Alixer Nexgen Therapeutics Ltd announced that the U.S. FDA has accepted its IND application for ALDP001 for the treatment of seasonal and perennial allergic rhinitis (AR), marking a significant milestone in advancing its first‑in‑class pipeline. ALDP001, a novel intranasal formulation, leverages a differentiated triple histamine receptor blockade (H1, H2, H4) to target both early‑ and late‑phase allergic responses, with potential for improved relief of nasal congestion, itching, and ocular symptoms.

Designed for rapid, localized action with minimal systemic exposure, the therapy addresses key limitations of current treatments, including delayed onset, incomplete symptom control, and poor adherence. With AR affecting millions of individuals worldwide and over 40% experiencing inadequate relief, there remains a significant unmet need for fast‑acting, comprehensive therapies. Alixer expects to announce topline results from its ongoing Phase 2 study in Canada, evaluating optimal dose and frequency using an allergen exposure chamber (EEC), in the coming weeks. Additionally, ALDP021 is being developed as a combination of ALDP001 with a corticosteroid to provide broader symptom control and coverage across both acute and chronic patient populations.