10 December 2025 – Brisbane, Australia | LTR Pharma Limited (ASX:LTP) has today announced that it has received regulatory clearance from Australia’s Therapeutic Goods Administration (TGA) to commence its clinical trial activities for a Phase II clinical study for its nasal erectile dysfunction treatment SPONTAN®. This follows confirmation and acceptance of the Company’s Clinical Trial Notification (CTN).
This regulatory clearance completes all requirements for study initiation in Australia and follows recent Human Research Ethics Committee (HREC) approval granted by Bellberry announced previously.
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.”
The Phase II study will assess single-dose and multiple-dose pharmacokinetics in approximately 27 healthy male participants across three cohorts. In line with FDA guidance for assessments for geriatric-use, approximately half of all participants will be aged at least 65 years of age.
The study is designed to generate prescribing insights for physicians that treat erectile dysfunction in 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 also underway, and patient recruitment is expected to commence in Q1 CY2026.
About us:
About LTR Pharma Limited (ASX:LTP)
LTR Pharma is a commercial-stage pharmaceutical company delivering innovative therapies to address significant unmet medical needs through its proprietary intranasal drug-delivery platform.
The Company has successfully commercialised its rapid-acting treatment technology in Australia and is expanding access whilst advancing regulatory pathways in the US and other key markets. LTR’s lead products, SPONTAN® and ROXUS®, are fast-acting intranasal sprays for the treatment of erectile dysfunction, enabling onset of action in 10 minutes or less. Building on this proven technology, the Company is now advancing OROFLOW®, a novel intranasal spray under development for the treatment of Oesophageal Motility Disorders (OMD) – a debilitating group of conditions affecting swallowing function.
Through strategic partnerships, LTR Pharma is expanding its pipeline and global footprint to deliver differentiated, patient-centric treatments that enhance quality of life.
Contact details:
Jane Morgan
Jane Morgan Management
Investor & Media Relations
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