Clinical Trials

The clinical trial landscape for JPH203 (Nanvuranlat) currently includes a clinical trial evaluating its therapeutic potential in oncology. Sponsored by J-Pharma Co., Ltd., this actively recruiting, Phase III multicenter study is assessing the efficacy and safety of the compound in patients with previously treated advanced biliary tract cancer. This pivotal late-stage investigation represents a critical effort to determine whether selective amino acid transport inhibition can improve clinical outcomes in refractory biliary malignancies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07265674 RECRUITING
Advanced Biliary Tract Cancer; Biliary Tract Cancer (BTC)
J-Pharma Co., Ltd.
 2026-05-11 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-07-01)

Check the JPH203 (Nanvuranlat) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

JPH203 selectively binds to L-type amino acid transporter 1 (LAT1), thereby blocking cellular uptake of essential amino acids such as leucine and disrupting downstream metabolic pathways required for cell survival. This intracellular nutrient deprivation suppresses tumor cell growth and proliferation, providing the mechanistic rationale for investigating Nanvuranlat in clinical trials for advanced biliary tract 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>).

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Note: Technical data last updated: Sep 1, 2026.