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Lipocine is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men’s and women’s health using its proprietary drug delivery technologies. Lipocine product development pipeline entails repositioning of established drugs with significantly improved patient compliance through an efficient 505(b)(2) regulatory pathway strategy.
TLANDO is an oral testosterone replacement product candidate containing Testosterone Undecanoate that is designed to help restore normal testosterone levels in hypogonadal men. TLANDO was well tolerated and met the primary end-point in Phase 3 testing and is currently being studied in two additional Phase 3 clinical trials. We believe TLANDO is a patient-preferred alternative to current non-orals without potential liability of accidental testosterone transfer to women and children; reliably restores and maintains testosterone levels; is more convenient than currently marketed products and has the potential to improve patient’s therapy, adherence and retention.
LPCN 1111 is a novel next generation oral testosterone replacement product candidate with potential for once-daily oral dosing and is currently in Phase 2 testing.
LPCN 1107 is targeted to be 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 with an end of Phase 2 meeting completed with the FDA.