Testosterone Replacement Therapy
Product Candidate: LPCN 1111
Once daily oral product for TRT.
Product Attributes:
TLANDO is an FDA-Approved oral testosterone replacement therapy with an established safety profile providing the convenience and simplicity of oral dosing – two capsules taken twice a day. LPCN 1111 is a next generation, oral, once daily dosing comprising of testosterone tridecanoate being developed for testosterone replacement therapy.
TLANDO is an FDA-Approved oral testosterone replacement therapy comprising testosterone undecanoate. TLANDO targets unmet needs following oral administration of two capsules twice a day in hypogonadal men including improvement in the quality of life and costs. Among the patients who participated in clinical trials, 80% experienced normal testosterone levels in approximately 24 days. The most common Adverse Reactions >2% reported in patients were increased blood prolactin, hypertension, hematocrit increase, upper respiratory tract infection, weight increase, musculoskeletal pain and headache. In general, TLANDO was well tolerated with no drug-related severe or serious adverse events reported in the Phase 3 clinical trials. Safety and efficacy of TLANDO in males less than 18 years old have not been established.
LPCN 1111 is a next-generation, novel ester prodrug of testosterone comprised of testosterone tridecanoate which uses our proprietary delivery technology to enhance solubility and improve systemic absorption. We completed a Phase 2b dose finding study in hypogonadal men in the third quarter of 2016. The primary objectives of the Phase 2b clinical study were to determine the starting Phase 3 dose of LPCN 1111 along with safety and tolerability of LPCN 1111 and its metabolites following oral administration of single and multiple doses in hypogonadal men. Good dose-response relationship was observed over the tested dose range in the Phase 2b study. Additionally, the target Phase 3 dose met primary and secondary end points.
Overall, LPCN 1111 was well tolerated with no drug-related severe or serious adverse events reported in the Phase 2b study. All future development and commercialization of LPCN 1111 in the U.S. and Canada will be the responsibility of Verity Pharma.
About Indication:
Hypogonadism is a common condition in the male population, with a higher prevalence in older men, obese men, and men with type 2 diabetes. It is estimated that approximately 35% of men older than 45 years of age and 30-50% of men with obesity or type 2 diabetes have hypogonadism. The main symptoms of hypogonadism are reduced libido/erectile dysfunction, reduced muscle mass and strength, increased adiposity, osteoporosis/low bone mass, depressed mood and fatigue.
Hypogonadism typically refers to a permanent deficiency of sex hormones rather than a temporary deficiency that may be related to acute/chronic illnesses or other medical, personal, or environmental factors. Primary hypogonadism describes disease states that intrinsically affect the gonads. Examples of these include genetic disorders, Turner syndrome and Kleinfelter syndrome. Secondary hypogonadism refers to disease states that affect gonadal-related structures such as the hypothalamus and pituitary gland that directly impact the development of gonads and as such the release of testosterone and other sexual hormones.
Low serum testosterone causes significant clinical impact and can result in erectile dysfunction, low libido, decreased muscle mass and strength, increased body fat, decreased bone density, decreased vitality and depressed mood. Furthermore, low serum testosterone concentrations have been found to be an independent predictor of a number of cardiovascular risk factors including obesity, abnormal lipid levels, hypertension, type 2 diabetes, and systemic inflammation. Well-designed, prospective clinical trials have determined that low testosterone levels are also independently associated with mortality risk.
TESTOSTERONE THERAPY IS ONLY RECOMMENDED FOR HYPOGONADISM PATIENTS. Boosting testosterone is NOT approved by the US Food and Drug Administration (FDA) to help improve your strength, athletic performance, physical appearance, or to treat or prevent problems associated with aging. Using testosterone for these purposes may be harmful to your health.
We believe there is considerable unmet need within men with hypogonadism due to low bioavailability of orally administered testosterone in gastrointestinal environment of insoluble drug. Hitherto, testosterone replacement therapy consists of testosterone patches, gels, pellets, and injections. However, Lipocine’s Lip’ral technology presents insoluble drugs efficiently to the intestinal absorption site, thus bringing the absorption process under formulation control and making the product robust to physiological variables such as dilution, pH and food effects.
Compared with testosterone injections, the oral treatment option with enhanced solubilization, faster and consistent absorption, and patient compliance presents a significant improvement for TRT due to its tolerability and negligible side effects. Lipocine has licensed the distribution and commercialization rights of TLANDO to Verity Pharma for the U.S. and Canada.
LPCN 1111 Once Daily Oral Testosterone
1. Endocrine Society. “Hypogonadism in Men – Endocrine Society.” Endocrine.org, Endocrine Society, 31 January 2024, https://www.endocrine.org/patient-engagement/endocrine-library/hypogonadism. Accessed 30 Apr. 2025.
2. P.N. Surampudi, C. Wang, R. Swerdloff. “Hypogonadism in the Aging Male Diagnosis, Potential Benefits, and Risks of Testosterone Replacement Therapy – Review.” Int. J. Endocrinology, 2012:625434. DOI:10.1155/2012/625434.
3. P. Dandona, M.T. Rosenberg. “A practical guide to male hypogonadism in the primary care setting.” Intl. J. Clin Prac., 2010:64(6), 682-696. DOI: 10.1111/j.1742-1241.2010.02355.x
4. J.A. McBride, C.C. Carson III, R.M. Coward. “Testosterone deficiency in the aging male.” Ther. Adv. Urol., 2016: 8(1), 41-60. DOI: 10.1177/1756287215612961.