An Overview of the Regulatory and Developmental Strategies of Chronotherapeutics

Abstract

The pivotal idea toward the development of chronotherapeutics is synchronizing the in vivo drug bioavailability with the rhythms of the disease to optimize therapeutic outcomes and minimize side effects, which is contrary to the homeostatic theory of drug delivery. The advent of formulation technologies, marketing exclusivities of innovative products, and provisions/amendments in regulatory frameworks have led to the development of commercial chronotherapeutic products, but their numbers are few and are confined mainly to diseases of the cardiovascular system. A major bottleneck for its development would be the understanding of rhythmic variations of disease, but following regulatory pathways for commercial development has always been challenging. In this article, a few commercial products have been investigated in view of their developmental strategies in order to find out the minimum preclinical and clinical studies needed for the development of chronotherapeutics.