相关临床试验
2
0 进行中
药物批准
2
批准总数
监管机构
1
监管机构数
成立时间
2017
已完成
2
100.0%
- Marius Pharmaceuticals has launched a post-marketing study to evaluate testosterone undecanoate (Kyzatrex) in 50 men aged 65-80 with hypogonadism for potential label expansion. - The six-month open-label study will assess quality of life changes and key health markers including cardiovascular parameters, body composition, strength measures, and inflammation. - Investigators will compare the drug's labeled titration protocol with a simplified once-daily dosing regimen to potentially benefit older patients with streamlined treatment plans. - The original approval was based on a phase 3 trial showing 88% of patients achieved normal testosterone levels, with the most common adverse event being increased blood pressure in 2.6% of patients.
- Health Canada has approved KYZATREX (testosterone undecanoate) capsules, marking the first oral testosterone replacement therapy available in softgel form for Canadian men with testosterone deficiency. - The approval addresses a significant medical need, with approximately 25% of Canadian men aged 40-62 years (roughly 3 million men) estimated to have biochemical testosterone deficiency. - Clinical trial data showed 88% of patients achieved normal testosterone levels, with the oral formulation offering a convenient alternative to injectable or transdermal treatments. - Marius Pharmaceuticals plans to launch the therapy in Canada through telehealth and traditional provider channels in the first half of 2026.
- Oral testosterone undecanoate (Jatenzo) significantly improved serum testosterone levels, with 92% of men achieving levels of 450 ng/dL or higher by day 105 in the inTUne phase 3 trial. - Sexual activity scores increased by 1.85 points from baseline to day 105, representing a clinically meaningful improvement that exceeded results seen in the TRAVERSE trial. - All eight sexual function domains showed significant improvements, including sexual desire, pleasure, erection quality, and mood parameters. - The study provides important efficacy data for oral testosterone therapy, which represents a relatively new treatment option in the United States after decades without FDA-approved oral formulations.
- KYZATREX, developed by Marius Pharmaceuticals, received FDA approval in 2022 as the first oral testosterone replacement therapy utilizing phytosterols for lymphatic absorption. - Clinical trials demonstrated up to 96% of patients achieved normal testosterone levels by Day 90, with improvements in quality of life, energy, and erectile function. - The therapy addresses a significant unmet need, with approximately 40% of men over 45 and 30-50% of men with obesity or diabetes suffering from hypogonadism. - The global testosterone replacement therapy market is projected to grow from $1.9 billion in 2022 to $2.9 billion by 2032, with oral formulations expected to register high growth rates.
- The FDA has eliminated the cardiovascular black box warning from testosterone replacement therapy products, following conclusive evidence from the 5,000-patient TRAVERSE trial showing no increased cardiovascular risks. - Marius Pharmaceuticals' KYZATREX® and other testosterone products will now carry updated labeling, with specific blood pressure monitoring requirements replacing the previous cardiovascular warning. - The landmark decision is expected to improve access to testosterone therapy for millions of patients globally, shifting focus from safety concerns to potential therapeutic benefits.
