Drugs / Mirdametinib
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Ezmekly | — | 2025-07-17 | europa.eu ↗ |
| Approved | US (FDA) | GOMEKLI | — | 2025-02-11 | fda.gov ↗ |
Trials 27 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT05028166 Background | — | histiocytic and dendritic cell neoplasm, plexiform neurofibroma | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | Available | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mirdametinib | “NF106: A Neurofibromatosis Clinical Trials Consortium Phase II Trial of the MEK Inhibitor Mirdametinib (PD-0325901) in Adolescents and Adults With NF1-Related Plexiform Neurofibromas.” PMID 33507822 ↗ Jan 2021 |
| Known as | Pd 03525901 | ChEMBL registry synonym — accepted as the source's own label CHEMBL507361 ↗ |
| Known as | Pd 901 | ChEMBL registry synonym — accepted as the source's own label CHEMBL507361 ↗ |
| Known as | PD-0325901 | “NF106: A Neurofibromatosis Clinical Trials Consortium Phase II Trial of the MEK Inhibitor Mirdametinib (PD-0325901) in Adolescents and Adults With NF1-Related Plexiform Neurofibromas.” PMID 33507822 ↗ Jan 20219“This is a 2-part Phase 1b study of BGB-283 (lifirafenib) and PD-0325901 (mirdametinib) combination in participants with tumors.” NCT03905148 ↗ “Mirdametinib (PD-0325901) is a highly selective non-ATP-competitive inhibitor of MEK1 and MEK2.” NCT06843967 ↗ |
| Action | Inhibit | “Dual specificity mitogen-activated protein kinase kinase 2 inhibitor” CHEMBL507361 ↗2“Dual specificity mitogen-activated protein kinase kinase 1 inhibitor” CHEMBL507361 ↗ “PD-0325901 (oral MEK inhibitor)” NCT01347866 ↗ |
| Modality | Small molecule | “highly selective small-molecule inhibitor” NCT03962543 ↗ |
| Route | Oral | “PD-0325901 was administered orally at 20 mg twice daily (BID) for 21 consecutive days followed by 7 days of no treatment.” PMID 21516509 ↗ Apr 2011 |
| Target | MAP2K1 | “Dual specificity mitogen-activated protein kinase kinase 1 inhibitor” CHEMBL507361 ↗ |
| Target | MAP2K2 | “Dual specificity mitogen-activated protein kinase kinase 2 inhibitor” CHEMBL507361 ↗ |