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Data updated: Jun 28, 2026

MEGACE (megestrol acetate) · Bristol-Myers Squibb

Infectious Disease Approved 1971-08-18

MEGACE is FDA-approved to treat 4 conditions (same as MEGESTROL ACETATE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
54
Years on Market

Details

Status
Discontinued
First Approved
1971-08-18
Routes
ORAL
Dosage Forms
SUSPENSION, TABLET

Companies

Bristol-Myers Squibb
Active Ingredient: MEGESTROL ACETATE

MEGACE Approval History

1972
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Original
New Indication
New Form
Label Update
93 FDA actions from 1971 to 2019
Jul 2019 SUPPL
Label · Labeling
FDA Letter Label
May 2016 SUPPL
Mfg · Manufacturing (CMC)
Apr 2012 SUPPL
Label · Labeling
FDA Letter Label

What MEGACE Treats

4 indications

MEGACE is approved for 4 conditions since its original approval in 1971. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Anorexia
  • Cachexia
  • Weight Loss
  • Acquired Immunodeficiency Syndrome

Same approved indications as MEGESTROL ACETATE (same active ingredient).

Source: FDA Label
📋

Clinical Trial Registry

23 trials
Trial Sponsor ID Phase Status Title
NCT05538897 NCI-2022-07505 NCI-2022-07505, NRG-GY028 Ph 1, Ph 2 active not recruiting Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers
NCT04939090 A222004 NCI-2021-03303, UG1CA189823 Ph 3 active not recruiting Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients
NCT07436793 INST UNM 2502 PRO-WINDOW NCI-2025-06611, INST UNM 2502 PRO-WINDOW Ph 2 recruiting Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial
NCT04576104 NCI-2020-07529 NCI-2020-07529, NCI20-02-01 Ph 2 active not recruiting Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer
NCT03671811 results posted 17327 NCI-2018-01555, 17327 Ph 2 active not recruiting Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy
NCT06998758 MATRIX E2025078 Ph 3 recruiting Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Locally Advanced CRC
NCT07254416 AKZ-ADC-01 Ph 4 not yet recruiting A Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients
NCT03815019 iKanEat results posted STUDY00142352 Ph 4 completed iKanEat: A Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children
NCT04491643 53211029-02 Ph 2 completed Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma
NCT05255653 RAINBO RAINBO ENGOT-en14-1,2,3,4, CCTG EN.10 TAPER arm A POLE Ph 2, Ph 3 recruiting Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features
NCT03241888 2017-30-1 Ph 2, Ph 3 completed Megestrol Acetate Plus LNG-IUS in Young Women With Endometrial Atypical Hyperplasia
NCT04607252 V01 2020-10 Ph 2, Ph 3 terminated Metformin Plus Megestrol Acetate As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia
NCT04491682 53211029-01 Ph 2, Ph 3 completed Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia
NCT05332483 MA-EEC 4858 Ph 1 terminated Study of Megestrol Acetate in Grade 2 Endometrioid Endometrial Cancer
NCT04897217 IRB00074615 WFBCCC 99321, P30CA012197 Ph 3 withdrawn Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia
NCT02269670 results posted IRB00071229 NCI-2014-02092, WINSHIP2563-13 Ph 2 terminated Phase II Study of Everolimus Beyond Progression
NCT01968317 results posted 134119a4500 Ph 2 completed Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma
NCT03241914 2017-30-2 Ph 2, Ph 3 completed Megestrol Acetate Plus LNG-IUS in Young Women With Early Endometrial Cancer
NCT00729586 results posted NCI-2009-01085 NCI-2009-01085, GOG-0248 Ph 2 completed Temsirolimus With or Without Megestrol Acetate and Tamoxifen Citrate in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer
NCT01200602 results posted MC0896 NCI-2010-01938, 09-007533 Ph 2 terminated Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy
NCT01943058 5U-12-1 NCI-2013-01725, 5U-12-1 Ph 2 withdrawn Megestrol Acetate or Levonorgestrel-Releasing Intrauterine System in Treating Patients With Atypical Endometrial Hyperplasia or Endometrial Cancer
NCT01456624 2011-0686 Ph 1 completed Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fasting and Fed Condition
NCT01501396 201202023 Ph 2 withdrawn Megestrol Acetate With or Without Mirtazapine in Treating Cancer Patients With Weight Loss or Loss of Appetite
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

MEGACE FDA Label Details

Indications & Usage

FDA Label (PDF)

MEGACE is FDA-approved to treat 4 conditions — same approved indications as MEGESTROL ACETATE.

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Data Sources

FDA Approval: NDA020264 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.