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An update from LTR Pharma Limited ( (AU:LTP) ) is now available.
LTR Pharma has completed recruitment for its Phase II pharmacokinetic clinical study of SPONTAN, a rapid-acting intranasal spray for erectile dysfunction, enrolling 27 participants across three cohorts. The final cohort is now undergoing a 15-day dosing regimen at a clinical research facility, receiving both SPONTAN and a control vardenafil tablet.
Around half of the trial participants are aged 65 or older, generating geriatric-focused pharmacokinetic data to inform dose optimisation and future U.S. labelling discussions where older patients are often initiated on lower oral PDE5 doses. Designed in line with FDA Pre-IND guidance, the Phase II trial is a key step in LTR Pharma’s 505(b)(2) regulatory pathway, with initial data expected in the second quarter of calendar 2026, underscoring disciplined execution of its clinical and U.S. expansion strategy.
More about LTR Pharma Limited
LTR Pharma Limited is a commercial-stage pharmaceutical company focused on innovative intranasal drug-delivery therapies for significant unmet medical needs. The company has commercialised rapid-acting erectile dysfunction treatments SPONTAN and ROXUS in Australia, is advancing regulatory pathways in the U.S. and other key markets, and is developing OROFLOW for oesophageal motility disorders. Through strategic partnerships, LTR Pharma is expanding its pipeline and global footprint with differentiated, patient-centric treatments that aim to enhance quality of life.
Average Trading Volume: 301,621
Technical Sentiment Signal: Strong Sell
Current Market Cap: A$79.98M
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