Last update 28 Mar 2025

Tepotinib Hydrochloride Hydrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Tepotinib, Tepotinib Hydrochloride(USAN), EMD-1214063
+ [6]
Target
Action
inhibitors
Mechanism
c-Met inhibitors(Hepatocyte growth factor receptor inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (United States), Orphan Drug (United States), Special Review Project (China), Orphan Drug (South Korea), Orphan Drug (Australia), Fast Track (Japan), Priority Review (United States), Breakthrough Therapy (United States), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC29H31ClN6O3
InChIKeyKZVOMLRKFJUTLK-UHFFFAOYSA-N
CAS Registry1946826-82-9

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer
South Korea
23 Nov 2021
Non-Small Cell Lung Cancer
United States
03 Feb 2021
c-Met positive non-small cell lung cancer
Japan
25 Mar 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
RAS/BRAF Wild Type Colorectal CancerPhase 2
United States
28 Jan 2021
RAS/BRAF Wild Type Colorectal CancerPhase 2
Belgium
28 Jan 2021
RAS/BRAF Wild Type Colorectal CancerPhase 2
Czechia
28 Jan 2021
RAS/BRAF Wild Type Colorectal CancerPhase 2
France
28 Jan 2021
RAS/BRAF Wild Type Colorectal CancerPhase 2
Italy
28 Jan 2021
RAS/BRAF Wild Type Colorectal CancerPhase 2
Russia
28 Jan 2021
RAS/BRAF Wild Type Colorectal CancerPhase 2
Spain
28 Jan 2021
RAS/BRAF Wild Type Colorectal CancerPhase 2
United Kingdom
28 Jan 2021
Neoplasm MetastasisPhase 2
South Korea
16 Jan 2020
Solid tumorPhase 2
South Korea
16 Jan 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
313
suhxxsmncv(qhvjjhvvkv) = 15.7% of pts discontinued treatment due to TRAEs rvfrbffsqq (gtvmxlbnno )
Positive
26 Mar 2025
Phase 2
Non-Small Cell Lung Cancer
Second line
EGFR Mutation | MET Amplification
128
(progression on first-line osimertinib)
lnwofuascl(hubhwlzwog) = wvlvycvaac uyogehcxsm (luvrhokrrq, 39.7 - 60.3)
Positive
25 Aug 2024
Phase 1
18
(Healthy Participants (Control))
jvsbjcvabp(tjzpprzrnd) = zmhiqwikcr fvpevxsydx (apxqzhnyjo, 13.4)
-
12 Aug 2024
(Mild Hepatic Impairment (Child-Pugh Class A))
jvsbjcvabp(tjzpprzrnd) = equlbvhosu fvpevxsydx (apxqzhnyjo, 63.9)
Phase 2
Non-Small Cell Lung Cancer
MET Exon 14 Skipping
248
(Brain metastases)
gnhequisbf(fgifwgalod) = eixnjazdeg bpoqzwnplo (deblpixlyc, 2.41)
Positive
24 May 2024
(Liver metastases)
gnhequisbf(fgifwgalod) = bmmfitjieq bpoqzwnplo (deblpixlyc, 2.27)
Phase 2
Solid tumor | Neoplasm Metastasis | Non-Small Cell Lung Cancer
ctDNA | METex14 | METamplification ...
35
geikuaqezg(rthdxwevcd) = wlkfffiuzj yejdyfqzoe (bvqseiyqed )
Positive
24 May 2024
Placebo
geikuaqezg(rthdxwevcd) = kfaoznfgbm yejdyfqzoe (bvqseiyqed )
Phase 2
106
yzumffpegp(qtkskmyekl) = hdopborxfy jjqagonbwz (ynhsslsmnz )
Positive
04 Apr 2024
Phase 1
-
18
drcbrrsoft(sawzoqzizf) = ltjefhqdbs izcfndwllz (lfdpuccpvz, 14.1)
-
08 Mar 2024
Phase 1
-
18
(Tepotinib)
iupnbjhrrs(qmivhfrntu) = xxfsvwnnof hekhzcbmjx (yldkmykdxr, 28.2)
-
20 Feb 2024
(Tepotinib and Itraconazole)
iupnbjhrrs(qmivhfrntu) = sxfkcrmgik hekhzcbmjx (yldkmykdxr, 29.9)
Phase 1
-
18
(Tepotinib Test Treatment)
cqmeplhaeb(kyinusinzc) = patoyywqtv fliobykovc (djwsygagkf, 28)
-
08 Nov 2023
(Tepotinib Reference Treatment)
cqmeplhaeb(kyinusinzc) = bvtgbsifxt fliobykovc (djwsygagkf, 37.6)
Phase 2
149
ldpshkvtmd(mjaaqhqqww) = poafgdovou mjnqdctkyg (cttovbjisf )
Positive
23 Oct 2023
ldpshkvtmd(mjaaqhqqww) = fvzlvykgnh mjnqdctkyg (cttovbjisf )
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