MHRA Approves BetaGlue Therapeutics’ Clinical Trial Application for YntraDose™ in unresectable Locally Advanced Pancreatic Cancer (uLA-PDAC)

On November 12, 2025 BetaGlue Therapeutics ("BetaGlue" or the "Company") a clinical-stage oncology company developing an innovative radiotherapy solution for the targeted treatment of solid tumours, reported that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has approved the Clinical Trial Application for YntraDose in unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC).

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The clinical study is an early feasibility clinical investigation and will assess safety and performance in patients with unresectable locally advanced pancreatic ductal adenocarcinoma. LA-PDAC remains a significant health concern and an unmet medical need. The incidence of LA-PDAC has increased by 1.0% per year since the late 1990s, and it is projected to become the second-leading cause of cancer-related mortality by 2030.

"The approval by the MHRA represents a fundamental milestone in the clinical development of YntraDose and a meaningful step forward in our commitment to innovation in oncology," said Alexis Peyroles, CEO of BetaGlue Therapeutics. "This authorization enables us to initiate our first clinical study in the UK in Q1 2026, marking a critical step toward delivering a novel therapeutic option for patients with unresectable locally advanced pancreatic cancer, one of the most aggressive and deadly malignancies. We are proud of the dedication shown by our team and Clinical Advisory Board and grateful for the collaborative engagement with regulatory authorities".

(Press release, BetaGlue Therapeutics, NOV 12, 2025, View Source [SID1234661240])