Trexapharm is an Australian clinical-stage biotechnology company developing TREXAVIVE®, a patented and proprietary microdose combination therapy with treatment-resistant depression as its lead clinical indication and potential development opportunities in PTSD.
A differentiated clinical-stage asset targeting major unmet needs in mental health.
Trexapharm is developing TREXAVIVE®, a patented and proprietary microdose combination therapy designed to provide rapid, non-sedating outpatient treatment with sustained benefit.
TREXAVIVE® has already generated encouraging human proof-of-concept evidence and is continuing to build real-world clinical experience through Australia’s Special Access Scheme.
Trexapharm is pursuing a staged development strategy designed to further de-risk TREXAVIVE® and support regional and global pharmaceutical partnering.
Treatment-resistant depression is Trexapharm’s lead clinical indication, with PTSD representing an additional potential development opportunity for TREXAVIVE®.
A differentiated clinical-stage asset with multiple drivers of value.
TREXAVIVE® is supported by a growing international intellectual property portfolio.
Encouraging proof-of-concept evidence, with improvement observed from Day 4 and benefit remaining visible through Week 12.
Ongoing Australian patient access and prescribing through the TGA Special Access Scheme.
Rapid · Non-Sedating · Outpatient · Designed for Sustained Benefit
Controlled clinical development designed to build on the existing human and real-world evidence and further de-risk TREXAVIVE®.
A staged development strategy designed to support regional and global pharmaceutical partnerships.
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A large and growing global market with significant unmet need in treatment-resistant depression.
Many patients do not respond adequately to conventional antidepressants, while newer rapid-acting treatments such as ketamine-based therapies can require repeated supervised administration and monitoring.
TREXAVIVE® is being developed to bridge this treatment gap through a rapid, non-sedating outpatient treatment model designed for sustained benefit.
04.
Encouraging Human Proof-of-Concept in treatment-resistant depression
An open-label proof-of-concept study in 10 adults with treatment-resistant major depressive disorder demonstrated an encouraging clinical signal.
Early change observed
Largest observed mean improvement
Benefit remained visible
Participants completed
treatment
No serious adverse
events reported
Small, open-label and uncontrolled proof-of-concept study; findings require confirmation in a randomised controlled trial.
Two complementary mechanisms.
One integrated approach.
TREXAVIVE® combines very low doses of flumazenil and naltrexone through complementary mechanisms across brain systems involved in mood regulation, stress response, reward and pleasure processing, and neuroinflammatory signalling.
A staged pathway from real-world experience to global development.
→ Australian real-world clinical experience
→ Randomised Phase IIa clinical development
→ Potential U.S. clinical development opportunity
→ Progressing towards formal registration pathways
→ Regional and global development opportunities
→ Broader market opportunity following successful development and regulatory approvals
→ Australian real-world clinical experience
→ Randomised Phase IIa clinical development
→ Potential U.S. clinical development opportunity
→ Progressing towards formal registration pathways
→ Regional and global development opportunities
Granted patent protection
Granted patent protection
Expanding international patent portfolio
TREXAVIVE® is supported by a growing international intellectual property portfolio providing a foundation for continued clinical development and potential global commercialisation.
For more information on TREXAVIVE®, the clinical evidence, treatment-resistant depression market opportunity, intellectual property, development strategy and pathway to pharmaceutical partnering, access the latest Trexapharm Corporate Presentation.
