contraceptive drug, a progestin and a synthetic oral contraceptive. It is a steroid ester, an acetate ester, a 20-oxo steroid and a 3-oxo-Delta(4) steroid. It is functionally related to a megestrol. |
| Classification | Small molecule |
| Drug class | estrogens; progestins |
| 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(C)C4=CC(=O)CC[C@]4(C)[C@H]3CC[C@@]21C |
Identifiers
| PDB | — |
| CAS-ID | 595-33-5 |
| RxCUI | 29451 |
| ChEMBL ID | CHEMBL1201139 |
| ChEBI ID | — |
| PubChem CID | 11683 |
| DrugBank | DB00351 |
| UNII ID | EA6LD1M70M (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
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Safety
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Adverse Events
Top Adverse Reactions
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51,847 adverse events reported
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