Brexpiprazole in India and the United States: A Comparative Review of Regulatory Status, Clinical Evidence, Market Access, and Evidence Gaps.

Brexpiprazole is a serotonin-dopamine activity modulator first cleared by the United States Food and Drug Administration (FDA) in 2015 for adults with schizophrenia and as an adjunct to antidepressants in major depressive disorder (MDD); later authorizations extended its use to adolescent schizophrenia and to agitation arising in dementia due to Alzheimer's disease. Over the past decade, randomized controlled trials, long-term open-label extensions, and analyses of real-world claims have converged on a consistent efficacy profile and a tolerability profile that has generally been favorable, although direct head-to-head comparisons with other second-generation agents remain limited. The evidence base and access environment differ markedly between the two countries. In the United States, brexpiprazole is an established product with an extensive clinical evidence base supplemented by real-world claims, utilization, safety, and economic analyses. In contrast, India has only recently received regulatory approval for brexpiprazole, and brexpiprazole-specific clinical, real-world utilization, pricing, reimbursement, and pharmacoeconomic data remain limited. This narrative review consolidates the pharmacology, clinical-trial findings, safety record, and health-economic data on brexpiprazole and contrasts the mature evidence environment of the United States with the emerging one in India. The principal Indian evidence gap is therefore no longer regulatory recognition but the generation of local data on availability, affordability, utilization, effectiveness, and pharmacoeconomic value. Framed as a collaboration between Christian Medical College and Hospital, Ludhiana, and New York Medical College at St Clare's and St Mary's, New Jersey, the review aims to support the equitable and evidence-based uptake of newer antipsychotics in emerging settings.