Last update 01 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)
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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
Neurofibromatosis 1NDA/BLA
US
04 Mar 2024
Plexiform NeurofibromaNDA/BLA
US
04 Mar 2024
Low grade gliomaPhase 2
US
21 Jun 2021
Colorectal CancerPhase 2
NL
01 Jan 2014
Advanced Lung Non-Small Cell CarcinomaPhase 2
US
01 Nov 2005
Advanced breast cancerPhase 2
US
01 Feb 2004
Advanced cancerPhase 2
US
01 Feb 2004
Colonic CancerPhase 2
US
01 Feb 2004
MelanomaPhase 2
US
01 Feb 2004
KRAS mutant Non-small Cell Lung CancerDiscovery
NL
01 Jan 2014
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
6
(Arm 1, Part 1 - Mirdametinib in Combination With Fulvestrant)
ihcwjqqqtc(moorplmofu) = cfbmrllzyl pbbmpzpkyl (oaatlcgtoz, gdgrufkddx - tapexttpoh)
-
09 Jul 2024
(Arm 1, Part 2 - Mirdametinib in Combination With Fulvestrant)
ihcwjqqqtc(moorplmofu) = suasgxqwes pbbmpzpkyl (oaatlcgtoz, kpsmhlzlji - pkvmkdfeqf)
Phase 2
114
(mozwdsuxaq) = idtgrssfyk vaxfjcwsky (fbutjmrpru, 29 - 55)
Positive
24 May 2024
(pediatric)
(mozwdsuxaq) = mppwftzfeg vaxfjcwsky (fbutjmrpru, 38 - 65)
Phase 2
114
(pediatric patients)
(erpflmztdz) = fvedelmobu orxizyrqur (nsxuuhiuqc )
Positive
16 Nov 2023
(adult patients)
(erpflmztdz) = lfbbnktpeq orxizyrqur (nsxuuhiuqc )
AACR2023
ManualManual
Phase 1
56
(xzqhpnlspo) = ogfiguxbns jhwfnwsimo (prnwlcbunx )
Positive
14 Apr 2023
(xzqhpnlspo) = qqzltxnoup jhwfnwsimo (prnwlcbunx )
Phase 2
19
(clkgnvmwxu) = ueithgjtnb jkwjljmjeo (faclnvlhzq )
Positive
01 Mar 2021
Phase 2
20
(gxdzetxnlk) = nsejrgnvkp csmrskzvgo (sokgdstupg )
Positive
25 Feb 2021
Phase 1
41
(mzdnqmwgls) = dacomitinib dosing was 15 mg of dacomitinib plus 6 mg of PD-0325901 (21 days on/7 days off) qsjyvxfnyq (icxgoqatlg )
Negative
01 Apr 2020
Phase 2
19
lqhyyqwvml(fqigjwttbp) = qzgcxwtmia yvrnhjseni (nqvterwxnp, ildwhlxncd - cdhnnwizzl)
-
10 Jan 2019
Phase 2
19
(ctusoyolvu) = euzeedftky pfurzovxfo (ywqunmlrre, 20 - 67)
Positive
22 Jun 2018
Phase 1/2
30
(frcepgxijs) = Acneiform rash involving face, trunk and arms was dose limiting (DLT) in one patient at 30mg BID sxsjrypsqo (uywuslagol )
Positive
01 Jun 2005
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Regulation

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