TLANDO is approved by the FDA as a testosterone replacement therapy
Verity Pharma is a specialty pharmaceutical company focused on delivering meaningful solutions to healthcare professionals and their patients. (Credit: Pawel Czerwinski on Unsplash)
Lipocine, a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that commercialization of TLANDO in the U.S. has been transitioned to its licensee Verity Pharma, effective February 1, 2024, enabling the continuity of patient access to TLANDO.
TLANDO is the first and only oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that does not require dose titration.
In January 2024, Lipocine and Gordon Silver Limited entered into an exclusive license agreement under which Verity Pharma will market TLANDO in the United States and, if approved, in Canada.
Under the terms of the license agreement, Lipocine has received the second tranche of the $11m license fee, $5m.
In addition, per the license agreement, Gordon Silver Limited is to make license fee payments of $2.5 million and $1 million no later than January 1, 2025, and January 1, 2026, respectively.
TLANDO is approved by the FDA as a testosterone replacement therapy (“TRT”) in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). TLANDO was developed using Lipocine’s proprietary Lip’ral drug delivery technology platform.
Source: Company Press Release