FDA fast tracks Lipocine’s oral androgen receptor agonist for sarcopenia in cirrhosis
Click Here to Manage Email Alerts
The FDA granted fast track designation to Lipocine’s LPCN 1148, an oral androgen receptor agonist containing testosterone dodecanoate, for the treatment of sarcopenia in patients with decompensated cirrhosis, according to the manufacturer.
The agency’s decision is based on results from a phase 2 proof-of-concept study which demonstrated LPCN 1148 not only improved sarcopenia but also related outcomes in patients with decompensated cirrhosis. According to a company press release, the drug is intended to be a “first in class” therapy candidate with a “novel mechanism of action for management of cirrhosis.”
“We are excited the FDA has recognized that sarcopenia is a serious condition and that LPCN 1148 has the potential to provide clinical benefits for these patients where no therapy currently exists,” Mahesh V. Patel, PhD, president and CEO of Lipocine, said in the release. “We are encouraged that the positive primary endpoint results from our successful proof-of-concept study were recognized by the FDA as evidence of clinical effectiveness of LPCN 1148 in improving sarcopenia in patients with cirrhosis.”
The FDA’s fast track designation is intended to hasten the development and review processes of prospective treatments that may address unmet medical needs. The designation allows for early and frequent communication with the FDA throughout the regulatory review process and may also qualify a treatment for accelerated approval and priority review when relevant criteria are met.
Read more about
Click Here to Manage Email Alerts