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LPCN 1021: Oral Product Candidate for Testosterone Replacement Therapy

LPCN 1021 is a novel oral product candidate of Testosterone (T) containing Testosterone Undecanoate (TU) that is designed to help restore normal T levels in males for conditions associated with a deficiency or absence of endogenous testosterone.

LPCN 1021 is designed to overcome many of the issues related to TRT products on the U.S. market. LPCN 1021 received a Complete Response Letter from the FDA on June 28, 2016 with two new clinical studies being conducted to address the deficiency cited. LPCN 1021 is being studied for both Primary and Secondary hypogonadism and is targeted to the established chronic US TRT market.

Topicals
  • image Black box warning
  • Secondary exposure to testosterone
  • image No freedom to use around pregnant loved ones
  • image Skin irritation potential
  • image Messy to apply and wait to dry
Injectables
  • image Black box warning
  • Pulmonary oil microembolism (POME) and  anaphylaxis shock
  • image Pain from injection
  • image Scarring/injection site reactions
  • image Risk of infection
  • image Not flexible for dose reversals
  • image Needle phobia/fatigue
image
 

Challenges With Oral T

  • Native Testosterone: short half-life (minutes) of testosterone blood levels that would require very frequent (impractical) dosing
  • Methyl Testosterone is reported to have liver safety issues
 

LPCN 1021 Product Attributes

LPCN 1021 is an oral testosterone replacement product candidate containing Testosterone Undecanoate (TU) that is designed to help restore normal testosterone levels in hypogonadal men.

LPCN 1021 is currently being studied in two clinical trials: the Dosing Validation Study and the Dosing Flexibility Study. Previously LPCN 1021 was studied in a 52-week pivotal Phase 3 clinical study known as the Study of Oral Androgen Replacement (SOAR).

Compliance rates of currently approved TRT therapies are as follows:3

image

In a recent survey of 28 leading endocrinologists and urologists4, 94% responded that they believed an oral TRT will improve patient compliance.

Survey question:
In your opinion, will oral testosterone improve patient compliance compared to existing options?

Survey

1  IMS Health, 2013
2  Archives of Internal Medicine, 2008
3  FDA Advisory Committee Meeting September 17, 2014
4  Lipocine Internal Study, 2014