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LPCN 1021: Oral Product Candidate for Testosterone Replacement Therapy

LPCN 1021 is a twice-daily novel oral product candidate of Testosterone (T) prodrug, Testosterone Undecanoate (TU), that is being evaluated as a replacement therapy 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 and LPCN 1021 is currently under FDA review. LPCN 1021 is being studied for both Primary and Secondary hypogonadism and is targeted to the established chronic US TRT market.

Topicals
  • image Transfer potential to children, partner and pets
  • image No freedom to use around pregnant loved ones
  • image Skin irritation potential
Injectables
  • image Lung impairment potential
  • image Scarring/injection site reactions
  • image Risk of infection
  • image Not flexible for dose reversals
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 a twice daily oral product candidate of testosterone (T) prodrug, Testosterone Undecanoate (TU), that is being evaluated as a replacement therapy in males for conditions associated with a deficiency or absense of endogenous testosterone.

LPCN 1021 was studied in a 52-week pivotal Phase 3 clinical study known as the Study of Oral Androgen Replacement (SOAR). There were three dosing options: 150 mg BID, 225 mg BID and 300 mg BID. The target label for LPCN 1021 is consistent with the TRT class label for other approved products.

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