LOXO-292 (Selpercatinib) Clinical Trials

Size	Price	Qty
5mg	USD 267
25mg	USD 570

Clinical Trials

Selpercatinib (LOXO-292) is evaluated across numerous clinical trials spanning Early Phase 1 through Phase 4, focusing on non-small cell lung cancer, medullary thyroid carcinoma, papillary thyroid cancer, RET fusion-positive advanced solid tumors, and pharmacokinetics in healthy and organ-impaired subjects. Driven by industry sponsors such as Loxo Oncology and Eli Lilly alongside research networks like M.D. Anderson Cancer Center and the SWOG Cancer Research Network, these studies encompass recruiting, active not recruiting, and completed statuses to support regulatory approval.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06458036	RECRUITING	Differentiated Thyroid Cancer; Pediatric Cancer; Cancer; Cancer, Thyroid	Children's Hospital of Philadelphia	2024-07-29	PHASE2
NCT07010393	NOT_YET_RECRUITING	Thyroid Neoplasms	Fujian Medical University	2025-07-01	PHASE4
NCT04759911	ACTIVE_NOT_RECRUITING	Malignant Thyroid Gland Neoplasm; Poorly Differentiated Thyroid Gland Carcinoma; Recurrent Thyroid Gland Carcinoma; Thyroid Gland Anaplastic Carcinoma; Thyroid Gland Medullary Carcinoma; Thyroid Gland Papillary Carcinoma; Thyroid Gland Squamous Cell Carcinoma	M.D. Anderson Cancer Center	2021-02-26	PHASE2
NCT02925234	RECRUITING	Cancer; Tumors; Neoplasm; Neoplasia	The Netherlands Cancer Institute	2016-08	PHASE2
NCT07146893	NOT_YET_RECRUITING	Cachexia-Anorexia Syndrome	University of Oklahoma	2026-02-26	EARLY_PHASE1
NCT06195228	RECRUITING	Advanced Thyroid Cancer Patients Who Received Target Therapy	Fudan University	2020-01-01	PHASE4
NCT04268550	ACTIVE_NOT_RECRUITING	Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8	SWOG Cancer Research Network	2020-04-08	PHASE2
NCT04819100	ACTIVE_NOT_RECRUITING	Carcinoma, Non-Small-Cell Lung	Eli Lilly and Company	2021-12-20	PHASE3
NCT03944772	ACTIVE_NOT_RECRUITING	Non-Small Cell Lung Cancer	AstraZeneca	2019-06-25	PHASE2
NCT03155620	ACTIVE_NOT_RECRUITING	Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Histiocytic Sarcoma; Juvenile Xanthogranuloma; Langerhans Cell Histiocytosis; Malignant Glioma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Recurrent Soft Tissue Sarcoma; Refractory Ewing Sarcoma; Refractory Glioma; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Primary Central Nervous System Neoplasm; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Rhabdoid Tumor; Stage III Osteosarcoma AJCC v7; Stage III Soft Tissue Sarcoma AJCC v7; Stage IV Osteosarcoma AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Stage IVA Osteosarcoma AJCC v7; Stage IVB Osteosarcoma AJCC v7; Wilms Tumor	National Cancer Institute (NCI)	2017-07-31	PHASE2
NCT05668962	RECRUITING	Thyroid Cancer; Thyroid Carcinoma; Metastatic Thyroid Cancer; Follicular Thyroid Cancer; Unresectable Thyroid Gland Carcinoma; Papillary Thyroid Cancer	Massachusetts General Hospital	2023-03-01	PHASE2
NCT03157128	ACTIVE_NOT_RECRUITING	Non-Small Cell Lung Cancer; Medullary Thyroid Cancer; Colon Cancer; Any Solid Tumor	Eli Lilly and Company	2017-05-02	PHASE1; PHASE2
NCT04591431	UNKNOWN	Breast Cancer; Gastrointestinal Cancer; Non Small Cell Lung Cancer; Other Cancer	Fondazione per la Medicina Personalizzata	2020-10-07	PHASE2
NCT03899792	ACTIVE_NOT_RECRUITING	Medullary Thyroid Cancer; Infantile Myofibromatosis; Infantile Fibrosarcoma; Papillary Thyroid Cancer; Soft Tissue Sarcoma	Eli Lilly and Company	2019-06-13	PHASE1; PHASE2
NCT04320888	ACTIVE_NOT_RECRUITING	Hematopoietic and Lymphatic System Neoplasm; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Hepatoblastoma; Recurrent Histiocytic and Dendritic Cell Neoplasm; Recurrent Langerhans Cell Histiocytosis; Recurrent Lymphoma; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Glioma; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Rhabdoid Tumor; Recurrent Rhabdomyosarcoma; Recurrent Soft Tissue Sarcoma; Recurrent WHO Grade 2 Glioma; Refractory Ependymoma; Refractory Ewing Sarcoma; Refractory Hepatoblastoma; Refractory Histiocytic and Dendritic Cell Neoplasm; Refractory Langerhans Cell Histiocytosis; Refractory Lymphoma; Refractory Malignant Germ Cell Tumor; Refractory Malignant Glioma; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Refractory Soft Tissue Sarcoma; Refractory WHO Grade 2 Glioma; Wilms Tumor	National Cancer Institute (NCI)	2021-05-03	PHASE2
NCT05906836	COMPLETED	Healthy	Eli Lilly and Company	2023-07-27	PHASE1
NCT05364645	WITHDRAWN	Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8	SWOG Cancer Research Network	2022-07-25	PHASE2
NCT04211337	ACTIVE_NOT_RECRUITING	Medullary Thyroid Cancer	Loxo Oncology, Inc.	2020-02-11	PHASE3
NCT04194944	ACTIVE_NOT_RECRUITING	Non-Small Cell Lung Cancer	Eli Lilly and Company	2020-02-17	PHASE3
NCT05089019	COMPLETED	Healthy	Loxo Oncology, Inc.	2021-10-29	PHASE1
NCT05324124	COMPLETED	Healthy	Loxo Oncology, Inc.	2022-04-19	PHASE1
NCT05324124	Completed	Healthy	Loxo Oncology Inc.\|Eli Lilly and Company	2022-04-19	Phase 1
NCT05136404	COMPLETED	Healthy	Loxo Oncology, Inc.	2021-12-03	PHASE1
NCT05136404	Completed	Healthy	Loxo Oncology Inc.\|Eli Lilly and Company	2021-12-03	Phase 1
NCT05089019	Completed	Healthy	Loxo Oncology Inc.\|Eli Lilly and Company	2021-10-29	Phase 1
NCT04782076	COMPLETED	Healthy	Loxo Oncology, Inc.	2021-03-05	PHASE1
NCT04280081	ACTIVE_NOT_RECRUITING	Solid Tumor; Medullary Thyroid Cancer	Eli Lilly and Company	2020-03-16	PHASE2
NCT04782076	Completed	Healthy	Loxo Oncology Inc.\|Eli Lilly and Company	2021-03-05	Phase 1
NCT04280081	Active not recruiting	Solid Tumor\|Medullary Thyroid Cancer	Loxo Oncology Inc.\|Eli Lilly and Company	2020-03-16	Phase 2
NCT05436912	COMPLETED	Healthy; Hepatic Impairment	Eli Lilly and Company	2018-12-10	PHASE1
NCT05338502	COMPLETED	Healthy	Eli Lilly and Company	2019-07-08	PHASE1
NCT05469100	COMPLETED	Healthy; Renal Insufficiency	Eli Lilly and Company	2018-12-19	PHASE1
NCT05630274	COMPLETED	Healthy	Eli Lilly and Company	2019-04-16	PHASE1
NCT05338515	COMPLETED	Healthy	Eli Lilly and Company	2019-02-12	PHASE1
NCT05469113	COMPLETED	Healthy	Eli Lilly and Company	2019-01-29	PHASE1
NCT05630287	COMPLETED	Healthy	Eli Lilly and Company	2018-08-01	PHASE1
NCT05468164	COMPLETED	Healthy	Eli Lilly and Company	2018-05-31	PHASE1
NCT05338476	COMPLETED	Healthy	Eli Lilly and Company	2018-07-12	PHASE1
NCT05338489	COMPLETED	Healthy	Eli Lilly and Company	2018-05-11	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-24)

Check the LOXO-292 (Selpercatinib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Selpercatinib is a highly selective ATP-competitive kinase inhibitor that specifically binds to wild-type and mutant RET receptor tyrosine kinases, effectively blocking receptor auto-phosphorylation and downstream oncogenic signal transduction pathways. This potent molecular inhibition halts RET-driven cellular proliferation and induces targeted apoptosis, resulting in tumor regression across RET-altered malignancies including non-small cell lung cancer and medullary thyroid carcinoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).