GAIA AG, a digital therapeutics company, has entered into an exclusive strategic partnership with Daiichi Sankyo Europe to commercialise lipodia, a digital therapeutic developed to support adults living with Hypercholesterolemia. The collaboration will take effect following regulatory approval of the therapy.

The partnership combines GAIA’s expertise in developing clinically validated, fully automated digital therapeutics with Daiichi Sankyo Europe’s scientific leadership in cardiovascular risk management. Both companies are members of the German Association of Research-Based Pharmaceutical Companies.

Under the agreement, Daiichi Sankyo Europe will receive exclusive commercialisation rights for lipodia, expanding its cardiovascular portfolio into the rapidly growing field of digital therapeutics. The collaboration will initially focus on Germany, Europe’s largest healthcare market, with potential expansion into other major European markets in the future.

Cardiovascular diseases remain the leading cause of death in Europe, responsible for more than 10,000 deaths daily. However, health experts estimate that nearly 80 percent of heart disease and stroke cases could be prevented through effective management of risk factors such as high blood pressure, high cholesterol, diabetes, smoking, obesity and physical inactivity.

Lipodia is designed to address behavioural and lifestyle factors that contribute to cardiovascular risk. Built on evidence-based behavioural health science and psychological therapy methods, the digital therapeutic uses interactive dialogues and personalised guidance to help patients adopt and maintain healthier daily routines. The platform can be accessed through connected devices, enabling flexible and location-independent use.

Dr Mario Weiss, Chief Executive Officer of GAIA AG, said digital therapeutics represent a new dimension in cardiovascular care by addressing behavioural and psychological barriers that medication alone cannot resolve. He noted that the partnership with Daiichi Sankyo Europe will help integrate the therapy into routine clinical care and extend its reach to patients and physicians.

Oliver Appelhans, Head of the EU Specialty Business Unit at Daiichi Sankyo Europe, emphasised that the company aims to support patients beyond pharmaceutical treatments. He said combining drug-based therapies with evidence-based digital health tools could strengthen long-term cardiovascular outcomes and support a more holistic approach to heart health.

To expand patient access, GAIA plans to apply for reimbursement once data from a pivotal phase III randomised clinical trial become available. If approved, lipodia could be prescribed by physicians and reimbursed through Germany’s digital health application reimbursement pathway, making it accessible through statutory health insurance.

The collaboration reflects a broader shift in healthcare toward integrated treatment approaches that combine traditional medicines with digital solutions to support long-term disease management.

GAIA AG has over 25 years of experience in developing digital therapeutics and has validated the effectiveness of its products through more than 30 randomised controlled trials and meta-analyses across therapeutic areas including mental health, immunology, rheumatology and chronic pain.