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topical testosterone gel
topical testosterone gel is a Androgen replacement therapy Small molecule drug developed by Clarus Therapeutics, Inc.. It is currently FDA-approved for Testosterone replacement therapy in adult males with hypogonadism. Also known as: T-gel, LY900011, Axiron, Testosterone Solution 2%.
Topical testosterone gel delivers testosterone through the skin to replace deficient hormone levels in hypogonadal men.
Topical testosterone gel is a small molecule androgen receptor agonist, classified as an agonist. It is used to treat conditions such as hip fracture, frailty, sarcopenia, physical frailty, and elective hip replacement, often in conjunction with supervised exercise training.
At a glance
| Generic name | topical testosterone gel |
|---|---|
| Also known as | T-gel, LY900011, Axiron, Testosterone Solution 2%, Testim |
| Sponsor | Clarus Therapeutics, Inc. |
| Drug class | Androgen replacement therapy |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | FDA-approved |
Mechanism of action
Testosterone is absorbed percutaneously and enters systemic circulation to restore physiological testosterone concentrations. This activates androgen receptors throughout the body, promoting development and maintenance of male sexual characteristics, muscle mass, bone density, and other androgen-dependent functions. The topical formulation allows for controlled, non-invasive hormone replacement therapy.
Approved indications
- Testosterone replacement therapy in adult males with hypogonadism
Common side effects
- Application site reactions (erythema, irritation)
- Acne
- Polycythemia
- Prostate-related effects
- Gynecomastia
Key clinical trials
- Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc (PHASE2)
- Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial (PHASE2, PHASE3)
- Adaptions and Resiliency to Multi-Stressor OpeRations (PHASE4)
- Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy (PHASE3)
- A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism (PHASE4)
- Starting a Testosterone and Exercise Program After Hip Injury (PHASE3)
- Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill (PHASE2)
- Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- topical testosterone gel CI brief — competitive landscape report
- topical testosterone gel updates RSS · CI watch RSS
- Clarus Therapeutics, Inc. portfolio CI
Frequently asked questions about topical testosterone gel
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Related
- Drug class: All Androgen replacement therapy drugs
- Target: All drugs targeting Androgen receptor
- Manufacturer: Clarus Therapeutics, Inc. — full pipeline
- Therapeutic area: All drugs in Endocrinology
- Indication: Drugs for Testosterone replacement therapy in adult males with hypogonadism
- Also known as: T-gel, LY900011, Axiron, Testosterone Solution 2%, Testim
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing