LTR Pharma has marked a key milestone with over 1,000 SPONTAN prescriptions under Australia’s Special Access Scheme and is advancing clinical trials and US market preparations for its erectile dysfunction treatments.
- SPONTAN surpasses 1,000 prescriptions via TGA Special Access Scheme
- Phase II pharmacokinetic study underway with initial data due Q2 2026
- ROXUS development on track for US launch in first half of 2026
- Strategic investment increases stake in omega-3 producer LevOmega to 43%
- Strong cash position of A$25.9 million supports ongoing R&D and commercial activities
Clinical Milestone for SPONTAN
LTR Pharma Limited (ASX, LTP) has achieved a significant clinical milestone with SPONTAN, its intranasal erectile dysfunction treatment, surpassing 1,000 prescriptions under the Therapeutic Goods Administration’s Special Access Scheme (SAS). This milestone reflects growing real-world use, particularly among complex patient groups such as those with post-prostate cancer erectile dysfunction. While SAS prescribing is not a commercial sales program, the data collected is providing valuable insights that will shape future regulatory submissions and commercial strategies.
Advancing Clinical Trials
The company has also made strong progress in its clinical development pipeline. The Phase II pharmacokinetic study for SPONTAN received ethics and regulatory approvals in December 2025, with patient recruitment commencing in January 2026. This randomised cross-over study includes approximately 27 healthy male participants, half aged 65 or older, aligning with FDA guidelines for geriatric use. The first patients have been dosed, and initial data is expected in the second quarter of 2026, a crucial step toward FDA 505(b)(2) regulatory approval.
ROXUS US Market Launch on Horizon
Meanwhile, development of ROXUS, another intranasal ED treatment, is progressing on schedule for a planned US launch in the first half of 2026. The company is leveraging the FDA’s 503(a) personalised medicine pathway to expedite market entry. Preparations include building commercial infrastructure targeting men’s health clinics and telehealth channels, supported by an established Scientific Advisory Board featuring experts like Dr Amy Pearlman and Dr Andrew Sun. This positions LTR Pharma to tap into the substantial US$3.7 billion erectile dysfunction market independently of SPONTAN’s FDA approval timeline.
Strategic Investment in LevOmega
In a strategic move, LTR Pharma increased its ownership in LevOmega Pty Ltd from 33% to approximately 43% through a A$1 million investment. LevOmega focuses on sustainable, pharmaceutical-grade omega-3 products, addressing global supply constraints for EPA and DHA. This investment strengthens LTR Pharma’s position in the broader pharmaceutical supply chain and complements its innovation-driven growth strategy.
Financial Position and Outlook
Financially, LTR Pharma remains well-capitalised with a cash balance of A$25.9 million as of 31 December 2025. This robust cash position underpins ongoing research and development, including the SPONTAN Phase II study and ROXUS US launch preparations. The company’s quarterly R&D spend of A$1.3 million reflects active advancement across its pipeline. Executive Chairman Lee Rodne emphasised the company’s momentum toward transforming erectile dysfunction treatment globally, highlighting the importance of real-world data and regulatory progress in shaping future growth.
Bottom Line?
With clinical milestones achieved and US market entry imminent, LTR Pharma is poised for a pivotal year ahead.
Questions in the middle?
- How will initial Phase II data impact SPONTAN’s FDA approval timeline?
- What commercial strategies will LTR Pharma deploy post-ROXUS US launch?
- Could further strategic investments like LevOmega reshape LTR Pharma’s growth trajectory?