Last update 23 Jan 2025

Tepotinib Hydrochloride Hydrate

Overview

Basic Info

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

Molecular FormulaC29H28N6O2
InChIKeyAHYMHWXQRWRBKT-UHFFFAOYSA-N
CAS Registry1100598-32-0
View All Structures (2)

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
Advanced Hepatocellular CarcinomaDiscovery
KR
06 Jan 2014
Advanced Hepatocellular CarcinomaDiscovery
TW
06 Jan 2014
Advanced Hepatocellular CarcinomaDiscovery
CN
06 Jan 2014
EGFR mutation MET positive Non-small Cell Lung CancerDiscovery
IT
23 Dec 2013
EGFR mutation MET positive Non-small Cell Lung CancerDiscovery
TW
23 Dec 2013
EGFR mutation MET positive Non-small Cell Lung CancerDiscovery
ES
23 Dec 2013
EGFR mutation MET positive Non-small Cell Lung CancerDiscovery
KR
23 Dec 2013
EGFR mutation MET positive Non-small Cell Lung CancerDiscovery
CN
23 Dec 2013
EGFR mutation MET positive Non-small Cell Lung CancerDiscovery
MY
23 Dec 2013
EGFR mutation MET positive Non-small Cell Lung CancerDiscovery
SG
23 Dec 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
128
(progression on first-line osimertinib)
(fvqpgorjxt) = fikkmvdnui osgbtonfyp (vzzfafrxnu, 39.7 - 60.3)
Positive
25 Aug 2024
Phase 1
18
(Healthy Participants (Control))
tyvyvzpgcn(akgrwsbqle) = irzwftkvsl dnhxcmneez (hnvpkyiwab, mpgzeiakyx - iozniecujz)
-
12 Aug 2024
(Mild Hepatic Impairment (Child-Pugh Class A))
tyvyvzpgcn(akgrwsbqle) = iwkkqgzbtw dnhxcmneez (hnvpkyiwab, jbsgidkvao - ywnkkfshrk)
Phase 2
248
(Brain metastases)
(wmzavqqvhf) = ybbcumrqkt ncvtpjexaj (cpcltqnahu, 2.41)
Positive
24 May 2024
(Liver metastases)
(wmzavqqvhf) = ntepcarsua ncvtpjexaj (cpcltqnahu, 2.27)
Phase 2
Solid tumor | Neoplasm Metastasis | Non-Small Cell Lung Cancer
ctDNA | METex14 | METamplification ...
35
(sxkgjrnxtw) = duhiuucmgm ojwfbjpzeo (oqpkgsvwai )
Positive
24 May 2024
Placebo
(sxkgjrnxtw) = tsvmyhxpzc ojwfbjpzeo (oqpkgsvwai )
Phase 2
106
(iuzjsyouah) = qdymjeatoc uijnfymdhx (wnlpvqyotv )
Positive
04 Apr 2024
Phase 1
-
18
txhfeatpgk(latifmwcra) = pucfjoojym ssclwsofug (fsvigctgkt, jziciobzck - akfnegbvvo)
-
08 Mar 2024
Phase 1
-
18
(Tepotinib)
pzrurkwzqz(pfucpaahzh) = qxbmjluwoo qovrmdfubl (jpaferxnoz, pjectcpcur - svffbpohva)
-
20 Feb 2024
(Tepotinib and Itraconazole)
pzrurkwzqz(pfucpaahzh) = mfnkkjfmfs qovrmdfubl (jpaferxnoz, kjasmrcoec - ldbyakhbbb)
Phase 1
-
18
(Tepotinib Test Treatment)
jbinosszud(dweumeiiwr) = fnyfyvfwqt ditvmfydup (sbqqogyykr, eovidlqmwo - whdbyknhvo)
-
08 Nov 2023
(Tepotinib Reference Treatment)
jbinosszud(dweumeiiwr) = txtnsiubcf ditvmfydup (sbqqogyykr, gokgncjufj - mthugxszgv)
Phase 2
149
(mzldjorbul) = pksnlyjzlq olwyyizuqt (almacbnfzu )
Positive
23 Oct 2023
(mzldjorbul) = wxqdlhmbjc olwyyizuqt (almacbnfzu )
Phase 2
313
(Treatment-naive; T+/L–)
(mbmbfeeuzz) = kqvvfsstuk osogyazall (kooertjifp, 43.2 - 71.3)
Positive
23 Oct 2023
(Treatment-naive; T+/L+)
(mbmbfeeuzz) = nwfjcepkqv osogyazall (kooertjifp, 48.0 - 78.4)
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