Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed mosaic neurofibromatosis type 1 1 milestone | |||||
| Filed | EU (EMA) | — | mosaic neurofibromatosis type 1 | — | “SpringWorks’ Marketing Authorization Application for mirdametinib for the treatment of children and adults with NF1-PN was validated by the European Medicines Agency (EMA)” springworkstx.com ↗ “The CHMP opinion was based on the Marketing Authorization Application (MAA) for mirdametinib, which was validated by the EMA in August 2024.” springworkstx.com ↗ “The marketing authorisation application for mirdametinib has been validated by the European Medicines Agency (EMA)” springworkstx.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved · conditional | EU (EMA) | Ezmekly | — | 2025-07-17 | europa.eu ↗ |
| Approved | US (FDA) | GOMEKLI | — | 2025-02-11 | fda.gov ↗ |
Trials 29
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2025-07-18 | Merck KGaA, Darmstadt, Germany | Regulatory European Commission Grants Conditional Approval of EZMEKLY emdgroup.com ↗
The European Commission granted approval for EZMEKLY for the treatment of adult and pediatric patients with NF1-PN. |
| 2025-07-18 | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | Regulatory European Commission Grants Conditional Approval of EZMEKLY® (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN springworkstx.com ↗
This approval represents an important advance, especially for adults who previously did not have an approved treatment. |
| 2025-05-23 | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | Regulatory SpringWorks Therapeutics Receives Positive CHMP Opinion for Mirdametinib for the Treatment of Adult and Pediatric Patients with NF1-PN springworkstx.com ↗ |
| 2025-02-11 | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | Regulatory SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN springworkstx.com ↗ |
| 2023-04-17 | BeOne Medicines | Results BeiGene and SpringWorks Present Clinical Data on Lifirafenib, in Combination with Mirdametinib, in Patients with Advanced or Refractory Solid Tumors with MAPK Pathway Aberrations at the American Association for Cancer Research Annual Meeting 2023 beonemedicines.com ↗
The early clinical data reported here demonstrate the potential of this vertical combination strategy in addressing the substantial unmet medical need represented by patients with tumors driven by these genetic alterations. |
All press releases naming this drug 6 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 32 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 ↗ |