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Drug ReportsMegestrol
Megestrol acetate
Megace, 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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Events Timeline
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Megace, Megestrol (discontinued: Megace, Megestrol)
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 ESEndoN-021778 RX2005-07-05
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
megace esNew Drug Application2014-03-18
megestolANDA2010-01-22
megestrol acetateANDA2024-12-19
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Megestrol Acetate, Megace Es, Endo Pharms Inc
71015762024-04-22U-755
90400882024-04-22U-755
91015402024-04-22DPU-755
91015492024-04-22U-755
91078272024-04-22U-755
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
111 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B201111—4
Wasting syndromeD019282——1111—4
CachexiaD002100HP_0004326R641111—4
AnorexiaD000855HP_0002039R63.0—111—3
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD013577——1————1
Hiv wasting syndromeD019247EFO_0007312—1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMegestrol acetate
INNmegestrol
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 classestrogens; progestins
Image (chem structure or protein)Loading
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-ID595-33-5
RxCUI—
ChEMBL IDCHEMBL1201139
ChEBI ID—
PubChem CID11683
DrugBankDB00351
UNII IDEA6LD1M70M (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Megestrol acetate
+
Megestrol
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,889 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,231 adverse events reported
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