BLU-667 (Pralsetinib) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 237

Clinical Trials

Multiple clinical trials evaluate the therapeutic profile of pralsetinib across Phase 1 through Phase 4 studies, focusing on RET-fusion non-small cell lung cancer, medullary thyroid cancer, and advanced RET-altered solid tumors. Sponsored by academic medical centers and pharmaceutical companies such as Hoffmann-La Roche, Genentech, and Blueprint Medicines, these trials encompass diverse recruitment statuses, including recruiting, active, completed, withdrawn, and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04589845	ACTIVE_NOT_RECRUITING	Solid Tumors	Hoffmann-La Roche	2021-01-18	PHASE2
NCT07010393	NOT_YET_RECRUITING	Thyroid Neoplasms	Fujian Medical University	2025-07-01	PHASE4
NCT07418879	NOT_YET_RECRUITING	Non-small Cell Lung Cancer; RET Fusion; Pralsetinib	Fudan University	2026-02-05
NCT06563999	RECRUITING	Lung Cancer Stage III; Mutation	Sun Yat-sen University	2024-11-01	PHASE2
NCT04760288	WITHDRAWN	Medullary Thyroid Cancer	Hoffmann-La Roche	2023-11-30	PHASE3
NCT07704658	RECRUITING	NSCLC (Non-small Cell Lung Cancer); Thyroid Cancer; Solid Tumor Malignancies; Advanced Malignancies	Rigel Pharmaceuticals	2026-03-04	PHASE4
NCT06195228	RECRUITING	Advanced Thyroid Cancer Patients Who Received Target Therapy	Fudan University	2020-01-01	PHASE4
NCT04302025	RECRUITING	Non-small Cell Lung Cancer	Genentech, Inc.	2020-11-06	PHASE2
NCT04222972	TERMINATED	RET-fusion Non Small Cell Lung Cancer; Lung Neoplasm; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Disease; Carcinoma, Bronchogenic; Bronchial Diseases; Head and Neck Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms by Histologic Type; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue	Hoffmann-La Roche	2020-07-24	PHASE3
NCT06482086	RECRUITING	Locally Advanced Thyroid Gland Carcinoma	West China Hospital	2021-06-01	PHASE2
NCT04591431	UNKNOWN	Breast Cancer; Gastrointestinal Cancer; Non Small Cell Lung Cancer; Other Cancer	Fondazione per la Medicina Personalizzata	2020-10-07	PHASE2
NCT03037385	COMPLETED	RET-altered Non Small Cell Lung Cancer; Medullary Thyroid Cancer; RET-altered Papillary Thyroid Cancer; RET-altered Colon Cancer; RET-altered Solid Tumors; Lung Neoplasm; Carcinoma, Non-Small-Cell Lung; Thyroid Diseases; Thyroid Neoplasm; Thyroid Cancer, Papillary; Carcinoma, Neuroendocrine; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Disease; Carcinoma, Bronchogenic; Bronchial Neoplasms; Endocrine System Diseases; Endocrine Gland Neoplasm; Head and Neck Neoplasms; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Colonic Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasm; Digestive System Disease; Gastrointestinal Disease; Colonic Diseases; Intestinal Disease	Hoffmann-La Roche	2017-03-17	PHASE1; PHASE2
NCT04632992	COMPLETED	Advanced Unresectable or Metastatic Solid Malignancy	Genentech, Inc.	2021-01-13	PHASE2
NCT04760288	Withdrawn	Medullary Thyroid Cancer	Hoffmann-La Roche	2023-11-30	Phase 3
NCT04697446	Unknown status	RET-fusion Non Small Cell Lung Cancer\|Lung Neoplasm\|Carcinoma Non-Small-Cell Lung\|Respiratory Tract Neoplasms\|Thoracic Neoplasms\|Neoplasms by Site\|Neoplasms\|Lung Diseases\|Respiratory Tract Diseases\|Carcinoma Bronchogenic\|Bronchial Diseases\|Head and Neck Neoplasms\|Carcinoma\|Neoplasms by Histologic Type\|Neoplasms Germ Cell and Embryonal\|Neoplasms Nerve Tissue\|Metastatic Non Small Cell Lung Cancer	Blueprint Medicines Corporation\|Analysis Group Inc.	2020-12-01	--
NCT03037385	Completed	RET-altered Non Small Cell Lung Cancer\|Medullary Thyroid Cancer\|RET-altered Papillary Thyroid Cancer\|RET-altered Colon Cancer\|RET-altered Solid Tumors\|Lung Neoplasm\|Carcinoma Non-Small-Cell Lung\|Thyroid Diseases\|Thyroid Neoplasm\|Thyroid Cancer Papillary\|Carcinoma Neuroendocrine\|Respiratory Tract Neoplasms\|Thoracic Neoplasms\|Neoplasms by Site\|Neoplasms\|Lung Diseases\|Respiratory Tract Disease\|Carcinoma Bronchogenic\|Bronchial Neoplasms\|Endocrine System Diseases\|Endocrine Gland Neoplasm\|Head and Neck Neoplasms\|Adenocarcinoma Papillary\|Adenocarcinoma\|Carcinoma\|Neoplasms Glandular and Epithelial\|Neoplasms by Histologic Type\|Neuroendocrine Tumors\|Neuroectodermal Tumors\|Neoplasms Germ Cell and Embryonal\|Neoplasms Nerve Tissue\|Colonic Neoplasms\|Colorectal Neoplasms\|Intestinal Neoplasms\|Gastrointestinal Neoplasms\|Digestive System Neoplasm\|Digestive System Disease\|Gastrointestinal Disease\|Colonic Diseases\|Intestinal Disease	Hoffmann-La Roche	2017-03-17	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-09-04)

Check the BLU-667 (Pralsetinib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pralsetinib selectively binds to and inhibits wild-type and oncogenic mutant RET kinase, blocking downstream phosphorylation events and suppressing intracellular pro-survival signaling pathways. Consequently, this targeted inhibition decreases tumor cell viability and arrests proliferation, providing clinical efficacy against RET-driven malignancies such as non-small cell lung cancer and medullary thyroid cancer.

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>).