mirdametinib
Trade name: Gomekli
Small moleculeapprovedOrphan Drug FDA
Approved
Feb 11, 2025
Clinical trial activity
26 trials · 35 clinical orgs · 1 marketing orgs
Phase 1
17
Phase 2
19
Phase 3
0
Phase 4
0
Earliest trial started Feb 1, 2004 (NCT00147550)
Timeline
2010s
- Oct 30, 2018
Orphan Drug Designation
2020s
- Feb 11, 2025
Earliest FDA Approval
- Feb 11, 2025
SpringWorks Therapeutics, Inc. — Marketing Organization
Indications
Approved for
Studied for
- Arteriovenous Malformations · Phase 2
- Breast Neoplasms · Phase 1/Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Colonic Neoplasms · Phase 1/Phase 2
- Colorectal Neoplasms · Phase 1/Phase 2
- Glioma · Phase 1/Phase 2
- Growth · Phase 2
- Healthy Volunteers · Phase 1
- Histiocytosis · Phase 2
- Histiocytosis, Langerhans-Cell · Phase 2
- Histiocytosis, Sinus · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Liposarcoma · Phase 1/Phase 2
- Liposarcoma, Myxoid · Phase 1/Phase 2
- Liver Diseases · Phase 1
- Lymphangioma · Phase 2
- Lymphangioma, Cystic · Phase 2
- Lymphatic Diseases · Phase 2
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 2
- Melanoma · Phase 2
- Multiple Myeloma · Phase 1/Phase 2
- Mutation · Phase 2
- Neoplasms · Phase 1/Phase 2
- Neurofibroma, Plexiform · Phase 2
- Neurofibrosarcoma · Early Phase 1
- ras Proteins · Phase 2
- Vascular Diseases · Phase 2
- Vascular Malformations · Phase 2
- Venous Cutdown · Phase 2
- Xanthogranuloma, Juvenile · Phase 2
Mechanism of action
Approval history
- approvedPriority reviewFeb 11, 2025
Chemistry & pharmacology
Loading structure…
SMILES
O=C(NOC[C@H](O)CO)c1ccc(F)c(F)c1Nc1ccc(I)cc1F- Mol. weight
- 482.2 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL507361 ↗
Also known as
- pd0325901
- pd 0325901
- pd-0325901
- pd-0325901
- pd-0325901
- pd-0325901
- pd-0325901
- pd325901
- pd 325901
- pd-325901
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07279233 | Phase 1 | Dec 31, 2025 | SpringWorks Therapeutics, Inc. |
| NCT07061951 | Phase 2 | Oct 31, 2025 | Harvard University, National Cancer Institute (NCI) |
| NCT07237100 | Phase 2 | Oct 13, 2025 | Sutter Health |
| NCT06997276 | Phase 1 | May 7, 2025 | SpringWorks Therapeutics, Inc. |
| NCT06876142 | Phase 1/Phase 2 (Phase 2) | Mar 20, 2025 | National Cancer Institute (NCI) |
| NCT06843967 | Phase 1/Phase 2 (Phase 2) | Feb 19, 2025 | Memorial Sloan-Kettering Cancer Center, SpringWorks Therapeutics, Inc. |
| NCT06666348 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2025 | C17 Council, St. Justine's Hospital |
| NCT06693284 | Early Phase 1 (Phase 1) | Dec 1, 2024 | University of Minnesota |
| NCT06159166 | Phase 1/Phase 2 (Phase 2) | Jan 10, 2024 | Johns Hopkins University |
| NCT06153173 | Phase 2 | Dec 31, 2023 | University of Cincinnati |
| NCT05983159 | Phase 2 | Sep 30, 2023 | Murdoch University, Peter MacCallum Cancer Centre, University of Melbourne |
| NCT05937906 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2023 | Centre Georges Francois Leclerc |
| NCT05580770 | Phase 1/Phase 2 (Phase 2) | Mar 1, 2023 | SpringWorks Therapeutics, Inc. |
| NCT05054374 | Phase 1/Phase 2 (Phase 2) | Sep 14, 2021 | Memorial Sloan-Kettering Cancer Center |
| NCT04923126 | Phase 1/Phase 2 (Phase 2) | Jun 21, 2021 | SpringWorks Therapeutics, Inc., St. Jude Children's Hospital |
| NCT03962543 | Phase 2 | Jul 31, 2019 | SpringWorks Therapeutics, Inc. |
| NCT03905148 | Phase 1/Phase 2 (Phase 2) | Mar 28, 2019 | BeOne Medicines, SpringWorks Therapeutics, Inc. |
| NCT02510001 | Phase 1 | Nov 1, 2014 | Array BioPharma, Covance, European Commission, Oakland University, Pfizer, Q2 solutions, QPS, Queen's University, Belfast, Universidad Autonoma de Barcelona, University of Antwerp, University of Oxford, University of Paris, University of Turin, Velindre NHS Trust |
| NCT02096471 | Phase 2 | Jun 1, 2014 | University of Alabama, Birmingham |
| NCT02039336 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2014 | Erasmus University Rotterdam, Netherlands Cancer Institute, Pfizer, Utrecht University |
Showing 20 of 26 trials
Page 1 / 2
Organizations
Research & Development (35)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| SpringWorks Therapeutics, Inc. | For profit | 8 | 5 | 3 | 2019 |
| Pfizer | For profit | 5 | 3 | 2 | 2004 |
| Harvard University | Academic/Hospital | 2 | 1 | 1 | 2014 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 2 | 2 | 1 | 2021 |
| National Cancer Institute (NCI) | Government | 2 | 2 | 1 | 2025 |
| Array BioPharma | For profit | 1 | 0 | 1 | 2014 |
| BeOne Medicines | For profit | 1 | 1 | 1 | 2019 |
| C17 Council | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Centre Georges Francois Leclerc | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Covance | For profit | 1 | 0 | 1 | 2014 |
| Erasmus University Rotterdam | Academic/Hospital | 1 | 0 | 1 | 2014 |
| European Commission | Government | 1 | 0 | 1 | 2014 |
| Johns Hopkins University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Murdoch University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Netherlands Cancer Institute | Academic/Hospital | 1 | 1 | 1 | 2014 |
| Oakland University | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Peter MacCallum Cancer Centre | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Q2 solutions | For profit | 1 | 0 | 1 | 2014 |
| QPS | For profit | 1 | 0 | 1 | 2014 |
| Queen's University, Belfast | Academic/Hospital | 1 | 0 | 1 | 2014 |
35 organizations
Page 1 / 2
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| SpringWorks Therapeutics, Inc. | For profit | MKTG | Feb 11, 2025 |