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NATESTO Testosterone Nasal Gel
NATESTO delivers testosterone through nasal absorption to replace deficient testosterone in hypogonadal men.
NATESTO delivers testosterone through nasal absorption to replace deficient testosterone in hypogonadal men. Used for Testosterone replacement therapy in adult males with hypogonadism.
At a glance
| Generic name | NATESTO Testosterone Nasal Gel |
|---|---|
| Also known as | NATESTO |
| Sponsor | Acerus Pharmaceuticals Corporation |
| Drug class | Androgen replacement therapy |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | FDA-approved |
Mechanism of action
Testosterone is a naturally occurring androgen hormone that binds to androgen receptors throughout the body to promote male sexual characteristics, muscle development, bone density, and overall metabolic function. NATESTO is a nasal gel formulation that allows testosterone to be absorbed through the nasal mucosa, providing systemic hormone replacement therapy. This route of administration offers an alternative to intramuscular injections and transdermal patches for testosterone replacement in hypogonadal men.
Approved indications
- Testosterone replacement therapy in adult males with hypogonadism
Common side effects
- Nasal irritation or discomfort
- Headache
- Rhinitis
- Epistaxis
- Acne
- Polycythemia
Key clinical trials
- Testosterone and Neural Function (EARLY_PHASE1)
- Natesto Spermatogenesis Reboot (PHASE4)
- The Effects of Natesto For Treatment Of Hypogonadism (EARLY_PHASE1)
- Evaluation of Testosterone Nasal Gel in Hypogonadal Boys (PHASE1)
- Natesto Testosterone Nasal Gel for Hypogonadal Men (PHASE4)
- A Study to Monitor Ambulatory Blood Pressure Monitoring in Hypogonadal Men Treated With Nasal Testosterone Gel (PHASE4)
- Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™ (PHASE4)
- Efficacy and Safety of Testosterone Nasal Gel for Treating Hypogonadism in 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:
- NATESTO Testosterone Nasal Gel CI brief — competitive landscape report
- NATESTO Testosterone Nasal Gel updates RSS · CI watch RSS
- Acerus Pharmaceuticals Corporation portfolio CI