Lipocine's clinical development pipeline includes four programs: TLANDO, LPCN 1144, LPCN 1111 and LPCN 1107.

TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. It received a Complete Response Letter from the US Food and Drug Administration (FDA) on May 8, 2018.

LPCN 1144, an oral prodrug of bioidentical testosterone, is being developed as a treatment of non-alcoholic steatohepatitis and is currently being studied in a proof-of-concept clinical study.

LPCN 1111, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing and is currently in Phase II testing.

LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. An end of Phase II meeting with the FDA has been completed.