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Megace

(Megestrol Acetate)

Phase 3Small molecule

Bristol-Myers Squibb

Megestrol acetate is used to treat loss of appetite and weight loss in patients with AIDS, and to treat certain types of cancer (particularly endometrial and breast cancer). It can help patients regain appetite and gain weight.[1] Megace is currently being investigated across 12 indications[3], with its most advanced program in Phase 3.[1]

Megace is one of 188 small molecule programs targeting Endometrial Cancer. It is currently in Phase 3.

12

Indications

58

Total Trials

14

Active Trials

187

Competitors

Pipeline

Status by Indication[3][1]

Indication

Endometrial CancerRecruiting

HyperplasiaCompleted

AIDSUnknown

Adrenal InsufficiencyActive, not recruiting

CachexiaUnknown

Inborn Error of ImmunityUnknown

FIGO Grade 1 Endometrial Endometrioid AdenocarcinomaActive, not recruiting

Advanced/metastatic Breast CancerRecruiting

Endometrial CarcinomaRecruiting

Weight LossCompleted

Endometrial CancerPhase 3

Recruiting

HyperplasiaPhase 3

Completed

AIDSPreclinical

Unknown

Adrenal InsufficiencyPreclinical

Active, not recruiting

CachexiaPreclinical

Unknown

Inborn Error of ImmunityPreclinical

Unknown

FIGO Grade 1 Endometrial Endometrioid AdenocarcinomaPreclinical

Active, not recruiting

Advanced/metastatic Breast CancerPhase 3

Recruiting

Endometrial CarcinomaPhase 3

Recruiting

Weight LossPhase 3

Completed

Showing 10 of 12 indications

Competition

Competitive Landscape

103 competitors in Endometrial Cancer

#DrugCompanyPhaseTrials

Taxol

Keytruda

Femara

Paraplatin

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Lenvima

Lynparza

Depo-Provera

Tecentriq

Trodelvy

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Endometrial Carcinoma

NCT06417736

Phase 3Active, not recruiting

Advanced Malignant Solid Neoplasm

NCT04939090

Q1 2027

PreclinicalActive, not recruiting

FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma

NCT05538897

Phase 2/3Recruiting

Endometrioid Carcinoma

NCT05316467

Phase 2/3Recruiting

Hyperplasia

NCT05316493

Q2 2027

Post-ApprovalNot yet recruiting

Nausea and Vomiting

NCT07254416

Clinical

Trials by Indication[1]

Endometrial Cancer10 trials

High-Dose Megestrol in Treating Patients With Metastatic Breast Cancer, Endometrial Cancer, or Mesothelioma

Unknown status·SSt. Vincent Medical Center - Los Angeles·Phase 1/2·NCT00002465

Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy

Active, not recruiting·—·Phase 2·NCT03671811·44 enrolled

Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer

Terminated·GGynecologic Oncology Group·Phase 3·NCT00016341

Show 7 more trials

Temsirolimus With or Without Megestrol Acetate and Tamoxifen Citrate in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00729586·73 enrolled

The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer

Completed· Ipsen logo

Ipsen·Phase 2·NCT00910091·73 enrolled

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer

Recruiting·FFudan University·Phase 2·NCT05247268·104 enrolled

Megestrol Acetate Plus LNG-IUS in Young Women With Early Endometrial Cancer

Completed·FFudan University·Phase 2/3·NCT03241914·64 enrolled

Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer

Active, not recruiting·NNorthwestern University·Phase 2·NCT04576104·51 enrolled

Refining Adjuvant Treatment in Endometrial Cancer Based on Molecular Features

Recruiting·LLeiden University Medical Center·Phase 2/3·NCT05255653·1,615 enrolled

Study of Megestrol Acetate in Grade 2 Endometrioid Endometrial Cancer

Terminated·SSunnybrook Health Sciences Centre·Phase 1·NCT05332483·5 enrolled

Weight loss10 trials

Study to Evaluate the Effect of Megestrol Acetate in Weight Loss in Dementia Patients

Terminated·RRottapharm Spain·Phase 2/3·NCT00503516·39 enrolled

Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy

Terminated·MMayo Clinic·Phase 2·NCT01200602·1 enrolled

Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer

Completed·WWake Forest University Health Sciences·Phase 3·NCT00070148·155 enrolled

Show 7 more trials

Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00031707·429 enrolled

Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer

Completed·WWake Forest University Health Sciences·Phase 3·NCT00006799·13 enrolled

Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment

Completed·UUniversity of South Florida·Phase 2·NCT00066248·70 enrolled

Megestrol Acetate With or Without Mirtazapine in Treating Cancer Patients With Weight Loss or Loss of Appetite

Withdrawn·WWashington University School of Medicine·Phase 2·NCT01501396

Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Locally Advanced CRC

Recruiting·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 3·NCT06998758·60 enrolled

Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss

Completed·NNorthwestern University·Phase 2·NCT00004912

A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001079·80 enrolled

Atypical Endometrial Hyperplasia5 trials

Metformin Plus Megestrol Acetate As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia

Terminated·FFudan University·Phase 2/3·NCT04607252·12 enrolled

Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia

Completed·FFudan University·Phase 2/3·NCT04491682·36 enrolled

Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate

Completed·NNYU Langone Health·Phase 2·NCT00483327·31 enrolled

Show 2 more trials

Megestrol Acetate or Levonorgestrel-Releasing Intrauterine System in Treating Patients With Atypical Endometrial Hyperplasia or Endometrial Cancer

Withdrawn·UUniversity of Southern California·Phase 2·NCT01943058

Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia

Withdrawn·WWake Forest University Health Sciences·Phase 3·NCT04897217

Breast Cancer4 trials

Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer

Completed· Pfizer logo

Pfizer·Phase 3·NCT01237327·84 enrolled

A Study Evaluating Megestrol Acetate Modulation in Hormone Receptor Positive Advanced Breast Cancer

Unknown status·IInstituto Nacional de Cancer, Brazil·Phase 2·NCT03024580·20 enrolled

A Pre-operative Window Study of Letrozole Plus PR Agonist (Megestrol Acetate) Versus Letrozole Alone in Post-menopausal Patients With ER-positive Breast Cancer

Completed·—·Phase 2·NCT03306472·198 enrolled

Show 1 more trial

Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer

Completed·YYale University·Phase 2·NCT00002680·40 enrolled

Hyperplasia4 trials

Liraglutide Plus Megestrol Acetate in Endometrial Atypical Hyperplasia

Withdrawn·XXiaojun Chen·Phase 2/3·NCT04683237

Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia

Recruiting·XXiaojun Chen·Phase 2/3·NCT05316493·172 enrolled

Megestrol Acetate Plus LNG-IUS in Young Women With Endometrial Atypical Hyperplasia

Completed·FFudan University·Phase 2/3·NCT03241888·180 enrolled

Show 1 more trial

Megestrol in Treating Patients With Endometrial Neoplasia or Endometrial Hyperplasia

Terminated·GGynecologic Oncology Group·Phase 2·NCT00503581·9 enrolled

20 more indications

Endometrial Carcinoma3 trials

Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women

Recruiting·WWomen's Hospital School Of Medicine Zhejiang University·N/A·NCT06417736·75 enrolled

Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification

Recruiting·FFudan University·Phase 2/3·NCT07319429·260 enrolled

Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma

Completed·FFudan University·Phase 2·NCT04491643·48 enrolled

Anorexia2 trials

A Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00002067

Mirtazapine Versus Megestrol Acetate in Treatment of Anorexia-cachexia in Advanced Cancer Patients.

Unknown status·—·Phase 2·NCT05380479·80 enrolled

Lung Cancer2 trials

Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer

Completed·WWake Forest University Health Sciences·Phase 3·NCT00031785·25 enrolled

The Safety and Effect Study of Acupuncture for Anorexia in Patients With Gastrointestinal Tract and Lung Cancers

Unknown status·XXinqiao Hospital of Chongqing·Phase 2/3·NCT02619266·160 enrolled

Megestrol Acetate2 trials

A Study of Megestrol Acetate in HIV-Infected Children

Completed·GGamma Project - ACTU·N/A·NCT00002182·25 enrolled

Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate

Completed·UUniversity of Arkansas·N/A·NCT00575029·7 enrolled

Effectiveness1 trial

The Safety and Effectiveness of Megace in HIV-Infected Women

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT00002345·40 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Study to Evaluate the Effect of Megestrol Acetate in Severe Chronic Obstructive Pulmonary Disease With Loss of Weight

Completed·RRottapharm Spain·Phase 2·NCT00507949·40 enrolled

Randomized1 trial

iKanEat: A Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children

Completed·UUniversity of Kansas Medical Center·Phase 4·NCT03815019·70 enrolled

Absorption1 trial

Evaluating the Effect of Food on Absorption of Megace ES

Completed· Endo Pharmaceuticals logo

Endo Pharmaceuticals·Phase 1·NCT00638079·24 enrolled

Malnutrition1 trial

A Study of Different Doses of Megestrol Acetate in Patients With AIDS Who Have Anorexia and Malnutrition

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00002300

Liver Cancer1 trial

Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

Completed·NNational Medical Research Council (NMRC), Singapore·Phase 3·NCT00041275·300 enrolled

Phase II1 trial

Phase II Study of Everolimus Beyond Progression

Terminated·EEmory University·Phase 2·NCT02269670·3 enrolled

Combination Therapy1 trial

A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000737·56 enrolled

Central precocious puberty1 trial

Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine

Completed·—·Phase 4·NCT03963752·126 enrolled

Endometrioid Carcinoma1 trial

Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma

Recruiting·XXiaojun Chen·Phase 2/3·NCT05316467·89 enrolled

Nausea and vomiting1 trial

A Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 4·NCT07254416·120 enrolled

Adenocarcinoma1 trial

Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma

Completed·XXiaojun Chen·Phase 2·NCT01968317·150 enrolled

Advanced/Metastatic Breast Cancer1 trial

A Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Trial Evaluating Megestrol Acetate for the Management of Fatigue in Advanced Breast Cancer Patients Treatment With Trastuzumab Deruxtecan

Recruiting·SSun Yat-sen University·Phase 3·NCT07543536·132 enrolled

Advanced Malignant Solid Neoplasm1 trial

A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia

Active, not recruiting·AAlliance for Clinical Trials in Oncology·Phase 3·NCT04939090·227 enrolled

FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma1 trial

A Phase IB and Randomized Phase II Trial of Megestrol Acetate With or Without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT05538897·96 enrolled

Endometrial Endometrioid Adenocarcinoma1 trial

Evaluating Promising Progestins in Endometrial Cancer Through a Rotating Umbrella Surgical Window Trial - The PRO-WINDOW TRIAL for Endometrial Cancer

Recruiting·NNew Mexico Cancer Research Alliance·Phase 2·NCT07436793·140 enrolled

Sources

References

[1]
ClinicalTrials.gov — 58 trial records for Megestrol Acetate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Megestrol Acetate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Megestrol Acetate. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Progesterone Receptor Agonist[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Bristol-Myers Squibb

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