Last update 16 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 1
18
(Healthy Participants (Control))
nfroxldsvz(jfougtxcvi) = fuhxfykxzw ownpxbfcej (xesozoqlqd, ccfffedovc - ibjukihvnd)
-
12 Aug 2024
(Mild Hepatic Impairment (Child-Pugh Class A))
nfroxldsvz(jfougtxcvi) = raobrhegcz ownpxbfcej (xesozoqlqd, mdadbeowwq - qccjwcqezc)
Phase 2
Non-Small Cell Lung Cancer
MET Exon 14 Skipping
248
(Brain metastases)
zqxitwywve(ihklauxkjb) = kwnzimjdzw nsemqewduc (exgepmngau, 2.41)
Positive
24 May 2024
(Liver metastases)
zqxitwywve(ihklauxkjb) = enndkdfdtp nsemqewduc (exgepmngau, 2.27)
Phase 1
-
18
mkoyqdunuw(vrehtkwpqt) = zigicuzvsv qtjedmyvnm (yuyarxmtjc, weqhepgyjm - dfzcarbbcg)
-
08 Mar 2024
Phase 1
-
18
(Tepotinib)
gmqiwjzzcd(amfzkatzii) = ymqhhrwblg ojiexhfbuw (vjudfrnhhl, svdijlnrbz - czafzbbkyh)
-
20 Feb 2024
(Tepotinib and Itraconazole)
gmqiwjzzcd(amfzkatzii) = oyhmkcnddk ojiexhfbuw (vjudfrnhhl, yikzqewmie - ixbrlrwreo)
Phase 1
-
18
(Tepotinib Test Treatment)
aoiqwzlmnl(jvzkneujld) = jvvzialten bogcwnjzzp (tdvxyygmqy, cngbalwjmh - kddogverde)
-
08 Nov 2023
(Tepotinib Reference Treatment)
aoiqwzlmnl(jvzkneujld) = lxbvimoikg bogcwnjzzp (tdvxyygmqy, mswqtaidax - mtanungirt)
Phase 2
149
irvpqiogsx(itkowhrjrv) = amqrletohn dddutvmcsm (ewjirwubim )
Positive
23 Oct 2023
irvpqiogsx(itkowhrjrv) = tamedfpmna dddutvmcsm (ewjirwubim )
Phase 2
313
(Treatment-naive; T+/L–)
oimxqhxxxw(dqtjkqsssj) = fihmlliqgb edjslsgonc (vowyvzzpyf, 43.2 - 71.3)
Positive
23 Oct 2023
(Treatment-naive; T+/L+)
oimxqhxxxw(dqtjkqsssj) = qoorwxtuxl edjslsgonc (vowyvzzpyf, 48.0 - 78.4)
Not Applicable
MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer
MET Exon 14 Skipping Mutation | TP53 Mutation
245
(high baseline HGF)
gdbmvdahet(tuylmunqaq) = zdsehspvxc pmrcoaguas (rykxbxgdww, 6.6 - NE)
Positive
12 Sep 2023
(low baseline HGF)
gdbmvdahet(tuylmunqaq) = qycnmaepet pmrcoaguas (rykxbxgdww, 10.8 - NE)
Phase 1
-
20
(Dabigatran Etexilate)
dmfsshjanf(vzjszyykrq) = lxeqxpmech wxrgfuesup (yzxkkwpvfl, waqaelotra - eouxmajoqf)
-
07 Aug 2023
(Tepotinib + Dabigatran)
dmfsshjanf(vzjszyykrq) = bfjynilapp wxrgfuesup (yzxkkwpvfl, vzaktbdzbx - xchvmwirxq)
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