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Axiron Testosterone Topical Solution
Axiron delivers testosterone transdermally to replace deficient testosterone levels in hypogonadal men.
Axiron delivers testosterone transdermally to replace deficient testosterone levels in hypogonadal men. Used for Testosterone replacement therapy in adult males with hypogonadism.
At a glance
| Generic name | Axiron Testosterone Topical Solution |
|---|---|
| Also known as | Axiron solution |
| Sponsor | Clarus Therapeutics, Inc. |
| Drug class | Testosterone replacement therapy (TRT) |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | Phase 3 |
Mechanism of action
Axiron is a topical solution containing testosterone that is absorbed through the skin, bypassing first-pass hepatic metabolism. It restores physiological testosterone levels in men with hypogonadism, thereby improving symptoms such as low libido, erectile dysfunction, fatigue, and mood disturbances. The transdermal delivery system provides steady-state hormone levels with once-daily application.
Approved indications
- Testosterone replacement therapy in adult males with hypogonadism
Common side effects
- Application site reactions (irritation, erythema)
- Acne
- Polycythemia
- Gynecomastia
- Headache
- Mood changes
Key clinical trials
- A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men (PHASE3)
- The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel (PHASE4)
- A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations (PHASE3)
- A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations (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:
- Axiron Testosterone Topical Solution CI brief — competitive landscape report
- Axiron Testosterone Topical Solution updates RSS · CI watch RSS
- Clarus Therapeutics, Inc. portfolio CI