LTR Pharma (ASX:LTP) has reached an important milestone in the development of its novel erectile dysfunction therapy, announcing today that Australia’s Therapeutic Goods Administration (TGA) has granted regulatory clearance for the company to begin its Phase 2 clinical study of SPONTAN, a fast-acting nasal formulation intended to offer an alternative to traditional oral PDE5 inhibitors.
The approval, confirmed through acceptance of LTR Pharma’s Clinical Trial Notification (CTN), finalises all regulatory requirements for trial initiation in Australia. It follows recent ethics approval from the Bellberry Human Research Ethics Committee, meaning the company now has both essential pillars firmly in place.
For Executive Chairman Lee Rodne, the clearance marks a meaningful step forward in advancing a treatment designed with a particularly underserved population in mind.
“The TGA’s regulatory clearance of our CTN represents an important milestone that enables the formal commencement of our Phase II study,” Rodne said. “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.”
By delivering therapy via a nasal spray, LTR Pharma hopes to offer a faster-acting and potentially more versatile option.
The upcoming Phase 2 trial will evaluate single- and multiple-dose pharmacokinetics in approximately 27 healthy male participants, divided into three cohorts. In line with FDA guidance on geriatric assessments, around half of the participants will be at least 65 years old. The study’s purpose is not only to advance SPONTAN through clinical development, but to generate practical prescribing insights for clinicians managing erectile dysfunction in older patients.
With the TGA’s green light secured, LTR Pharma is now progressing site activation activities, with recruitment expected to begin in the first quarter of calendar year 2026.