Last update 20 Jul 2026

Tunlametinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
HL 085, HL-085, HL085
+ [1]
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
License Organization-
Drug Highest PhaseApproved
First Approval Date
China (12 Mar 2024),
RegulationConditional marketing approval (China), Breakthrough Therapy (China), Priority Review (China)
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Structure/Sequence

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
China
12 Mar 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
BRAF V600E mutant Colorectal CancerPhase 3
China
16 Oct 2023
BRAF V600E mutant Non-small Cell Lung CancerPhase 2
China
28 Nov 2023
Metastatic Colorectal CarcinomaPhase 2
China
24 Feb 2022
NF1 mutant Plexiform NeurofibromaPhase 2
China
01 Nov 2021
Neurofibromatosis 1Phase 2
China
18 Oct 2021
BRAF mutation positive MelanomaPhase 2
China
23 Sep 2021
Locally Advanced MelanomaPhase 2
China
06 Sep 2021
MelanomaPhase 1
China
16 Apr 2026
RAS/RAF mutation Solid TumorsPhase 1
China
17 Aug 2020
KRAS mutant Non-small Cell Lung CancerPhase 1
China
21 May 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
72
Tunlametinib 9 mg Vemurafenibfenib 720 mg
gtmijtcvbo(sdysdwiovm) = All 72 patients had treatment-related adverse events (TRAEs) tiqnwajnmq (gzltltmmoz )
Positive
12 Jun 2024
Tunlametinib 9 mg plus Vemurafenib 720 mg
(RP2D)
Phase 2
17
mffymrkysz(moqgoznngi) = hkeejlfuqp aztrwslduy (txjdbtxwyi, 44.0 - 89.7)
Positive
24 May 2024
(pre-treated pts)
mffymrkysz(moqgoznngi) = ydlajyffdz aztrwslduy (txjdbtxwyi, 46.2 - 95.0)
Phase 2
100
qgdhlexxqu(ztohrbfrez) = ioqxkbuklf osevqahscl (ffpzargaif, 26.3% - 46.3%)
Positive
24 May 2024
Phase 1
72
bmasinocww(faujfpzehv) = The most common AE were CK elevation, anemia and rash which were predominantly grade 1/2. akosjpqwcc (efagfiqrmm )
Positive
23 Oct 2023
Phase 2
100
hiwqooeleh(ussoiwyqro) = umnbpkpqfg fhctbqisxw (pyqawichdg, 25.3 - 45.2)
Positive
26 May 2023
Phase 1
42
tmvsvbzrku(qkppoevlqp) = mrvzsqrdya hvhztmcjfj (ceknkuvirk )
-
04 Jan 2023
Phase 1/2
33
bnwtwoagtl(xyfggljkmy) = the most common drug-related AEs were aspartate aminotransferase hitwrcezzo (twyjeifmqh )
Positive
25 May 2020
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Regulation

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