- In August 2024, Akari Therapeutics announced that it had received positive and constructive Pre-Investigational New Drug (Pre-IND) feedback from the FDA on July 29, 2024. The feedback offers greater clarity regarding Akari’s final IND-enabling preclinical studies, drug manufacturing processes, and Phase 1 clinical development strategy for PAS-nomacopan—a long-acting, intravitreal treatment candidate for geographic atrophy (GA). PAS-nomacopan is a bispecific inhibitor targeting both complement component C5 and leukotriene B4 (LTB4).
- In April 2024, IntelGenx announced early clinical dosing of repurposed montelukast in Parkinson’s disease patients—indicating expanding therapeutic exploration for leukotriene antagonists beyond respiratory use
- In May 2024, a U.S. FDA-affiliated study revealed that montelukast binds to brain receptors involved in mood and cognition. This strengthened the case for including neuropsychiatric risk warnings on its label, underscoring the importance of updated safety measures
