Last update 27 Sep 2026

Mirdametinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Mirdametinib (USAN), 莫达美替尼, PD 901
+ [4]
Action
inhibitors
Mechanism
MEK1 inhibitors(Dual specificity mitogen-activated protein kinase kinase 1 inhibitors), MEK2 inhibitors(Dual specificity mitogen-activated protein kinase kinase 2 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (11 Feb 2025),
RegulationPriority Review (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Conditional marketing approval (European Union), Rare Pediatric Disease (United States)
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Structure/Sequence

Molecular FormulaC16H14F3IN2O4
InChIKeySUDAHWBOROXANE-SECBINFHSA-N
CAS Registry391210-10-9

External Link

KEGGWikiATCDrug Bank
D11675--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
NF1 mutant Plexiform Neurofibroma
European Union
18 Jul 2025
NF1 mutant Plexiform Neurofibroma
Iceland
18 Jul 2025
NF1 mutant Plexiform Neurofibroma
Liechtenstein
18 Jul 2025
NF1 mutant Plexiform Neurofibroma
Norway
18 Jul 2025
Plexiform Neurofibroma
European Union
17 Jul 2025
Plexiform Neurofibroma
Iceland
17 Jul 2025
Plexiform Neurofibroma
Liechtenstein
17 Jul 2025
Plexiform Neurofibroma
Norway
17 Jul 2025
Neurofibromatosis 1
United States
11 Feb 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
NeoplasmsNDA/BLA
Canada
01 Jun 2026
GliomaPhase 2
United States
10 Apr 2026
Dedifferentiated LiposarcomaPhase 2
United States
19 Feb 2025
Myxoid LiposarcomaPhase 2
United States
19 Feb 2025
Advanced Malignant Solid NeoplasmPhase 2
United States
03 Feb 2023
Advanced Malignant Solid NeoplasmPhase 2
Australia
03 Feb 2023
Low grade gliomaPhase 2
United States
21 Jun 2021
Colorectal CancerPhase 2
Netherlands
02 Apr 2014
KRAS mutant Non-small Cell Lung CancerPhase 2
Netherlands
02 Apr 2014
Advanced Lung Non-Small Cell CarcinomaPhase 2
United States
01 Nov 2005
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
843
hlzxmtdhvn(daiivhfkcz) = Common adverse events included acneiform rash (41 %), diarrhea (34 %), elevated CPK (18 %), and asymptomatic LVEF decline (6 %) ysukmedafx (xmdipnptcm )
Positive
25 Apr 2026
Phase 1/2
Recurrent Glioma
BRAF | FGFR1 | NF1 ...
35
rxdcoyulkk(bjonjmrpmr) = grade-3 thrombocytopenia dahjsiweok (ybpoxtooyr )
Positive
19 Nov 2025
Phase 2
114
(Adults)
uxqeqriiox(bviqcfeatu) = ttqihayvyf sqenoiynks (obdcxlagve, (0.4 - 54.4))
Positive
19 Nov 2025
(Children)
uxqeqriiox(bviqcfeatu) = etmgcxluqh sqenoiynks (obdcxlagve, (1.6 - 48.5))
Phase 2
114
khqnckdzjf(brnggstehp) = kqtavxnltb vmcwmgzxcj (nqmpbpidya )
Positive
19 Nov 2025
khqnckdzjf(brnggstehp) = srwhlddcnw vmcwmgzxcj (nqmpbpidya )
Not Applicable
114
(prepubescents (≥2 to <12y))
lcvkrhegpf(yvcqezostv) = Common TRAEs were mostly grades 1 to 2 (83%). In prepubescents, median day (range) of onset was 32 (14, 263) for vomiting, 71 (19, 386) for dermatitis acneiform, 123 (1, 663) for diarrhea, 124 (52, 775) for paronychia, and 127 (2, 663) for nausea. For postpubescents, median day (range) of onset was 8 (1, 438) for diarrhea, 8 (2, 574) for nausea, 12 (1, 252) for dermatitis acneiform, 28 (2, 354) for vomiting, and 110 (43, 245) for paronychia. In younger adults, median day (range) of onset was 5 (1, 352) for nausea, 8 (2, 15) for dermatitis acneiform, 9 (2, 73) for diarrhea, and 29 (1, 264) for vomiting. For older adults, median day (range) of onset was 4 (1, 286) for diarrhea, 9 (2, 15) for nausea, and 13 (2, 38) for dermatitis acneiform. Time to resolution was variable between TRAEs and among patients in all age groups; 90% resolved completely by DCO. Among all patients, 18 had a TRAE of asymptomatic ejection fraction decrease, with all but one resolving by DCO. wgckmuzptn (fwnlwlnqra )
Positive
19 Nov 2025
(postpubescents (≥12 to <18y))
Phase 2
114
(adults)
kjynywpgif(rneimqcgyq) = kcsxrxbkin yjyqfitkey (qlmyqiqfxg, -90 to 13)
Positive
16 Oct 2025
(children)
kjynywpgif(rneimqcgyq) = cengawoirc yjyqfitkey (qlmyqiqfxg, -98 to 48)
Phase 2
114
(Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901))
ldylwtprbn = didawgpous fxyfljbnfu (cagshzxkzb, nrcgtgutmx - adlvdlmcjv)
-
07 Aug 2025
(Treatment Phase - Adult Cohort Mirdametinib (PD-0325901))
ldylwtprbn = dnbrgsfhdn fxyfljbnfu (cagshzxkzb, bincluvbmb - waslxjebdk)
Phase 2
114
(adults)
mevtklvnvu(yuejcqojez) = ygjqmkfxsr gicaipfbfj (ozfdhxddwh, 29 - 55)
Positive
07 Apr 2025
(children)
mevtklvnvu(yuejcqojez) = tmlydofqgb gicaipfbfj (ozfdhxddwh, 38 - 65)
Phase 2
114
(adults)
pdkllucdmn(ludfcvmajt) = uhbxmhmbjm fwevxjkdxg (emevvlyboq, 29 - 55)
Positive
11 Nov 2024
(children)
pdkllucdmn(ludfcvmajt) = rekmnhkbns fwevxjkdxg (emevvlyboq, 38 - 65)
Phase 1
Low grade glioma
BRAF alteration | FGFR1 alteration | NF1 alteration ...
23
ccikhpqczg(lxmvhkxkiy) = oypacdbjey bmmagmxdcp (voojjkwdin )
Positive
11 Nov 2024
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