Selitrectinib (LOXO-195) Clinical Trials

Size	Price	Qty
5mg	USD 157
25mg	USD 477

Clinical Trials

Multiple Phase 1 clinical trials sponsored by Bayer have evaluated selitrectinib (BAY 2731954), all of which have achieved completed recruitment status. These studies investigated the compound in adult and pediatric patients with previously treated NTRK fusion-positive solid tumors, as well as fundamental pharmacokinetic parameters and food effects in healthy adults.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04275960	Completed	Solid Tumors Harboring NTRK Fusion	Bayer	2020-02-28	Phase 1
NCT03215511	Completed	Solid Tumors Harboring NTRK Fusion	Bayer	2017-07-03	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Selitrectinib (LOXO-195) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Selitrectinib selectively binds to and inhibits wild-type and mutant tropomyosin receptor kinase (TRK) enzymes—including TRKA G595R, TRKC G623R, and TRKA G667C—thereby blocking downstream signal transduction pathways. This target-specific enzymatic inhibition suppresses tumor cell proliferation and survival, ultimately providing anti-tumor activity in patients with solid tumors harboring NTRK fusions.

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>).