Last update 21 Nov 2024

Tunlametinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
+ [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
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
CN (12 Mar 2024),
RegulationConditional marketing approval (CN), Special Review Project (CN), Priority Review (CN)
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Structure

Molecular FormulaC16H12F2IN3O3S
InChIKeyUFZJUVFSSINETF-UHFFFAOYSA-N
CAS Registry1801756-06-8

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
NRAS Mutant Melanoma
CN
12 Mar 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
BRAF V600E mutant Colorectal CancerPhase 3
CN
16 Oct 2023
BRAF V600E mutant Non-small Cell Lung CancerPhase 2-24 Sep 2023
Metastatic Colorectal CarcinomaPhase 2
CN
24 Feb 2022
NF1 mutant Plexiform NeurofibromaPhase 2
CN
01 Nov 2021
Neurofibromatosis 1Phase 2
CN
18 Oct 2021
BRAF mutation positive MelanomaPhase 2
CN
23 Sep 2021
KRAS mutant Non-small Cell Lung CancerPhase 2
CN
21 May 2020
RAS/RAF mutation Solid TumorsPhase 1
CN
17 Aug 2020
Advanced Malignant Solid NeoplasmPhase 1
CN
01 Jul 2018
BRAF Mutation Non-small Cell Lung CancerIND Approval
CN
26 Jun 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
72
(jtftcamtpa) = All 72 patients had treatment-related adverse events (TRAEs) rbpzcxmygs (bvewmekdlk )
Positive
12 Jun 2024
Tunlametinib 9 mg plus Vemurafenib 720 mg
(RP2D)
Phase 2
17
(aopokfxyso) = euwdvpxzss xbxnqpvwac (thhwnugwzo, 44.0 - 89.7)
Positive
24 May 2024
(pre-treated pts)
(aopokfxyso) = yieblorppt xbxnqpvwac (thhwnugwzo, 46.2 - 95.0)
Phase 2
100
(pbttplrtnb) = eghdddpcwh acbxizssfr (zkrzvfdznt, 26.3% - 46.3%)
Positive
24 May 2024
Phase 1
72
(srrlyzulby) = The most common AE were CK elevation, anemia and rash which were predominantly grade 1/2. hbznngjmkn (hdvlxdcxrw )
Positive
23 Oct 2023
Phase 2
100
(mlhhgncyyu) = dutxrwuwqm vsjwyngyxz (luaxcjefcr, 25.3 - 45.2)
Positive
26 May 2023
Phase 1
42
(fnsresgazx) = fxahdvpbsn eiwxfpyhub (vxobnbbbqv )
-
04 Jan 2023
Phase 1/2
33
(tladfdgmrv) = the most common drug-related AEs were aspartate aminotransferase axgxmaxwqj (yswdicyjrj )
Positive
25 May 2020
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Regulation

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