IDO-IN-2 Clinical Trials

Size	Price	Qty
10mg	USD 170
50mg	USD 570

Clinical Trials

The clinical evaluation of IDO-IN-2 (GDC-0919) includes a clinical trial assessing its therapeutic potential in patients with solid tumors. Sponsored by Genentech, Inc., this completed Phase 1 study investigated the safety, tolerability, and pharmacology of IDO-IN-2 administered in combination with the anti-PD-L1 antibody atezolizumab. Overall, clinical development for this compound focuses on early-phase safety profiling and combinatorial immunotherapeutic strategies for solid malignancy management.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02471846	Completed	Solid Tumor	Genentech Inc.	2015-07-28	Phase 1

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

Check the IDO-IN-2 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

IDO-IN-2 acts as a potent inhibitor of indoleamine 2,3-dioxygenase 1 (IDO1), binding to the enzyme to prevent the enzymatic degradation of L-tryptophan into kynurenine. By mitigating local tryptophan depletion and kynurenine-mediated immunosuppression, this inhibition restores cytotoxic T-cell activity, suppressing immune evasion across solid tumor microenvironments.

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>).