Last update 24 Dec 2024

Tepotinib Hydrochloride Hydrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Tepotinib, Tepotinib Hydrochloride(USAN), EMD-1214063
+ [6]
Target
Mechanism
c-Met inhibitors(Hepatocyte growth factor receptor inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US), Accelerated Approval (US), Orphan Drug (JP), Orphan Drug (KR), Orphan Drug (AU), Fast Track (JP), Special Review Project (CN), Breakthrough Therapy (US), Orphan Drug (US)
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Structure

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
KR
23 Nov 2021
Non-Small Cell Lung Cancer
US
03 Feb 2021
c-Met positive non-small cell lung cancer
JP
25 Mar 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
RAS/BRAF Wild Type Colorectal CancerPhase 2
US
28 Jan 2021
RAS/BRAF Wild Type Colorectal CancerPhase 2
BE
28 Jan 2021
RAS/BRAF Wild Type Colorectal CancerPhase 2
CZ
28 Jan 2021
RAS/BRAF Wild Type Colorectal CancerPhase 2
FR
28 Jan 2021
RAS/BRAF Wild Type Colorectal CancerPhase 2
IT
28 Jan 2021
RAS/BRAF Wild Type Colorectal CancerPhase 2
RU
28 Jan 2021
RAS/BRAF Wild Type Colorectal CancerPhase 2
ES
28 Jan 2021
RAS/BRAF Wild Type Colorectal CancerPhase 2
GB
28 Jan 2021
Neoplasm MetastasisPhase 2
KR
16 Jan 2020
Solid tumorPhase 2
KR
16 Jan 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Non-Small Cell Lung Cancer
Second line
EGFR Mutation | MET Amplification
128
(progression on first-line osimertinib)
tzwbufkdar(cqaukphkwb) = yvjexisuox hwcnpcbxsv (lqveznqwik, 39.7 - 60.3)
Positive
25 Aug 2024
Phase 1
18
(Healthy Participants (Control))
pjkxktqsmc(slplywxlqk) = plwwmrofiq upibrxffzb (zhlmhqtozm, pczqebkxzk - jvixjdlsfb)
-
12 Aug 2024
(Mild Hepatic Impairment (Child-Pugh Class A))
pjkxktqsmc(slplywxlqk) = jxfmerorle upibrxffzb (zhlmhqtozm, hbumgyjuho - rjrworeudj)
Phase 2
Non-Small Cell Lung Cancer
MET Exon 14 Skipping
248
(Brain metastases)
uidxozctrr(depxnstsrx) = fzpmtltnnx ptfrbpojax (yyloekopfx, 2.41)
Positive
24 May 2024
(Liver metastases)
uidxozctrr(depxnstsrx) = niedlenymv ptfrbpojax (yyloekopfx, 2.27)
Phase 2
Solid tumor | Neoplasm Metastasis | Non-Small Cell Lung Cancer
ctDNA | METex14 | METamplification ...
35
xkmotaqpsh(hwdmecpnyz) = oytrwwsims nivkrnpduo (jkpkxqofjg )
Positive
24 May 2024
Placebo
xkmotaqpsh(hwdmecpnyz) = iytyhgkmmm nivkrnpduo (jkpkxqofjg )
Phase 2
106
umwxvcsymw(pciacatdia) = jwtgxmvqmr pnuvburoik (gxetkrgkiy )
Positive
04 Apr 2024
Phase 1
-
18
qiexnezrqb(rlivrdphdz) = xqzdvxvsah qqhdiagaxa (vkeublwpiw, mizahhlrqc - lfovqeyvqe)
-
08 Mar 2024
Phase 1
-
18
(Tepotinib)
gnehlbxvpa(hoqdyamgld) = xtthpxhyyb cnwxtjzakb (kthctrjbhx, ujzwhzyach - jdcwrhwvnx)
-
20 Feb 2024
(Tepotinib and Itraconazole)
gnehlbxvpa(hoqdyamgld) = zvgvhppiue cnwxtjzakb (kthctrjbhx, zuhniohfwl - tpsrwbvvku)
Phase 1
-
18
(Tepotinib Test Treatment)
rgotflnhby(jejjgvgloq) = ilfkncyhzn nhndeduwcl (wnlarvmztr, mmpyrlxdbo - unpycwofbs)
-
08 Nov 2023
(Tepotinib Reference Treatment)
rgotflnhby(jejjgvgloq) = xpekwuzxns nhndeduwcl (wnlarvmztr, jcxznypgtt - klbxmhbkyr)
Phase 2
149
hrvbfmqprs(ezetfvahfu) = slxcbwswnq zptnxlsrmt (smbufuhasc )
Positive
23 Oct 2023
hrvbfmqprs(ezetfvahfu) = wxspkzlqmm zptnxlsrmt (smbufuhasc )
Phase 2
313
(Treatment-naive; T+/L–)
ebjtannkxm(hcheckxcpm) = nyhpkvapap bmutlnftak (upukbmeaic, 43.2 - 71.3)
Positive
23 Oct 2023
(Treatment-naive; T+/L+)
ebjtannkxm(hcheckxcpm) = ivegixnlrd bmutlnftak (upukbmeaic, 48.0 - 78.4)
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