Drugs / Selpercatinib
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (6) | US (FDA) | RETEVMO | — | 2022-09-21 – 2026-07-14 | fda.gov ↗ |
| Approved | EU (EMA) | Retsevmo | — | 2021-02-11 | europa.eu ↗ |
| Approved | US (FDA) | RETEVMO | — | 2020-05-08 | fda.gov ↗ |
Trials 36 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07146893 | Feb 2026 → Feb 2027 expected | — | University of Oklahoma | Not yet recruiting | No outcome recorded |
| Phase 115 trials | ||||||
| Phase 1 | NCT05906836 | Jul → Oct 2023 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05324124 | Apr → Jun 2022 | — | Loxo Oncology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05136404 | Dec 2021 → Mar 2022 | — | Loxo Oncology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05089019 | Oct 2021 → Jul 2022 | — | Loxo Oncology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04782076 | Mar → May 2021 | — | Loxo Oncology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05338502 | Jul → Sep 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05630274 | Apr → Jun 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05338515 | Feb → Mar 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05469113 | Jan → Mar 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05469100 | Dec 2018 → Aug 2019 | impaired renal function disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05436912 | Dec 2018 → Oct 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05630287 | Aug → Sep 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05338476 | Jul → Aug 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05468164 | May → Sep 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05338489 | May → Jul 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03899792 | Jun 2019 → Nov 2024 overdue | fibrosarcoma, infantile myofibromatosis, medullary thyroid gland carcinoma, thyroid gland papillary carcinoma | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03157128 | May 2017 → Feb 2025 overdue | colon carcinoma, medullary thyroid gland carcinoma, non-small cell lung carcinoma | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT06458036 | Jul 2024 → Nov 2030 expected | childhood malignant neoplasm, differentiated thyroid carcinoma | Children's Hospital of Philadelphia | Recruiting | No outcome recorded |
| Phase 2 | NCT05668962 | Mar 2023 → Mar 2025 overdue | thyroid gland follicular carcinoma, thyroid gland papillary carcinoma | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05364645 | Jul 2022 → Jun 2023 | non-small cell lung carcinoma | SWOG Cancer Research Network | Withdrawn | No outcome recorded |
| Phase 2 | NCT04320888 | May 2021 → Sep 2024 overdue | Ewing sarcoma, Langerhans cell histiocytosis, Wilms tumor, ependymoma +10 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04759911 | Feb 2021 → Nov 2027 expected | medullary thyroid gland carcinoma, poorly differentiated thyroid gland carcinoma, thyroid gland papillary carcinoma, thyroid gland squamous cell carcinoma +1 | M.D. Anderson Cancer Center | Active not recruiting | 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 | NCT04268550 | Apr 2020 → Dec 2026 expected | non-small cell lung carcinoma | SWOG Cancer Research Network | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04280081 | Mar 2020 → Mar 2021 overdue | medullary thyroid gland carcinoma | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03944772 | Jun 2019 → May 2025 overdue | non-small cell lung carcinoma | AstraZeneca | 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 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT04819100 | Dec 2021 → Jan 2026 overdue | non-small cell lung carcinoma | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04194944 | Feb 2020 → May 2023 overdue | non-small cell lung carcinoma | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04211337 | Feb 2020 → May 2023 overdue | medullary thyroid gland carcinoma | Loxo Oncology, Inc. | 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 | ||||||
| — | NCT03906331 | — | RET fusion positive cancer, breast cancer, colon carcinoma, malignant pancreatic neoplasm +3 | Eli Lilly and Company | Approved for marketing | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 39 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Selpercatinib | “This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also...” NCT03157128 ↗35“Selpercatinib” NCT04817956 ↗ |
| Known as | LOXO-292 | “This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also...” NCT03157128 ↗1“A Phase 2 Study of Oral Selpercatinib (LOXO-292) in Patients With Advanced Solid Tumors, Including Rearranged in Transfection (RET) Fusion-Positive Solid Tumors, Medullary...” NCT04280081 ↗ |
| Known as | LY3527723 | “A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation” NCT04280081 ↗ |
| Known as | Ret inhibitor loxo-292 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4559134 ↗ |
| Known as | Retevmo | “Selpercatinib (also known by the brand name Retevmo®/Retsevmo®) is a new treatment available in multiple countries” PMID 35969032 ↗ Aug 2022 |
| Known as | Retsevmo | “Selpercatinib (also known by the brand name Retevmo®/Retsevmo®) is a new treatment available in multiple countries” PMID 35969032 ↗ Aug 2022 |
| Action | Inhibit | “a first-in-class, highly selective, and potent small molecule RET kinase inhibitor” PMID 38661071 ↗ Feb 2025 |
| Modality | Small molecule | “a first-in-class, highly selective, and potent small molecule RET kinase inhibitor” PMID 38661071 ↗ Feb 2025 |
| Route | Oral | “receive selpercatinib PO BID” NCT03155620 ↗ |
| Target | RET | “a first-in-class, highly selective, and potent small molecule RET kinase inhibitor” PMID 38661071 ↗ Feb 2025 |