LTR Pharma has entered into an exclusive pilot commercialisation agreement with Marius Pharmaceuticals, a US pharmaceutical company focused on men’s health, to introduce Marius’ lead product, KYZATREX® (testosterone undecanoate oral capsules), in Australia. KYZATREX is FDA-approved and commercially available in the United States.
Strategic rationale
Testosterone deficiency affects energy, mood, muscle mass, bone density and sexual function. It remains underdiagnosed and undertreated in Australia, where most replacement therapy is delivered by injection, gel, patch or implant.
KYZATREX uses a proprietary formulation designed to facilitate lymphatic absorption, reducing the first-pass hepatic metabolism associated with earlier oral testosterone therapies, and is supported by clinical data demonstrating its ability to restore testosterone levels in men with testosterone deficiency.
Commercial structure and regulatory status
The agreement establishes an initial exclusive pilot commercialisation phase in Australia, supported by an inventory commitment sized to establish prescriber demand and operational processes. During the six-month evaluation period, LTR Pharma will retain exclusivity in Australia while the parties evaluate physician adoption, patient demand and the feasibility of pursuing a potential TGA registration pathway.
Following the evaluation period, LTR Pharma has a right to negotiate an exclusive licence for KYZATREX in Australia. KYZATREX is not registered by the TGA; initial patient access will be facilitated through the Special Access Scheme, which enables medical practitioners to prescribe unapproved therapeutic goods for individual patients in accordance with applicable TGA requirements.
LTR Pharma Executive Chairman, Lee Rodne, said:
“We are pleased to partner with Marius to introduce KYZATREX in Australia. As an FDA-approved oral testosterone therapy, KYZATREX represents a complementary opportunity to broaden our men’s health portfolio by leveraging the clinical networks, telehealth channels and commercial infrastructure we have already established through SPONTAN. At the same time, we remain focused on execution of our core programs, with ROXUS moving toward U.S. commercial launch through SHED and Strive, the final SPONTAN Phase II report expected shortly and planning underway for the pivotal Phase III study in 2027.”