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METHYLERGONOVINE MALEATE
Methylergonovine Maleate is a marketed drug primarily indicated for the routine management of uterine atony. The key composition patent is set to expire in 2028, providing a clear period of exclusivity and potential revenue stability. The primary risk is the lack of significant trial results or revenue data, which may limit strategic planning and investor confidence.
At a glance
| Generic name | METHYLERGONOVINE MALEATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1946 |
Approved indications
- Routine management of uterine atony
- Control of uterine hemorrhage in second stage of labor
Common side effects
- Hypertension
- Headache
- Seizure
- Hypotension
- Abdominal pain
- Nausea
- Vomiting
Serious adverse events
- Acute myocardial infarction
- Coronary arterial spasm
- Vasospasm
- Vasoconstriction
- Cerebrovascular accident
- Ventricular fibrillation
- Ventricular tachycardia
- Atrioventricular block
- Anaphylaxis
- Water intoxication
Drug interactions
- CYP 3A4 inhibitors (e.g., Macrolide Antibiotics and Protease Inhibitors)
- CYP3A4 inducers (e.g., nevirapine, rifampicin)
- Beta-blockers
- Anesthetics (e.g., halothan, methoxyfluran)
- Glyceryl trinitrate and other antianginal drugs
Key clinical trials
- Ergometrine Versus Carbetocin to Decrease Blood Loss in Myomectomy (NA)
- Prophylactic Regimen of Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative for Primary Prevention of Postpartum Hemorrhage in Intrapartum Cesarean Section Versus Intravenous Carbetocin Alone (NA)
- Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial (PHASE4)
- Prophylactic Methylergonovine for Twin Cesarean (PHASE4)
- Misoprostol Versus Active Management of Labour in CS (PHASE1)
- Multimodal Uterotonics at the Time of Cesarean Section in Laboring Patients (PHASE4)
- Intravenous Versus Intramuscular Administration of Methylergonovine for Uterine Contraction in Cesarean Sections (EARLY_PHASE1)
- Uterotonic Prophylaxis Trial (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- METHYLERGONOVINE MALEATE CI brief — competitive landscape report
- METHYLERGONOVINE MALEATE updates RSS · CI watch RSS