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Testosterone undecanoate

Generic Name
Testosterone undecanoate
Brand Names
Aveed, Jatenzo, Kyzatrex, Tlando
Drug Type
Small Molecule
Chemical Formula
C30H48O3
CAS Number
5949-44-0
Unique Ingredient Identifier
H16A5VCT9C
Background

Testosterone undecanoate is the ester prodrug of testosterone and has a mid-chain fatty acid at the carbon 17β position. It was developed via fatty acid esterification of testosterone in order to achieve orally administer testosterone. There are oral and intramuscular formulations available for testosterone undecanoate: both formulations are indicated for testosterone replacement therapy in adult males with hypogonadism.

Testosterone is a critical male hormone that is responsible for the normal growth and development of the male sex organs and for the maintenance of secondary sex characteristics. Male hypogonadism, resulting from insufficient testosterone secretion, can result symptoms and signs of testosterone deficiency, such as decreased libido, erectile dysfunction, and loss of muscle and bone mass. Testosterone replacement therapy aims to restore the levels of testosterone, thereby improving symptoms and signs of testosterone deficiency.

Indication

Testosterone undecanoate is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. These conditions include:

Testosterone undecanoate is not used to treat age-related hypogonadism.

Associated Conditions
Testosterone Deficiency
Associated Therapies
Hormone Replacement Therapy

FDA Removes Cardiovascular Black Box Warning from Testosterone Products Following TRAVERSE Trial Results

• The FDA has eliminated the cardiovascular black box warning from testosterone replacement therapy products, following conclusive evidence from the 5,000-patient TRAVERSE trial showing no increased cardiovascular risks. • Marius Pharmaceuticals' KYZATREX® and other testosterone products will now carry updated labeling, with specific blood pressure monitoring requirements replacing the previous cardiovascular warning. • The landmark decision is expected to improve access to testosterone therapy for millions of patients globally, shifting focus from safety concerns to potential therapeutic benefits.

FDA Updates Testosterone Product Labels Following TRAVERSE Trial Safety Data

• The FDA has mandated new labeling changes for testosterone products based on the TRAVERSE trial, which demonstrated cardiovascular safety in high-risk men with hypogonadism. • Multiple ambulatory blood pressure monitoring studies revealed consistent increases in blood pressure across all testosterone product classes, prompting new warning requirements. • The FDA is removing boxed warnings about cardiac risks while retaining limitations for age-related hypogonadism use, based on comprehensive safety evaluations.

FDA Grants Fast Track Designation to Lipocine's LPCN 1148 for Sarcopenia in Decompensated Cirrhosis

• The FDA has granted Fast Track designation to Lipocine's LPCN 1148 for treating sarcopenia in patients with decompensated cirrhosis, addressing an unmet medical need. • LPCN 1148, an oral prodrug of bioidentical testosterone, demonstrated improved sarcopenia and clinical outcomes in a Phase 2 proof-of-concept study. • The Fast Track program aims to accelerate LPCN 1148's development, offering increased FDA communication and potential for priority review and accelerated approval. • Sarcopenia, affecting many with decompensated cirrhosis, significantly reduces quality of life and survival, making LPCN 1148 a potential 'First in Class' therapy.

Lipocine Inc. Advances in Metabolic and Endocrine Disorders Treatment

Lipocine Inc., a clinical-stage biopharmaceutical company, is making significant strides in the treatment of metabolic and endocrine disorders through its proprietary drug delivery technology. The company has announced various clinical trial results, financial updates, and strategic partnerships aimed at advancing its pipeline of innovative treatments.
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