Tlando: Another Oral Testosterone Undecanoate OK'd for Hypogonadism

[Nelson Vergel]

FDA approval of Tlando follows in the footsteps of Jatenzo​

The recommended dosage is 225 mg orally twice daily with food. It does not require dose titration.

"We believe Tlando's oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options," noted Apple.

The drug was also deemed a Schedule III controlled substance, due to risks of abuse and misuse of testosterone.

Tlando joins an already lengthy list of testosterone treatments, the vast majority of which are injectable or topical. This approval most closely follows the 2019 approval of Clarus Therapeutics' own version of oral testosterone undecanoate marketed under the trade name Jatenzo.

 

[Nelson Vergel]

TLANDO & TLANDO XR - novel oral prodrugs of testosterone

www.excelmale.com

A new oral T (TLANDO) treatment regimen without dose titration requirement for male hypogonadism

A new oral testosterone (TLANDO) treatment regimen without dose titration requirement for male hypogonadism (2022) Anthony DelConte, Kongnara Papangkorn Kilyoung Kim Benjamin J. Bruno Nachiappan Chidambaram Mohit Khera Irwin Goldstein Tobias S. Kohler Martin Miner Adrian S. Dobs Mahesh V. Patel...

www.excelmale.com

 

[mlair]

How would 225 mg twice daily compare to injection dosages and cream dosages?

 

[Nelson Vergel]

Here is the blood concentration under different meal conditions

 

[Nelson Vergel]

I am attaching the document presented to the FDA by the company and some important tables below.

 

[Nelson Vergel]

 

[mlair]

Thanks, Nelson!