Merck KGaA and Remepy Join Forces to Develop Combo Drug-Digital Therapies.

Remepy has announced a collaboration with Merck KGaA, Darmstadt, Germany, a leading science and technology company, to explore the development of Hybrid Drugs across multiple therapeutic areas.

The collaboration is initially focused on some programs in the US in a rare tumor area, while potentially establishing a broader framework to explore additional Hybrid Drug opportunities across the therapeutic portfolio of Merck KGaA, Darmstadt, Germany, in the future.

Research increasingly shows that the most effective care is multidisciplinary and integrative, combining medication with behavioural and therapeutic interventions. Hybrid Drugs integrate these evidence-based motor, physical, and cognitive interventions alongside medication to improve clinical outcomes.

According to Towards Healthcare, the prescription digital therapeutics market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 5.92 billion in 2026 to approximately USD 37.59 billion by 2035, representing a compound annual growth rate (CAGR) of 22.8% from 2026 to 2035. Growth is driven by the growing investments in telehealth, and partnerships between health tech companies and payers are helping increase patient access and provider adoption. The integration of AI/ML, wearables, and smartphone applications allows PDTs to deliver continuous, evidence-based cognitive-behavioural therapies (CBT) and biofeedback directly to patients in a convenient, discreet, and cost-effective manner.

About Merck KGaA and Remepy

Merck KGaA and digital therapeutics startup Remepy are partnering to develop "Hybrid Drugs" single-prescription products that pair pharmaceuticals with AI-driven, personalized mobile apps, which aim to boost clinical efficacy while avoiding the tough reimbursement hurdles plaguing standalone prescription digital therapeutics (PDTs).
It follows a hybrid mechanism where app-based software runs concurrently, personalized physical, behavioral, and symptom-tracking protocols alongside the medication to support holistic patient care.

The integration is designed to align PDURS Strategy with the FDA's Prescription Drug Use-Related Software (PDURS) guidelines. By submitting the drug and software together, they become a unified, FDA-evaluated treatment rather than separate interventions.

The duo’s collaboration will focus on a confidential rare cancer indication,PhD, co-founder and co-CEO of Remepy, Dr Michal Tsur, said, multi-disciplinary care can hold a lot of value. “Drug-software solutions are particularly rewarding in the context of rare diseases, as patients often have limited access to care and information.

A recent report by Towards Healthcare highlights that the prescription digital therapeutics market is witnessing growth driven by the need for scalable mental health and chronic disease management. This growth is accelerated by widespread smartphone adoption and favourable regulatory pathways. With clinically proven efficacy, PDTx solutions require a licensed clinician's prescription and are built on clinical trial evidence.