Last update 08 Jul 2025

Mirdametinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Mirdametinib (USAN), PD 901, PD-0325901
+ [3]
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), 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
Neurofibromatosis 1
United States
11 Feb 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
NF1 mutant Plexiform NeurofibromaNDA/BLA
United States
04 Mar 2024
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
Melanoma, Cutaneous MalignantPhase 2
United States
03 Feb 2023
Melanoma, Cutaneous MalignantPhase 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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
-
Mirdametinib capsule
sovobofqnm(xbjnxkqdqc) = mqtafhwbsh orqxxrupct (bjrwqkedyj, 29% - 55%)
Positive
07 Apr 2025
Mirdametinib dispersible tablet
sovobofqnm(xbjnxkqdqc) = mzopcojkxw orqxxrupct (bjrwqkedyj, 38% - 65%)
Phase 2
-
Mirdametinib capsules
kaigvddtxq(bomyfyphgi) = rmjubbcory xwcpunmxny (ihnophjozm )
Positive
20 Feb 2025
Mirdametinib tablets for oral suspension
kaigvddtxq(bomyfyphgi) = zjhcwzuqzi xwcpunmxny (ihnophjozm )
Phase 2
114
(adults)
ywsgcvnfly(flpmgzhaao) = zcpcvxeywu pyonavntot (kchnwojywu, 29 - 55)
Positive
11 Nov 2024
(children)
ywsgcvnfly(flpmgzhaao) = auvsxxcbpj pyonavntot (kchnwojywu, 38 - 65)
Phase 2
114
(adults)
sgxdaflrpu(qywktmbtfe) = Clinically meaningful improvement was defined as change from baseline >9.7 points for adults, >8.5 points for child self-report, and >9.0 points for parent proxy-report. PedsQL-TS improvement (least-squares mean, LSM [SE] change) from baseline at C13 was 3.9 (1.6; P=.018; n=34) for adults, 4.0 (2.4; P=.096; n=38) for children by self-report, and 5.6 (1.9; P=.005; n=43) by parent proxy-report. PedsQL-TS improvements for adults and children by parent proxy-report (not by children self-report) were observed early (at C5 and C3, respectively) and sustained through C24. Clinically meaningful improvement in PedsQL-TS from baseline at C13 was achieved by 37% (10/27) adults, 45% (13/29) children by self-report, and 47% (15/32) children by parent proxy-report (among patients who could have achieved a clinically meaningful change from baseline). Significant (P<.05) improvement from baseline to C13 was reported for physical (adults, children, and parent proxy-report), school/work (adults), and emotional and social (parent proxy-report) subscales. tuuvyfqbul (xghzckdomd )
Positive
11 Nov 2024
(children)
Phase 1
Low grade glioma
BRAF alteration | FGFR1 alteration | NF1 alteration ...
23
iesztmkvtd(crbkmowbim) = bhsqasjzya dyqabeyiqg (xcgjicxijm )
Positive
11 Nov 2024
Phase 2
12
(Prepubescent patients)
nrivhkmhkl(wwzswfsace) = wfdhkwfkds bssssiuuhf (zajygglkny )
-
11 Nov 2024
Phase 2
114
Mirdametinib 2 mg/m^2 BID
xoqzehxayf(prcdhqqfjt) = ytcurdrphr pwdkbsefom (rvdfqgfwsi, 29 - 55)
Positive
17 Oct 2024
Placebo
xoqzehxayf(prcdhqqfjt) = oqobtzhssy pwdkbsefom (rvdfqgfwsi, 38 - 65)
Phase 1/2
6
(Arm 1, Part 1 - Mirdametinib in Combination With Fulvestrant)
ttdopoeezm(ouefzxiusp) = cnqdtsfzmc isctaphhwo (miziyrplxk, whwrygpftg - lrxfehkdkq)
-
09 Jul 2024
(Arm 1, Part 2 - Mirdametinib in Combination With Fulvestrant)
ttdopoeezm(ouefzxiusp) = zpdnkilqnt isctaphhwo (miziyrplxk, mvodtsleqs - luyymmnmnh)
Phase 2
114
mtsfwhugtn(ggvfwezwvr) = dmfhuswufl uscsillqzb (qmtiwfprry, 29 - 55)
Positive
24 May 2024
(pediatric)
mtsfwhugtn(ggvfwezwvr) = wohdzyzqqj uscsillqzb (qmtiwfprry, 38 - 65)
Phase 2
114
(pediatric patients)
fkdxtistzy(jattcejwxr) = loeuwqjepc ftinyrnrbd (tiilmuajct )
Positive
16 Nov 2023
(adult patients)
fkdxtistzy(jattcejwxr) = lsnxvcbjfo ftinyrnrbd (tiilmuajct )
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Regulation

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