April 13, 2026
J-Pharma Co., Ltd.
J-Pharma Co., Ltd. hereby announces that an archived video of a webinar (online seminar) hosted by the Cholangiocarcinoma Foundation, regarding the global Phase 3 clinical trial (study name: Beacon-BTC) of “Nanvuranlat,” an investigational product for advanced biliary tract cancer, has been made available.
During the event, Dr. Eric Rowinsky, Study Director for this clinical trial on behalf of the sponsor (J-Pharma) and responsible for overall medical oversight, provided an overview of the study. In addition, our President and CEO, Masuhiro Yoshitake, participated in the Q&A session and addressed questions from attendees.
■ Webinar Details
Date and Time: April 9, 2026, 4:00 PM – 5:00 PM Eastern Time
(April 10, 2026, 5:00 AM – 6:00 AM Japan Standard Time)
Title:
Understanding a Phase 3 Clinical Study of Nanvuranlat for Advanced Biliary Tract Cancer
Speaker:
Eric Rowinsky, MD
Chief Medical Officer, Uniphar Development
Q&A Session:
Eric Rowinsky, MD
Masuhiro Yoshitake
President and CEO, J-Pharma Co., Ltd.
Organizer:
Cholangiocarcinoma Foundation
Sponsor:
J-Pharma Co., Ltd.
The webinar recording is available at:
https://youtu.be/OzCJlff5KkA
The Cholangiocarcinoma Foundation is a U.S.-based non-profit organization dedicated to supporting patients with cholangiocarcinoma and advancing research in this field.
About Global Phase 3 Clinical Trial (Study Name: Beacon-BTC)
The name “Beacon-BTC” was chosen in the hope that this study will serve as a beacon of hope for patients with biliary tract cancer (BTC).
Beacon-BTC aims to evaluate the efficacy and safety of our investigational product, nanvuranlat, in patients with BTC receiving second-line therapy, for whom treatment options remain extremely limited. The study consists of two parts, with overall survival (OS) as the primary endpoint.
In Part A, approximately 30 patients per group will be enrolled to determine the optimal dose of nanvuranlat from three dosing regimens in comparison with Physician’s Best Choice* (PBC).
In Part B, approximately 180 patients per group will be enrolled to compare the selected nanvuranlat regimen with PBC.
* Physician’s Best Choice (PBC) refers to a treatment selected by the physician from among currently approved standard therapies or commonly used regimens deemed appropriate for each patient. In this trial, the options are FOLFOX therapy, FOLFIRI therapy, or best supportive care.
About Nanvuranlat
Nanvuranlat is a novel LAT1-selective inhibitor originally discovered by J-Pharma and is the first small-molecule compound of its kind to be clinically developed worldwide. If approved as a pharmaceutical product, it has the potential to become a first-in-class drug with a novel mechanism of action for its target disease.
Since 2015, J-Pharma has conducted Phase 1 clinical studies in multiple solid tumors and identified its potential for the treatment of advanced biliary tract cancer. A Phase 2 clinical study targeting advanced biliary tract cancer was conducted starting in 2018, demonstrating that nanvuranlat monotherapy provides clinically meaningful benefit.*
Nanvuranlat was designated as an orphan drug by the U.S. Food and Drug Administration (FDA) in April 2022. Furthermore, on September 25, 2024, the FDA approved the Investigational New Drug (IND) application for clinical studies in cancer patients. In addition, in May 2025, J-Pharma confirmed that the Chemistry, Manufacturing, and Controls (CMC) at the commercial manufacturing scale meet the quality standards required by the FDA.
* Publication on the results of the Japan Phase 2 clinical study of Nanvuranlat:
Furuse et al. A Phase 2 Placebo-Controlled Study of the Effect and Safety of Nanvuranlat in Patients with Advanced Biliary Tract Cancers Previously Treated by Systemic Chemotherapy. Clin Cancer Res. 2024; 30(18):3990–3995.
About J-Pharma Co., Ltd.
J-Pharma Co., Ltd. aims to pursue new possibilities for SLC transporters and contribute to the hope and health of people worldwide through the development of innovative new drugs that address unmet medical needs. Under this mission, the Company has focused on LAT1 (L-type amino acid transporter 1), one of the SLC transporters discovered by the Company’s founder, and is advancing the development of LAT1 inhibitors to address the needs of patients with cancer and autoimmune diseases, where existing drugs are insufficient.
For more information, please visit: https://www.j-pharma.com/en/
Inquiries:
J-Pharma Co., Ltd.
Planning Department
TEL : +81-3-6432-4270
https://www.j-pharma.com/en/contact