Marius Pharmaceuticals
 | |
| Privately held company | |
| ISIN | 🆔 |
| Industry | Biopharmaceuticals |
| Founded 📆 | 2017 |
| Founder 👔 | |
| Headquarters 🏙️ | Raleigh, North Carolina |
Area served 🗺️ | |
Key people | Himanshu Shah, Executive Chairman/Founder
Shalin Shah, CEO Amit Shah, COO |
| Products 📟 | Kyzatrex (testosterone undecanoate) |
| Members | |
Number of employees | |
| 🌐 Website | https://mariuspharma.com/ |
| 📇 Address | |
| 📞 telephone | |
Marius Pharmaceuticals, headquartered in Raleigh, N.C., is a specialty pharmaceutical company focusing on treating conditions that are primarily associated with hypogonadism, or testosterone deficiency.[1]
History[edit]
In September 2018, Marius Pharmaceuticals announced preliminary data for their Phase 3 clinical trial that evaluated SOV-2012-F1 in men who suffered from hypogonadism. SOV-2012-F1, which is Marius’ proprietary oral testosterone replacement therapy (TRT), used phytosterols to enhance absorption through the lymphatic system. The predictable pharmacokinetics of Marius’ formulation were expected to provide the framework for an improved therapeutic effect in clinical practice, better patient compliance, and a reduction in adverse events associated with poor therapeutic control.[2]
On May 21, 2020, the United States Patent and Trademark Office (USPTO) issued two patents related to its lead asset Kyzatrex.[3]
In January 2021, Marius submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval of Kyzatrex, a novel oral testosterone undecanoate soft gel capsule for the treatment of primary and secondary hypogonadism in men.[4] The NDA submission was based on efficacy and safety data from its pivotal study (NCT04467697) in which Kyzatrex generated the most comprehensive ABPM data in its class. Kyzatrex was well-tolerated by participants, with more than 96% of those subjects who completed 90 days of treatment achieving average testosterone levels in the normal range in the pivotal Phase 3 study. The most common treatment-emergent adverse event (TEAE) related to treatment in the pooled Phase 3 studies was hypertension. While there were no serious TEAEs across the Phase 3 trials that were considered to be related to the study drug.
In August 2022, Marius Pharmaceuticals received approval of Kyzatrex (testosterone undecanoate) by the U.S. Food and Drug Administration.[5] Kyzatrex was approved in three dosage strengths, 100mg, 150mg, and 200mg.
Testosterone and Hypogonadism[edit]
Testosterone is a hormone that plays a crucial role in the development and maintenance of male characteristics. It is primarily produced in the testes and is responsible for regulating various bodily functions, including muscle mass, bone density, sex drive, and red blood cell production. Testosterone levels peak during puberty and gradually decline with age, leading to a variety of physical and psychological changes. Low levels of testosterone have been linked to numerous health problems, including osteoporosis, diabetes, and heart disease. Testosterone replacement therapy has been shown to be effective in treating symptoms of low testosterone, improving bone density and muscle mass, and reducing the risk of some chronic conditions.
Hypogonadism is a condition in which the body does not produce enough testosterone. It can be caused by various factors, including genetic disorders, such as Klinefelter's Syndrome, chemotherapy, radiation therapy, and injury to the testicles.[6] Men with hypogonadism may experience a wide range of symptoms, including decreased sex drive, erectile dysfunction, fatigue, and depression. Hypogonadism can also lead to physical changes, such as decreased muscle mass, increased body fat, and decreased bone density, putting men at risk for fractures and osteoporosis. The condition affects many men worldwide, particularly those over the age of 40. Testosterone replacement therapy (TRT) is often used to treat hypogonadism, but it can also have side effects and requires careful monitoring. Early detection and treatment of hypogonadism can improve quality of life and reduce the risk of complications associated with low testosterone levels.
References[edit]
- ↑ "Marius Pharmaceuticals". Retrieved 2023-04-18.
- ↑ "Marius Pharmaceuticals Completes Efficacy Portion of its Re-Tune Phase 3 Study Evaluating Their Innovative Oral Testosterone Formulation in Hypogonadal Men". www.businesswire.com. 2018-09-26. Retrieved 2023-04-18.
- ↑ Capital, Shah (2020-05-21). "Marius Pharmaceuticals Announces Issuance of Two Key Patents Protecting its Proprietary Oral Testosterone Therapy". GlobeNewswire News Room. Retrieved 2023-04-18.
- ↑ "FDA approval sought for novel oral testosterone replacement therapy for hypogonadism". Urology Times. Retrieved 2023-04-18.
- ↑ "Marius Pharmaceuticals Receives FDA Approval of KYZATREX™, an Oral Testosterone Replacement Therapy". BioSpace. Retrieved 2023-04-18.
- ↑ Kumar, Peeyush et al. “Male hypogonadism: Symptoms and treatment.” Journal of advanced pharmaceutical technology & research vol. 1,3 (2010): 297-301. doi:10.4103/0110-5558.72420
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