Overview
Misoprostol is a prostaglandin analog used to reduce the risk of NSAID related ulcers, manage miscarriages, prevent post partum hemorrhage, and also for first trimester abortions. The stimulation of prostaglandin receptors in the stomach reduces gastric acid secretion, while stimulating these receptors in the uterus and cervix can increase the strength and frequency of contractions and decrease cervical tone. Misoprostol was granted FDA approval on 27 December 1988.
Background
Misoprostol is a prostaglandin analog used to reduce the risk of NSAID related ulcers, manage miscarriages, prevent post partum hemorrhage, and also for first trimester abortions. The stimulation of prostaglandin receptors in the stomach reduces gastric acid secretion, while stimulating these receptors in the uterus and cervix can increase the strength and frequency of contractions and decrease cervical tone. Misoprostol was granted FDA approval on 27 December 1988.
Indication
Misoprostol is indicated as a tablet to reduce the risk of NSAID induced gastric ulcers but not duodenal ulcers in high risk patients. Misoprostol is also formulated in combination with diclofenac to treat symptoms of osteoarthritis or rheumatoid arthritis in patients with a high risk of developing gastric ulcers. Misoprostol is used off label for the management of miscarriages, prevention of post partum hemorrhage, and is also used alone or in combination with mifepristone in other countries for first trimester abortions.
Associated Conditions
- Gastric Ulcer
- Incomplete Abortion
- Missed Abortion
- Postpartum Haemorrhage (PPH)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/14 | N/A | Completed | Ankara Etlik City Hospital | ||
2025/04/27 | Phase 4 | Recruiting | |||
2025/04/03 | Not Applicable | Completed | |||
2025/03/13 | Early Phase 1 | Active, not recruiting | Hagar Muhammad Abdulfattah Muhammad | ||
2025/02/28 | Not Applicable | Recruiting | |||
2025/01/09 | Phase 3 | Not yet recruiting | |||
2024/12/10 | Not Applicable | Completed | Hayat Abad Medical Complex, Peshawar. | ||
2024/11/01 | Not Applicable | Recruiting | |||
2024/07/16 | Phase 1 | Recruiting | |||
2024/06/11 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Preferred Pharmaceuticals Inc. | 68788-7103 | ORAL | 200 ug in 1 1 | 5/4/2023 | |
| Rebel Distributors Corp. | 21695-425 | ORAL | 200 ug in 1 1 | 11/10/2009 | |
| Micro Labs Limited | 42571-133 | ORAL | 200 ug in 1 1 | 1/5/2023 | |
| Bryant Ranch Prepack | 71335-1183 | ORAL | 200 ug in 1 1 | 2/3/2022 | |
| Actavis Pharma, Inc. | 0591-0398 | ORAL | 200 ug in 1 1 | 1/31/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0025-1451 | ORAL | 100 ug in 1 1 | 7/9/2021 | |
| Micro Labs Limited | 42571-254 | ORAL | 200 ug in 1 1 | 11/7/2022 | |
| Nivagen Pharmaceuticals, Inc. | 75834-264 | ORAL | 200 ug in 1 1 | 11/25/2022 | |
| Greenstone LLC | 59762-0028 | ORAL | 200 ug in 1 1 | 12/1/2022 | |
| Mylan Pharmaceuticals Inc. | 59762-0028 | ORAL | 200 ug in 1 1 | 12/1/2022 |
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 |
|---|---|---|---|---|---|
| MISEL TABLETS 200 mcg | SIN10877P | TABLET | 200 mcg | 4/20/1999 | |
| CYTOTEC TABLET 200 mcg | SIN03501P | TABLET | 200 mcg | 6/15/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Misoprostol Tablets | 国药准字H20000668 | 化学药品 | 片剂 | 3/24/2020 | |
| Misoprostol Tablets | 国药准字HJ20150043 | 化学药品 | 片剂 | 5/15/2024 | |
| Misoprostol Tablets | 国药准字H20094136 | 化学药品 | 片剂 | 11/22/2023 | |
| Misoprostol Tablets | 国药准字H20084598 | 化学药品 | 片剂 | 6/9/2023 | |
| Misoprostol Tablets | 国药准字H20073696 | 化学药品 | 片剂 | 3/4/2022 | |
| Misoprostol Tablets | 国药准字HJ20150042 | 化学药品 | 片剂 | 5/15/2024 | |
| Misoprostol Vaginal Tablets | 国药准字H20203249 | 化学药品 | 片剂 | 6/12/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CYTOTEC misoprostol 200 microgram tablet bottle - EX | 46849 | Proqualix Pty Ltd - in Administration | Medicine | A | 10/15/1993 |
| ANGUSTA misoprostol 25 microgram tablet blister pack | 381571 | Medicine | A | 12/20/2022 | |
| GyMiso misoprostol 200 microgram oral tablet blister pack | 188015 | Medicine | A | 8/29/2012 | |
| MS-2 Step composite pack [MIFEPRISTONE LINEPHARMA 200 MG TABLET mifepristone 200 mg tablet blister; GyMiso misoprostol 200 microgram tablet blister] | 210574 | Medicine | A | 6/4/2014 | |
| CYTOTEC Misoprostol 200 microgram tablet blister pack | 63983 | Medicine | A | 6/23/1998 | |
| MS-2 Step composite pack [MIFEPRISTONE LINEPHARMA 200 MG TABLET mifepristone 200 mg tablet blister; GyMiso misoprostol 200 microgram tablet blister] | 462239 | Medicine | A | 1/21/2025 |