Positive regulatory feedback from EMA and FDA for mouthwash treatment known as Muc1 (previously NG11-2),to help prevent radiotherapy-induced mouth ulcers (oral mucositis)
24th April 2026
VasoDynamics Ltd, the pharmaceutical company developing patient-friendly therapies for the prevention of debilitating side-effects induced by anti-cancer treatments, is pleased to confirm that, following the Parallel Scientific Advice meeting in February 2026, encouraging feedback has been obtained from both the EMA & FDA on the Pathway to Market and Pivotal Trial of Muc1 (NG11-2), a novel product for the prevention of severe oral mucositis induced by radiotherapy.
This Advice adds to that previously received from UK Medicines Healthcare Regulatory Agency (MHRA) and Dutch Medicines Evaluation Board (MEB) and confirms the EU & US Regulatory requirements necessary to obtain a future Marketing Authorisation and will enable an efficient and cost-effective clinical programme to be pursued.
Both Agencies recognised that prevention of oral mucositis induced by radiotherapy is a currently unmet medical need.
Dr Ningfeng Fiona Li, CEO of VasoDynamics, said:
“We are delighted to receive constructive and encouraging Scientific Advice from both the EMA & FDA. We greatly appreciate the valuable advice on the design of future Muc1 (NG11-2) studies and confirmation of the pathway to Market Approval. Combining this Advice with that previously received from MEB in the Netherlands, and MHRA in the UK, we now have a clear roadmap to bring Muc1 (NG11-2) to patients and the market in near future.”
Notes to Editors:
About VasoDynamics
VasoDynamics is a clinical-stage, pharmaceutical development company based in Stevenage-London, UK. Recognising the mounting cost pressures facing healthcare payers all over the world, the company is developing highly cost-effective medicines for the prevention of debilitating and often dose-limiting complications of cancer therapy, such as chemotherapy and radiotherapy induced mucositis, dermatitis, and hair-loss.
