Olomorasib (Unassigned Enantiomer) Clinical Trials

Size	Price	Qty
5mg	USD 247
25mg	USD 739

Clinical Trials

Sponsored by Eli Lilly and Company and Loxo Oncology Inc., numerous Phase I, Phase II, and Phase III clinical trials are evaluating olomorasib (LY3537982) across diverse indications, including advanced solid tumors, non-small-cell lung carcinoma, metastatic disease, and colorectal, endometrial, ovarian, pancreatic, and biliary neoplasms. Several Phase I clinical trials assess pharmacokinetics, drug interactions, and safety in healthy volunteers as well as participants with hepatic or renal impairment. Across these trials, recruitment statuses range from actively recruiting and active, not recruiting, to completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06119581	RECRUITING	Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis	Eli Lilly and Company	2023-12-21	PHASE3
NCT04956640	ACTIVE_NOT_RECRUITING	Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms; Biliary Tract Neoplasms	Eli Lilly and Company	2021-07-19	PHASE1; PHASE2
NCT07439250	COMPLETED	Healthy	Eli Lilly and Company	2026-03-02	PHASE1
NCT07137689	COMPLETED	Renal Insufficiency	Eli Lilly and Company	2025-08-18	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
NCT06235983	COMPLETED	Advanced Solid Tumors	Eli Lilly and Company	2024-02-29	PHASE1
NCT06111521	COMPLETED	Healthy	Eli Lilly and Company	2023-10-27	PHASE1
NCT06235983	Recruiting	Advanced Solid Tumors	Eli Lilly and Company	2024-02-29	Phase 1
NCT05860933	COMPLETED	Healthy	Eli Lilly and Company	2023-05-08	PHASE1
NCT05901311	COMPLETED	Healthy	Eli Lilly and Company	2023-06-05	PHASE1
NCT05824858	COMPLETED	Healthy	Eli Lilly and Company	2023-04-12	PHASE1
NCT05901311	Completed	Healthy	Eli Lilly and Company\|Loxo Oncology Inc.	2023-06-05	Phase 1
NCT05860933	Completed	Healthy	Eli Lilly and Company\|Loxo Oncology Inc.	2023-05-08	Phase 1
NCT05824858	Completed	Healthy	Eli Lilly and Company\|Loxo Oncology Inc.	2023-04-12	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-24)

Check the Olomorasib (Unassigned Enantiomer) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Olomorasib selectively binds to and inhibits the mutated KRAS-G12C protein, thereby blocking oncogenic downstream signaling cascades and suppressing the proliferation of KRAS G12C-mutant tumor cells. By arresting cell growth driven by constitutive KRAS activation, this targeted inhibition provides therapeutic efficacy against KRAS G12C-driven malignancies, supporting its clinical evaluation in advanced solid tumors such as non-small-cell lung cancer and colorectal neoplasms.

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>).