Lipocine Inc., incorporated on October 13, 2011, is a specialty pharmaceutical company. The Company is focused on applying its oral drug delivery technology for the development of pharmaceutical products in the area of men's and women's health. The Company's primary development programs are based on oral delivery solutions for bioavailable drugs. The Company has a portfolio of product candidates designed to produce pharmacokinetic characteristics and facilitates lower dosing requirements, bypass first-pass metabolism, reduce side effects, and eliminates gastrointestinal interactions that limit bioavailability. The Company's lead product candidate, LPCN 1021, is an oral testosterone replacement therapy (TRT), designed for twice-a-day dosing and is in Phase III testing.
The Company's additional pipeline candidates include LPCN 1111, an oral testosterone therapy product targeted for once daily dosing, which is in Phase II testing, and LPCN 1107, an oral therapy for the prevention of preterm birth, which is in Phase I testing. These products are based on its Lip'ral promicellar drug delivery technology platform. Lip'ral promicellar technology is a technology based on lipidic compositions, which form an optimal dispersed phase in the gastrointestinal environment for improved absorption of insoluble drugs.
LPCN 1021: An Oral Product Candidate for Testosterone Replacement Therapy
The Company's LPCN 1021 is an oral formulation of the chemical testosterone undecanoate (TU), an 11-carbon side chain attached to testosterone. LPCN 1021 is an ester prodrug of testosterone. The Company has completed its Study of Oral Androgen Replacement (SOAR) pivotal Phase III clinical study evaluating efficacy and safety of LPCN 1021. LPCN 1021 is well tolerated during 52 weeks of dosing. The Company also completed labeling food effect study for LPCN 1021, which indicates that the bioavailability of testosterone from LPCN 1021 is not affected by changes in meal fat content.
LPCN 1111: A Next-Generation Oral Product Candidate for TRT
LPCN 1111 is a next-generation, ester prodrug of testosterone, which uses the Lip'ral technology to enhance solubility and improve systemic absorption. The Company has initiated a Phase IIb dose finding study in hypogonadal men. The Phase IIb clinical study is an open label, two-period and multiple dose pharmacokinetic (PK) study in over 36 hypogonadal males. The Phase IIb clinical study has approximately three dose levels of LPCN 1111 in Period 1 and over two dose levels of LPCN 1111 in Period 2 in which approximately 12 subjects at each dose level receives treatment for over 14 days. It has completed a Phase IIa proof-of-concept study in hypogonadal men. The Phase IIa open-label, dose-escalating single and multiple dose study enrolled over 12 males. Results from the Phase IIa clinical study demonstrated the feasibility of a once daily dosing with LPCN 1111in hypogonadal men.
LPCN 1107: An Oral Product Candidate for the Prevention of Preterm Birth
LPCN 1107 is an oral hydroxyprogesterone caproate (HPC) product candidate indicated for the prevention of recurrent preterm birth. The Company has completed a multi-dose PK dose selection study in pregnant women. The multi-dose PK dose selection study is an open-label, four-period, four-treatment, randomized, single and multiple dose, PK study in pregnant women of over three dose levels of LPCN 1107 and the injectable HPC. The Company has completed a Phase Ib clinical study of LPCN 1107 in healthy pregnant women. It has also completed a Phase Ia clinical study of LPCN 1107 in healthy non-pregnant women. These studies determine the pharmacokinetics and bioavailability of LPCN 1107 relative to an intramuscular (IM) HPC, as well as the safety and tolerability.
The Company competes with AbbVie, Eli Lilly and Co., Endo International PLC, Impax Laboratories Inc., Valeant Pharmaceuticals International, Inc., Actavis Pharmaceuticals, Inc., Antares Pharma, Inc., SOV Therapeutics, Inc., Repros Therapeutics Inc., Novartis, Apricus Biosciences, Inc. and TesoRx Pharma LLC.
675 S Arapeen Dr Ste 202
The company trades on NASDAQ exchange. The company headquarter is located in Utah, UT.| Ticker | LPCN |
| Long Name | Lipocine Inc. |
| Short Name | Lipocine |