Evolution of Drug Development Trends in Multiple Sclerosis: Analysis of Mainland China and Global Landscapes From...

Multiple sclerosis (MS) is a leading cause of nontraumatic disability in young adults. Over the past two decades, pharmacotherapy for MS has advanced substantially. This study analyzes global trends in MS clinical trial activity, regional distribution, and drug development pipelines and compares research and development (R&D) patterns between mainland China and global settings to provide insights into future MS drug development.

MS-related clinical trials registered between November 1, 2004, and October 31, 2024, were retrieved from ClinicalTrials.gov, the EU Clinical Trials Register (EUCTR), the Center for Drug Evaluation (CDE) of China, and the Chinese Clinical Trial Registry (ChiCTR). Trial characteristics, including phase, sponsorship, geography, drug class, and therapeutic targets, were systematically analyzed and compared between mainland China and the global datasets.

A total of 1183 MS clinical trials were identified, including 83 conducted in mainland China. Overall, 967 trials (81.74%) were interventional and 216 (18.26%) were observational. Industry-sponsored trials accounted for 67.06% of all studies. Globally, MS clinical trial activity increased rapidly during the first decade and showed a more moderate pace after 2015, whereas trial numbers in mainland China rose sharply after 2018. This recent expansion in China was largely driven by bioequivalence (BE) studies and late-phase trials. After normalizing by the number of prevalent MS cases, substantial geographic heterogeneity in clinical trial density persisted. Europe consistently exhibited high case-adjusted trial density, while mainland China remained in the lower-to-middle categories. Chemical drugs accounted for a slightly higher number of registered trials than biologics. The most frequently investigated therapeutic targets across all trials were IFNAR, CD20, and S1PR1. A subset of studies also explored dual-target strategies.

This registry-based study provides a comprehensive overview of global and mainland China MS drug clinical trials from 2004 to 2024. While global trial activity remained sustained over the past two decades, trial registrations in mainland China increased markedly in recent years, although the development structure differed from global patterns, with a higher proportion of BE studies and late-phase trials. These findings provide a reference for MS clinical drug development.