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
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/03/03 | Phase 3 | UNKNOWN | |||
2021/02/24 | Early Phase 1 | Withdrawn | |||
2021/02/16 | Not Applicable | Completed | |||
2021/01/26 | Phase 2 | UNKNOWN | Islamabad Medical and Dental College | ||
2021/01/05 | Not Applicable | UNKNOWN | |||
2020/12/28 | Phase 4 | Completed | |||
2020/11/27 | N/A | UNKNOWN | |||
2020/11/18 | Phase 3 | Completed | |||
2020/11/02 | N/A | Completed | |||
2020/10/27 | Phase 2 | Completed | Islamabad Medical and Dental College |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Greenstone LLC | 59762-0029 | ORAL | 200 ug in 1 1 | 12/1/2022 | |
| Mylan Pharmaceuticals Inc. | 59762-0029 | ORAL | 200 ug in 1 1 | 12/1/2022 | |
| GenBioPro Inc | 43393-203 | ORAL | 200 ug in 1 1 | 1/2/2013 | |
| BluePoint Laboratories | 68001-231 | ORAL | 200 ug in 1 1 | 4/21/2023 | |
| Aidarex Pharmaceuticals LLC | 33261-076 | ORAL | 200 ug in 1 1 | 1/15/2014 | |
| GenBioPro, Inc. | 43393-020 | ORAL | 200 ug in 1 1 | 1/9/2024 | |
| Novel Laboratories, Inc. | 40032-161 | ORAL | 200 ug in 1 1 | 12/21/2020 | |
| NuCare Pharmaceuticals,Inc. | 68071-4843 | ORAL | 200 ug in 1 1 | 2/17/2021 | |
| Amneal Pharmaceuticals LLC | 65162-436 | ORAL | 200 ug in 1 1 | 12/24/2021 | |
| Nivagen Pharmaceuticals, Inc. | 75834-265 | ORAL | 200 ug in 1 1 | 11/25/2022 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||