Patient Recruitment Commences for SPONTAN® Phase II Study

LTR Pharma has commenced patient recruitment for its Phase II pharmacokinetic clinical study of SPONTAN®, the Company’s rapid-acting intranasal spray for the treatment of erectile dysfunction. 

The study will assess single- and multiple-dose pharmacokinetics across three cohorts, with approximately half of participants aged 65 years or older. This design aligns with regulatory guidance and is intended to generate prescribing insights for a patient population that is frequently underserved by oral ED therapies. 

Recruitment follows completion of all regulatory approvals, and initial data are expected in Q2 CY2026. 

LTR Pharma Executive Chairman, Lee Rodne, said: 

"Commencing recruitment for our Phase II study is an important milestone that reflects the disciplined execution of our clinical development program. By including a dedicated cohort of men aged 65 and over, we are building clinical evidence for a population often underserved by oral ED therapies – and where SPONTAN's rapid, predictable intranasal delivery provides a meaningful advantage." 

Click to read the ASX release.