Megestrol Acetate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | MEGACE | — | 1971-08-18 | fda.gov ↗ |
Trials 89 · started per year
Also used as a comparator or background therapy in 27 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 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 211 trials | ||||||
| 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 |
| Phase 2 | NCT07436793 Comparator | Jun 2026 → Jun 2030 expected | endometrial disorder, endometrial endometrioid adenocarcinoma | New Mexico Cancer Research Alliance | Recruiting | No outcome recorded |
| Phase 2 | NCT05380479 Comparator | Jun 2022 → Jan 2023 | eating disorder | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
| Phase 2 | NCT05247268 Comparator | Mar 2022 → Mar 2027 expected | endometrial carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT03283488 Comparator | Mar 2019 → Feb 2022 | eating disorder, hypoproteinemia, hypercatabolic | University of Sao Paulo | Completed | No outcome recorded |
| Phase 2 | NCT02269670 Background | Nov 2014 → Jan 2021 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, progesterone-receptor positive breast cancer | Emory University | Terminated | No outcome recorded |
| Phase 2 | NCT02064725 Background | Sep 2014 → Jan 2018 | endometrial carcinoma | Kevelt AS | Unknown | No outcome recorded |
| Phase 2 | NCT01206478 Background | Aug 2010 → Dec 2014 | avoidant/restrictive food intake disorder | Ann Davis, PhD, MPH, ABPP | Completed | No outcome recorded |
| Phase 2 | NCT00420563 Comparator | Sep 2009 → Jan 2011 | cancer | Centre Oscar Lambret | Completed | No outcome recorded |
| Phase 2 | NCT00910091 Comparator | Aug 2009 → Jan 2012 | endometrial cancer | Ipsen | Completed | No outcome recorded |
| Phase 2 | NCT00739830 Comparator | Aug 2008 → Feb 2011 | endometrial cancer | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT04607252 Comparator | Jan → Jun 2021 | atypical endometrial hyperplasia | Fudan University | Terminated | No outcome recorded |
| Phase 2/3 | NCT04385667 Comparator | May 2020 → Dec 2022 | atypical endometrial hyperplasia | Zagazig University | Completed | No outcome recorded |
| Phase 2/3 | NCT02619266 Comparator | Dec 2015 → Dec 2016 | eating disorder | Xinqiao Hospital of Chongqing | Unknown | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT06671548 Background | Jan 2024 → Nov 2026 expected | leiomyoma | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT04897217 Comparator | Jun 2023 → Oct 2024 | atypical endometrial hyperplasia | Wake Forest University Health Sciences | Withdrawn | No outcome recorded |
| Phase 3 | NCT04939090 Comparator | Jan 2022 → Apr 2027 expected | cancer, hematopoietic and lymphoid cell neoplasm | Alliance for Clinical Trials in Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00637806 Comparator | Jun → Sep 2006 | — | Par Pharmaceutical, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00637728 Comparator | Jun → Sep 2006 | eating disorder | Par Pharmaceutical, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00070148 Comparator | Mar 2004 → Aug 2007 | cancer of unknown primary site | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01237327 Comparator | Nov 2001 → Dec 2007 | breast cancer | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00005975 Comparator | Apr 1998 → Sep 2001 | female breast carcinoma | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06417736 Background | Dec 2023 → Jul 2025 overdue | endometrial cancer | Women's Hospital School Of Medicine Zhejiang University | Recruiting | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2003-05-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval of Megestrol Acetate Oral Suspension tevapharm.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 119 sources stand behind the page.
| Field | Value | Cited 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 ↗102“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 ↗ “Typical regimens include medroxyprogesterone acetate (400-600 mg/day) or megestrol acetate (160-320 mg/day).” NCT07462663 ↗ “Megestrol acetate (Megace) is a synthetic derivative of the natural occurring steroid hormone, progesterone.” NCT05492487 ↗ “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 “with oral medroxyprogesterone acetate (MPA) 500mg/d or megestrol acetate (MA) 320mg/d” NCT06468215 ↗ “Pharmacokinetics of a nanocrystal-containing megestrol acetate formulation” PMID 27191767 ↗ Sep 2016 “megestrol acetate (MA, 160 mg qd po)/megestrol acetate (MPA, 500 mg qd po)” NCT06914297 ↗ “megestrol acetate 40 mg orally 4 times daily for up to 5 years.” PMID 24724218 ↗ Mar 2014 “megestrol acetate (1 mg) administered orally once daily” NCT06671548 ↗ “Megestrol acetate 800mg/20ml, Suspension, Single dose” NCT01589562 ↗ “megestrol acetate ("YiLiZhi") 160-320mg/d orally” NCT05945407 ↗ “Megestrol Acetate” NCT05255653 ↗ |
| 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 ↗ |
| 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 ↗ |
| 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 ↗ |