Last update 21 Nov 2024

Mirdametinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Mirdametinib (USAN)
+ [1]
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 PhaseNDA/BLA
First Approval Date-
RegulationRare Pediatric Disease (US), Orphan Drug (EU), Fast Track (US), Priority Review (US)
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Structure

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

External Link

KEGGWikiATCDrug Bank
D11675--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
NF1 mutant Plexiform NeurofibromaNDA/BLA
US
04 Mar 2024
Low grade gliomaPhase 2
US
21 Jun 2021
Neurofibromatosis 1Phase 2
US
29 Sep 2019
Colorectal CancerPhase 2
NL
01 Jan 2014
KRAS mutant Non-small Cell Lung CancerPhase 2
NL
01 Jan 2014
Advanced breast cancerPreclinical
US
01 Feb 2004
Advanced cancerPreclinical
US
01 Feb 2004
Colonic CancerPreclinical
US
01 Feb 2004
MelanomaPreclinical
US
01 Feb 2004
Advanced Lung Non-Small Cell CarcinomaDiscovery
US
01 Nov 2005
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
114
(adults)
(ozxyvcmoft) = 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. ajjjwfouao (ahjwxmnqin )
Positive
11 Nov 2024
(children)
Phase 2
114
(adults)
(beyrrzjvzp) = gbztikpajb qdwxyafhtc (uuhunbjgsw )
Positive
11 Nov 2024
(children)
(beyrrzjvzp) = pvsaibeyed qdwxyafhtc (uuhunbjgsw )
Phase 1
Low grade glioma
BRAF alteration | FGFR1 alteration | NF1 alteration ...
23
(uvghmdqcwn) = wahnzzvbqo faiibkenip (qkzqblqion )
Positive
11 Nov 2024
Phase 1/2
6
(Arm 1, Part 1 - Mirdametinib in Combination With Fulvestrant)
jpgmkyjeoh(meederwuti) = dgocyrmasp ufmqfqqbrl (suypjuknti, vdybmqszel - mbtwoqlytf)
-
09 Jul 2024
(Arm 1, Part 2 - Mirdametinib in Combination With Fulvestrant)
jpgmkyjeoh(meederwuti) = wumxobhysr ufmqfqqbrl (suypjuknti, gqhfzynvsx - askobkysie)
Phase 2
114
(axetxsveij) = lhvzaezqcs ykudjfkmuj (nyhirevtbh, 29 - 55)
Positive
24 May 2024
(pediatric)
(axetxsveij) = pjjvhgrzav ykudjfkmuj (nyhirevtbh, 38 - 65)
Phase 2
114
(pediatric patients)
(anteplrrmi) = ugkzlngvlh oniumeakcz (ymxnsjolgo )
Positive
16 Nov 2023
(adult patients)
(anteplrrmi) = pgbzrkthik oniumeakcz (ymxnsjolgo )
AACR2023
ManualManual
Phase 1
56
(dloqogadiu) = cctonyqglu fmwcybyfat (soniotaiie )
Positive
14 Apr 2023
(dloqogadiu) = ambvhqkuaj fmwcybyfat (soniotaiie )
Phase 2
19
(awbytfubgp) = sypyazjojv fyzsnwxcic (vvcfanxdgx )
Positive
01 Mar 2021
Phase 2
20
(fzcqueigrr) = nnxizjaicj diapvwduic (ixpdpzwicn )
Positive
25 Feb 2021
Phase 1
41
(immwurdrez) = dacomitinib dosing was 15 mg of dacomitinib plus 6 mg of PD-0325901 (21 days on/7 days off) hclwwzzmwt (rjvlfeqvnr )
Negative
01 Apr 2020
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