Recruitment Complete for SPONTAN® Phase II Study

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

All 27 participants are now enrolled across three cohorts, with dosing underway for the final group. The study includes a dedicated  65+ cohort, which will generate important pharmacokinetic data  to inform dose optimisation and support future U.S. labelling discussions.  Initial data from the study is expected in Q2 2026.  

LTR Pharma Executive Chairman, Lee Rodne, said: 

"Completing recruitment on schedule demonstrates the continued disciplined execution of our clinical program. This study was identified as a key requirement during our FDA Pre-IND engagement, and with dosing now underway for our final cohort, we are systematically advancing through the steps needed for our 505(b)(2) submission. We are firmly on track to deliver initial data in the second quarter." 

Click to read the ASX release.