On April 28, 2026 Remepy, the pioneer of Hybrid Drugs, reported a collaboration with Merck KGaA, Darmstadt Germany, a leading science and technology company, to explore the development of Hybrid Drugs across multiple therapeutic areas.
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The collaboration will initially focus 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.
Hybrid Drugs are an emerging therapeutic category that combine pharmacological treatments with personalized digital therapeutic protocols delivered through a mobile app. Research increasingly shows that the most effective care is multidisciplinary and integrative, combining medication with behavioral and therapeutic interventions. Hybrid Drugs integrate these evidence-based motor, physical, and cognitive interventions alongside medication to improve clinical outcomes1.
"We are excited about our collaboration with Merck KGaA, Darmstadt, Germany, that is a leading science and technology company," said Dr. Michal Tsur, Co-founder and Co-CEO at Remepy. "Remepy’s Hybrid Drug platform combines traditional drugs with evidence-based AI enabled digital interventions delivering personalized, adaptive integrative treatment. The new advances in regulatory frameworks, supporting the integration of software with drugs, enable the pharma industry to use the power of the digital world to differentiate drugs, enhance their efficacy and amplify their label. We are looking forward to accelerating the delivery of innovative and effective therapies to patients who need them most."
Recent developments, including the introduction of FDA Prescription Drug Use-Related Software (PDURS) guidance, and evolving SaMD-Drug combination pathways are creating clearer regulatory routes for integrating digital therapeutic components directly into pharmaceutical products. Advances in FDA digital health initiatives and guidance on AI for medical devices are opening the door to a new generation of innovative therapeutic solutions.
Hybrid Drugs introduce a new economic model for digital health. By combining a drug and a therapeutic application into a single prescription product, hybrid drugs shift digital health innovation into the established economics of pharmaceutical development, commercialization, and reimbursement.
(Press release, Merck KGaA, APR 28, 2026, View Source [SID1234664872])