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Oral Testosterone Undecanoate
Oral testosterone undecanoate is a testosterone replacement therapy that restores physiological testosterone levels in hypogonadal men.
Oral testosterone undecanoate is a testosterone replacement therapy that restores physiological testosterone levels in hypogonadal men. Used for Testosterone replacement therapy in adult males with hypogonadism.
At a glance
| Generic name | Oral Testosterone Undecanoate |
|---|---|
| Also known as | Kyzatrex, testosterone undecanoate, Oral TU |
| Sponsor | Clarus Therapeutics, Inc. |
| Drug class | Androgen replacement therapy |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | Phase 3 |
Mechanism of action
Testosterone undecanoate is an esterified form of testosterone designed for oral absorption. It is absorbed through the lymphatic system via the intestinal tract, bypassing first-pass hepatic metabolism, and is then hydrolyzed to release free testosterone. This allows for sustained restoration of testosterone levels in men with testosterone deficiency.
Approved indications
- Testosterone replacement therapy in adult males with hypogonadism
Common side effects
- Polycythemia
- Acne
- Gynecomastia
- Mood changes
- Headache
Key clinical trials
- Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer (PHASE2)
- Comparing Direct and Indirect Detection Methods of Multiple Routes of Testosterone Administration (EARLY_PHASE1)
- An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD (PHASE2)
- A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial (PHASE2)
- Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men (PHASE3)
- Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17 (PHASE1, PHASE2)
- The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis (PHASE2)
- Patient Satisfaction After Switching to Oral Testosterone Undecanoate (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:
- Oral Testosterone Undecanoate CI brief — competitive landscape report
- Oral Testosterone Undecanoate updates RSS · CI watch RSS
- Clarus Therapeutics, Inc. portfolio CI