A New Era in Tuberculosis Prevention and Treatment: Breakthroughs in Drug Development and Future Prospects.

Abstract

Tuberculosis (TB) remains a significant global public health challenge, despite recent advances in drug development. However, a comprehensive and systematic overview of the current clinical trial landscape in TB prevention and treatment is still lacking. This study aims to systematically review recent breakthroughs in TB drug development, assess their scientific value and global impact, and provide valuable insights for clinicians and policymakers involved in TB control efforts. We systematically searched the INFORMA pharmaceutical database to identify 1041 clinical trial projects related to TB. Two independent researchers screened and extracted the data, and discrepancies were resolved through consultation with a third researcher. Inclusion criteria were: (1) trials explicitly focused on TB drug development, (2) studies containing detailed descriptions of drug mechanisms or therapeutic targets, and (3) interventional studies. Exclusion criteria were the absence of key information, incomplete datasets, or non-interventional study designs. Descriptive statistical analyses were employed to systematically summarize trial characteristics, and data distribution features were visualized accordingly. Between 1990 and 2025, the number of TB-related clinical trials increased significantly, with a notable peak observed between 2018 and 2023. China and South Africa emerged as leading contributors to research activity, while the United States and the United Kingdom accounted for the majority of "Completed" trials. Despite the emergence of novel agents, traditional cornerstone drugs continued to dominate the development pipeline. Bedaquiline, in particular, demonstrated rapid, largely driven by supportive health policies. Academic institutions were the primary funding of TB trials, and regional analysis revealed heightened research activity in Asia and Africa. However, the global distribution of research resources remained uneven, highlighting the need for improved collaboration mechanisms to promote both health equity and innovation. This study systematically offers a comprehensive review of recent breakthroughs in TB drug development, revealing the current status and persistent challenges facing global clinical trials. Realizing the goal of ending TB will require sustained investment in scientific innovation, equitable resource allocation, and steadfast political commitment. Through coordinated global efforts, a new era in TB prevention and treatment is within reach.