Marius is focused on treating widespread conditions which have largely been caused by deficiencies in our endocrine system. Some of the most prevalent and deadly diseases in the US today have links to these deficiencies and due to the structural balances that must be achieved, optimal formulations are necessary to achieve effectiveness and safety.
The suffering of patients with these endocrine deficiencies have tremendous effects on functional abilities and downstream health consequences. At Marius, our goal is to improve the functional lives of patients and also reduce the risks of the downstream effects of Endocrine imbalance.
Developing a New Standard of Care in Oral Testosterone.
Our vision is to bring a safe and efficacious treatment to the tens of millions of Men world-wide suffering from Low Testosterone. This under-diagnosed deficiency inflicts serious consequences on many aspects of male life.
Our lead candidate is a unique oral testosterone replacement therapy which overcomes many of the problems that have been typically associated with currently approved testosterone therapy products. Our proprietary delivery technology has achieved optimal absorption with all meal types resulting in a higher bioavailability of TU and a unique PK profile. Planning of Phase 3 studies are currently underway which will pave the way for FDA Approval.
Our proprietary oral T-replacement therapy uses testosterone undecanoate, a pro-drug of testosterone, to overcome many of the problems associated with earlier attempts to formulate and deliver oral testosterone for therapeutic treatment. Testosterone undecanoate (TU) is absorbed through the intestinal lymphatic system, overcoming difficulties related to oral testosterone absorption via the portal vein (the usual route for absorption of medication taken orally). We have used our proprietary delivery technology to achieve optimal formulation characteristics.
Specific Marius proprietary formulation attributes include:
- Ability to increase amount of formulated TU per unit dose.
- Rapid and complete release of TU after oral administration to foster bioavailability
- Unique PK profile
- Low inter- and intra-subject variability in TU exposure, thereby minimizing the risk for testosterone elevations beyond the therapeutic range
- Near normal DHT/T ratio
Our product is well tolerated and has not shown any significant adverse effects in hypogonadal men to date. If clinical trials continue to support the early profile of our product, when approved, it may offer a safe and effective oral T-replacement treatment for men suffering from low testosterone.
Key Benefits of Our Solution for CDGP:
Simple Oral Delivery
Advantageous Release Profile
Positive Efficacy & Safety Profile
Marius is also looking to address Klinefelter's syndrome with Phase II Studies planned.
Testosterone Deficiency (Adult Men)
/ hīpō • Gōna • dizəm /
Hypogonadism is often misdiagnosed as a host of other maladies, including depression and erectile dysfunction. It is conservatively estimated that adult male hypogonadism affects 19 million American men, up to 88% of who go untreated.