MHRA Grants Approval To BetaGlue Therapeutics For Clinical Trial Of YntraDose™ In Unresectable Locally Advanced Pancreatic Cancer

BetaGlue Therapeutics, a clinical-stage oncology company focused on developing innovative radiotherapy solutions for the targeted treatment of solid tumors, has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has approved its Clinical Trial Application for YntraDose in patients with unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC).

The upcoming study will be an early feasibility clinical investigation designed to assess the safety and performance of YntraDose in patients diagnosed with unresectable locally advanced pancreatic ductal adenocarcinoma. This form of pancreatic cancer remains one of the most serious and challenging malignancies to treat. LA-PDAC continues to represent a major unmet medical need, with its incidence increasing by approximately 1% each year since the late 1990s. Experts project that by 2030, it could become the second-leading cause of cancer-related deaths worldwide.

Commenting on the announcement, Alexis Peyroles, Chief Executive Officer of BetaGlue Therapeutics, stated that the MHRA’s approval marks a fundamental milestone in the clinical development of YntraDose and a significant step forward in the company’s mission to advance innovation in oncology. 

He added that this authorization allows BetaGlue to initiate its first clinical study in the United Kingdom in the first quarter of 2026, moving closer to offering a new therapeutic option for patients suffering from unresectable locally advanced pancreatic cancer, one of the most aggressive and life-threatening forms of the disease. Peyroles also expressed appreciation for the continued efforts of the company’s team and Clinical Advisory Board, as well as the constructive collaboration with regulatory authorities throughout the process.