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Megace (MEGESTROL ACETATE)
Megace (Megestrol Acetate) is a progestin medication developed by Bristol Myers Squibb, targeting the glucocorticoid receptor. It was approved by the FDA in 1971 for various indications, including anorexia from HIV, cachexia due to HIV, and hormone receptor-positive breast cancer. As an off-patent medication, Megace is available from multiple generic manufacturers. Key safety considerations include potential effects on blood sugar levels and liver function. Megace is a small molecule modality with high bioavailability of 90%.
At a glance
| Generic name | MEGESTROL ACETATE |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | Progestin |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1971 |
Approved indications
- Anorexia from HIV
- Cachexia due to HIV
- Endometrial carcinoma
- Hormone receptor positive malignant neoplasm of breast
- Nutritional deficiency associated with AIDS
Common side effects
- Weight gain
- Thromboembolic phenomena
- Heart failure
- Nausea and vomiting
- Edema
- Breakthrough menstrual bleeding
- Dyspnea
- Tumor flare
- Hyperglycemia
- Glucose intolerance
- Alopecia
- Hypertension
Key clinical trials
- Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers (PHASE1,PHASE2)
- SHAPE-ENDO: Multimodal Pre-Surgical Optimization in Patients With Obesity and Early-Stage Endometrial Cancer
- Megestrol Acetate for First-Line Treatment of Malnourished Non-Small Cell Lung Cancer (PHASE3)
- Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer (PHASE2)
- Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification (PHASE2,PHASE3)
- A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015) (PHASE2)
- Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients (PHASE3)
- Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Megace CI brief — competitive landscape report
- Megace updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI