Healthcare company Marius Pharmaceuticals has crossed another milestone, as the company’s oral testosterone replacement therapy KYZATREX™ has been approved by the U.S. Food and Drug Administration (FDA).
The company, which is entirely based in the Triangle, developed the proprietary drug as an oral softgel that can be absorbed by the human body through the lymphatic system, primarily, which the company noted in a statement avoids liver toxicity and eliminates the risk of application site reactions due to complications with intramuscular injections.
“Testosterone deficiency is a big blind spot in medicine today and our research will continue to explore the importance of testosterone in both male and female health,” said Shalin Shah, CEO of Marius, in the statement.
Testosterone deficiency affects 4 in 10 men older than age 45, with an estimated 15-18 million U.S. men affected, Shah said. As more than 90% of treatment is occurring through injections, according to Shah, the company’s new drug may provide an alternative for patients.
Shah told WRAL TechWire in an interview on Tuesday that the company invested hundreds of millions of dollars into its drug development program, and that the company is backed primarily by the local investment firm Shah Capital and other family investment offices that focus on healthcare. The firm raised $6 million in 2020 and 2021, WRAL TechWire previously reported.
The product will be available commercially in about five weeks, Shah told WRAL TechWire.
But that’s just the first step for the company, Shah said.
“We see testosterone playing a role in preventive healthcare and saving the U.S. billions of dollars if successful in driving broader awareness,” Shah told WRAL TechWire. “Hence we are pushing for annual testosterone testing in men over age 40.”
The company will continue to grow its commercialization side, Shah said, and has operated as an “extremely efficient company from day one.”
Marius was formed in 2017 and four members of its seven-member executive team are former employees of GlaxoSmithKline, WRAL TechWire previously reported.
Original Article Source: WRAL TechWire