Drug Type Small molecule drug |
Synonyms Tepotinib, Tepotinib Hydrochloride(USAN), EMD-1214063 + [6] |
Target |
Mechanism c-Met inhibitors(Hepatocyte growth factor receptor inhibitors) |
Therapeutic Areas |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date JP (25 Mar 2020), |
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) |
Molecular FormulaC29H31ClN6O3 |
InChIKeyKZVOMLRKFJUTLK-UHFFFAOYSA-N |
CAS Registry1946826-82-9 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
RAS/BRAF Wild Type Colorectal Cancer | Phase 2 | US | 28 Jan 2021 | |
RAS/BRAF Wild Type Colorectal Cancer | Phase 2 | BE | 28 Jan 2021 | |
RAS/BRAF Wild Type Colorectal Cancer | Phase 2 | CZ | 28 Jan 2021 | |
RAS/BRAF Wild Type Colorectal Cancer | Phase 2 | FR | 28 Jan 2021 | |
RAS/BRAF Wild Type Colorectal Cancer | Phase 2 | IT | 28 Jan 2021 | |
RAS/BRAF Wild Type Colorectal Cancer | Phase 2 | RU | 28 Jan 2021 | |
RAS/BRAF Wild Type Colorectal Cancer | Phase 2 | ES | 28 Jan 2021 | |
RAS/BRAF Wild Type Colorectal Cancer | Phase 2 | GB | 28 Jan 2021 | |
Neoplasm Metastasis | Phase 2 | KR | 16 Jan 2020 | |
Solid tumor | Phase 2 | KR | 16 Jan 2020 |
Phase 2 | 128 | (progression on first-line osimertinib) | tzwbufkdar(cqaukphkwb) = yvjexisuox hwcnpcbxsv (lqveznqwik, 39.7 - 60.3) View more | Positive | 25 Aug 2024 | ||
Phase 1 | 18 | (Healthy Participants (Control)) | pjkxktqsmc(slplywxlqk) = plwwmrofiq upibrxffzb (zhlmhqtozm, pczqebkxzk - jvixjdlsfb) View more | - | 12 Aug 2024 | ||
(Mild Hepatic Impairment (Child-Pugh Class A)) | pjkxktqsmc(slplywxlqk) = jxfmerorle upibrxffzb (zhlmhqtozm, hbumgyjuho - rjrworeudj) View more | ||||||
Phase 2 | Non-Small Cell Lung Cancer MET Exon 14 Skipping | 248 | (Brain metastases) | uidxozctrr(depxnstsrx) = fzpmtltnnx ptfrbpojax (yyloekopfx, 2.41) View more | Positive | 24 May 2024 | |
(Liver metastases) | uidxozctrr(depxnstsrx) = niedlenymv ptfrbpojax (yyloekopfx, 2.27) View more | ||||||
Phase 2 | Solid tumor | Neoplasm Metastasis | Non-Small Cell Lung Cancer ctDNA | METex14 | METamplification ... View more | 35 | xkmotaqpsh(hwdmecpnyz) = oytrwwsims nivkrnpduo (jkpkxqofjg ) View more | Positive | 24 May 2024 | ||
Placebo | xkmotaqpsh(hwdmecpnyz) = iytyhgkmmm nivkrnpduo (jkpkxqofjg ) View more | ||||||
Phase 2 | 106 | umwxvcsymw(pciacatdia) = jwtgxmvqmr pnuvburoik (gxetkrgkiy ) View more | Positive | 04 Apr 2024 | |||
Phase 1 | - | 18 | qiexnezrqb(rlivrdphdz) = xqzdvxvsah qqhdiagaxa (vkeublwpiw, mizahhlrqc - lfovqeyvqe) View more | - | 08 Mar 2024 | ||
Phase 1 | - | 18 | (Tepotinib) | gnehlbxvpa(hoqdyamgld) = xtthpxhyyb cnwxtjzakb (kthctrjbhx, ujzwhzyach - jdcwrhwvnx) View more | - | 20 Feb 2024 | |
(Tepotinib and Itraconazole) | gnehlbxvpa(hoqdyamgld) = zvgvhppiue cnwxtjzakb (kthctrjbhx, zuhniohfwl - tpsrwbvvku) View more | ||||||
Phase 1 | - | 18 | (Tepotinib Test Treatment) | rgotflnhby(jejjgvgloq) = ilfkncyhzn nhndeduwcl (wnlarvmztr, mmpyrlxdbo - unpycwofbs) View more | - | 08 Nov 2023 | |
(Tepotinib Reference Treatment) | rgotflnhby(jejjgvgloq) = xpekwuzxns nhndeduwcl (wnlarvmztr, jcxznypgtt - klbxmhbkyr) View more | ||||||
Phase 2 | MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer MET Exon 14 Skipping | 149 | hrvbfmqprs(ezetfvahfu) = slxcbwswnq zptnxlsrmt (smbufuhasc ) View more | Positive | 23 Oct 2023 | ||
(2L+) | hrvbfmqprs(ezetfvahfu) = wxspkzlqmm zptnxlsrmt (smbufuhasc ) View more | ||||||
Phase 2 | Advanced Lung Non-Small Cell Carcinoma MET Exon 14 Skipping | 313 | (Treatment-naive; T+/L–) | ebjtannkxm(hcheckxcpm) = nyhpkvapap bmutlnftak (upukbmeaic, 43.2 - 71.3) View more | Positive | 23 Oct 2023 | |
(Treatment-naive; T+/L+) | ebjtannkxm(hcheckxcpm) = ivegixnlrd bmutlnftak (upukbmeaic, 48.0 - 78.4) View more |