Nanvuranlat, Physician's Best Choice, Best Supportive Care, Folfiri Regimen
Biliary Tract Cancer (Btc), Advanced Biliary Tract Cancer
Phase III
Recruiting
A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer
Nov 11, 2025
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does J-Pharma Co.,Ltd. (520A) have in its pipeline
520A is currently developing the following drugs: Jph034, Nanvuranlat, Physician's Best Choice, Best Supportive Care, Folfiri Regimen. These drug candidates are in various stages of clinical development as the company works toward FDA approval.