New York, NY, April 28, 2026 - Remepy, the pioneer of Hybrid Drugs, today 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 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 outcomes[1].
“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.
About Remepy
Remepy is pioneering Hybrid Drugs™, a new class of medicine that combines pharmacological treatments with evidence-based personalized, AI-driven motor, cognitive and behavioral interventions delivered through a mobile app. By combining biology, behavior and technology into a single prescription, Remepy enhances clinical outcomes beyond medication alone. Hybrid Drugs follow traditional pharma development, validation, regulation and reimbursement, leveraging emerging regulatory frameworks for drug-software combinations. For more information, please visit www.remepy.com.
Media contact:
Tsipi Haitovsky
Global Media Liaison
Remepy
press@remepy.com
[1] References:
- Drug + digital is an emerging validated category - Rohaj A, Bulaj G. Digital Therapeutics for Improving Effectiveness of Pharmaceutical Drugs and Biological Products: Preclinical and Clinical Studies Supporting Development of Drug + Digital Combination Therapies for Chronic Diseases. Journal of Clinical Medicine. 2024 Jan 11;13(2):403. doi: 10.3390/jcm13020403. PMID: 38276909. PMC10816409.
- Multidisciplinary + medication is superior to medication alone - Katon WJ, Lin EHB, Von Korff M, Ciechanowski P, Ludman EJ, Young B, et al. Collaborative Care for Patients with Depression and Chronic Illnesses. New England Journal of Medicine. 2010;363(27):2611–2620. doi: 10.1056/NEJMoa1003955.
- Behavioral/physical/cognitive interventions improve outcomes alongside drugs - (1) Kollins SH, Childress A, Heusser AC, Lutz J. Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. npj Digital Medicine. 2021 Mar 26;4(1):58. doi: 10.1038/s41746-021-00429-0. PMID: 33772054. PMC7998014. (2) Mao JJ, Ismaila N, Bao T, Bruner D, Chi CM, Cohen L, et al. Integrative Medicine for Pain Management in Oncology: Society for Integrative Oncology–ASCO Guideline. Journal of Clinical Oncology. 2022;40(34):3998–4024. doi: 10.1200/JCO.22.01357.
