Drugs / Methylergonovine
Methylergonovine
also known as
methergine · Methyl ergometrine · Methylergonovine Maleate · Ergotyl · methylergometrine maleate · Metilergometrina · NSC-757104
Small molecule targets DRD1, HTR2B via inhibition / activation
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | METHERGINE | — | 1979-01-23 – 1981-06-17 | fda.gov ↗ |
| Approved | US (FDA) | METHERGINE | — | 1946-11-19 | fda.gov ↗ |
Trials 8
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03303235 | Jul → Oct 2020 | uterine disorder | Johns Hopkins University | Withdrawn | No outcome recorded |
| Phase 44 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT05772156 | Mar 2023 → Mar 2024 | obstetric disorder | Columbia University | Completed | No outcome recorded |
| Phase 4 | NCT03904446 | Jun 2019 → Feb 2021 | uterine disorder | Cynthia Wong | Completed | Met primary |
| Phase 4 | NCT02408965 | Mar 2015 → Mar 2017 | hemorrhagic disease | University of California, San Francisco | Completed | Missed primary |
| Phase 4 | NCT01549223 | Apr 2011 → Jan 2012 | hypotensive disorder, uterine disorder | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase not applicable3 trials · 1 missed | ||||||
| — | NCT07318467 | Jan → Jun 2026 overdue | — | Cairo University | Not yet recruiting | No outcome recorded |
| — | NCT00858832 | Dec 2008 → Jan 2011 | endometritis | University of South Florida | Completed | No outcome recorded |
| — | NCT00481533 | Jun 2005 → Jan 2007 | — | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | Completed | Missed primary |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT03390010 Comparator | Dec 2017 → Feb 2018 | — | Aljazeera Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03584854 Comparator | Mar 2019 → May 2022 | uterine disorder | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02101567 Comparator | May 2014 → Apr 2015 | anemia, hemorrhagic disease | Beni-Suef University | Completed | No outcome recorded |
| — | NCT07390864 Comparator | Jan → Jul 2026 overdue | leiomyoma | Cairo University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2018-09-12 | Impax Laboratories, LLC | Regulatory Amneal Announces FDA Approval and Launch of Generic Chlorpromazine Hydrochloride Tablets USP and Approval of Methylergonovine Maleate Tablets USP amneal.com ↗
The Company also received approval for a generic version of Methergine ® Tablets USP, 0.2 mg (Methylergonovine Maleate Tablets USP, 0.2 mg ), which it expects to launch shortly. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-09-12 | Impax Laboratories, LLC | Amneal Announces FDA Approval and Launch of Generic Chlorpromazine Hydrochloride Tablets USP and Approval of Methylergonovine Maleate Tablets USP amneal.com ↗ |
| 2018-06-04 | Lupin Limited | Lupin launches generic Methylergonovine Maleate Tabs USP in the US lupin.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Methylergonovine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03904446 ↗ |
| Known as | Ergotyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201356 ↗ |
| Known as | methergine | “methylergonovine maleate (methergine) 0.2 mg IM (intramuscular)” NCT01549223 ↗4“Oxytocin and Methergine (methyl ergometrine)” NCT02101567 ↗ |
| Known as | Methyl ergometrine | “Oxytocin and Methergine (methyl ergometrine)” NCT02101567 ↗ |
| Known as | methylergometrine maleate | “Group A will receive a combination regimen of intravenous Oxytocin (5-10IU), Tranexamic acid (intravenous bolus 1 gram), and intramuscular ergot derivative (methylergometrine...” NCT07318467 ↗ |
| Known as | Methylergonovine Maleate | “methylergonovine maleate (methergine) 0.2 mg IM (intramuscular)” NCT01549223 ↗1“Drug: Methylergonovine Maleate” NCT03584854 ↗ |
| Known as | Metilergometrina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201356 ↗ |
| Known as | NSC-757104 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201356 ↗ |
| Action | Activate | “Serotonin 2b (5-HT2b) receptor partial agonist” CHEMBL1201356 ↗ |
| Action | Inhibit | “Dopamine D1 receptor antagonist” CHEMBL1201356 ↗ |
| Modality | Small molecule | “semi-synthetic ergot alkaloid” NCT03303235 ↗ |
| Route | Oral | “Scheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay” NCT00858832 ↗ |
| Target | DRD1 | “Dopamine D1 receptor antagonist” CHEMBL1201356 ↗ |
| Target | HTR2B | “Serotonin 2b (5-HT2b) receptor partial agonist” CHEMBL1201356 ↗ |