TGA Provides Regulatory Clearance for SPONTAN ® Phase II Clinical Study

LTR Pharma has received regulatory clearance from the Therapeutic Goods Administration for the commencement of the SPONTAN® Phase II clinical study, completing all requirements following Bellberry HREC approval and enabling formal initiation of clinical activities in Australia.   

The Phase II study will assess single- and multiple-dose pharmacokinetics in approximately 27 healthy male participants across three cohorts. In line with FDA guidance for geriatric-use assessments, approximately half of all participants will be aged 65 years or older. The study is expected to generate important prescribing insights for physicians treating older men, a population that is frequently prescribed lower doses of oral PDE5 inhibitors such as Viagra and Cialis. 

With regulatory clearance now in place, site activation activities are underway, and patient recruitment is expected to commence in Q1 CY2026. 

LTR Pharma Executive Chairman, Lee Rodne, said: 

"The TGA’s regulatory clearance of our CTN represents an important milestone that enables the formal commencement of our Phase II study. With both ethics and regulatory requirements now complete, we are firmly on track to begin recruitment early in 2026. Importantly, this study is designed to provide valuable clinical insights for physicians treating erectile dysfunction in men aged 65 and over, a population that often requires adjusted dosing when using traditional oral PDE5 therapies.” 

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