Want to see LPCN full AI Analyst Report?
Lipocine (LPCN) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Lpcn 1154A | Depression, Postpartum, Depression, Post-Partum, Postpartum Depression (Ppd), Post-Natal Depression, Peripartum Depression, Postnatal Depression | Phase III | Recruiting | A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD | May 13, 2025 | ― |
| Lpcn 1148 | Sarcopenia, Liver Cirrhosis | Phase II | Completed | A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia | May 03, 2021 | ― |
| Lpcn 1144 | Nash - Nonalcoholic Steatohepatitis | Phase II | Completed | A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial | Dec 08, 2020 | ― |
| Lpcn 1144 Formulation A, Lpcn 1144 Formulation B | Nonalcoholic Steatohepatitis (Nash) | Phase II | Completed | The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis | Aug 16, 2019 | ― |
| Lpcn 1021 | Hypogonadism, Male | Phase III | Completed | Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men | Feb 21, 2019 | ― |
| Lpcn 1021 | Hypogonadism, Male | Phase III | Completed | Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021). | Aug 03, 2017 | ― |
| Lpcn 1021 | Hypogonadism, Male | Phase III | Completed | Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) | Aug 03, 2017 | ― |
| Oral Testosterone Undecanoate, Lpcn 1021, Topical Testosterone Gel 1.62 % | Male Hypogonadism | Phase III | Completed | Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism | Feb 20, 2014 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Lpcn 1154A | Phase III | Depression, Postpartum, Depression, Post-Partum, Postpartum Depression (Ppd), Post-Natal Depression, Peripartum Depression, Postnatal Depression | Recruiting | A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD | May 13, 2025 | ― |
| Lpcn 1148 | Phase II | Sarcopenia, Liver Cirrhosis | Completed | A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia | May 03, 2021 | ― |
| Lpcn 1144 | Phase II | Nash - Nonalcoholic Steatohepatitis | Completed | A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial | Dec 08, 2020 | ― |
| Lpcn 1144 Formulation A, Lpcn 1144 Formulation B | Phase II | Nonalcoholic Steatohepatitis (Nash) | Completed | The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis | Aug 16, 2019 | ― |
| Lpcn 1021 | Phase III | Hypogonadism, Male | Completed | Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men | Feb 21, 2019 | ― |
| Lpcn 1021 | Phase III | Hypogonadism, Male | Completed | Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021). | Aug 03, 2017 | ― |
| Lpcn 1021 | Phase III | Hypogonadism, Male | Completed | Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) | Aug 03, 2017 | ― |
| Oral Testosterone Undecanoate, Lpcn 1021, Topical Testosterone Gel 1.62 % | Phase III | Male Hypogonadism | Completed | Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism | Feb 20, 2014 | ― |
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Lipocine Inc (LPCN) have in its pipeline
Lipocine LPCN is currently developing the following drugs: Lpcn 1154A, Lpcn 1148, Lpcn 1144, Lpcn 1144 Formulation A, Lpcn 1144 Formulation B, Lpcn 1021, Oral Testosterone Undecanoate, Lpcn 1021, Topical Testosterone Gel 1.62 %. These drug candidates are in various stages of clinical development as the company works toward FDA approval.