Product Description
Mechanisms of Action: PI3K Inhibitor,mTOR
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Priority Review - Neurofibromatosis 1 *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: SpringWorks Therapeutics
Company Location: STAMFORD CT 06902
Company CEO: Saqib Islam
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, United States
Active Clinical Trial Count: 5
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
- Clinical Outcomes Reported - SpringWorks Therapeutics presented P2 Neurofibroma, Plexiform results on 2024-11-11 for Mirdametinib
Highest Development Phases
Phase 2: Glioma|Liposarcoma, Myxoid|Neurofibroma, Plexiform|Neurofibromatoses|Neurofibromatosis 1
Phase 1: Healthy Volunteers|Oncology Solid Tumor Unspecified
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| BGB-283/PD-0325901-AU-001 | P1 |
Active, not recruiting |
Oncology Solid Tumor Unspecified |
2025-09-30 |
23% |
2025-03-18 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
| SJ901 | P2 |
Recruiting |
Glioma |
2031-06-01 |
12% |
2021-06-29 |
Primary Endpoints |
| NCT06843967 | P2 |
Recruiting |
Liposarcoma, Myxoid |
2028-08-19 |
12% |
2025-03-01 |
Primary Endpoints |
| ReNeu | P2 |
Active, not recruiting |
Neurofibromatoses|Neurofibroma, Plexiform|Neurofibromatosis 1 |
2023-09-20 |
61% |
2023-12-14 |
Primary Completion Date|Primary Endpoints|Treatments |
| MEK-NF-103 | P1 |
Recruiting |
Healthy Volunteers |
2026-07-01 |
69% |
2025-05-31 |
Primary Endpoints|Treatments |