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LPCN 1021
LPCN 1021 is a novel oral androgen receptor agonist designed to deliver testosterone systemically for hormone replacement therapy.
LPCN 1021 is a novel oral androgen receptor agonist designed to deliver testosterone systemically for hormone replacement therapy. Used for Testosterone replacement therapy in hypogonadal men.
At a glance
| Generic name | LPCN 1021 |
|---|---|
| Also known as | TLANDO |
| Sponsor | Lipocine Inc. |
| Drug class | Androgen receptor agonist |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | Phase 3 |
Mechanism of action
LPCN 1021 is a lipid-based formulation of testosterone that aims to provide physiologic androgen replacement in hypogonadal men. The drug utilizes Lipocine's proprietary lipid formulation technology to improve oral bioavailability and absorption of testosterone, potentially offering an alternative to injectable or transdermal testosterone replacement therapies.
Approved indications
- Testosterone replacement therapy in hypogonadal men
Common side effects
- Polycythemia
- Elevated hematocrit
- Prostate-related adverse events
- Lipid abnormalities
Key clinical trials
- Body Composition Assessment in Transgender Population.
- Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening (PHASE4)
- Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism (PHASE2)
- Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC (PHASE2)
- Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (PHASE2)
- Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? (PHASE2, PHASE3)
- Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance (PHASE4)
- Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer (PHASE1)
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:
- LPCN 1021 CI brief — competitive landscape report
- LPCN 1021 updates RSS · CI watch RSS
- Lipocine Inc. portfolio CI