Megestrol Acetate clinical trials
Megestrol Acetate is named as an intervention in 12 current clinical trials in our China, Mexico, Italy and Egypt registers. 7 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Fudan University (2). The most-studied condition is Endometrial Hyperplasia.
Where Megestrol Acetate is approved
All regulators →Of the three regulators tracked here, the first to approve Megestrol Acetate was the US, on 18 Aug 1971. It is approved in 2 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of granulosa cell tumours (20 Mar 2017, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Megestrol Acetate
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Megestrol Acetate works
All drug targets →- Progesterone receptor agonist AgonistTarget: PGR progesterone receptorChEMBL only
- Atrophic VaginitisPhase 3
- DyspareuniaPhase 3
- Hot flashesPhase 3
- Weight lossPhase 3
- CancerPhase 3
- Endometrial cancerPhase 3
- Head and neck squamous cell carcinomaPhase 3
- Hepatocellular carcinomaPhase 3
- MalnutritionPhase 3
- Non-small cell lung carcinomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201139, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9128, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Megestrol Acetate
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 7 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Megestrol Acetate
- ChEMBL
- CHEMBL1201139
- DrugBank
- DB00351
- PubChem CID
- 11683
- CAS number
- 595-33-5
- FDA UNII
- TJ2M0FR8ES
- Wikidata
- Q6808975
- Wikipedia
- Megestrol acetate
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Megestrol Acetate
12 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Megestrol Acetate across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
7 single-substance products containing Megestrol Acetate on the HPRA medicines list.
- Megace 160 mg tabletsBausch Health Ireland Limited · PA22698/028/001 · Marketed
- Megace 40 mg/ml Oral SuspensionBausch Health Ireland Limited · PA22698/024/001 · Marketed
- Megace 160 mg TabletsIMED Healthcare Ltd. · PPA1463/191/001
- Megace 160 mg tabletsPCO Manufacturing Ltd. · PPA0465/323/002
- Megace 40 mg/ml Oral SuspensionIMED Healthcare Ltd., · PPA1463/161/001
Supply shortages
No entry for Megestrol Acetate in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Megestrol Acetate
26 conditionsAll 26 conditions
| Condition (as registered) | Trials |
|---|---|
| Endometrial Hyperplasia | 2 |
| Atypical Endometrial Hyperplasia | 1 |
| Fertility Issues | 1 |
| Overweight and Obesity | 1 |
| Advanced/Metastatic Breast Cancer | 1 |
| HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer | 1 |
| Neoadjuvant Chemotherapy | 1 |
| Weight Loss | 1 |
| Endometrial Cancer | 1 |
| Fertility | 1 |
| Efficacy | 1 |
| Safety | 1 |
| Megestrol Acetate | 1 |
| Adult Subject | 1 |
| Endometrial Cancer Stage I | 1 |
| Endometrial Neoplasm Malignant Stage I | 1 |
| Stage III Gastric Cancer | 1 |
| Adrenocortical Carcinoma | 1 |
| Endometrial Endometrioid Adenocarcinoma | 1 |
| Advanced Malignant Solid Neoplasm | 1 |
| Anorexia | 1 |
| Hematopoietic and Lymphoid Cell Neoplasm | 1 |
| FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma | 1 |
| FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma | 1 |
| Metastatic Endometrial Endometrioid Adenocarcinoma | 1 |
| Recurrent Endometrial Endometrioid Adenocarcinoma | 1 |
Sponsors
lead sponsor per trialBy country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 8 | 5 |
| Clinical trials in Mexico | 3 | 1 |
| Clinical trials in Italy | 1 | 1 |
| Clinical trials in Egypt | 1 | 0 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Megestrol Acetate trials
How many clinical trials are testing Megestrol Acetate?
12 current trials in our China, Mexico, Italy and Egypt registers name Megestrol Acetate (also registered as 6-diene-3) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Megestrol Acetate trials recruiting patients?
Yes. 7 of the 12 trials are recruiting: 5 with sites in China, 1 with sites in Mexico and 1 with sites in Italy. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Megestrol Acetate clinical trials?
Fudan University (2), Xiaojun Chen (1), Sun Yat-sen University (1) and Sixth Affiliated Hospital, Sun Yat-sen University (1), among 11 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Megestrol Acetate licensed in Ireland?
Yes. The HPRA medicines list includes 7 single-substance products containing Megestrol Acetate, for example Megace 160 mg tablets (Bausch Health Ireland Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Megestrol Acetate shortage?
Not in the lists we track: Megestrol Acetate has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Megestrol Acetate works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Megestrol Acetate works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Megestrol Acetate (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.