BetaGlue Therapeutics SpA

BetaGlue Therapeutics Receives Belgium Ministry of Health Approval for YntraDose Clinical Trial in Unresectable Locally Advanced Pancreatic Cancer (uLA-PDAC)

MILAN, Dec. 15, 2025 (GLOBE NEWSWIRE) -- BetaGlue^® Therapeutics (“BetaGlue” or the “Company”), a pioneering Italian clinical-stage oncology company developing an innovative radiotherapy solution for the targeted treatment of solid tumours, is proud to announce that the Belgium Ministry of Health (MOH) has approved its Clinical Trial Application for YntraDose^® in the treatment of unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC). This authorization follows the recent approvals from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Italian Ministry of Health.

The clinical study is expected to begin enrolling patients in early 2026, with preliminary results expected by the end of the year. This early feasibility clinical investigation aims to assess the safety, usability and feasibility of YntraDose^® administration in patients with unresectable LA-PDAC, a disease with limited effective treatment options and a significant unmet medical need. YntraDose^® is an innovative locoregional radiotherapy that utilize Yttrium-90 microspheres embedded in a rapidly polymerizing matrix to deliver targeted radiation directly to solid tumours. This approach is designed to maximize therapeutic efficacy while minimizing damage to surrounding healthy tissue, offering new hope to patients facing unresectable locally advanced pancreatic cancer - one of the most aggressive and difficult-to-treat malignancies.

“The approval from the Belgian Ministry of Health underscores the growing international recognition of our approach. With regulatory endorsements now secured in Belgium, the UK, and Italy, we are well-positioned to accelerate the clinical development of YntraDose building a strong foundation for future growth, competitive advantage and advancing this innovative solution to address urgent unmet medical needs,” said Alexis Peyroles, CEO, BetaGlue^® Therapeutics.

About BetaGlue Therapeutics
BetaGlue^® Therapeutics is a clinical-stage oncology company developing a novel radiotherapy platform technology for the localised and targeted treatment of unresectable solid tumours called YntraDose^® which is currently being evaluated for LA-PDAC and has further potential in other indications.

About YntraDose^®
YntraDose^® device is a locoregional therapy (LRT) intended for the percutaneous radio-ablation of unresectable solid tumors. It represents a novel technology that aim to deliver a targeted radiation dose using Yttrium-90 microspheres injected directly into the tumour site, within a glue matrix holding the Y-90 microspheres in place.

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