Clinical-Stage Companies / Lipocine

Lipocine

Pre-Approval PRO BETA

🟡

Slowing Activity

No new clinical trials started in 1-2 years. Monitor for changes in pipeline strategy. Last trial started: 6/16/2025

Total Trials

Phase 3

Phase 2

Recruiting

Score

Pipeline by Phase

Phase 3

Phase 2

Phase 1

Therapeutic Focus

Hypogonadism, Male Depression, Postpartum Depression, Post-Partum Postpartum Depression (PPD) Post-Natal Depression

Clinical Trials (8)

NCT06979544 Phase 3 COMPLETED

A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD

Started: 6/16/2025

NCT03868059 Phase 3 COMPLETED

Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men

Started: 4/30/2018

NCT03242408 Phase 3 COMPLETED

Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021)

Started: 1/1/2017

NCT03242590 Phase 3 COMPLETED

Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).

Started: 12/1/2016

NCT02081300 Phase 3 COMPLETED

Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism

Started: 2/1/2014

NCT04685993 Phase 2 COMPLETED

A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial

Started: 11/11/2020

NCT04874350 Phase 2 COMPLETED

A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia

Started: 11/30/2021

NCT04134091 Phase 2 COMPLETED

The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis

Started: 8/27/2019

Drug Candidates

LPCN 1154A LPCN 1144 LPCN 1148 LPCN 1144 Formulation A LPCN 1144 Formulation B LPCN 1021 Oral testosterone undecanoate, LPCN 1021 Topical testosterone gel 1.62 %

Activity Status: Slowing

Last Trial Started: 6/16/2025

Last Trial Ended: 2/17/2026

Trials (12 months): 0

Completed Trials: 8

Data sourced from ClinicalTrials.gov. This company has no FDA-approved drugs.