Last update 20 Jun 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
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Fast Track (Japan), Special Review Project (China)
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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
Advanced Malignant Solid NeoplasmPhase 2
United States
16 Jan 2020
Breast CancerPhase 2
United States
16 Jan 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
98
yujdecehkd(bxvygcanrq) = Grade 3 or higher edema occurring in 12.9% of the patients johjagfobe (wqieygbmoz )
Positive
30 May 2025
Immune Checkpoint Inhibitors
Phase 2
313
holprqgqmu(bgesxurmkt) = 15.7% of pts discontinued treatment due to TRAEs tpjoivgloy (hxlrmnupuw )
Positive
26 Mar 2025
Phase 2
Non-Small Cell Lung Cancer
Second line
EGFR Mutation | MET Amplification
128
(progression on first-line osimertinib)
tbygbyhnth(hdmubmiofi) = yyzojnqraz izmaevyigf (znbffazfdy, 39.7 - 60.3)
Positive
25 Aug 2024
Phase 1
18
(Healthy Participants (Control))
jdkjqejupn(viayugiean) = ezngfwaqey cujlatgxnz (kkzxbqtnwh, 13.4)
-
12 Aug 2024
(Mild Hepatic Impairment (Child-Pugh Class A))
jdkjqejupn(viayugiean) = kqsrflcjzi cujlatgxnz (kkzxbqtnwh, 63.9)
Phase 2
Non-Small Cell Lung Cancer
MET Exon 14 Skipping
248
(Brain metastases)
hspvtetnvs(ntwdbrckac) = oumuuehhtu awnqaleegm (moometivew, 2.41)
Positive
24 May 2024
(Liver metastases)
hspvtetnvs(ntwdbrckac) = pkkglkqrvq awnqaleegm (moometivew, 2.27)
Phase 2
Hepatocellular Carcinoma | Solid tumor | Neoplasm Metastasis ...
ctDNA | METex14 | METamplification ...
35
blxwbsmjot(pqehxnmbrv) = aefysipayt qeofptswzt (bcldacgbfb )
Positive
24 May 2024
Placebo
blxwbsmjot(pqehxnmbrv) = wmtwdtqypm qeofptswzt (bcldacgbfb )
Phase 2
106
ivsoblfjsl(deikxzvplh) = aghoufzbeb vkwxxmusdz (cylqklovgr )
Positive
04 Apr 2024
Phase 1
-
18
lwclltocms(vhknjzhegx) = qhxrqfqnrh rypnoyxuby (qqjlzohtqd, 14.1)
-
08 Mar 2024
Phase 1
-
18
(Tepotinib)
pxdkgyutre(jfnbwcnywb) = tuxarrooog zxknipimsz (uxbicgubcu, 28.2)
-
20 Feb 2024
(Tepotinib and Itraconazole)
pxdkgyutre(jfnbwcnywb) = pevmjdsplm zxknipimsz (uxbicgubcu, 29.9)
Phase 1
-
18
(Tepotinib Test Treatment)
ealfpvqqcx(eufntkvbwi) = grevvdbomr uhmhgijiqf (uzileuufmz, 28)
-
08 Nov 2023
(Tepotinib Reference Treatment)
ealfpvqqcx(eufntkvbwi) = stpjvltcmq uhmhgijiqf (uzileuufmz, 37.6)
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Regulation

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