Ethics Approval Received for SPONTAN® Phase II Clinical Study

LTR Pharma has received ethics approval to commence the SPONTAN® Phase II pharmacokinetic and multiple-dose study. Building on Phase I results that demonstrated 470% faster absorption versus oral tablets, this study marks the next step in the Company’s FDA 505(b)(2) development pathway. 

The study will evaluate single- and multiple-dose pharmacokinetics and includes a dedicated 65+ cohort to support future prescribing guidance for older men. 

Recruitment is expected to commence in Q1 CY2026. Initial data is anticipated in Q2 CY2026, with full study results expected mid-2026.  

LTR Pharma Executive Chairman, Lee Rodne, said: 

"Securing ethics approval allows us to commence a targeted Phase II study expressly designed to meet FDA expectations for multiple-dose pharmacokinetics and geriatric representation.  Importantly, this study will generate valuable data to help physicians make informed prescribing decisions for men aged 65 and older, who often receive reduced-dose oral PDE5 therapies.  With ROXUS on track for US market entry in the first half of 2026 and SPONTAN progressing through clinical development, we continue to execute our multi-market commercial strategy." 

Click to read the ASX release.