Product Description
Selpercatinib is an oral selective inhibitor of the tyrosine kinase receptor encoded by RET (rearranged during transfection), a proto-oncogene which is mutated or altered in many cancers such a medullary thyroid cancer and non-small cell lung cancer. Serum aminotransferase elevations are common during therapy with selpercatinib and can lead to dose modifications or drug discontinuation, but clinically apparent liver injury with jaundice has not been described with its use. (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK594575/)
Mechanisms of Action: RET Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Austria | Bangladesh | Belgium | Canada | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Netherlands | Norway | Poland | Portugal | Romania | Russia | Saudi Arabia | Slovakia | Spain | Sweden | Switzerland | Taiwan | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Eli Lilly
Company Location: Eastern America
Company CEO: David A. Ricks
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Mexico, Netherlands, Norway, Poland, Puerto Rico, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 23
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Eli Lilly presented P1 Oncology Solid Tumor Unspecified results on 2024-06-01 for Selpercatinib
Highest Development Phases
Phase 3: Medullary Carcinoma|Neuroendocrine Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Lung Cancer|Thyroid Cancer
Phase 2: Abnormalities, Multiple|Brain Stem Cancer|Central Nervous System Cancer|Colonic Diseases|Colorectal Cancer|Fibrosarcoma|Follicular Adenocarcinoma|Hodgkin Lymphoma|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Multiple Myeloma|Myofibromatosis|Oncology Solid Tumor Unspecified|Papillary Adenocarcinoma|Papillary Carcinoma|Papillary Follicular Carcinoma|Soft Tissue Cancer|Vision, Low
Phase 1: Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04819100 |
LIBRETTO-432 | P3 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2026-05-01 |
2025-12-30 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
|
NCT03157128 |
LIBRETTO-001 | P2 |
Active, not recruiting |
Thyroid Cancer|Colonic Diseases|Neuroendocrine Carcinoma|Non-Small-Cell Lung Cancer|Colorectal Cancer|Medullary Carcinoma |
2025-02-14 |
12% |
2025-04-23 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Treatments |
NCT03899792 |
LIBRETTO-121 | P2 |
Active, not recruiting |
Myofibromatosis|Fibrosarcoma|Thyroid Cancer|Soft Tissue Cancer |
2024-11-08 |
12% |
2026-01-07 |
|
2023-507703-63-00 |
LOXO-RET-18036 | P2 |
Active, not recruiting |
Oncology Solid Tumor Unspecified |
2024-10-28 |
2025-05-02 |
Treatments |
|
2019-000212-28 |
2019-000212-28 | P2 |
Active, not recruiting |
Central Nervous System Cancer |
2024-02-19 |
12% |
2025-05-06 |
Treatments |
NCT04280081 |
LIBRETTO-321 | P2 |
Active, not recruiting |
Thyroid Cancer|Medullary Carcinoma|Brain Stem Cancer|Neuroendocrine Carcinoma |
2021-03-25 |
12% |
2022-06-03 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT06458036 |
RAISE | P2 |
Recruiting |
Thyroid Cancer |
2030-11-01 |
12% |
2024-11-13 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT02925234 |
DRUP | P2 |
Recruiting |
Abnormalities, Multiple|Multiple Myeloma|Hodgkin Lymphoma|Vision, Low|Lymphoma, Non-Hodgkin|Lymphoma, B-Cell |
2027-09-01 |
12% |
2024-01-25 |
Primary Endpoints |
NCT05668962 |
ITOG | P2 |
Recruiting |
Papillary Follicular Carcinoma|Thyroid Cancer|Follicular Adenocarcinoma|Papillary Adenocarcinoma|Papillary Carcinoma |
2025-03-01 |
12% |
2024-10-22 |
|
2023-506784-33-00 |
J2G-MC-JZJX | P3 |
Active, not recruiting |
Small Cell Lung Cancer|Non-Small-Cell Lung Cancer |
2032-08-14 |
2025-05-02 |
||
NCT04211337 |
LIBRETTO-531 | P3 |
Active, not recruiting |
Thyroid Cancer|Medullary Carcinoma|Neuroendocrine Carcinoma |
2023-05-22 |
45% |
2024-01-19 |
Primary Endpoints|Study Completion Date|Treatments |
NCT04194944 |
LIBRETTO-431 | P3 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2023-05-01 |
4% |
2024-03-20 |
|
NCT05906836 |
J2G-MC-JZPB | P1 |
Completed |
Healthy Volunteers |
2023-10-31 |
23% |
2025-09-17 |
Patient Enrollment|Primary Endpoints|Treatments |
CTR20212707 |
CTR20212707 | P3 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
None |
2025-12-28 |
Patient Enrollment|Treatments|Trial Status |
|
2023-507702-13-00 |
LOXO-RET-17001 | P2 |
Active, not recruiting |
Thyroid Cancer |
2028-05-31 |
2025-05-02 |
Treatments |
|
JapicCTI-205222 |
JapicCTI-205222 | P2 |
Active |
Oncology Solid Tumor Unspecified |
2022-10-31 |
|||
CTR20192716 |
CTR20192716 | P2 |
Active, not recruiting |
Medullary Carcinoma |
None |
2025-04-29 |
Patient Enrollment|Treatments |
|
2020-005191-35 |
LIBRETTO-432 | P3 |
Active, not recruiting |
Small Cell Lung Cancer|Non-Small-Cell Lung Cancer |
2033-03-22 |
2025-07-09 |
Treatments |
|
2023-506782-56-00 |
J2G-MC-JZJB | P3 |
Active, not recruiting |
Thyroid Cancer |
2027-11-13 |
2025-05-02 |
Treatments |
|
2023-506783-14-00 |
J2G-MC-JZJC | P3 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2026-06-18 |
2025-05-02 |
Treatments |
|
2019-001979-36 |
LIBRETTO-431 | P3 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2026-06-14 |
4% |
2025-07-06 |
Treatments |
JapicCTI-205264 |
JapicCTI-205264 | P3 |
Active |
Unknown |
2026-02-28 |
|||
JapicCTI-205282 |
JapicCTI-205282 | P3 |
Active |
Unknown |
2024-12-16 |