Shuttle Pharma Enrollment Nears 50% In Phase 2 Glioblastoma Trial With Ropidoxuridine, Readout Expected In 2026

Shuttle Pharmaceuticals announced it is nearing 50% enrollment in the Phase 2 trial of Ropidoxuridine (IPdR), a novel radiation sensitizer being tested in combination with radiation therapy (RT) for glioblastoma, a highly aggressive brain cancer. Early data from participating sites indicate favorable tolerability, with no patient experiencing a toxicity level higher than grade 2 (on a 1–5 scale). Furthermore, 84% of enrolled patients have completed all seven treatment cycles, marking a strong adherence rate in this initial randomized study.

“We are incredibly encouraged by the expedited progress of our Phase 2 trial and the dedication of our team, clinical partners, and patients who are making this milestone possible. If approved, we believe that Ropidoxuridine has the potential to redefine the standard approach for how to care for patients with glioblastoma,” commented Shuttle Pharma’s Chairman and Chief Scientific Officer, Anatoly Dritschilo, M.D.  

The trial is evaluating two dose levels (960 mg/day and 1,200 mg/day) in 40 patients to determine an optimal dosage, followed by enrollment of an additional 14 patients at that dose. The goal is to establish increased survival compared to historical controls, with full enrollment targeted for completion later this year and data readout expected in 2026. Shuttle is concurrently analysing PK/PD samples to assess how drug concentration correlates with response and duration of action.

“This clinical trial is critical to the broader radiation therapy industry as we look to leverage radiation sensitisers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma. I look forward to continued trial execution as we aim to improve the lives of millions of patients impacted by cancer and to bring hope to patients and families around the world,” Dr. Dritschilo added.

Ropidoxuridine has received Orphan Drug Designation from the FDA, providing potential market exclusivity upon approval. Each year, approximately 800,000 cancer patients in the U.S. receive RT, with nearly 400,000 treated for curative purposes, the target population for radiation sensitizers. This market is expected to grow by over 22% in five years, positioning Shuttle’s lead candidate as a promising therapy in a field with significant unmet medical need.