LY-3381916 Clinical Trials

Size	Price	Qty
5mg	USD 149
25mg	USD 447

Clinical Trials

Sponsored exclusively by Eli Lilly and Company, multiple Phase 1 clinical trials evaluated LY-3381916 as both a standalone therapeutic agent and in combination with an anti-PD-L1 immune checkpoint antibody. These investigations targeted several advanced oncological conditions, specifically solid tumors, non-small cell lung cancer, renal cell carcinoma, and triple-negative breast cancer. Overall, recruitment across these trials has been terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03343613	TERMINATED	Solid Tumor; Non Small Cell Lung Cancer; Renal Cell Carcinoma; Triple Negative Breast Cancer	Eli Lilly and Company	2017-11-17	PHASE1
NCT03343613	Terminated	Solid Tumor\|Non Small Cell Lung Cancer\|Renal Cell Carcinoma\|Triple Negative Breast Cancer	Eli Lilly and Company	2017-11-17	Phase 1

(data from https://clinicaltrials.gov, updated on 2020-06-09)

Check the LY-3381916 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY-3381916 selectively binds to and inhibits indoleamine 2,3-dioxygenase 1 (IDO1), thereby blocking the enzymatic degradation of tryptophan into kynurenine and halting immunosuppressive metabolite accumulation in the tumor microenvironment. This inhibition reverses immune tolerance and restores T-cell-mediated anti-tumor responses, offering therapeutic potential against advanced malignancies such as non-small cell lung cancer, renal cell carcinoma, and triple-negative breast 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>).