Drugs / Tepotinib
Tepotinib
also known as
MSC2156119J · EMD 1214063 · MSC-2156119 · Tepmetko · TEPOTINIB HYDROCHLORIDE · Tepotinib hydrochloride hydrate · Tepotinib hydrochloride monohydrate
Small molecule targets MET via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | TEPMETKO | — | 2024-02-15 | fda.gov ↗ |
| Approved | EU (EMA) | Tepmetko | — | 2022-02-16 | europa.eu ↗ |
| Approved | US (FDA) | TEPMETKO | — | 2021-02-03 | fda.gov ↗ |
Trials 28 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 112 trials | ||||||
| Phase 1 | NCT07619339 | May 2026 → May 2029 expected | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05782361 | May 2023 → Mar 2028 expected | cancer of unknown primary site, non-small cell lung carcinoma | Institute of Cancer Research, United Kingdom | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05120960 | Feb 2023 → Apr 2024 | brain neoplasm | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT05203822 | Jan → Jul 2022 | — | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT05213481 | Dec 2021 → May 2022 | — | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT03628339 | Aug → Oct 2018 | — | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT03546608 | Jun 2018 → Feb 2019 | — | EMD Serono Research & Development Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03492437 | May → Aug 2018 | — | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT03531762 | May → Jul 2018 | — | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT03021642 | Jan → Mar 2016 | — | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT01832506 | Apr 2013 → Mar 2014 | cancer | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT01014936 | Nov 2009 → Oct 2015 | neoplasm | EMD Serono | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT06083857 | Jun 2024 → Dec 2027 expected | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04739358 | May 2022 → Jun 2023 | — | Criterium, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT05439993 | Mar 2022 → Jun 2026 | gastric cancer, gastroesophageal cancer | Hallym University Medical Center | Unknown | No outcome recorded |
| Phase 1/2 | NCT02115373 | May 2014 → Feb 2018 | hepatocellular carcinoma | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1/2 | NCT01988493 | Jan 2014 → Feb 2018 | hepatocellular carcinoma | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1/2 | NCT01982955 | Dec 2013 → Dec 2017 | non-small cell lung carcinoma | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT06031688 | Aug 2024 → May 2028 expected | non-small cell lung carcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 2 | NCT06106802 | Jun 2024 → Sep 2029 expected | non-small cell lung carcinoma | Samsung Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05159245 | Dec 2021 → Nov 2026 expected | cancer, hematopoietic and lymphoid cell neoplasm | Helsinki University Central Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04515394 | Jan 2021 → Mar 2022 | colorectal neoplasm | EMD Serono Research & Development Institute, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | No outcome recorded |
| Phase 2 | NCT04647838 | Jan 2020 → Feb 2023 | cancer | Chungbuk National University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03940703 | Sep 2019 → May 2023 overdue | non-small cell lung carcinoma | EMD Serono Research & Development Institute, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02864992 | Sep 2016 → May 2022 overdue | lung adenocarcinoma | EMD Serono Research & Development Institute, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06908993 | Dec 2025 → Mar 2028 expected | non-small cell lung carcinoma | French Cooperative Thoracic Intergroup | Recruiting | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tepotinib | “Tepotinib (MSC2156119J) is an oral, potent and highly selective small molecule” PMID 32328660 ↗ Aug 202026 |
| Known as | EMD 1214063 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3402762 ↗ |
| Known as | MSC-2156119 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3402762 ↗ |
| Known as | MSC2156119J | “A Phase Ib/II Multicenter, Randomized, Open Label Trial to Compare Tepotinib (MSC2156119J) Combined With Gefitinib Versus Chemotherapy as Second-Line Treatment” NCT01982955 ↗2“Tepotinib (MSC2156119J) is an oral, potent and highly selective small molecule” PMID 32328660 ↗ Aug 2020 |
| Known as | Tepmetko | ChEMBL registry synonym — accepted as the source's own label CHEMBL3402762 ↗ |
| Known as | TEPOTINIB HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3402762 ↗ |
| Known as | Tepotinib hydrochloride hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3402762 ↗ |
| Known as | Tepotinib hydrochloride monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3402762 ↗ |
| Action | Inhibit | “MET inhibitor” NCT01832506 ↗ |
| Modality | Small molecule | “small molecule mesenchymal-epithelial transition factor (MET) inhibitor” PMID 32328660 ↗ Aug 2020 |
| Route | Oral | “Tepotinib (MSC2156119J) is an oral” PMID 32328660 ↗ Aug 2020 |
| Target | MET | “MET inhibitor” NCT01832506 ↗ |