Kyzatrex FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 3, 2022.
FDA Approved: Yes (First approved July 27, 2022)
Brand name: Kyzatrex
Generic name: testosterone undecanoate
Dosage form: Capsules
Company: Marius Pharmaceuticals
Treatment for: Hypogonadism, Male
Kyzatrex (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.
- Kyzatrex is a proprietary oral softgel capsule that is absorbed primarily via the lymphatic system, thus avoiding liver toxicity. The oral delivery method eliminates the risk of application site reactions common with intramuscular testosterone injections as well as potential transference to women or children that can occur with topical testosterone gels and creams.
- Kyzatrex is administered orally in the morning and in the evening, with food. It is designed to mimic the daily rhythm of natural testosterone production compared to long-acting therapies.
- Warnings and precautions associated with Kyzatrex include polycythemia; worsening of benign prostatic hyperplasia (BPH) and potential risk of prostate cancer; venous thromboembolism (VTE); potential for abuse of testosterone; potential for adverse effects on spermatogenesis; edema; sleep apnea; and lipid changes.
- The most common adverse reaction is hypertension.
Development timeline for Kyzatrex
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