Nelson Vergel
Founder, ExcelMale.com
Nelson Vergel from ExcelMale.com and DiscountedLabs.com interviews Shalin Shah, CEO of Marius Pharmaceuticals, about Kyzatrex, an oral testosterone treatment. They discuss the treatment, misconceptions, unique aspects, potential side effects, dosing, and more.
Shah highlights that Kyzatrex restores testosterone to mid-normal therapeutic levels, avoiding the super-physiological levels seen with injections. This more closely mimics the natural diurnal rhythm of testosterone production, potentially reducing side effects like high hematocrit. Also, Kyzatrex does not significantly lower LH and FSH levels like injections do. This means that the hypothalamic-pituitary-testicular axis is not slowed down or shut down as much, which is important for long-term health and fertility.
In terms of blood pressure, Kyzatrex showed a minimal impact. The phase three trials used ambulatory blood pressure monitoring, revealing a clinically insignificant increase in systolic blood pressure of 1.7 mm Hg, which plateaued at six months.
History of Drug Approval
Shalin Shah shares that the journey of Kyzatrex began in 2009 with a group of ex-GSK scientists who identified the need for oral testosterone. Developing the drug was challenging, but they created a unique formulation with phytosterol esters, enhancing its bioavailability. Despite regulatory challenges around 2014 due to cardiovascular safety concerns, Marius Pharmaceuticals advanced Kyzatrex through phases of clinical trials. Shah, from an investment background, recognized the drug's potential and led the effort to get FDA approval, which was achieved on the first attempt in July 2022. The drug entered the market six months later.Awareness and Misconceptions
Vergel asks about the awareness of Kyzatrex among patients and doctors. Shah explains that awareness is gradually increasing. Initially, there was skepticism, but through education and support from top experts, Marius Pharmaceuticals is effectively communicating Kyzatrex’s benefits to the medical community and patients.Comparison to Other Treatments
Kyzatrex was compared to AndroGel in phase three trials, showing higher efficacy and consistent absorption. Unlike gels, which can vary based on skin type and body fat, Kyzatrex demonstrated a lower incidence of erythrocytosis (high hematocrit). In the trials, Kyzatrex had about a 2% incidence of erythrocytosis, which resolved with dose adjustment, making it easier to manage compared to other testosterone therapies.Shah highlights that Kyzatrex restores testosterone to mid-normal therapeutic levels, avoiding the super-physiological levels seen with injections. This more closely mimics the natural diurnal rhythm of testosterone production, potentially reducing side effects like high hematocrit. Also, Kyzatrex does not significantly lower LH and FSH levels like injections do. This means that the hypothalamic-pituitary-testicular axis is not slowed down or shut down as much, which is important for long-term health and fertility.
Safety and Emerging Data
Shah addresses concerns about liver toxicity, blood pressure, and lipid profiles. Kyzatrex is absorbed through the lymphatic system, bypassing the liver, unlike older oral testosterones. Phase three trials showed normal liver enzyme levels, beneficial reductions in total cholesterol, LDL, and triglycerides, and a slight reduction in HDL. Long-term data collection is ongoing to understand the full metabolic impact.In terms of blood pressure, Kyzatrex showed a minimal impact. The phase three trials used ambulatory blood pressure monitoring, revealing a clinically insignificant increase in systolic blood pressure of 1.7 mm Hg, which plateaued at six months.
Dosing Options
Kyzatrex is available in three capsule strengths: 100 mg, 150 mg, and 200 mg. Common dosing regimens include 300 mg BID (twice a day) and 400 mg BID, both showing positive outcomes in efficacy and safety.Access to Kyzatrex
Shah discusses the access model for Kyzatrex, which is available as a cash-only product. This approach bypasses insurance and PBMs, reducing costs and improving accessibility. Patients can obtain Kyzatrex through regular providers or telehealth services, typically costing around $200 per month. This model aligns with the broader trend of cash-based healthcare services, simplifying access for patients and providers.Additional Information
For more information about Kyzatrex, Shaw encourages visiting Kyzatrex.com for detailed information and access options. Additionally, RethinkTestosterone.com provides educational content about testosterone therapy.
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