Lipocine Receives CRL for Testosterone Replacement Candidate

The FDA has rejected Lipocine’s NDA for twice-daily testosterone candidate LPCN-1021 due to issues with its dosing algorithm.

For the candidate’s labeling, Lipocine proposed a titration scheme that differed from the one used in the company’s Phase 3 trials, which prompted the agency to reject the candidate. The company plans to request a meeting with the agency to further discuss the issue and determine a path for approval.

LPCN-1021 is indicated for treatment of hypogonadism and achieved its primary endpoint of normal range testosterone levels in an efficacy trial.