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Androgel (Testosterone Gel)
Androgel delivers testosterone transdermally to replace deficient testosterone levels in hypogonadal men.
Androgel delivers testosterone transdermally to replace deficient testosterone levels in hypogonadal men. Used for Hypogonadism (testosterone deficiency) in adult males.
At a glance
| Generic name | Androgel (Testosterone Gel) |
|---|---|
| Also known as | Testosterone gel, Androgel |
| Sponsor | National Institute on Aging (NIA) |
| Drug class | Androgen replacement therapy |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | FDA-approved |
Mechanism of action
Testosterone is absorbed through the skin and enters systemic circulation, where it binds to androgen receptors throughout the body to restore normal male hormone levels. This replacement therapy restores secondary sexual characteristics, muscle mass, bone density, and sexual function in men with clinically low testosterone.
Approved indications
- Hypogonadism (testosterone deficiency) in adult males
Common side effects
- Skin irritation at application site
- Acne
- Polycythemia (elevated red blood cell count)
- Gynecomastia (breast tissue enlargement)
- Mood changes/irritability
- Headache
Key clinical trials
- Body Composition Assessment in Transgender Population.
- Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening (PHASE4)
- Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (PHASE2)
- 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)
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:
- Androgel (Testosterone Gel) CI brief — competitive landscape report
- Androgel (Testosterone Gel) updates RSS · CI watch RSS
- National Institute on Aging (NIA) portfolio CI