Drugs / Capmatinib
Capmatinib
also known as
INC280 · CAPMATINIB (INCB28060) · Capmatinib dihydrochloride monohydrate · CAPMATINIB HYDROCHLORIDE · Capmatinib hydrochloride hydrate · Capmatinib hydrochloride monohydrate · INCB 28060 · INCB-28060 FREE BASE · +7 more
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) | TABRECTA | — | 2022-08-10 | fda.gov ↗ |
| Approved | EU (EMA) | Tabrecta | — | 2022-06-20 | europa.eu ↗ |
| Approved | US (FDA) | TABRECTA | — | 2020-05-06 | fda.gov ↗ |
Trials 50 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| Phase 1 | NCT05435846 | Aug 2022 → Nov 2023 | non-small cell lung carcinoma | Collin Blakely | Terminated | No outcome recorded |
| Phase 1 | NCT03742349 | Jan 2019 → Feb 2023 | triple-negative breast carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT03333343 | Jan 2018 → Oct 2026 expected | non-small cell lung carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02925104 | Dec 2016 → May 2018 | neoplasm | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02520752 | Dec 2015 → Jan 2017 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02626234 | Dec 2015 → Feb 2017 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02468661 | Sep 2015 → Nov 2017 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02386826 | Sep 2015 → Jul 2021 | colorectal cancer, gliosarcoma, renal cell carcinoma | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02474537 | Jun 2015 → Aug 2017 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02205398 | Jul 2014 → Jan 2017 | colorectal cancer, head and neck squamous cell carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT01911507 | Aug 2013 → Aug 2020 | non-small cell lung carcinoma | University of California, Davis | Completed | No outcome recorded |
| Phase 1 | NCT01324479 | Feb 2012 → Jul 2017 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01546428 | Feb 2012 → Jan 2016 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01072266 | Jan 2010 → Jul 2012 | metastatic malignant neoplasm | Incyte Corporation | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT05488314 | Dec 2022 → Jun 2026 overdue | non-small cell lung carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05243641 | Aug 2022 → Nov 2024 | breast cancer, metastatic neoplasm | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT02813135 | Aug 2016 → Feb 2031 expected | childhood malignant neoplasm | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02795429 | Jun 2016 → Jun 2021 | hepatocellular carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT02335944 | Jan 2015 → Nov 2020 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1/2 | NCT01870726 | Jan 2014 → Dec 2016 | high grade astrocytic tumor | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 224 trials | ||||||
| Phase 2 | NCT06054191 | Feb 2024 → Mar 2025 overdue | non-small cell lung carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05567055 | Oct 2023 → Sep 2026 | non-small cell lung carcinoma | Timothy Burns, MD, PHD | Withdrawn | No outcome recorded |
| Phase 2 | NCT04926831 | Aug 2022 → Mar 2024 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT05135845 | Mar 2022 → Apr 2023 | esophageal adenocarcinoma, gastric adenocarcinoma | Assistance Publique - Hôpitaux de Paris | Suspended | No outcome recorded |
| Phase 2 | NCT04677595 | May 2021 → Oct 2023 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04460729 | Nov 2020 → Nov 2023 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT04323436 | Aug 2020 → Dec 2022 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT04139317 | Jan 2020 → Jan 2022 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT03647488 | Dec 2018 → Sep 2020 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03693339 | Oct 2018 → Jun 2020 | lung cancer | Asan Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT03484923 | Sep 2018 → Dec 2022 | melanoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03240393 | Jul 2018 → Oct 2021 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT03040973 | Aug 2017 → Jul 2027 expected | — | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01964235 | Dec 2016 → Jul 2019 | hepatocellular carcinoma | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT02750215 | May 2016 → May 2021 | non-small cell lung carcinoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02414139 | Jun 2015 → Apr 2023 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02587650 | Mar 2015 → Jul 2018 | NTRK fusion positive cancer, RET fusion positive cancer, cutaneous melanoma | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 2 | NCT02323126 | Feb 2015 → Sep 2019 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT02276027 | Jan 2015 → Oct 2019 | lung adenocarcinoma, squamous cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02159066 | Jul 2014 → Jan 2023 | melanoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02019693 | Jan 2014 → Dec 2021 | kidney cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT01737827 | Mar 2013 → Apr 2023 | hepatocellular carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT01610336 | Apr 2012 → Jun 2016 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06988475 | Nov 2024 → Oct 2029 expected | gastric cancer, glioma, hematopoietic and lymphoid cell neoplasm, neuroblastoma +1 | Cancer Research UK | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05722886 | Mar 2023 → Oct 2029 expected | cancer, hematopoietic and lymphoid cell neoplasm | Cancer Research UK | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT04816214 | Sep 2021 → Dec 2022 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT04427072 | Sep 2020 → Feb 2023 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT03784014 | Oct 2019 → Dec 2023 | soft tissue sarcoma | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05110196 | Sep 2022 → Aug 2025 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT05642572 Background | May 2023 → Jun 2027 expected | non-small cell lung carcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04741789 Background | — | non-small cell lung carcinoma | Novartis Pharmaceuticals | No longer available | No outcome recorded |
Press releases naming this drug 19 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-06-22 | Novartis Pharmaceuticals | Novartis receives European Commission approval for Tabrecta® for the treatment of METex14 skipping advanced non-small cell lung cancer novartis.com ↗ |
| 2022-04-22 | Novartis Pharmaceuticals | Novartis receives positive CHMP opinion for Tabrecta® for patients with METex14 advanced non-small cell lung cancer novartis.com ↗ |
| 2022-04-22 | Incyte Corporation | Incyte Announces Positive CHMP Opinion for Capmatinib (Tabrecta®) for the Treatment of METex14 Advanced Non-Small Cell Lung Cancer incyte.com ↗ |
| 2021-06-04 | Novartis Pharmaceuticals | Novartis announces Tabrecta® first published overall survival and updated overall response data in patients with METex14 metastatic NSCLC novartis.com ↗ |
| 2020-09-02 | Novartis Pharmaceuticals | Novartis announces NEJM publication of pivotal study of Tabrecta™ in patients with METex14 metastatic non-small cell lung cancer novartis.com ↗ |
| 2020-09-02 | Incyte Corporation | Incyte Announces Pivotal GEOMETRY mono-1 Study Results of Capmatinib (Tabrecta™) in Patients with METex14 Metastatic Non-Small Cell Lung Cancer Published in NEJM incyte.com ↗ |
| 2020-06-29 | Novartis Pharmaceuticals | Novartis announces MET inhibitor Tabrecta™ approved in Japan for advanced non-small cell lung cancer with METex14 novartis.com ↗ |
| 2020-06-29 | Incyte Corporation | Incyte Announces Approval of Tabrecta™ (capmatinib) in Japan for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with METex14 incyte.com ↗ |
| 2020-05-06 | Novartis Pharmaceuticals | Novartis announces FDA approval of MET inhibitor Tabrecta™ for metastatic non-small cell lung cancer with METex14 novartis.com ↗ |
| 2020-05-06 | Incyte Corporation | Incyte Announces FDA Approval of Tabrecta™ (capmatinib) for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with METex14 incyte.com ↗ |
| 2020-02-11 | Novartis Pharmaceuticals | Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review novartis.com ↗ |
| 2020-02-11 | Incyte Corporation | Incyte Announces Acceptance and Priority Review of NDA for Capmatinib for Advanced Non-Small Cell Lung Cancer incyte.com ↗ |
| 2019-09-06 | Novartis Pharmaceuticals | Novartis investigational lung cancer therapy capmatinib (INC280) granted FDA Breakthrough Therapy Designation for patients with MET-mutated advanced non-small cell lung cancer novartis.com ↗ |
| 2019-06-03 | Novartis Pharmaceuticals | Novartis Shows Growing Strength in Lung Cancer Innovation with New Capmatinib Investigational Data and Novel Canakinumab Clinical Trials novartis.com ↗ |
| 2019-06-03 | Incyte Corporation | New Data from GEOMETRY mono-1 Study Show Clinically Meaningful Results in Patients with Non-Small Cell Lung Cancer with MET exon-14 Skipping Mutation Treated with Capmatinib incyte.com ↗ |
| 2018-10-19 | Novartis Pharmaceuticals | Novartis phase II GEOMETRY mono-1 trial of investigational medicine capmatinib (INC280) shows positive results in patients with MET mutated advanced NSCLC novartis.com ↗ |
| 2018-10-19 | Incyte Corporation | Phase 2 GEOMETRY mono-1 Trial of Investigational Medicine Capmatinib Shows Positive Results in Patients with MET-mutated Advanced NSCLC incyte.com ↗ |
| 2016-05-19 | Incyte Corporation | Incyte Highlights Jakafi® (ruxolitinib) and Capmatinib Abstracts to be Presented at the 2016 ASCO and EHA Annual Meetings incyte.com ↗ |
| 2013-04-29 | Incyte Corporation | Incyte Achieves $25 Million Milestone as c-MET Inhibitor INC280 Advances Into Phase II Development incyte.com ↗ |
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | capmatinib | “Pharmacokinetics and safety of capmatinib with food in patients with” PMID 34053700 ↗ May 2021 |
| Known as | CAPMATINIB (INCB28060) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗ |
| Known as | Capmatinib dihydrochloride monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗ |
| Known as | CAPMATINIB HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗ |
| Known as | Capmatinib hydrochloride hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗ |
| Known as | Capmatinib hydrochloride monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗ |
| Known as | INC280 | “Capmatinib (INC280)” NCT02750215 ↗ |
| Known as | INCB 28060 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗ |
| Known as | INCB-28060 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗ |
| Known as | INCB-28060A-1419 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗ |
| Known as | INCB028060 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01072266 ↗ |
| Known as | NVP-INC280 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗ |
| Known as | NVP-INC280-AAA | ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗ |
| Known as | NVP-INC280-NX | ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗ |
| Known as | NYP-INC280-NX | ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗ |
| Known as | Tabrecta | ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗ |
| Action | Inhibit | “MET inhibitor” PMID 32240796 ↗ Mar 2020 |
| Modality | Small molecule | — CHEMBL3188267 ↗ |
| Route | Oral | “Capmatinib is an oral, ATP-competitive, and highly potent, type 1b MET inhibitor.” PMID 31778267 ↗ Dec 2019 |
| Target | MET | “MET inhibitor” PMID 32240796 ↗ Mar 2020 |