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Oral testosterone undecanoate, LPCN 1021
Oral testosterone undecanoate, LPCN 1021 is a Androgen replacement therapy Small molecule drug developed by Lipocine Inc.. It is currently in Phase 3 development for Testosterone replacement therapy in adult males with hypogonadism.
Oral testosterone undecanoate replaces deficient testosterone by providing exogenous androgen that binds to androgen receptors throughout the body.
Oral testosterone undecanoate replaces deficient testosterone by providing exogenous androgen that binds to androgen receptors throughout the body. Used for Testosterone replacement therapy in adult males with hypogonadism.
At a glance
| Generic name | Oral testosterone undecanoate, LPCN 1021 |
|---|---|
| Sponsor | Lipocine Inc. |
| Drug class | Androgen replacement therapy |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | Phase 3 |
Mechanism of action
LPCN 1021 is an oral formulation of testosterone undecanoate designed to restore physiological testosterone levels in hypogonadal men. The drug is absorbed through the lymphatic system via lipid-based formulation, allowing it to bypass first-pass hepatic metabolism and achieve sustained testosterone levels. It acts as an androgen replacement therapy by supplementing endogenous testosterone deficiency.
Approved indications
- Testosterone replacement therapy in adult males with hypogonadism
Common side effects
- Polycythemia
- Elevated hematocrit
- Acne
- Mood changes
- Prostate-related events
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, LPCN 1021 CI brief — competitive landscape report
- Oral testosterone undecanoate, LPCN 1021 updates RSS · CI watch RSS
- Lipocine Inc. portfolio CI
Frequently asked questions about Oral testosterone undecanoate, LPCN 1021
What is Oral testosterone undecanoate, LPCN 1021?
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Who makes Oral testosterone undecanoate, LPCN 1021?
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Related
- Drug class: All Androgen replacement therapy drugs
- Target: All drugs targeting Androgen receptor
- Manufacturer: Lipocine Inc. — full pipeline
- Therapeutic area: All drugs in Endocrinology
- Indication: Drugs for Testosterone replacement therapy in adult males with hypogonadism
- Compare: Oral testosterone undecanoate, LPCN 1021 vs similar drugs
- Pricing: Oral testosterone undecanoate, LPCN 1021 cost, discount & access