Innovative investigational products for liver cancer and dementia recognised through the Innovative Licensing and Access Pathway ahead of next application round opening.
Two new medicines in development that could become effective therapies for patients in the future have been granted Innovation Passports (IP) through the UK's Innovative Licensing and Access Pathway (ILAP).
Innovation Passport designation is awarded to products that could address unmet clinical need and show potential to deliver significant benefits for patients. The ILAP is delivered through a partnership between the Medicines and Healthcare products Regulatory Agency (MHRA), NHS England, the UK Health Technology Assessment (HTA) bodies - the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) the All Wales Therapeutics and Toxicology Centre (AWTTC), and the Department of Health Northern Ireland.
Following assessment by the ILAP Selection Panel, an IP has been awarded to:
A biological medicine for hepatocellular carcinoma (liver cancer)
A small-molecule medicine for dementia with Lewy bodies
There are around 7,000 new liver cancer cases in the UK each year and hepatocellular carcinoma is the most common form. Dementia with Lewy bodies is a progressive and complex neurological condition that impacts around three in twenty dementia patients and treatment options remain limited.
These new IPs demonstrate the breadth of innovation that is supported through the ILAP and highlights the programme's role in accelerating the development of potentially transformative medicines across a wide range of therapeutic areas.
The Innovation Passport enables developers to access a range of services and enhanced regulatory and market access guidance through a coordinated pathway, designed to support the development of innovative medicines that address unmet patient needs.
The ILAP facilitates early and ongoing interaction with the MHRA, the HTA bodies and the NHS by offering a more efficient and joined-up engagement to help speed up access for patients.
The products awarded an IP are still in development, and any future availability will depend on the evidence of safety, effectiveness and value.
Companies developing innovative medicines that address unmet patient needs across all therapeutic areas are encouraged to review the eligibility criteria and submit an application. Full guidance is available on the MHRA website .
Applications for the next ILAP round open today (4 August 2026) and remain open until 4 November 2026.
James Pound, MHRA Executive Director, Innovation and Compliance, said:
"These latest Innovation Passport awards demonstrate the breadth and ambition of the Innovative Licensing and Access Pathway.
"By supporting innovative medicines across a diverse range of therapeutic areas, the ILAP helps developers engage with the regulatory system earlier and more effectively, with the ultimate goal of enabling earlier patient access to innovative new treatments.
"We are delighted to recognise these two innovative products and look forward to supporting their development through the pathway."
John Spoors, Programme Director for Commercial, Managed access and Medicines Policy at NICE said:
"We welcome the announcement that these two medicines have been granted Innovation Passports through the Innovative Licensing and Access Pathway. As an organisation committed to getting the best care to people fast, NICE welcomes the opportunity, through ILAP, to work with developers and partners across the health system to support evidence generation and early engagement on the issues that will shape future evaluation and patient access."
Sarah Knight, Senior Commercial Lead at NHS England, said:
"These Innovation Passport awards recognise promising new medicines in development that have the potential to benefit people living with liver cancer and dementia, who have limited treatment options.
"Through this innovative programme, NHS England is helping to provide pharmaceutical companies with earlier, joined-up advice and support, helping to fast-track drug development so treatments that prove safe, effective and good value can get to the people who need them sooner."
Dr Rob Peel, chair of the Scottish Medicines Consortium, said:
"The Scottish Medicines Consortium, as part of Healthcare Improvement Scotland, is pleased to see two more products enter the ILAP. Liver cancer is a devastating diagnosis for patients. The impact of dementia with Lewy bodies on patients and their families is far-reaching. We look forward to working with developers for these two products."
Dr Andrew Champion, AWTTC Programme Director, said:
"The latest Innovation Passports awarded through the Innovative Licensing and Access Pathway highlight the value and purpose of the process in supporting assessment of innovative medicines for patients with significant unmet clinical needs. AWTTC is proud to work alongside our UK partners to help improve access to promising new medicines that will ultimately benefit patients in Wales and across the UK."
James Harris, Interim General Manager, BeOne Medicines UK & Ireland Ltd. said:
"Patients with hepatocellular carcinoma continue to face a poor prognosis, underscoring the urgent need for new treatment options."
"We believe BGB-B2033 has the potential to make a meaningful difference for this patient population, and we welcome the opportunity to participate in the UK's Innovative Licensing and Access Pathway, which promotes early collaboration to accelerate patient access to potentially transformative medicines. We look forward to working closely with the MHRA and ILAP partners as we advance the development of this investigational medicine."
Dr. John Alam, CEO, CervoMed, said:
"We're grateful that CervoMed's investigational treatment, neflamapimod, will benefit from the integrated support provided by ILAP. The UK has been a global leader in research that has advanced the understanding and management of Dementia with Lewy bodies. With this designation, the UK government further demonstrates its conviction to accelerate access to treatments such as neflamapimod that have the potential to be a "step change" in the management of the estimated approximately 100,000 people in the UK living with this devastating disease. We look forward to the collaboration with UK regulators, HTA bodies, and NHS partners and work with those groups towards early alignment in the regulatory and reimbursement review process."
Notes:
Entry to ILAP is open to commercial and non-commercial developers worldwide. Applicants must submit medicines or drug-device combinations that have not yet entered their confirmatory trial, which will give more opportunity to benefit from the support offered within the pathway. More details can be found on the MHRA website .
The ILAP is a UK-wide initiative, comprising the following partners:
The All Wales Therapeutics and Toxicology Centre (AWTTC) (on behalf of NHS Health boards and Trusts in Wales)
The Medicines and Healthcare products Regulatory Agency (MHRA)
Scottish Medicines Consortium (SMC) (on behalf of NHS boards in Scotland)
Department of Health Northern Ireland
Supporting partners include:
Department of Health and Social Care (DHSC)
National Institute for Health Research (NIHR)
Office for Life Sciences (OLS)
Scottish Government
Welsh Government
Recently published articles that provide information on the benefit of the ILAP Target Development Profile and how the ILAP and the MHRA-NICE Aligned Pathway work together .
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
The MHRA is an executive agency of the Department of Health and Social Care.
