Marius Pharmaceuticals Submits New Drug Application to U.S. FDA for Next-Generation Oral Testosterone Replacement Therapy in Male Patients With Hypogonadism

January 5, 2021 |

4 min read

Marius Pharmaceuticals, a specialty pharmaceutical company focusing on treating conditions that are primarily associated with testosterone deficiency, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of KYZATREX®

KYZATREX^® NDA includes data demonstrating less than 2 mm Hg mean SBP increase as measured by Ambulatory Blood Pressure Monitoring (ABPM) in clinical study participants receiving the investigational drug

RALEIGH, N.C.--(BUSINESS WIRE)-- Marius Pharmaceuticals, a specialty pharmaceutical company focusing on treating conditions that are primarily associated with testosterone deficiency, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of KYZATREX^®, its novel oral testosterone undecanoate soft gelatin capsule for the treatment of primary and secondary hypogonadism in adult men.

KYZATREX^® has generated strong results in both safety and efficacy studies for KYZATREX^®for treatment of primary and secondary hypogonadism in men. Due to the robust results, especially regarding safety, Marius has requested a Priority Review that, if granted, would result in an anticipated six-month review period.

“Submission of our first NDA is an important milestone, which is the culmination of over a decade of meticulous research and dedication and is just the beginning for Marius, as our pipeline will continue to advance research and development in this important therapeutic area that has a multitude of effects on our health system,” said Himanshu H. Shah, Founder and Executive Chairman of Marius.

The NDA submission is 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 greater than 96% of those subjects completing 90 days of treatment achieving average testosterone levels in the normal range in the pivotal Phase 3 study. The most common treatment-related treatment-emergent adverse event (TEAE) in the pooled Phase 3 studies was hypertension, while there were no serious TEAEs across the Phase 3 trials deemed related to the study drug.

“We are extremely proud to have generated compelling efficacy and safety data in our Phase 3 trials,” commented Dr. Om Dhingra, Co-Founder and CEO of Marius. “We look forward to continuing to work collaboratively with the FDA on the review of our application, and if approved, KYZATREX^® has the potential to become the standard of care (SOC) for the treatment of primary and secondary hypogonadism globally.”

Marius also intends to file a marketing authorization application (MAA) with the European Medicines Agency in the first half of 2022. For more information about Marius Pharmaceuticals and KYZATREX^®, visit mariuspharma.com.

About Testosterone & Hypogonadism

Hypogonadism, often referred to as testosterone deficiency, is a condition that occurs when the body does not produce adequate levels of testosterone. In addition to testosterone’s widely accepted role in sexual and reproductive function, it also has important roles in numerous other metabolic and inflammatory processes. In the U.S. there are at least six million symptomatic men suffering from hypogonadism, and over 100 million men globally. The resulting medical costs associated with men with untreated hypogonadism and related comorbidities are more than $25 billion in the U.S. alone.

Hypogonadism is also the most common cause of secondary osteoporosis in men. Beyond these diseases, hypogonadism is a common comorbidity in a broader set of conditions from Type-2 diabetes to Non-Alcoholic Steatohepatitis (NASH).

About KYZATREX^®

KYZATREX^® if approved, will represent a novel oral testosterone replacement therapy option for adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

The ReTUNE™ study was a multi-center, 12-month study across the U.S. that studied the safety and efficacy of KYZATREX^® in hypogonadal subjects (total testosterone ≤ 281 ng/dL). Efficacy was determined by number of subjects in the normal, eugonadal range after 90 days of treatment, including dose titrations, while safety was monitored for a further 9 months while on a steady dose. In addition to testosterone parameters, the study collected Patient Reported Outcomes (PROs), which showed statistically significant results both from baseline and against its comparator. A pivotal six-month Phase 3 study was conducted, in which subjects were monitored using ABPM, now considered the standard BP assessment by the FDA and clinical experts. An improved dose regimen was also used in the pivotal six-month Phase 3 study. The results of the Phase 3 studies will be published in leading medical journals and presented at national conferences during 2021.

The FDA has conditionally accepted KYZATREX^® as the trade name for this investigational drug. The safety and efficacy have not been fully evaluated by any regulatory authority.

About Marius Pharmaceuticals

Marius is a specialty pharmaceutical company focusing on treating conditions that are primarily associated with hypogonadism, commonly referred to as testosterone deficiency. The company’s mission is to improve the functional lives of patients and reduce the risks of the downstream effects of endocrine imbalance by ensuring appropriate level of testosterone. For more information, please visit www.mariuspharma.com .