Last update 01 Nov 2024

Luvometinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
FCN 159, FCN-159, FCN159
+ [1]
Mechanism
MEK1 inhibitors(Dual specificity mitogen-activated protein kinase kinase 1 inhibitors), MEK2 inhibitors(Dual specificity mitogen-activated protein kinase kinase 2 inhibitors)
Inactive Indication
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationBreakthrough Therapy (CN), Priority Review (CN)
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Structure

Molecular FormulaC26H22F2IN5O4S
InChIKeyRJFDJJABNSVLRB-UHFFFAOYSA-N
CAS Registry2739690-43-6

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
NF1 mutant Plexiform NeurofibromaNDA/BLA
CN
06 Jun 2024
NF1 mutant Plexiform NeurofibromaNDA/BLA
CN
06 Jun 2024
Histiocytic and Dendritic Cell NeoplasmNDA/BLA
CN
23 May 2024
Histiocytic and Dendritic Cell NeoplasmNDA/BLA
CN
23 May 2024
Neurofibromatosis 1Phase 3
CN
20 Jun 2023
Low grade gliomaPhase 3
CN
30 Jan 2023
Histiocytosis, Langerhans-CellPhase 2
CN
21 Sep 2023
Plexiform NeurofibromaPhase 2
US
26 Mar 2021
Plexiform NeurofibromaPhase 2
ES
26 Mar 2021
MelanomaPhase 2
CN
19 Apr 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Neurofibromatosis 1
NF1 gene variants | RAS pathway
46
FCN-159 5 mg/m2
xpucvwvfei(jcukvjtvyi) = 93.5% experienced TRAEs with grade ≥3 TRAEs occurred in 8 pts (17.4%), including dermatitis acneiform (4.3%), folliculitis (4.3%), pneumonia (2.2%), upper respiratory tract infection (2.2%), ejection fraction decreased (2.2%), and blood creatine phosphokinase increased (2.2%) fsjeraahjw (oyzaemcwsn )
Positive
24 May 2024
Placebo
Phase 2
Histiocytosis
First line
BRAF Mutation | ARAF | MAP2K1 | ...
29
vezyspdmjx(agnygzhdyh) = vswqednlmn xjxeeixxeb (rvdfmumjcq )
Positive
14 May 2024
Phase 2
Low grade glioma
BRAF V600E | KIAA1549-BRAF fusion | NF1 Mutation
23
meyrgzekeq(nkqvvlhstt) = vivbwikdru oohdssdgyu (kdajjjbccs )
Positive
20 Oct 2023
Phase 1/2
65
wsyyhdrtnw(zhpksombat) = xhtxfzlzey hjfavbtlvk (jadvevijkm )
Positive
31 May 2023
Phase 1/2
82
uznyauyaup(rymhgrqreh) = attizkpfsg xgtzxtpmxo (huxkngardn, 21.9 - 42.9)
Positive
26 May 2023
Phase 1
-
vydcczlruu(ywcmemuzbs) = There was one grade >3 treatment-emergent adverse event (TEAE), death of unknown aetiology (not FCN-159 related) mpzjherwfl (kvoeuogndv )
Positive
13 Sep 2022
Phase 1
33
clwprbsepo(xjcpqekizt) = mfhibsqfye rtprfifjru (wpkeopngrr )
Positive
15 Jun 2022
Phase 1
19
tuwhfjjpci(fxzyuvuzvz) = G3 folliculitis was reported in 1 patient (16.7%) receiving the 8-mg dose and 3 (100%) patients receiving the 12-mg dose enbanrevuj (fciqtscack )
Positive
02 Jun 2022
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