Data updated: Sep 20, 2026
MEGACE ES (megestrol acetate) · ENDO OPERATIONS
Trial Activity: Stable 8 active trials
Infectious Disease
Approved 2005-07-05
MEGACE ES is FDA-approved to treat 4 conditions (same as MEGESTROL ACETATE).
Development Insights
Fudan University conducting 5 trials (23%)
47 indications explored (Broad Platform)
→ atypical endometrial hyperplasia (5 trials)
→ anorexia (3 trials)
→ endometrial carcinoma (3 trials)
1
Indication
--
Phase 3 Trials
21
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2005-07-05
- Routes
- ORAL
- Dosage Forms
- SUSPENSION
MEGACE ES Approval History
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
15 FDA actions from 2005 to 2018
Nov 2015 SUPPL
Mfg · Manufacturing (CMC)
Oct 2014 SUPPL
Mfg · Manufacturing (CMC)
Jul 2014 SUPPL
Mfg
Mar 2014 SUPPL
Mfg
Jun 2013 SUPPL
Mfg
Jan 2013 SUPPL
Mfg
What MEGACE ES Treats
4 indicationsMEGACE ES is approved for 4 conditions since its original approval in 2005. 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
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Clinical Trial Registry
22 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 |
| 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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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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 ES FDA Label Details
Indications & Usage
FDA Label (PDF)MEGACE ES is FDA-approved to treat 4 conditions — same approved indications as MEGESTROL ACETATE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment