Digital therapeutics: Emerging trends in clinical pharmacology

Digital therapeutics (DTx) are software-based interventions intended to prevent, manage, or treatmedical disorders and are distinguished from general digital-health tools by a therapeutic claimsupported by clinical evidence. Their clinical value is increasingly being explored alongsidepharmacotherapy, particularly for medication adherence, behavioral modification, symptommanagement, and adjunctive treatment. However, DTx should not be equated with mobile health(mHealth), telemedicine, wearable devices, remote patient monitoring, or Artificial Intelligence (AI);these technologies may support a DTx but are not synonymous with it. This narrative reviewsummarizes the evolution, definitions, clinical evidence, regulatory landscape, and emergingapplications of DTx with emphasis on clinical pharmacology. Literature was identified fromPubMed/MEDLINE, Scopus, Web of Science, ScienceDirect, Google Scholar, and SpringerLink, withadditional regulatory and product information obtained from official regulatory sources. Particularattention was given to randomized or controlled clinical studies, prescription DTx, medication-relatedoutcomes, and regulatory terminology. Clinical evidence indicates that selected DTx can improvedisease-specific outcomes, including abstinence and treatment retention in substance-use disorders,attention outcomes in pediatric attention-deficit/hyperactivity disorder, insomnia severity, depressionsymptoms as an adjunct to antidepressants, glycemic control, and migraine frequency. Nevertheless,evidence is heterogeneous, long-term effectiveness and engagement remain uncertain for severalproducts, and DTx do not routinely provide pharmacokinetic monitoring or autonomous doseadjustment. Future clinical-pharmacology applications should therefore focus on evidence-basedmedication adherence support, pharmacogenomics-informed decision support, therapeutic drugmonitoring, adverse-drug-reaction surveillance, and integration with interoperable clinical systemswhile maintaining appropriate human oversight, cybersecurity, and post-market evaluation.