Company Description

Lipocine Inc., a clinical-stage biopharmaceutical company, engages in the research and development for the delivery of drugs using its proprietary delivery technology.

The company offers TLANDO, an oral testosterone replacement therapy (TRT) comprising testosterone undecanoate.

It also develops LPCN 1154 (BRLIZIO), an oral neuro-steroid in a Phase 3 pivotal trial for postpartum depression; LPCN 1148, a prodrug of testosterone and testosterone laurate that has completed a Phase 2 trial for the management of decompensated cirrhosis; LPCN 1107, an oral hydroxy progesterone caproate product that has completed a Phase 2 trial for the prevention of recurrent preterm birth; LPCN 1144, an oral prodrug of bioidentical testosterone that has completed a Phase 2 trial for pre-cirrhotic non-alcoholic steatohepatitis; and LPCN 2401, an oral formulation comprising a proprietary anabolic androgen receptor agonist that is in a Phase 2 trial to manage incretin mimetic use in obesity management.

In addition, the company is developing LPCN 2201, an oral brexanolone formulation that has completed a Phase 1 trial for major depressive disorders; LPCN 2203, an oral candidate that has completed a Phase 1 trial for management of essential tremor; and LPCN 2101, a neuroactive steroids (NAS) candidate that has completed a Phase 1 trial for drug-resistant epilepsy and women with epilepsy.

The company’s products focus on neurological and psychiatric central nervous system (CNS) disorders, liver disease, and hormone supplementation in the United States.

It has a collaboration with Verity Pharmaceuticals, Inc. to develop and commercialize TLANDO; and TLANDO XR (LPCN 1111), a once-daily oral product candidate that has completed a Phase 2 trial for testosterone replacement therapy.

Lipocine Inc. was founded in 1997 and is headquartered in Salt Lake City, Utah.