A group of people representing AXYS and the Klinefelter Syndrome community traveled to Washington,
DC in early January 2018 to provide public comments at an FDA hearing related to the approval of a new
oral testosterone drug called Jatenzo.
The Clarus drug company has developed this oral pill as an alternative for men that require testosterone
replacement therapy (TRT). Currently the only options for TRT involve the use of gels, patches, injections
or pellet implants. All of these options have different challenges and difficulties that can cause some
men to become frustrated and stop following their recommended replacement plan. This can lead to
multiple physical and emotional difficulties for some KS individuals. We believe an oral alternative would
be easier for many people and would help them start and continue their TRT programs.
AXYS representatives and other KS adults provided testimony to the FDA Advisory Committee several
years ago at the first public hearing on Jatenzo. Those efforts were not successful at the time and the
FDA requested more studies and evaluations. Those studies were completed and the FDA agreed to
reconsider the drug for approval. The Clarus company requested that we provide testimony once again
to help explain why this oral alternative could be such a big improvement for KS individuals that require
TRT to maintain optimal health.
We were disappointed when the FDA did not vote in favor of Jatenzo again, but the vote was closer this
time and the company will be asking for another reconsideration. We have been writing letters to the
FDA as well as individual senators and representatives to put more pressure on the FDA and we would
ask all of our members to assist us in our efforts by contacting their own congressional representatives
to get involved. This could be a very important drug to help KS people so please contact the AXYS Board
Chairperson, Gary Glissman at email@example.com to find out what you can do. We have
template letters and can help you find email addresses for your elected representatives if you need
Related webinar: Dr. Jay Newmark – Testosterone Replacement Therapy in Adult Males