3 December 2025 – Melbourne, Australia | LTR Pharma Limited (ASX:LTP) has today announced it has received Human Research Ethics Committee (HREC) approval from Bellberry (NHMRC-certified) for its SPONTAN® Phase II pharmacokinetic and multiple-dose clinical study, paving the way for recruitment to commence in Q1 calendar year 2026.
The Phase II study has been designed in accordance with FDA Pre-IND guidance to characterise single and multiple-dose pharmacokinetics. Approximately 50% of participants will be aged 65 years or older, addressing FDA geriatric use requirements and supporting prescribing considerations for older men who are often prescribed lower doses of oral PDE5 tablets (such as Viagra) due to pharmacokinetic or tolerability factors.
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."
This randomised cross-over study will be conducted at Scientia Clinical Research in Sydney and will recruit approximately 27 healthy male participants across three cohorts. Each participant will complete a 15-day residential period and will receive both single and multiple doses of SPONTAN®, along with a control vardenafil tablet.
Southern Star Research has been appointed as the Clinical Research Organisation (CRO), with Resolian Bioanalytics conducting pharmacokinetic blood sample analysis. Initial data is expected in Q2 calendar year 2026, with full study results anticipated by mid-2026.
Following the ethics approval, LTR Pharma will also submit a Clinical Trial Notification to the Therapeutic Goods Administration (TGA) in Australia. The Phase II study is a key requirement in the Company’s FDA 505(b)(2) development pathway and builds on LTR Pharma’s completed Phase I study, which demonstrated 470% faster absorption versus oral tablets.
About us:
About LTR Pharma
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.
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Jane Morgan
Jane Morgan Management
Investor & Media Relations
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