Megestrol acetate
Megestrol (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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Megestrol (discontinued: Megace, Megestrol)
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
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Abbreviated New Drug Application (ANDA)
Megestrol acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MEGACE | Bristol Myers Squibb | N-020264 DISCN | 1993-09-10 | 1 products, RLD |
| MEGACE | Bristol Myers Squibb | N-016979 DISCN | 1982-01-01 | 2 products, RLD |
| MEGACE ES | Endo | N-021778 DISCN | 2005-07-05 | 1 products, RLD |
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Brand Name | Status | Last Update |
|---|---|---|
| megace es | New Drug Application | 2014-03-18 |
| megestol | ANDA | 2010-01-22 |
| megestrol acetate | ANDA | 2025-05-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
| endometrial neoplasms | EFO_0004230 | D016889 | — |
| cachexia | — | D002100 | R64 |
| anorexia | — | D000855 | R63.0 |
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FDA
EMA
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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
107 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cachexia | D002100 | — | R64 | 2 | 11 | 9 | 3 | 2 | 26 |
| Wasting syndrome | D019282 | — | — | 1 | 10 | 9 | 1 | 2 | 22 |
| Anorexia | D000855 | — | R63.0 | 1 | 9 | 8 | 2 | — | 19 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 3 | 1 | 1 | 2 | 8 |
| Esophageal neoplasms | D004938 | — | C15 | — | — | 1 | 1 | — | 2 |
| Second primary neoplasms | D016609 | — | — | — | — | — | 1 | — | 1 |
| Feeding and eating disorders | D001068 | — | F50 | — | — | — | 1 | — | 1 |
| Feeding behavior | D005247 | — | — | — | — | — | 1 | — | 1 |
| Feeding and eating disorders of childhood | D019959 | — | — | — | — | — | 1 | — | 1 |
| Precocious puberty | D011629 | — | E22.8 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 4 | 18 | 4 | — | 3 | 24 |
| Hyperplasia | D006965 | EFO_0000536 | — | — | 13 | 7 | — | 2 | 16 |
| Neoplasms | D009369 | — | C80 | — | 9 | 5 | — | 2 | 15 |
| Endometrial hyperplasia | D004714 | — | N85.0 | — | 12 | 7 | — | 2 | 15 |
| Carcinoma | D002277 | — | C80.0 | — | 7 | 4 | — | 1 | 11 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 5 | 2 | — | — | 7 |
| Endometrioid carcinoma | D018269 | — | — | 1 | 4 | 1 | — | 3 | 7 |
| Weight loss | D015431 | — | — | — | 4 | 4 | — | — | 7 |
| Lung neoplasms | D008175 | — | C34.90 | — | 2 | 4 | — | — | 6 |
| Infertility | D007246 | EFO_0000545 | — | — | 4 | 3 | — | — | 4 |
Show 24 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 1 | 5 | — | — | 1 | 7 |
| Hiv wasting syndrome | D019247 | EFO_0007312 | — | 1 | 2 | — | — | 1 | 4 |
| Uterine neoplasms | D014594 | EFO_0003859 | C55 | — | 2 | — | — | 1 | 3 |
| Adenocarcinoma | D000230 | — | — | 1 | 2 | — | — | 1 | 3 |
| Recurrence | D012008 | — | — | 1 | 3 | — | — | — | 3 |
| Carcinoma in situ | D002278 | — | D09.9 | — | 2 | — | — | — | 2 |
| Fatigue | D005221 | — | R53.83 | — | 1 | — | — | 1 | 2 |
| Vomiting | D014839 | — | R11.1 | — | 1 | — | — | — | 1 |
| Nausea | D009325 | — | R11.0 | — | 1 | — | — | — | 1 |
| Triple negative breast neoplasms | D064726 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | 1 | 3 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
| Absorption | D000042 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | — | — | — | — | 3 | 3 |
| Fertility preservation | D059247 | — | — | — | — | — | — | 2 | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | — | 2 | 2 |
| Adrenal insufficiency | D000309 | — | — | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | — | 1 | 1 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | — | — | — | 1 | 1 |
| Failure to thrive | D005183 | — | — | — | — | — | — | 1 | 1 |
| Digestive system neoplasms | D004067 | — | — | — | — | — | — | 1 | 1 |
| Conservative treatment | D000072700 | — | — | — | — | — | — | 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 | — |
| ChEMBL ID | CHEMBL1201139 |
| ChEBI ID | — |
| PubChem CID | 11683 |
| DrugBank | DB00351 |
| UNII ID | EA6LD1M70M (ChemIDplus, GSRS) |
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Megestrol acetate
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Megestrol
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2,272 adverse events reported
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