Drugs / Megestrol Acetate
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Megestrol Acetate

Other / unclassified

Developed for
atypical endometrial hyperplasia · endometrial cancer · eating disorder · HIV wasting syndrome · hypoproteinemia, hypercatabolic · endometrial carcinoma · breast cancer · non-small cell lung carcinoma
+30 more · endometrial endometrioid adenocarcinoma · small cell lung carcinoma · cancer · chemotherapy-induced toxicity · endometrium adenocarcinoma · head and neck cancer · HIV infectious disease · nutritional disorder · adrenal cortex carcinoma · anorexia nervosa · breast neoplasm · cancer-related condition · chronic obstructive pulmonary disease · dementia · endometrioid adenocarcinoma · esophageal squamous cell carcinoma · gastric carcinoma · gastroesophageal cancer · head and neck squamous cell carcinoma · idiopathic central precocious puberty · intraepithelial neoplasia · liver cancer · malignant mesothelioma · paraneoplastic gastrointestinal syndrome · squamous cell intraepithelial neoplasia · stage I endometrioid carcinoma · uterine cancer · uterine corpus cancer · uterus carcinoma in situ · endometrial disorder
Investigated by
National Cancer Institute (NCI) · Changchun GeneScience Pharmaceutical Co., Ltd. · Fudan University · Bristol-Myers Squibb · Henan Cancer Hospital · Xiaojun Chen
+88 more · Northwestern University · Peking University People's Hospital · Asan Medical Center · Beijing Chao Yang Hospital · Guangzhou Institute of Respiratory Disease · Gynecologic Oncology Group · Hunan Province Tumor Hospital · LG Life Sciences · NRG Oncology · National Institute of Allergy and Infectious Diseases (NIAID) · Peking Union Medical College Hospital · Peking University Third Hospital · Rottapharm Spain · Shengjing Hospital · Sun Yat-sen University · The First Affiliated Hospital of Henan University of Science and Technology · Tongji Hospital · Wake Forest University Health Sciences · Aiping Zhou · Alliance for Clinical Trials in Oncology · Anticancer Fund, Belgium · Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Brazilian National Cancer Institute · Cambridge University Hospitals NHS Foundation Trust · Cancer Research UK Cambridge Institute · Chang Gung Memorial Hospital · Children's Hospital of Fudan University · City of Hope Medical Center · Covance · Daewon Pharmaceutical Co., Ltd. · Endo USA Inc., a Keenova Therapeutics Company · Gamma Project - ACTU · Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Hospital Universitari de Bellvitge · Huashan Hospital · Huazhong University of Science and Technology · KK Women's and Children's Hospital · Mayo Clinic · Merck Sharp & Dohme LLC · Milton S. Hershey Medical Center · NCIC Clinical Trials Group · NYU Langone Health · Nanfang Hospital, Southern Medical University · National Center for Research Resources (NCRR) · National Medical Research Council (NMRC), Singapore · Ontario Institute for Cancer Research · Par Pharmaceutical, Inc. · Peking University · Qilu Hospital of Shandong University · Qingdao Central Hospital · Quintiles, Inc. · Roxane Laboratories · SFBC Anapharm · Second Xiangya Hospital of Central South University · Severance Hospital · Shaanxi Provincial Cancer Hospital · Shandong Cancer Hospital and Institute · Shandong University · Shanghai 6th People's Hospital · Shanghai Changning Maternity & Infant Health Hospital · Shanxi Bethune Hospital · Shenzhen Fifth People's Hospital · Sixth Affiliated Hospital, Sun Yat-sen University · St. Vincent Medical Center - Los Angeles · Sunnybrook Health Sciences Centre · TTY Biopharm · The First Affiliated Hospital with Nanjing Medical University · The Rogosin Institute · Third Military Medical University · Tianjin Cancer Hospital Airport Hospital · Tianjin Medical University · Tianjin Medical University Cancer Institute and Hospital · Tianjin Medical University General Hospital · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · all 94 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) MEGACE — 1971-08-18 fda.gov ↗

Trials 90 · started per year

today
US approved 1971
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 19 trials · 1 met primary
Phase 1 NCT07338487 Apr → Dec 2026 expected cervical cancer, hypoproteinemia, hypercatabolic Second Xiangya Hospital of Central South University Recruiting No outcome recorded
Phase 1 NCT07130617 Sep 2025 → Jul 2026 overdue — Changchun GeneScience Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 1 NCT05332483 Jul 2022 → Oct 2023 endometrial cancer Sunnybrook Health Sciences Centre Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT06147908 Jul → Oct 2022 — Daewon Pharmaceutical Co., Ltd. Completed Met primary
Phase 1 NCT01383330 Jul → Sep 2011 — Asan Medical Center Unknown No outcome recorded
Phase 1 NCT01342055 Mar → May 2011 — LG Life Sciences Completed No outcome recorded
Phase 1 NCT02446353 Apr → Jun 2010 — LG Life Sciences Completed Mixed
Phase 1 NCT00637403 May 2006 — Par Pharmaceutical, Inc. Terminated No outcome recorded
Phase 1 NCT00000737 — HIV wasting syndrome, hypoproteinemia, hypercatabolic National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT05538897 Mar 2023 → Jan 2027 expected endometrial endometrioid adenocarcinoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 1/2 NCT00002465 Dec 1987 → ? breast cancer, endometrial cancer, malignant mesothelioma St. Vincent Medical Center - Los Angeles Unknown No outcome recorded
Phase 234 trials · 2 met primary · 1 missed
Phase 2 NCT07565415 Jun 2026 → Sep 2027 expected hepatocellular carcinoma, hypoproteinemia, hypercatabolic, nutritional disorder Nanfang Hospital, Southern Medical University Not yet recruiting No outcome recorded
Phase 2 NCT07391826 Feb → Dec 2026 expected gastric carcinoma The First Affiliated Hospital with Nanjing Medical University Not yet recruiting No outcome recorded
Phase 2 NCT07377734 Jan 2026 → Dec 2027 expected atypical endometrial hyperplasia, endometrial cancer Wang Jianliu Recruiting No outcome recorded
Phase 2 NCT07246070 Dec 2025 → Aug 2026 overdue chemotherapy-induced toxicity Aiping Zhou Not yet recruiting No outcome recorded
Phase 2 NCT07092137 Oct 2025 → Oct 2026 expected lung cancer Guangzhou Institute of Respiratory Disease Not yet recruiting No outcome recorded
Phase 2 NCT06979596 Aug 2025 → Nov 2027 expected cancer Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 2 NCT06909383 Jun 2025 → Jun 2026 overdue paraneoplastic gastrointestinal syndrome, small cell lung carcinoma Guangzhou Institute of Respiratory Disease Not yet recruiting No outcome recorded
Phase 2 NCT06914297 Apr 2025 → Oct 2027 expected endometrial cancer Fudan University Recruiting No outcome recorded
Phase 2 NCT06793228 Jan 2025 → Jan 2027 expected small cell lung carcinoma Henan Cancer Hospital Not yet recruiting No outcome recorded
Phase 2 NCT05913427 Jun 2022 → Jun 2027 expected adrenal cortex carcinoma Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Recruiting No outcome recorded
Phase 2/38 trials · 2 missed
Phase 2/3 NCT07319429 Jan 2026 → Dec 2027 expected endometrial cancer, infertility disorder Fudan University Recruiting No outcome recorded
Phase 2/3 NCT05316493 Jun 2022 → Feb 2026 overdue atypical endometrial hyperplasia, infertility disorder Xiaojun Chen Recruiting No outcome recorded
Phase 2/3 NCT05316467 May 2022 → Feb 2026 endometrial carcinoma, female infertility, obesity disorder Xiaojun Chen Terminated No outcome recorded Stop: Enrollment
Phase 2/3 NCT04683237 Mar 2021 → Nov 2025 atypical endometrial hyperplasia, infertility disorder, obesity disorder Xiaojun Chen Withdrawn No outcome recorded Stop: Enrollment
Phase 2/3 NCT04491682 Sep 2020 → Jun 2022 atypical endometrial hyperplasia Fudan University Completed No outcome recorded
Phase 2/3 NCT03241914 Jul 2017 → Jun 2020 stage I endometrioid carcinoma Fudan University Completed Missed primary
Phase 2/3 NCT03241888 Jul 2017 → Jun 2020 atypical endometrial hyperplasia Fudan University Completed Missed primary
Phase 2/3 NCT00503516 Jun 2007 → Dec 2009 dementia Rottapharm Spain Terminated No outcome recorded Stop: Enrollment
Phase 319 trials · 2 missed
Phase 3 NCT07796789 Aug 2026 → Aug 2027 expected nasopharyngeal carcinoma Sun Yat-sen University Recruiting No outcome recorded
Phase 3 NCT07831902 Jun 2026 → Dec 2030 expected endometrial cancer University College, London Recruiting No outcome recorded
Phase 3 NCT07543536 May 2026 → Apr 2029 expected breast cancer Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 3 NCT07477808 Apr 2026 → Apr 2028 expected non-small cell lung carcinoma Hunan Province Tumor Hospital Not yet recruiting No outcome recorded
Phase 3 NCT07356037 Jan 2026 → Jun 2027 expected HIV wasting syndrome, hepatocellular carcinoma Changchun GeneScience Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT06998758 Nov 2025 → May 2027 expected — Sixth Affiliated Hospital, Sun Yat-sen University Recruiting No outcome recorded
Phase 3 NCT07150663 Aug 2025 → Jun 2027 expected non-small cell lung carcinoma Changchun GeneScience Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT06961188 Jun 2025 → Jun 2027 expected non-small cell lung carcinoma Changchun GeneScience Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT06828757 May 2025 → Dec 2026 expected non-small cell lung carcinoma Hunan Province Tumor Hospital Not yet recruiting No outcome recorded
Phase 3 NCT06961201 May 2025 → Dec 2026 expected small cell lung carcinoma Changchun GeneScience Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 410 trials · 1 met primary
Phase 4 NCT07462663 Jan 2027 → Apr 2031 expected atypical endometrial hyperplasia, endometrial cancer, intraepithelial neoplasia, morbid obesity Hospital Universitari de Bellvitge Not yet recruiting No outcome recorded
Phase 4 NCT07254416 Dec 2025 → Dec 2026 expected — Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 4 NCT07243379 Sep 2025 → Dec 2026 expected — Changchun GeneScience Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 4 NCT06963593 Jun 2025 → Jun 2027 expected gastroesophageal cancer Peking University Not yet recruiting No outcome recorded
Phase 4 NCT03815019 Aug 2019 → Mar 2025 eating disorder University of Kansas Medical Center Completed No outcome recorded
Phase 4 NCT03963752 Aug 2019 → Aug 2022 idiopathic central precocious puberty Children's Hospital of Fudan University Completed No outcome recorded
Phase 4 NCT03777930 Dec 2018 → Oct 2020 cancer-related condition Shenzhen Fifth People's Hospital Unknown No outcome recorded
Phase 4 NCT02595723 Jul 2015 → Nov 2016 cognitive impairment with or without cerebellar ataxia University of Texas Southwestern Medical Center Completed Met primary
Phase 4 NCT00163072 Oct 2005 → Dec 2012 hypoproteinemia, hypercatabolic Milton S. Hershey Medical Center Withdrawn No outcome recorded
Phase 4 NCT00002345 — HIV infectious disease, eating disorder, hypoproteinemia, hypercatabolic Bristol-Myers Squibb Completed No outcome recorded
Phase not applicable8 trials
— NCT07408505 Jun 2026 → Dec 2027 expected pancreatic ductal adenocarcinoma Shandong Cancer Hospital and Institute Recruiting No outcome recorded
— NCT06830018 Jan 2025 → Jan 2026 overdue — Changchun GeneScience Pharmaceutical Co., Ltd. Recruiting No outcome recorded
— NCT06549855 Oct 2024 → Jul 2029 expected endometrial cancer, endometrioid adenocarcinoma Peking University People's Hospital Not yet recruiting No outcome recorded
— NCT06468215 Jul 2024 → Jul 2028 expected endometrial endometrioid adenocarcinoma Peking University People's Hospital Not yet recruiting No outcome recorded
— NCT05945407 Aug 2016 → Dec 2023 overdue endometrial cancer, endometrial endometrioid adenocarcinoma Peking University People's Hospital Recruiting No outcome recorded
— NCT00575029 Apr → Dec 2004 adrenocortical insufficiency University of Arkansas Completed No outcome recorded
— NCT00004664 Jun 1995 → ? AIDS, HIV wasting syndrome National Center for Research Resources (NCRR) Completed No outcome recorded
— NCT00002182 — HIV infectious disease Gamma Project - ACTU Completed No outcome recorded
Comparator or background therapy27 trials
Phase 1 NCT01589562 Comparator Apr → Jun 2012 — Daewon Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1 NCT01456624 Comparator Sep 2011 → Jun 2012 — Asan Medical Center Completed No outcome recorded
Phase 1 NCT01397214 Comparator Jul → Sep 2011 eating disorder, hypoproteinemia, hypercatabolic Boryung Pharmaceutical Co., Ltd Completed No outcome recorded
Phase 1 NCT00638079 Comparator Jun → Jul 2006 — Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 2 NCT07714070 Background Jul 2026 → Sep 2027 expected atypical endometrial hyperplasia, endometrial cancer, progesterone resistance Peking University People's Hospital Not yet recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2025-06-18 Changchun GeneScience Pharmaceutical Co., Ltd. Regulatory NMPA Approves New Indication Clinical Trial of Megestrol Acetate Oral Suspension genscigroup.com ↗
Recently, GenSci received approval from the National Medical Products Administration (NMPA) for the product registration clinical trial application of Megestrol Acetate Oral Suspension (Megaxia®).
2003-05-06 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Approval of Megestrol Acetate Oral Suspension tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has approved the company's ANDA for Megestrol Acetate Oral Suspension USP, 40 mg/mL.

All press releases naming this drug 3 releases

DateIssuerRelease

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 120 sources stand behind the page.

FieldValueCited text
Known as megestrol acetate “High-potency progestin given orally as background therapy in both groups: medroxyprogesterone acetate 250-500 mg/day or megestrol acetate 160-320 mg/day, with the specific...” NCT07714070 ↗
103

“OBJECTIVE: To compare the efficacy of the levonorgestrel intrauterine system (LNG-IUS) versus megestrol acetate (MA) in inducing complete regression among women with atypical...” PMID 38425141 ↗ Feb 2024

“Eligible patients will be enrolled into the study and administered sodium cridanimod (500 mg i.m./ twice a week) in combination with megestrol acetate (160 mg p.o./ day) or...” NCT02064725 ↗

“Megestrol acetate (Megace®) is a progestin analog that is FDA approved for the palliative treatment of breast and endometrial carcinoma.” NCT00163072 ↗

“They will take oral high-dose progestin (Medroxyprogesterone Acetate 250mg-500mg/d or Megestrol Acetate 160mg-320mg/d) daily.” NCT07377734 ↗

“Tolerability and pharmacokinetics of two formulations of megestrol acetate under fed conditions in healthy volunteers.” PMID 25450470 ↗ Oct 2014

“all subjects determined to be PrR positive will receive progestin monotherapy, megestrol acetate, for up to 24 weeks.” NCT03077698 ↗

“Megestrol acetate (Megace) is a synthetic derivative of the natural occurring steroid hormone, progesterone.” NCT05492487 ↗

“Typical regimens include medroxyprogesterone acetate (400-600 mg/day) or megestrol acetate (160-320 mg/day).” NCT07462663 ↗

“two orally administered megestrol acetate suspensions (625 mg/5 mL) in healthy Korean male subjects” PMID 38586120 ↗ Mar 2024

“Efficacy of megestrol acetate (MA) was evaluated in patients who did not respond to CH.” PMID 18989154 ↗ Nov 2008

Show 93 more sources

Known as MA-ES “It is available in its original formulation, Megace (MAOS), and as a nanocrystal dispersion, Megace ES (MA-ES).” PMID 19774117 ↗ Sep 2009
Known as MAOS “It is available in its original formulation, Megace (MAOS), and as a nanocrystal dispersion, Megace ES (MA-ES).” PMID 19774117 ↗ Sep 2009
Known as Megace “Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Megestrol Acetate (Megace) Versus an N-3 Fatty Acid (EPA) Enriched Nutritional Supplement Versus Both for...” NCT00031707 ↗
8

“Various progestins have been investigated including Megace (megesterol acetate) and Provera (medroxyprogesterone acetate) for the treatment of endometrial cancer.” NCT00584857 ↗

“Megestrol acetate (Megace®) is a progestin analog that is FDA approved for the palliative treatment of breast and endometrial carcinoma.” NCT00163072 ↗

“It is available in its original formulation, Megace (MAOS), and as a nanocrystal dispersion, Megace ES (MA-ES).” PMID 19774117 ↗ Sep 2009

“Megestrol acetate (Megace) is a synthetic derivative of the natural occurring steroid hormone, progesterone.” NCT05492487 ↗

“Megestrol Acetate (Megace)” NCT00070148 ↗

“Drug: megace” NCT01383330 ↗

NCT01383330 ↗

NCT01456624 ↗

Known as Megace acetate “Megace acetate oral suspension” NCT01397214 ↗
Known as Megesterol Acetate ClinicalTrials.gov intervention name — accepted as the source's own label NCT00584857 ↗
Known as megestrol “Hormone therapy using megestrol may fight liver cancer by blocking the uptake of estrogen.” NCT00041275 ↗
12

“Tablets of 160mg megestrol will be used according to randomization.” NCT05380479 ↗

NCT02644408 ↗

NCT06828757 ↗

NCT00004664 ↗

NCT00002680 ↗

NCT00420563 ↗

NCT01206478 ↗

NCT04430361 ↗

NCT02595723 ↗

NCT03283488 ↗

Show 2 more sources

Known as Megestrol acetate: Megace “Megestrol acetate: Megace” NCT01968317 ↗
Known as MPA “megestrol acetate (MA, 160 mg qd po)/megestrol acetate (MPA, 500 mg qd po)” NCT06914297 ↗
Known as Nano-crystalline Megestrol Acetate “Nano-crystalline megestrol acetate is administered as an oral suspension at a dose of 625 mg once daily (5 mL, 125 mg/mL) starting concurrently with first-line chemotherapy and...” NCT07408505 ↗
1

“The oral suspension of megestrol acetate adopts nano-crystal technology (referred to as nano-crystalline megestrol acetate)” NCT07092137 ↗

Known as YiLiZhi “megestrol acetate ("YiLiZhi") 160-320mg/d orally” NCT05945407 ↗
Action Inhibit “Hormone therapy using megestrol may fight cancer by reducing the production of these hormones.” NCT00002465 ↗
Modality Other / unclassified “Megestrol Acetate (MA) is a progesterone-like hormone” NCT00575029 ↗
Route Oral “Megace oral suspension daily” NCT00002345 ↗