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Testosterone (T) Gel 1.62%
Testosterone gel delivers exogenous testosterone through transdermal absorption to replace deficient endogenous testosterone in hypogonadal men.
Testosterone gel delivers exogenous testosterone through transdermal absorption to replace deficient endogenous testosterone in hypogonadal men. Used for Testosterone replacement therapy in adult males with hypogonadism.
At a glance
| Generic name | Testosterone (T) Gel 1.62% |
|---|---|
| Sponsor | Abbott |
| Drug class | Androgen replacement therapy |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | Phase 3 |
Mechanism of action
Testosterone is a naturally occurring androgen that binds to androgen receptors throughout the body to promote development and maintenance of male sexual characteristics, muscle mass, bone density, and other physiological functions. The 1.62% gel formulation allows for transdermal delivery, providing steady-state testosterone levels with once-daily application. This replacement therapy restores testosterone to normal physiological ranges in men with clinically low testosterone (hypogonadism).
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
- Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men (PHASE1)
- Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men (PHASE3)
- A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism (PHASE4)
- T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin (PHASE1, PHASE2)
- An Open-Label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62% Applied to the Upper Arms and Shoulders and Use of a T-shirt Barrier (PHASE1)
- Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism (PHASE3)
- TRT in Combination With Electrical Stimulation and Standing: Effect on Muscle and Bone in Spinal Cord Injured Males (PHASE1, PHASE2)
- Testosterone Treatment for 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:
- Testosterone (T) Gel 1.62% CI brief — competitive landscape report
- Testosterone (T) Gel 1.62% updates RSS · CI watch RSS
- Abbott portfolio CI