Drugs / Larotrectinib
Larotrectinib
also known as
BAY2757556 · Vitrakvi · ARRY-470 · ARRY-470 SULFATE · larotrectinib sulfate · LOXO-101 · LOXO-101 (ARRY-470) · LOXO-101 sulfate · +1 more
Small molecule targets NTRK1, NTRK2, NTRK3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | VITRAKVI | — | 2021-03-25 – 2025-04-09 | fda.gov ↗ |
| Approved · conditional | EU (EMA) | Vitrakvi | — | 2019-09-19 | europa.eu ↗ |
| Approved | US (FDA) | VITRAKVI | — | 2018-11-26 | fda.gov ↗ |
Trials 19 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04655404 | Apr 2021 → Dec 2026 expected | diffuse intrinsic pontine glioma | Nationwide Children's Hospital | Recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT03056599 | Dec 2016 → Jul 2021 | soft tissue sarcoma | Presage Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT02122913 | May 2014 → Feb 2017 | NTRK fusion positive cancer | Bayer | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02637687 | Dec 2015 → Jul 2024 overdue | NTRK fusion positive cancer | Bayer | Active not recruiting | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT06563999 | Nov 2024 → Nov 2027 expected | lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT05783323 | Feb 2024 → Oct 2026 expected | childhood malignant neoplasm, differentiated thyroid carcinoma | Children's Hospital of Philadelphia | Recruiting | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05725200 | Sep 2022 → Dec 2038 expected | colorectal cancer | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06482086 | Jun 2021 → Dec 2024 overdue | thyroid gland carcinoma | West China Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04879121 | Apr 2021 → Nov 2027 expected | metastatic malignant neoplasm | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT03834961 | Oct 2019 → Sep 2024 overdue | acute leukemia, central nervous system neoplasm, pediatric fibrosarcoma | Children's Oncology Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03213704 | Aug 2017 → Sep 2024 overdue | Ewing sarcoma/peripheral primitive neuroectodermal tumor, Langerhans cell histiocytosis, ependymoma, hepatoblastoma +9 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03155620 | Jul 2017 → Mar 2025 overdue | Ewing sarcoma, Langerhans cell histiocytosis, Wilms tumor, conventional osteosarcoma +13 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06390852 | Mar 2017 → Dec 2026 expected | adult lymphoma, plasma cell myeloma, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02576431 | Sep 2015 → Sep 2025 | NTRK fusion positive cancer | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT02465060 | Aug 2015 → Dec 2026 expected | breast carcinoma, carcinoma of esophagus, cervical carcinoma, colon carcinoma +17 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07010393 | Jul 2025 → Dec 2027 expected | thyroid tumor | Fujian Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06195228 | Jan 2020 → Dec 2026 expected | — | Fudan University | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03025360 | — | NTRK fusion positive cancer | Bayer | Approved for marketing | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Larotrectinib | “larotrectinib 100 mg orally twice daily” NCT06145308 ↗ |
| Known as | ARRY-470 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3889654 ↗ |
| Known as | ARRY-470 SULFATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3889654 ↗ |
| Known as | BAY2757556 | “Larotrectinib (Vitrakvi, BAY2757556)” NCT02637687 ↗3“Larotrectinib (Vitrakvi, BAY2757556)” NCT03025360 ↗ “BAY2757556 (Larotrectinib, Vitrakvi)” NCT02576431 ↗ “Larotrectinib (Vitrakvi, BAY2757556)” NCT02122913 ↗ |
| Known as | larotrectinib sulfate | “Patients receive larotrectinib sulfate orally (PO) or via nasogastric (NG)- or gastric (G)-tube twice per day (BID) on days 1-28.” NCT03213704 ↗ |
| Known as | LOXO-101 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3889654 ↗ |
| Known as | LOXO-101 (ARRY-470) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3889654 ↗ |
| Known as | LOXO-101 sulfate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3889654 ↗ |
| Known as | LOXO-101LOXO 101LOXO101A-9048 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3889654 ↗ |
| Known as | Vitrakvi | “BAY2757556 (Larotrectinib, Vitrakvi)” NCT02576431 ↗3“Larotrectinib (Vitrakvi, BAY2757556)” NCT02122913 ↗ “Larotrectinib (Vitrakvi, BAY2757556)” NCT02637687 ↗ “Larotrectinib (Vitrakvi, BAY2757556)” NCT03025360 ↗ |
| Action | Inhibit | “because it blocks the action of these genes in cancer cells” NCT02122913 ↗ |
| Modality | Small molecule | “Larotrectinib, a highly selective small-molecule inhibitor of the TRK kinases” PMID 29606586 ↗ Mar 2018 |
| Route | Oral | “receive larotrectinib (LOXO-101) PO BID” NCT02465060 ↗ |
| Target | NTRK1 | “The drug may be used to treat cancer with a change in a particular gene (NTRK1, NTRK2 or NTRK3), because it blocks the action of these genes in cancer cells.” NCT02122913 ↗ |
| Target | NTRK2 | “The drug may be used to treat cancer with a change in a particular gene (NTRK1, NTRK2 or NTRK3), because it blocks the action of these genes in cancer cells.” NCT02122913 ↗ |
| Target | NTRK3 | “The drug may be used to treat cancer with a change in a particular gene (NTRK1, NTRK2 or NTRK3), because it blocks the action of these genes in cancer cells.” NCT02122913 ↗ |