Lipocine

Lipocine has dosed the first patient in its pivotal Phase 3 clinical trial of LPCN 1154, an oral formulation of brexanolone for treating postpartum depression.

Verity Pharma, Lipocine's licensing partner, has filed a New Drug Submission for TLANDO in Canada, marking a key regulatory milestone for the first FDA-approved oral testosterone replacement therapy that requires no dose titration.

• The sarcopenia market remains largely untapped with no approved drug therapies in major markets, despite significant unmet medical needs in an aging global population. • DelveInsight reports 18+ pharmaceutical companies actively developing 20+ pipeline drugs for sarcopenia, with promising candidates including Biophytis' BIO101, TNF Pharmaceuticals' MYMD-1, and Epirium Bio's MF-300. • Recent regulatory milestones include Fast Track Designation for Lipocine's LPCN1148 for sarcopenia in patients with decompensated cirrhosis, signaling increased recognition of sarcopenia as a distinct clinical condition.

Lipocine Inc. received updated FDA guidance requiring a Phase 3 safety and efficacy study for their oral postpartum depression treatment LPCN 1154, beyond the previously completed PK bridge data.

The FDA has granted Fast Track designation to Lipocine's LPCN 1148 for the treatment of sarcopenia in patients with decompensated cirrhosis.

The FDA has granted Fast Track designation to Lipocine's LPCN 1148 for treating sarcopenia in patients with decompensated cirrhosis, addressing an unmet medical need.

Lipocine has completed dosing in a pivotal pharmacokinetic study for LPCN 1154, an oral formulation of brexanolone designed to treat postpartum depression with 48-hour outpatient dosing.