MedPath

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 Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated Cirrhosis

Lipocine Inc. announced FDA Fast Track Designation for LPCN 1148, targeting sarcopenia in decompensated cirrhosis patients. LPCN 1148, an oral testosterone prodrug, showed promise in a Phase 2 study, improving sarcopenia and clinical outcomes. This designation aims to expedite its development and review, addressing a significant unmet medical need.
stocktitan.net
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Lipocine's LPCN 1148 Secures FDA Fast Track Status for Sarcopenia Treatment in Decompensated Cirrhosis Patients

Lipocine Inc. received FDA Fast Track Designation for LPCN 1148, an oral prodrug of bioidentical testosterone, as a treatment for sarcopenia in decompensated cirrhosis patients. The designation aims to expedite development and review, highlighting its potential as a first-in-class therapy for a condition with unmet medical needs.
lipocine.com
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FDA Grants Fast Track Designation to Lipocine for LPCN 1148 Targeting Sarcopenia in Decompensated Cirrhosis Patients

Lipocine Inc. announced FDA Fast Track Designation for LPCN 1148, an oral prodrug of bioidentical testosterone, targeting sarcopenia in decompensated cirrhosis patients. A Phase 2 study showed improved sarcopenia and clinical outcomes. Fast Track aims to expedite development and review, offering benefits like frequent FDA meetings and eligibility for Accelerated Approval.
ir.lipocine.com
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FDA Grants Fast Track Designation to Lipocine for LPCN 1148

FDA granted Fast Track Designation to Lipocine's LPCN 1148, an oral prodrug of bioidentical testosterone, for treating sarcopenia in decompensated cirrhosis patients. LPCN 1148 showed potential in improving sarcopenia and clinical outcomes in a Phase 2 study, aiming to be a first-in-class treatment with a novel mechanism for cirrhosis management.
prnewswire.com
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Lipocine Announces Supply and Distribution Agreement with Pharmalink to Commercialize TLANDO

Lipocine Inc. announces an exclusive supply and distribution agreement with Pharmalink for TLANDO, its oral testosterone replacement therapy, in the GCC countries. Under the terms, Lipocine receives an upfront payment and will supply TLANDO upon Marketing Authorizations, while Pharmalink will handle promotion, distribution, and sales in the region.
pharmexec.com
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WellSync Partners With Marius to Offer Oral TRT Treatment on Digital Platform

WellSync partners with Marius Pharmaceuticals to offer Kyzatrex, an FDA-approved oral testosterone replacement therapy (TRT) on its digital platform, enhancing men's health care accessibility.
prnewswire.com
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WellSync and Marius Pharmaceuticals Collaborate to Offer FDA-approved Oral

WellSync collaborates with Marius Pharmaceuticals to offer KYZATREX® (testosterone undecanoate) CIII capsules on its virtual care platform, streamlining TRT access for patients.
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