LTR Pharma (ASX:LTP) has commenced patient recruitment for its Phase 2 pharmacokinetic study of SPONTAN, the company's rapid-acting intranasal spray for the treatment of erectile dysfunction, in Australia.
The study will evaluate single- and multiple-dose pharmacokinetics in approximately 27 healthy male participants across three cohorts, with around half aged 65 or older to address the prescribing needs of older men—a demographic often underserved by oral PDE5 inhibitors such as Viagra and Cialis.
Recruitment follows completion of regulatory requirements, including Human Research Ethics Committee approval from Bellberry and TGA acceptance of the company's clinical trial notification, announced on Dec. 10, 2025. Initial data from the study are expected in the second quarter of 2026.
LTR Pharma Executive Chairman Lee Rodne said, "Commencing recruitment for our Phase 2 study is an important milestone, reflecting the disciplined execution of our clinical development program. Including a dedicated cohort of men aged 65 and over allows us to generate clinical evidence for a population often underserved by oral ED therapies, where SPONTAN's rapid, predictable intranasal delivery can provide a meaningful advantage."