Product Description
Mirdametinib inhibits MEK1 and MEK2, which occupy pivotal positions in the MAPK pathway. The MAPK pathway is a key signaling network that regulates cell growth and survival and that plays a central role in multiple cancers and rare diseases when dysregulated. (Sourced from: https://springworkstx.com/pipeline/mirdametinib/)
Mechanisms of Action: PI3K Inhibitor, mTOR
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Priority Review - Neurofibromatosis 1 *
Approval Status: Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: SpringWorks Therapeutics
Company Location:
Company CEO: Saqib Islam
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Germany, United States
Active Clinical Trial Count: 7
Recent & Upcoming Milestones
- Clinical Outcomes Reported - SpringWorks Therapeutics presented P1 Glioma results on 2024-11-22 for Mirdametinib
- Clinical Outcomes Reported - SpringWorks Therapeutics presented P2 Neurofibroma, Plexiform results on 2024-11-22 for Mirdametinib
- PDUFA date for mirdametinib in NF1-pn is February 28, 2025, with promising results from phase 2b trials presented.
Highest Development Phases
Phase 2: Glioma|Liposarcoma, Myxoid|Neurofibroma, Plexiform|Neurofibromatoses|Neurofibromatosis 1
Phase 1: Healthy Volunteers|Oncology Solid Tumor Unspecified
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06843967 |
NCT06843967 | P2 |
Recruiting |
Liposarcoma, Myxoid |
2028-08-19 |
12% |
2025-03-01 |
Primary Endpoints |
NCT03962543 |
ReNeu | P2 |
Active, not recruiting |
Neurofibroma, Plexiform|Neurofibromatoses|Neurofibromatosis 1 |
2023-09-20 |
12% |
2023-12-14 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT03905148 |
BGB-283/PD-0325901-AU-001 | P1 |
Completed |
Oncology Solid Tumor Unspecified |
2024-10-09 |
12% |
2026-01-08 |
Primary Completion Date|Primary Endpoints |
2025-522000-24-00 |
MEK-NF1-104 | P1 |
Not yet recruiting |
Neurofibroma, Plexiform |
2032-02-28 |
|||
NCT04923126 |
SJ901 | P2 |
Recruiting |
Glioma |
2031-06-01 |
12% |
2021-06-29 |
Primary Endpoints |
NCT07279233 |
MEK-NF1-105 | P1 |
Not yet recruiting |
Healthy Volunteers |
2026-02-01 |
88% |
2025-12-27 |
Primary Endpoints|Treatments |
NCT06997276 |
MEK-NF-103 | P1 |
Recruiting |
Healthy Volunteers |
2026-07-01 |
88% |
2025-05-31 |
Primary Endpoints|Treatments |