BetaGlue Therapeutics has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has approved the Clinical Trial Application for YntraDose in unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC).
The clinical study is an early feasibility clinical investigation and will assess safety and performance in patients with unresectable LA-PDAC and will be initiated in 2026.
The YntraDose device is a localised treatment designed to destroy solid tumours that can’t be removed by surgery.
It uses a novel approach that delivers a precise dose of radiation directly into the tumour by injecting Yttrium-90 microspheres held in place by a special glue-like matrix.
Why this matters
LA-PDAC remains a significant health concern and an unmet medical need.
The incidence of LA-PDAC has increased by one per cent per year since the late 1990s.
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 authorisation 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.”