olomorasib Clinical Trials

Size	Price	Qty
1mg	USD 197
5mg	USD 347

Clinical Trials

Numerous clinical trials evaluate olomorasib as monotherapy and combination therapy across Phase I through Phase III development, focusing on KRAS G12C-mutated malignancies—specifically locally advanced and metastatic non-small cell lung cancer—as well as pharmacokinetic and safety profiles in healthy volunteers and participants with hepatic insufficiency. Sponsored by organizations including Eli Lilly and Company, Janssen Research & Development, and the UNC Lineberger Comprehensive Cancer Center, these studies encompass varied recruitment statuses ranging from completed clinical pharmacology trials to actively recruiting, suspended, and upcoming protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07639242	SUSPENDED	Lung Cancer; Lung Cancer (NSCLC); Locally Advanced NSCLC; Metastatic NSCLC - Non-Small Cell Lung Cancer	UNC Lineberger Comprehensive Cancer Center	2026-10	PHASE2
NCT06890598	RECRUITING	Carcinoma, Non-Small-Cell Lung	Eli Lilly and Company	2025-03-27	PHASE3
NCT07227025	RECRUITING	Carcinoma, Non-Small-Cell Lung	Janssen Research & Development, LLC	2026-03-03	PHASE1; PHASE2
NCT07794592	NOT_YET_RECRUITING	Healthy Volunteers	Eli Lilly and Company	2026-08	PHASE1
NCT07439250	COMPLETED	Healthy	Eli Lilly and Company	2026-03-02	PHASE1
NCT07124013	COMPLETED	Healthy	Eli Lilly and Company	2025-09-16	PHASE1
NCT07044271	COMPLETED	Healthy	Eli Lilly and Company	2025-07-11	PHASE1
NCT06719128	COMPLETED	Hepatic Insufficiency; Healthy	Eli Lilly and Company	2024-12-06	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-28)

Check the olomorasib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Olomorasib is a highly selective inhibitor that specifically binds to the GDP-bound inactive state of the mutant KRAS G12C protein, effectively blocking downstream oncogenic signaling pathways and suppressing tumor cell proliferation. By preventing KRAS G12C-mediated signal transduction, olomorasib impairs cellular survival, providing a targeted therapeutic strategy for KRAS G12C-mutated advanced solid tumors, including non-small cell lung cancer currently being evaluated in clinical trials.

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>).