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AndroGel 1.62%
AndroGel 1.62% is a Androgen replacement therapy Small molecule drug developed by Repros Therapeutics Inc.. It is currently FDA-approved for Testosterone replacement therapy in adult males with hypogonadism. Also known as: Testosterone gel.
AndroGel 1.62% is a testosterone replacement therapy that restores physiological testosterone levels in hypogonadal men.
AndroGel 1.62% is a small molecule testosterone gel used to treat conditions such as hypogonadism and loss of muscle mass. It is applied topically using a pump.
At a glance
| Generic name | AndroGel 1.62% |
|---|---|
| Also known as | Testosterone gel |
| Sponsor | Repros Therapeutics Inc. |
| Drug class | Androgen replacement therapy |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | FDA-approved |
Mechanism of action
The drug delivers testosterone transdermally through a gel formulation applied to the skin, where it is absorbed into the systemic circulation. Testosterone binds to androgen receptors throughout the body to restore normal male sexual function, muscle mass, bone density, and other androgen-dependent physiological processes in men with clinically low testosterone.
Approved indications
- Testosterone replacement therapy in adult males with hypogonadism
Common side effects
- Application site reactions (erythema, pruritus)
- Acne
- Polycythemia
- Gynecomastia
- Headache
Key clinical trials
- Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc (PHASE2)
- Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism (PHASE4)
- Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men (PHASE1)
- A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men (PHASE4)
- 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)
- Efficacy of Testosterone Gel to Restore Normal Serum Values of Testosterone During the Acute Phase of Critical Illness in Adult ICU Patients (PHASE2)
- A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism (PHASE4)
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 1.62% CI brief — competitive landscape report
- AndroGel 1.62% updates RSS · CI watch RSS
- Repros Therapeutics Inc. portfolio CI
Frequently asked questions about AndroGel 1.62%
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Related
- Drug class: All Androgen replacement therapy drugs
- Target: All drugs targeting Androgen receptor
- Manufacturer: Repros Therapeutics Inc. — full pipeline
- Therapeutic area: All drugs in Endocrinology
- Indication: Drugs for Testosterone replacement therapy in adult males with hypogonadism
- Also known as: Testosterone gel
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing