> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/megestrol-acetate-d15299dc-52b5-4b77-a983-b7a643fb06ca
> Record changed: 2026-11-04

# Megestrol acetate

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201139)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201139)

First approval year

1971

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201139)

## Development status

**First approval year**

1971

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201139)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201139)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201139)

**Drug name**

Megestrol acetate

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201139)

**Molecular weight**

384.52

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201139)

**Structure (SMILES)**

CC(=O)O\[C@\]1(C(C)=O)CC\[C@H\]2\[C@@H\]3C=C(C)C4=CC(=O)CC\[C@\]4(C)\[C@H\]3CC\[C@@\]21C

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201139)

### Brand names (6)

- megace
- Megace
- megace es
- Megace es
- megestrol acetate
- Megestrol acetate

### Other names (71)

- 17 hydroxy 6 methylpregna 4 6 diene 3 20 dione acetate
- 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate
- 5071
- 6 methyl 3 20 dioxopregna 4 6 dien 17 yl acetate who ip
- 6-METHYL-3,20-DIOXOPREGNA-4,6-DIEN-17-YL ACETATE \[WHO-IP\]
- apetrol es megace
- bdh 1298
- BDH 1298
- BDH-1298
- chronopil
- Chronopil
- MEDROXYPROGESTERONE ACETATE IMPURITY G \[EP IMPURITY\]
- MEDROXYPROGESTERONE ACETATE IMPURITY G \[WHO-IP\]
- medroxyprogesterone acetate impurity g ep impurity
- medroxyprogesterone acetate impurity g who ip
- megace
- Megace
- megesterol acetate
- Megesterol acetate
- megestrol
- Megestrol
- megestrol 17 alpha acetate
- Megestrol 17.alpha.-acetate
- megestrol acetate
- Megestrol acetate

And 46 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 595-33-5

**ChEMBL ID**

CHEMBL1201139

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201139)

**InChIKey**

RQZAXGRLVPAYTJ-GQFGMJRRSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201139)

**PubChem compound IDs**

- 11683

**FDA ingredient codes (UNII)**

- TJ2M0FR8ES

### ATC classification codes (3)

- G03AC05
- G03DB02
- L02AB01

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201139)

### RxNorm IDs (RxCUI) (2)

- 6703
- 29451

## Regulatory information

### United States

**Applicant**

BRISTOL MYERS SQUIBB

**Approval date**

18 Aug 1971

**Application number**

NDA016979

### Other regulatory facts

**Patents**

0

**Designations**

1

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Approval status

**United States (FDA)**

Approved

## Pharmacology

### Drug classification

**Drug name stem**

\-estr-; -gest-

#### Administration routes

- Oral

### Mechanisms of action

- **Mechanism**  
Progesterone receptor agonist

**Action type**  
Agonist

**Target**  
Progesterone receptor

**Protein identifier**  
P06401

### Open Targets mechanisms

- **Mechanism**  
Progesterone receptor agonist

**Action type**  
Agonist

**Target**  
Progesterone receptor

### DrugCentral mechanisms

- **Action type**  
Agonist

**Gene symbol**  
PGR

**Protein identifier**  
P06401

**Organism**  
Homo sapiens

**Target development level**  
Clinical

### Investigated indications (21)

- **Condition**  
Pulmonary Disease, Chronic Obstructive

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000341

**Subject identifier**  
D029424
- **Condition**  
Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Acquired Immunodeficiency Syndrome

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000765

**Subject identifier**  
D000163
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003869

**Subject identifier**  
D001943
- **Condition**  
Endometrial Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0004230

**Subject identifier**  
D016889
- **Condition**  
Head and Neck Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0006859

**Subject identifier**  
D006258
- **Condition**  
HIV Wasting Syndrome

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0007312

**Subject identifier**  
D019247
- **Condition**  
Endometrial Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0007532

**Subject identifier**  
D016889
- **Condition**  
Adrenal Cortex Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1000796

**Subject identifier**  
D000306
- **Condition**  
Endometrial Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:1001512

**Subject identifier**  
D016889
- **Condition**  
Dementia

**Highest recorded phase**  
2

**Condition identifier**  
HP:0000726

**Subject identifier**  
D003704
- **Condition**  
Anorexia

**Highest recorded phase**  
4

**Condition identifier**  
HP:0002039

**Subject identifier**  
D000855
- **Condition**  
Cachexia

**Highest recorded phase**  
4

**Condition identifier**  
HP:0004326

**Subject identifier**  
D002100
- **Condition**  
Hot Flashes

**Highest recorded phase**  
3

**Condition identifier**  
HP:0031217

**Subject identifier**  
D019584
- **Condition**  
Liver Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0002691

**Subject identifier**  
D008113
- **Condition**  
Uterine Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0002715

**Subject identifier**  
D014594
- **Condition**  
Primary Immunodeficiency Diseases

**Highest recorded phase**  
4

**Condition identifier**  
MONDO:0003778

**Subject identifier**  
D000081207
- **Condition**  
Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
MONDO:0004992

**Subject identifier**  
D009369
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0007254

**Subject identifier**  
D001943
- **Condition**  
Endometrial Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0011962

**Subject identifier**  
D016889
- **Condition**  
Carcinoma in Situ

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0024474

**Subject identifier**  
D002278

### Open Targets indications (54)

- **Condition identifier**  
EFO\_0000341

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0000764

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000765
- **Condition identifier**  
EFO\_0003060

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0004230
- **Condition identifier**  
EFO\_0006859

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0007312

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0008572

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_1000098
- **Condition identifier**  
EFO\_1000235

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1001271

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_1001512

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1001514

**Highest recorded phase**  
1
- **Condition identifier**  
HP\_0000846
- **Condition identifier**  
HP\_0001508
- **Condition identifier**  
HP\_0001824

**Highest recorded phase**  
3
- **Condition identifier**  
HP\_0002039
- **Condition identifier**  
HP\_0002039

**Highest recorded phase**  
4
- **Condition identifier**  
HP\_0004326
- **Condition identifier**  
HP\_0004326

**Highest recorded phase**  
4
- **Condition identifier**  
HP\_0030016

**Highest recorded phase**  
3
- **Condition identifier**  
HP\_0031217

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0001627
- **Condition identifier**  
MONDO\_0001627

**Highest recorded phase**  
2

And 29 more, listed on the interactive page.

### Reported adverse events (42)

- **Event**  
abasia

**Reports**  
8

**Reporting signal score**

10.0433
- **Event**  
addison's disease

**Reports**  
5

**Reporting signal score**

18.6822
- **Event**  
adrenal insufficiency

**Reports**  
49

**Reporting signal score**

168.81
- **Event**  
adrenal suppression

**Reports**  
4

**Reporting signal score**

13.1953
- **Event**  
androgen deficiency

**Reports**  
5

**Reporting signal score**

24.1936
- **Event**  
asthenia

**Reports**  
33

**Reporting signal score**

9.8565
- **Event**  
blood chloride decreased

**Reports**  
9

**Reporting signal score**

26.4238
- **Event**  
blood cortisol decreased

**Reports**  
7

**Reporting signal score**

28.033
- **Event**  
blood glucose increased

**Reports**  
18

**Reporting signal score**

15.5701
- **Event**  
blood testosterone decreased

**Reports**  
8

**Reporting signal score**

22.1206
- **Event**  
blood urea increased

**Reports**  
10

**Reporting signal score**

14.5168
- **Event**  
breast cancer

**Reports**  
13

**Reporting signal score**

15.6482
- **Event**  
breast cancer metastatic

**Reports**  
14

**Reporting signal score**

40.291
- **Event**  
carbohydrate antigen 15-3 increased

**Reports**  
4

**Reporting signal score**

15.5362
- **Event**  
cognitive disorder

**Reports**  
11

**Reporting signal score**

10.5609
- **Event**  
decreased appetite

**Reports**  
24

**Reporting signal score**

11.9261
- **Event**  
deep vein thrombosis

**Reports**  
113

**Reporting signal score**

280.888
- **Event**  
dementia alzheimer's type

**Reports**  
98

**Reporting signal score**

510.404
- **Event**  
failure to thrive

**Reports**  
10

**Reporting signal score**

27.4786
- **Event**  
haematocrit

**Reports**  
3

**Reporting signal score**

18.0732
- **Event**  
hypogonadism

**Reports**  
5

**Reporting signal score**

16.6613
- **Event**  
hypomagnesaemia

**Reports**  
9

**Reporting signal score**

12.9995
- **Event**  
intracranial pressure increased

**Reports**  
6

**Reporting signal score**

13.0971
- **Event**  
invasive lobular breast carcinoma

**Reports**  
5

**Reporting signal score**

20.5318
- **Event**  
listless

**Reports**  
7

**Reporting signal score**

21.4448

And 17 more, listed on the interactive page.

### Trial references (37)

- NCT00001079  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00001079)
- NCT00002067  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002067)
- NCT00006799  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00006799)
- NCT00031707  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00031707)
- NCT00031785  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00031785)
- NCT00163072  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00163072)
- NCT03283488  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03283488)
- NCT01200602  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01200602)
- NCT01501396  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01501396)
- NCT05380479  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380479)
- NCT00002680  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002680)
- NCT01237327  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01237327)
- NCT02269670  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02269670)
- NCT03306472  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03306472)
- NCT00005975  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00005975)
- NCT00016341  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00016341)
- NCT00739830  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00739830)
- NCT00910091  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00910091)
- NCT05255653  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05255653)
- NCT05332483  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332483)
- NCT00041275  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00041275)
- NCT00070148  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00070148)
- NCT00420563  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00420563)
- NCT00503516  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00503516)
- NCT00503581  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00503581)

And 12 more, listed on the interactive page.

## Dosing

**Dose**

800mg

**Route**

Oral

**How often**

Once daily

### Conditions of use

- Shake well before using

## Chemical properties

**Hydrogen bond acceptors**

4

**Hydrogen bond donors**

0

**Polar surface area**

60.44

**Calculated partition coefficient (ALogP)**

4.58

**Calculated partition coefficient (XLogP)**

3.1

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

2

**Heavy atoms**

28

**Molecular formula**

C24H32O4

**Monoisotopic mass**

384.23005950

**Natural product**

Yes

## National Drug Codes

- 0116-4011
- 0121-0945
- 0121-1038
- 0555-0606
- 0555-0607
- 0904-7236
- 0904-7577
- 24979-041
- 51407-910
- 60687-916
- 64380-158
- 64380-159
- 64380-160
- 68094-063
- 68094-174
- 69339-160
- 70954-896
- 71205-943
- 81033-150
- 17856-0060
- 68788-8714
- 71335-2181
- 71335-2544

## Evidence counts

**Recorded assays**

3,527

**Active assays**

175

### Active assay types (4)

- Confirmatory
- Other
- Screening
- Summary

## Pharmacologic actions

- Antineoplastic Agents, Hormonal  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D018931.html)
- Appetite Stimulants  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D019167.html)

## Biological measurements

These details could not be displayed.

## Related records

### Trials (102)

- A Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
- A Clinical Trial to Evaluate Pharmacokinetics of Daewon DW-ES(A) 625mg/5ml, Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in Healthy Male Volunteers Under Fed Condition
- A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome
- A Phase II Study of Therapy With Paclitaxel, Carboplatin and Megesterol Acetate for the Management of Uterine Cancer
- A Pilot Study on Fertility Conservative Treatment of Atypical Endometrial Hyperplasia in Singapore
- A Pre-operative Window Study of Letrozole Plus PR Agonist (Megestrol Acetate) Versus Letrozole Alone in Post-menopausal Patients With ER-positive Breast Cancer
- A Preliminary Exploratory Study of Cadonilimab Combined With Progestin for Fertility-Sparing Treatment in Early Endometrial Cancer
- A Prospective Real-World Observational Study of Nanocrystalline Megestrol Acetate in Patients With Cancer Cachexia
- A Randomized Clinical Trial of Megestrol Acetate as an Appetite Stimulant in Malnourished Children With Cancer
- A Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia
- A Study Evaluating Megestrol Acetate Modulation in Hormone Receptor Positive Advanced Breast Cancer
- A Study of Different Doses of Megestrol Acetate in Patients With AIDS Who Have Anorexia and Malnutrition
- A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
- A Study of Megestrol Acetate in HIV-Infected Children
- [A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)](https://trialight.com/data/trial/a-study-of-mk-5684-in-people-with-certain-solid-tumors-mk-461c8734-405e-4e5a-93a0-93cbf569e545.md)
- A Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients
- Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate
- Clinical Study on Nanocrystalline Megestrol Acetate for Appetite Improvement and Weight Gain in Pre-Cachexia and Cachexia Stages Key Terminology Analysis
- Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
- Clinical Trial of Ridaforolimus Compared to Progestin or Chemotherapy for Advanced Endometrial Carcinoma (MK-8669-007 AM6)

### Approved for (4)

- [AIDS](https://trialight.com/data/condition/aids-2a92a841-de6e-51af-bf3e-a52f5bafea66.md)
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md)
- Inborn error of immunity
- [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md)

### In development for (25)

- Adrenal cortex carcinoma Phase 2
- Atypical endometrial hyperplasia Phase 2
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 3
- [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Phase 3
- [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) Phase 1
- [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) Phase 2
- [Dementia](https://trialight.com/data/condition/dementia-c61efc95-c071-50d2-9df7-acb34b2a720c.md) Phase 2
- [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) Phase 3
- [Endometrial carcinoma](https://trialight.com/data/condition/endometrial-carcinoma-d0794a04-ff16-5af6-8fb7-7b3d6bd6c537.md) Phase 3
- Endometrioid adenocarcinoma Phase 2
- [Endometrium adenocarcinoma](https://trialight.com/data/condition/endometrium-adenocarcinoma-074853a7-50ad-5555-acac-5df9f272841f.md) Phase 2
- [Endometrium neoplasm](https://trialight.com/data/condition/endometrium-neoplasm-26985bd5-b9dd-55b8-9a46-6068daab5c23.md) Phase 3
- [Gastric adenocarcinoma](https://trialight.com/data/condition/gastric-adenocarcinoma-6bb74a55-7ba6-53e3-a113-22296a84d6ae.md) Phase 2
- [Head and neck cancer](https://trialight.com/data/condition/head-and-neck-cancer-3a2645b9-a3db-5103-b6f8-5d2ec40c5339.md) Phase 2
- [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) Phase 3
- [Hepatocellular carcinoma](https://trialight.com/data/condition/hepatocellular-carcinoma-fc1014ac-5a3c-551d-98ea-95306009e299.md) Phase 3
- [HIV infectious disease](https://trialight.com/data/condition/hiv-infectious-disease-1260f28c-d667-55f9-b221-15d5017fde05.md) Phase 2
- HIV wasting syndrome Phase 2
- Intraepithelial neoplasia Phase 2
- Liver cancer Phase 3

### Other linked conditions (3)

- [Malignant pancreatic neoplasm](https://trialight.com/data/condition/malignant-pancreatic-neoplasm-5dd0b53e-5962-50ea-a2e5-cf2444bd0485.md)
- [Pancreatic ductal adenocarcinoma](https://trialight.com/data/condition/pancreatic-ductal-adenocarcinoma-77c1c5a8-638b-51d0-b18e-2c881b8902e5.md)
- [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md)

### Targets (1)

- [PGR](https://trialight.com/data/target/pgr-4e536b31-8799-5ace-a427-be36fd8a5f9f.md) Progesterone receptor agonist

---

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