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Lipocine pipeline products are based on its proprietary solubilization technology for effective oral delivery of water insoluble drugs to improve patient compliance.



PRODUCT
(Indication)
RESEARCH /
PRECLINICAL
PHASE 1 /
PHASE 2
PHASE 3 NDA
Men's Health
       
         
TLANDO (Oral Testosterone Replacement Therapy)
PDUFA action date February 8, 2018
 
         
LPCN 1111 (Next Generation Oral T)
End of P2 Meeting 4Q '17
   
         
Women's Health
       
         
LPCN 1107 (Prevention of Preterm Birth)
CMC: Process Characterization & scale-up complete 4Q'17
   
         
 

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, has been granted orphan drug designation by the FDA, and has completed an end of Phase 2 meeting with the FDA.