BetaGlue® Therapeutics Secures Belgium Approval For YntraDose® Clinical Trial In Unresectable Pancreatic Cancer Following UK And Italy Authorizations

BetaGlue® Therapeutics, an Italian clinical-stage oncology company developing innovative radiotherapy solutions for solid tumours, announced that the Belgium Ministry of Health has approved its Clinical Trial Application for YntraDose® in the treatment of unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC). This approval follows recent authorizations from the UK’s Medicines and Healthcare products Regulatory Agency and the Italian Ministry of Health, reflecting growing international recognition of the company’s approach.

The clinical study is expected to begin enrolling patients in early 2026, with preliminary results anticipated by the end of the year. This early feasibility trial will evaluate the safety, usability, and feasibility of YntraDose® administration in patients with unresectable LA-PDAC, a condition with very limited treatment options and significant unmet medical needs. 

YntraDose® is a locoregional radiotherapy therapy that uses Yttrium-90 microspheres embedded in a rapidly polymerizing matrix to deliver targeted radiation directly to solid tumours. This innovative approach is designed to maximize therapeutic effectiveness while minimizing exposure to surrounding healthy tissue, providing new treatment potential for patients facing one of the most aggressive and difficult-to-treat forms of pancreatic cancer.

Alexis Peyroles, Chief Executive Officer of BetaGlue® Therapeutics, stated that the approval from Belgium, alongside the UK and Italy, positions the company to accelerate clinical development of YntraDose®. He emphasized that these regulatory endorsements help build a strong foundation for future growth, strengthen the company’s competitive advantage, and advance a novel treatment addressing urgent unmet medical needs in oncology.