TGA provides regulatory clearance for LTR Pharma to start SPONTAN phase II ED study
The Therapeutic Goods Administration provides regulatory clearance for LTR Pharma to start its SPONTAN erectile dysfunction nasal spray phase II clinical study in Australia.
TGA provides regulatory clearance for LTR Pharma’s SPONTAN erectile dysfunction nasal spray phase II clinical study
Company has now met all regulatory requirements for commencement of the phase II study in Australia
All requirements for study initiation now complete with patient recruitment expected to start in Q1 CY26
Special Report: LTR Pharma has received an early Christmas present with the Therapeutic Goods Administration (TGA) providing regulatory clearance to start its SPONTAN erectile dysfunction (ED) nasal spray phase II clinical study in Australia.
LTR Pharma (ASX:LTP) said with the TGA confirming and accepting a Clinical Study Notification (CTN) and recent Human Research Ethics Committee (HREC) approval granted by Bellberry all requirements for study initiation have been completed.
With regulatory clearance now in place, site activation activities are underway, and patient recruitment is expected to start in Q1 CY26.
Study expected to generate prescribing insights
The phase II study will assess single- and multiple-dose pharmacokinetics in ~27 healthy male participants across three cohorts.
In line with FDA guidance for geriatric-use assessments, approximately half of all participants will be aged 65 years or older.
The study is expected to generate important prescribing insights for physicians treating older men, a population that is frequently prescribed lower doses of oral PDE5 inhibitors such as Viagra and Cialis.
‘On track to begin recruitment’
LTR Pharma executive chairman Lee Rodne said the TGA’s regulatory clearance represents an important milestone that enables the formal start of the phase II study.
“With both ethics and regulatory requirements now complete, we are firmly on track to begin recruitment early in 2026,” he said.
“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.”
This article was developed in collaboration with LTR Pharma, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Originally published as TGA provides regulatory clearance for LTR Pharma to start SPONTAN phase II ED study
