Mirdametinib Clinical Trials (2026): 20 Studies for Healthy & Advanced Unresectable Melanoma
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
20 Mirdametinib clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 19 indications (including Healthy & Advanced Unresectable Melanoma) and 849 total planned enrollment. 13 Mirdametinib clinical trials are actively recruiting at 30 U.S. sites across 13 states. Most recent activity: NCT06666348 (Apr 2033).
Where to Participate: All Mirdametinib Trial Sites in the U.S. (30 sites across 13 states)
Every actively recruiting Mirdametinibtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| CA | City of Hope Comprehensive Cancer Center | Duarte91010 | NCT07061951 | Map |
| CA | City of Hope at Irvine Lennar | Irvine92618 | NCT07061951 | Map |
| CA | University of California Davis Comprehensive Cancer Center | Sacramento95817 | NCT07061951 | Map |
| CA | California Pacific Medical Center - Sutter Health | San Francisco94115 | NCT07237100 | Map |
| FL | Clinical Pharmacology of Miami | Miami33172 | NCT06997276 | Map |
| FL | Orlando Clinical Research Center | Orlando32809 | NCT06997276 | Map |
| MD | Johns Hopkins Hospital | Baltimore21287 | NCT06159166 | Map |
| MA | Dana-Farber Cancer Institute | Boston02215 | NCT07061951 | Map |
| MN | University of Minnesota | Minneapolis55414 | NCT06693284 | Map |
| NJ | Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | Basking Ridge07920 | NCT06843967 | Map |
| NJ | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge07920 | NCT07539441 | Map |
| NJ | Memorial Sloan Kettering Monmouth (Limited protocol activities) | Middletown07748 | NCT07539441 | Map |
| NJ | Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown07748 | NCT06843967 | Map |
| NJ | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale07645 | NCT06843967 | Map |
| NJ | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale07645 | NCT07539441 | Map |
| NY | Memorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities) | Commack11725 | NCT06843967 | Map |
| NY | Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) | Commack11725 | NCT07539441 | Map |
| NY | Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison10604 | NCT06843967 | Map |
| NY | Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison10604 | NCT07539441 | Map |
| NY | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York10065 | NCT06843967 | Map |
| NY | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York10065 | NCT07539441 | Map |
| NY | Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Rockville Centre11570 | NCT07539441 | Map |
| NY | Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale11553 | NCT06843967 | Map |
| NC | UNC Lineberger Comprehensive Cancer Center | Chapel Hill27599 | NCT07061951 | Map |
| OH | Cincinnati Children's Hospital Medical Center | Cincinnati45229 | NCT06153173 | Map |
| OH | Ohio State University Comprehensive Cancer Center | Columbus43210 | NCT07061951 | Map |
| PA | University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh15232 | NCT07061951 | Map |
| TN | St. Jude Children's Research Hospital | Memphis38105 | NCT04923126 | Map |
| TX | American Research Corporation (Texas Liver Institute) | San Antonio78215 | NCT06997276 | Map |
| UT | Huntsman Cancer Institute/University of Utah | Salt Lake City84112 | NCT07061951 | Map |
Mirdametinib clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | terminated | suspended | not yet recruiting | available | Total |
|---|---|---|---|---|---|---|---|---|
| Early P1 | 1 | 1 | ||||||
| P1 | 1 | 2 | 3 | |||||
| P1/P2 | 6 | 1 | 1 | 1 | 9 | |||
| P2 | 4 | 1 | 1 | 6 | ||||
| N/A | 1 | 1 |
Recruiting Mirdametinib clinical trials (13)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT06666348 | MIRVPhase 1/2 Study of Mirdametinib + Vinblastine for Newly Diagnosed/Previously Untreated PLGG + Activation of MAPK | P1/P2 | Pediatric Low-grade Glioma | 50 | Jan 2026 |
| NCT07521657 | NF118Efficacy of Mirdametinib Alone or Combination With Radiotherapy for Germline and Sporadic NF1-Altered High-Grade Glioma | P2 | Neurofibromatosis 1 (NF1) | 55 | Aug 2026 |
| NCT04923126 | SJ901SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma | P1/P2 | Low-Grade Glioma | 132 | Jun 2021 |
| NCT06153173 | Mirdametinib in Histiocytic Disorders | P2 | Langerhans Cell Histiocytosis (LCH) | 40 | Feb 2024 |
| NCT07237100 | Mirdametinib in Patients With Advanced NF1-mutant Melanoma | P2 | Advanced Unresectable Melanoma | 10 | Oct 2025 |
| NCT07061951 | Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia | P2 | Recurrent Chronic Lymphocytic Leukemia | 20 | May 2026 |
| NCT07539441 | A Study of Mirdametinib in People With Central Nervous System Tumors | P1/P2 | Central Nervous System Tumors | 26 | Apr 2026 |
| NCT05937906 | IMMUNOMEKClinical Trial Evaluating the Safety and Efficacy of Chemoimmunotherapy Plus Short Course of Mek Inhibitor in First Line of Treatment of Metastatic Non Squamous Non Small Cell Lung Adenocarcinoma With PDL1 < 50 %. | P1/P2 | Non-Small Cell Lung Cancer | 24 | Jul 2026 |
| NCT06159166 | MirdaMirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF). | P1/P2 | NF1 | 24 | Feb 2024 |
| NCT06843967 | A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma | P1/P2 | Well Differentiated Liposarcoma | 54 | Feb 2025 |
| NCT05983159 | TARGET-VMA Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations | P2 | Slow-Flow Vascular Malformation | 50 | Sep 2024 |
| NCT06693284 | A Window of Opportunity Trial of Mirdametinib Plus Vorinostat for NF1 Associated, H3K27 Trimethylation Deficient Malignant Peripheral Nerve Sheath Tumor [MPNST] | Early P1 | Primary Malignant Peripheral Nerve Sheath Tumors | 8 | Nov 2025 |
| NCT06997276 | Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib | P1 | Healthy | 32 | May 2025 |
Mirdametinib clinical trials by indication
Healthy (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06997276 | — | P1 | recruiting | Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib |
| NCT07279233 | — | P1 | completed | To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants |
Neurofibromatosis 1 (NF1) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07521657 | NF118 | P2 | not yet recruiting | Efficacy of Mirdametinib Alone or Combination With Radiotherapy for Germline and Sporadic NF1-Altered High-Grade Glioma |
Multiple Myeloma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06876142 | — | P1/P2 | suspended | Combination Therapy (Mirdametinib and Sirolimus) for RAS Mutated Relapsed Refractory Multiple Myeloma |
Non-Small Cell Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05937906 | IMMUNOMEK | P1/P2 | recruiting | Clinical Trial Evaluating the Safety and Efficacy of Chemoimmunotherapy Plus Short Course of Mek Inhibitor in First Line of Treatment of Metastatic Non Squamous Non Small Cell Lung Adenocarcinoma With PDL1 < 50 %. |
Recurrent Chronic Lymphocytic Leukemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07061951 | — | P2 | recruiting | Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia |
Central Nervous System Tumors (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07539441 | — | P1/P2 | recruiting | A Study of Mirdametinib in People With Central Nervous System Tumors |
Pediatric Low-grade Glioma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06666348 | MIRV | P1/P2 | recruiting | Phase 1/2 Study of Mirdametinib + Vinblastine for Newly Diagnosed/Previously Untreated PLGG + Activation of MAPK |
Primary Malignant Peripheral Nerve Sheath Tumors (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06693284 | — | Early P1 | recruiting | A Window of Opportunity Trial of Mirdametinib Plus Vorinostat for NF1 Associated, H3K27 Trimethylation Deficient Malignant Peripheral Nerve Sheath Tumor [MPNST] |
Advanced Unresectable Melanoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07237100 | — | P2 | recruiting | Mirdametinib in Patients With Advanced NF1-mutant Melanoma |
Well Differentiated Liposarcoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06843967 | — | P1/P2 | recruiting | A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma |
Slow-Flow Vascular Malformation (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05983159 | TARGET-VM | P2 | recruiting | A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations |
NF1 (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06159166 | Mirda | P1/P2 | recruiting | Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF). |
Langerhans Cell Histiocytosis (LCH) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06153173 | — | P2 | recruiting | Mirdametinib in Histiocytic Disorders |
Advanced Solid Tumor (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05580770 | — | P1/P2 | terminated | Mirdametinib + BGB-3245 in Advanced Solid Tumors |
Breast Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05054374 | — | P1/P2 | completed | A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer |
Low-Grade Glioma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04923126 | SJ901 | P1/P2 | recruiting | SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma |
Plexiform Neurofibroma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03962543 | ReNeu | P2 | active not recruiting | MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas |
Solid Tumor, Adult (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03905148 | — | P1 | completed | Study of the Safety and Pharmacokinetics of BGB-283 (Lifirafenib) and PD-0325901 (Mirdametinib) in Participants With Advanced or Refractory Solid Tumors |
Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05028166 | — | N/A | available | Individual Patient Compassionate Use of Mirdametinib |
Mirdametinib pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| NF118 | NCT07521657 | P2 | not yet recruiting | Neurofibromatosis 1 (NF1) | 55 | — |
| ReNeu | NCT03962543 | P2 | active not recruiting | Plexiform Neurofibroma | 114 | PMID 39514826 |
| TARGET-VM | NCT05983159 | P2 | recruiting | Slow-Flow Vascular Malformation | 50 | PMID 19126370 |
Terminated and withdrawn Mirdametinib trials (2)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT06876142suspendedCombination Therapy (Mirdametinib and Sirolimus) for RAS Mutated Relapsed Refractory Multiple Myeloma
- NCT05580770terminatedMirdametinib + BGB-3245 in Advanced Solid Tumors
All Mirdametinib trials (20)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06666348 | MIRV | Phase 1/2 Study of Mirdametinib + Vinblastine for Newly Diagnosed/Previously Untreated PLGG + Activation of MAPK | P1/P2 | recruiting | 50 | St. Justine's Hospital | Jan 2026 |
| NCT06876142 | Combination Therapy (Mirdametinib and Sirolimus) for RAS Mutated Relapsed Refractory Multiple Myeloma | P1/P2 | suspended | 54 | National Cancer Institute (NCI) | Jul 2026 | |
| NCT07521657 | NF118 | Efficacy of Mirdametinib Alone or Combination With Radiotherapy for Germline and Sporadic NF1-Altered High-Grade Glioma | P2 | not yet recruiting | 55 | University of Alabama at Birmingham | Aug 2026 |
| NCT04923126 | SJ901 | SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma | P1/P2 | recruiting | 132 | St. Jude Children's Research Hospital | Jun 2021 |
| NCT06153173 | Mirdametinib in Histiocytic Disorders | P2 | recruiting | 40 | Children's Hospital Medical Center, Cincinnati | Feb 2024 | |
| NCT07237100 | Mirdametinib in Patients With Advanced NF1-mutant Melanoma | P2 | recruiting | 10 | Kevin Kim, MD | Oct 2025 | |
| NCT07061951 | Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia | P2 | recruiting | 20 | National Cancer Institute (NCI) | May 2026 | |
| NCT07539441 | A Study of Mirdametinib in People With Central Nervous System Tumors | P1/P2 | recruiting | 26 | Memorial Sloan Kettering Cancer Center | Apr 2026 | |
| NCT05937906 | IMMUNOMEK | Clinical Trial Evaluating the Safety and Efficacy of Chemoimmunotherapy Plus Short Course of Mek Inhibitor in First Line of Treatment of Metastatic Non Squamous Non Small Cell Lung Adenocarcinoma With PDL1 < 50 %. | P1/P2 | recruiting | 24 | Centre Georges Francois Leclerc | Jul 2026 |
| NCT03962543 | ReNeu | MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas | P2 | active not recruiting | 114 | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | Sep 2019 |
| NCT06159166 | Mirda | Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF). | P1/P2 | recruiting | 24 | Johns Hopkins University | Feb 2024 |
| NCT06843967 | A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma | P1/P2 | recruiting | 54 | Memorial Sloan Kettering Cancer Center | Feb 2025 | |
| NCT05983159 | TARGET-VM | A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations | P2 | recruiting | 50 | Murdoch Childrens Research Institute | Sep 2024 |
| NCT06693284 | A Window of Opportunity Trial of Mirdametinib Plus Vorinostat for NF1 Associated, H3K27 Trimethylation Deficient Malignant Peripheral Nerve Sheath Tumor [MPNST] | Early P1 | recruiting | 8 | University of Minnesota | Nov 2025 | |
| NCT06997276 | Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib | P1 | recruiting | 32 | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | May 2025 | |
| NCT07279233 | To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants | P1 | completed | 36 | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | Dec 2025 | |
| NCT03905148 | Study of the Safety and Pharmacokinetics of BGB-283 (Lifirafenib) and PD-0325901 (Mirdametinib) in Participants With Advanced or Refractory Solid Tumors | P1 | completed | 91 | BeiGene | May 2019 | |
| NCT05580770 | Mirdametinib + BGB-3245 in Advanced Solid Tumors | P1/P2 | terminated | 23 | SpringWorks Therapeutics, Inc. | Feb 2023 | |
| NCT05054374 | A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer | P1/P2 | completed | 6 | Memorial Sloan Kettering Cancer Center | Sep 2021 | |
| NCT05028166 | Individual Patient Compassionate Use of Mirdametinib | — | available | 0 | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | — |
Mirdametinib clinical trials: frequently asked questions
- How many Mirdametinib clinical trials are there?
- 20 Mirdametinib clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 12 are actively recruiting participants. 3 are marked completed.
- Are Mirdametinib clinical trials recruiting in 2026?
- Yes — 12 Mirdametinib trials are actively recruiting in 2026, with 30 U.S. sites across 13 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Mirdametinib being studied for?
- Mirdametinib is being studied for Healthy, Advanced Unresectable Melanoma, Arteriovenous Malformation (AVM), Arteriovenous Malformations, Breast Cancer and 63 more. The trials are grouped by indication on this page.
- What phase is Mirdametinib in?
- Mirdametinib clinical trials span 6 Phase 2, 3 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Mirdametinib clinical trials?
- The lead sponsor across the most Mirdametinib trials is SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, with 13 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Mirdametinibas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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