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Testosterone gel 1%
Testosterone gel delivers exogenous testosterone through transdermal absorption to replace deficient endogenous testosterone and restore normal androgen levels.
Testosterone gel delivers exogenous testosterone through transdermal absorption to replace deficient endogenous testosterone and restore normal androgen levels. Used for Testosterone replacement therapy in adult males with hypogonadism.
At a glance
| Generic name | Testosterone gel 1% |
|---|---|
| Also known as | Androgel 1%, T gel, Testosterone gel, AndroGel |
| Sponsor | University of Colorado, Denver |
| Drug class | Androgen replacement therapy |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | FDA-approved |
Mechanism of action
Testosterone is applied topically as a 1% gel formulation, allowing percutaneous absorption into systemic circulation. It binds to androgen receptors throughout the body to restore physiological testosterone levels in hypogonadal patients, promoting development and maintenance of male sexual characteristics, muscle mass, bone density, and other androgen-dependent functions.
Approved indications
- Testosterone replacement therapy in adult males with hypogonadism
Common side effects
- Application site reactions (erythema, pruritus)
- Acne
- Polycythemia
- Gynecomastia
- Headache
- Mood changes/irritability
Key clinical trials
- Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening (PHASE4)
- Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (PHASE1)
- Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer (PHASE1)
- Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance (PHASE4)
- Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (PHASE2)
- Testosterone and Neural Function (EARLY_PHASE1)
- Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc (PHASE2)
- Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers (PHASE2)
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:
- Testosterone gel 1% CI brief — competitive landscape report
- Testosterone gel 1% updates RSS · CI watch RSS
- University of Colorado, Denver portfolio CI