Overview
17-Hydroxy-6-methylpregna-3,6-diene-3,20-dione. A progestational hormone used most commonly as the acetate ester. As the acetate, it is more potent than progesterone both as a progestagen and as an ovulation inhibitor. It has also been used in the palliative treatment of breast cancer.
Background
17-Hydroxy-6-methylpregna-3,6-diene-3,20-dione. A progestational hormone used most commonly as the acetate ester. As the acetate, it is more potent than progesterone both as a progestagen and as an ovulation inhibitor. It has also been used in the palliative treatment of breast cancer.
Indication
For the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). Also used for the palliative management of recurrent, inoperable, or metastatic breast cancer, endometrial cancer, and prostate cancer in Canada and some other countries.
Associated Conditions
- Anorexia
- Cachexia
- Inoperable Carcinoma of Breast
- Inoperable Endometrial Carcinoma
- Metastatic Breast Carcinoma
- Recurrent Breast Carcinoma
- Recurrent Endometrial Carcinoma
- Significant, Unexplained Weight Loss
- Metastatic Endometrial carcinoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/31 | Phase 3 | Not yet recruiting | Sixth Affiliated Hospital, Sun Yat-sen University | ||
2022/09/14 | Phase 1 | Active, not recruiting | |||
2022/08/08 | Phase 2 | UNKNOWN | KK Women's and Children's Hospital | ||
2022/05/18 | Phase 2 | UNKNOWN | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2022/04/18 | Phase 1 | Terminated | |||
2022/02/24 | Phase 2 | Recruiting | Leiden University Medical Center | ||
2021/06/25 | Phase 3 | Recruiting | |||
2021/05/21 | Phase 3 | Withdrawn | |||
2020/10/29 | Phase 2 | Terminated | |||
2020/10/06 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| PINNACLE PHARMA LLC | 81646-120 | ORAL | 40 mg in 1 mL | 7/8/2021 | |
| McKesson Corporation dba SKY Packaging | 63739-549 | ORAL | 400 mg in 10 mL | 12/18/2023 | |
| State of Florida DOH Central Pharmacy | 53808-0614 | ORAL | 40 mg in 1 1 | 6/7/2010 | |
| Par Pharmaceutical, Inc. | 49884-290 | ORAL | 40 mg in 1 1 | 5/3/2022 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-0907 | ORAL | 40 mg in 1 mL | 1/18/2021 | |
| Teva Pharmaceuticals USA, Inc. | 0555-0607 | ORAL | 40 mg in 1 1 | 5/31/2016 | |
| Atlantic Biologicals Corps | 17856-0949 | ORAL | 125 mg in 1 mL | 3/18/2014 | |
| Teva Pharmaceuticals USA, Inc. | 0555-0606 | ORAL | 20 mg in 1 1 | 5/31/2016 | |
| Morton Grove Pharmaceuticals, Inc. | 60432-126 | ORAL | 40 mg in 1 mL | 6/10/2020 | |
| Golden State Medical Supply, Inc. | 60429-433 | ORAL | 40 mg in 1 1 | 8/15/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| APO-MEGESTROL TABLET 40 mg | SIN10156P | TABLET | 40 mg | 10/5/1998 | |
| APO-MEGESTROL TABLET 160 mg | SIN10157P | TABLET | 160 mg | 10/5/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Megestrol Acetate Soft Capsules | 国药准字H20020242 | 化学药品 | 胶囊剂 | 4/15/2020 | |
| Megestrol Acetate Oral Suspension | 安成国际药业股份有限公司 | 国药准字HC20210002 | 化学药品 | 口服混悬剂 | 5/8/2021 |
| Megestrol Acetate Capsules | 国药准字H19991017 | 化学药品 | 胶囊剂 | 6/5/2020 | |
| Megestrol Acetate Capsules | 国药准字H19991016 | 化学药品 | 胶囊剂 | 6/5/2020 | |
| Megestrol Acetate Capsules | 国药准字H20010553 | 化学药品 | 胶囊剂 | 7/14/2020 | |
| Megestrol Acetate Dispersible Tablets | 国药准字H20010419 | 化学药品 | 片剂(分散) | 6/5/2020 | |
| Megestrol Acetate Dispersible Tablets | 国药准字H20123089 | 化学药品 | 片剂 | 9/13/2021 | |
| Megestrol Acetate Dispersible Tablets | 国药准字H20073644 | 化学药品 | 片剂 | 2/21/2020 | |
| Megestrol Acetate Dispersible Tablets | 国药准字H20040001 | 化学药品 | 片剂 | 7/2/2020 | |
| Megestrol Acetate Dispersible Tablets | 国药准字H20010074 | 化学药品 | 片剂 | 4/13/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| MEGESIA TABLETS 40MG | N/A | N/A | N/A | 4/14/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||