LTR Pharma (ASX:LTP) said that the Therapeutic Goods Administration confirmed and accepted its clinical trial notification for the phase two clinical study of SPONTAN, its intranasal spray for the treatment of erectile dysfunction, which will assess single- and multiple-dose pharmacokinetics in around 27 healthy male participants across three groups, according to a Wednesday filing with the Australian Securities Exchange.

This provides regulatory clearance for the commencement of clinical trial activities in Australia. Around half of all participants will be aged 65 years or older, in line with US Food and Drug Administration guidance. Patient recruitment is expected to start in the March quarter of 2026.

The study secured a recent Human Research Ethics Committee approval from Bellberry.

Its shares rose over 1% in recent trading on Wednesday.