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Landscape of Preterm Birth Therapeutics and a Path Forward
Brahm Seymour Coler1,2, Oksana Shynlova3,4, Adam Boros-Rausch3
1Department of Obstetrics and Gynecology, University of Washington, Seattle, WA 98195, USA.
Insights
Effective preterm birth (PTB) treatments are urgently needed. This review examines current tocolytic agents, their limitations, and strategies to overcome obstacles in developing new therapies for preterm labor.
Area of Science:
- Obstetrics and Gynecology
- Neonatal Medicine
- Pharmacology
Background:
- Preterm birth (PTB) is a leading cause of infant mortality and morbidity globally.
- Current tocolytic agents offer limited efficacy and brief delays in preterm labor.
- There is a significant unmet need for improved therapeutics, especially in low- and middle-income countries.
Purpose of the Study:
- To review the current landscape of preterm birth therapeutics.
- To assess the history, mechanisms, efficacy, and adverse effects of existing tocolytic agents.
- To identify regulatory hurdles and obstacles hindering novel tocolytic development.
Main Methods:
- Comprehensive literature review of preterm birth therapeutics.
- Analysis of drug development history, mechanisms of action, and clinical efficacy data.
- Examination of regulatory pathways and market challenges for new tocolytic agents.
Main Results:
- Existing tocolytics primarily target downstream parturition mediators with limited success.
- Newer agents aim to selectively target inflammatory pathways for enhanced tocolysis.
- Pharmaceutical interest is low due to small market size and regulatory challenges, resulting in a stagnant drug pipeline.
Conclusions:
- Novel therapeutics targeting inflammatory checkpoints show promise for more effective tocolysis.
- Overcoming regulatory hurdles and increasing pharmaceutical interest are crucial for advancing PTB drug development.
- Expedited development pathways are necessary to meet the global demand for effective preterm birth treatments.
Abstract:
Preterm birth (PTB) remains the leading cause of infant morbidity and mortality. Despite 50 years of research, therapeutic options are limited and many lack clear efficacy. Tocolytic agents are drugs that briefly delay PTB, typically to allow antenatal corticosteroid administration for accelerating fetal lung maturity or to transfer patients to high-level care facilities. Globally, there is an unmet need for better tocolytic agents, particularly in low- and middle-income countries. Although most tocolytics, such as betamimetics and indomethacin, suppress downstream mediators of the parturition pathway, newer therapeutics are being designed to selectively target inflammatory checkpoints with the goal of providing broader and more effective tocolysis. However, the relatively small market for new PTB therapeutics and formidable regulatory hurdles have led to minimal pharmaceutical interest and a stagnant drug pipeline. In this review, we present the current landscape of PTB therapeutics, assessing the history of drug development, mechanisms of action, adverse effects, and the updated literature on drug efficacy. We also review the regulatory hurdles and other obstacles impairing novel tocolytic development. Ultimately, we present possible steps to expedite drug development and meet the growing need for effective preterm birth therapeutics.
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