TheraRadar
Data updated: May 26, 2026

METHYLERGONOVINE MALEATE

Women's Health Approved 2008-11-24

METHYLERGONOVINE MALEATE is indicated for the treatment of Uterine Atony; Hemorrhage; Subinvolution of the Uterus.

Source: FDA Label • AM REGENT
8
Indications
--
Phase 3 Trials
17
Years on Market

Details

Status
Prescription
First Approved
2008-11-24
Routes
INJECTION, ORAL
Dosage Forms
INJECTABLE, TABLET

METHYLERGONOVINE MALEATE Approval History

2009
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2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2008 to 2021
Jan 2021 ORIGINAL
Update
May 2020 ORIGINAL
Update
Mar 2019 ORIGINAL
Update

What METHYLERGONOVINE MALEATE Treats

3 indications

METHYLERGONOVINE MALEATE is approved for 3 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Uterine Atony
  • Hemorrhage
  • Subinvolution of the Uterus
Source: FDA Label

METHYLERGONOVINE MALEATE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to METHYLERGONOVINE MALEATE

3 of 4

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CARBOPROST TROMETHAMINE
CARBOPROST TROMETHAMINE
1 shared
EUGIA PHARMA
Shared indications:
Uterine Atony
HEMABATE
CARBOPROST TROMETHAMINE
1 shared
Pfizer
Shared indications:
Uterine Atony
LYSTEDA
TRANEXAMIC ACID
1 shared
AMRING PHARMS
Shared indications:
Hemorrhage
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03584854 results posted 2018P000775-A Ph 4 completed Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

METHYLERGONOVINE MALEATE FDA Label Details

Indications & Usage

FDA Label (PDF)

METHYLERGONOVINE MALEATE is indicated for the treatment of Uterine Atony; Hemorrhage; Subinvolution of the Uterus.

Looking for the branded version?

METHERGINE

Full clinical data, patents, trials, and competitive landscape for methylergonovine maleate.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.