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COMPANY

Lipocine

lipocine.com ↗

Clinical Phase 3

Profile checked Oct 10, 2026

Keywords: Male Hypogonadism Postpartum Depression Post-partum Depression Postnatal Depression Post-Natal Depression Peripartum Depression NASH - Nonalcoholic Steatohepatitis Liver Cirrhosis Sarcopenia Nonalcoholic Steatohepatitis LPCN 1021 LPCN 1154A LPCN 1144 LPCN 1148

9Trials (company is sponsor)

Timeline

  1. Trial start Phase 3: Brexanolone Lifting Outcomes Of Moms source ↗
  2. Trial start Phase 3: A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD source ↗
  3. Partnership Partnership / licensing announced May 6, 2025. Source: SEC filing. source ↗
  4. Partnership Partnership / licensing announced Oct 31, 2024. Source: SEC filing. source ↗
  5. Trial start Phase 2: A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia source ↗
  6. Trial start Phase 2: A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial source ↗
  7. Trial start Phase 2: The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis source ↗
  8. Trial start Phase 3: Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men source ↗
  9. Trial start Phase 3: Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) source ↗
  10. Trial start Phase 3: Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021). source ↗
  11. Trial start Phase 3: Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Last 2 years.

Clinical trials (lead sponsor) 9

RecordTitlePhaseStatusStartPrimary completion
NCT07822321Brexanolone Lifting Outcomes Of MomsPhase 3Recruiting2026-092027-08 (estimated)
NCT06979544A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPDPhase 3CompletedJun 16, 2025Jan 16, 2026 (actual)
NCT04685993A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 TrialPhase 2CompletedNov 11, 2020Mar 1, 2022 (actual)
NCT04874350A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and SarcopeniaPhase 2CompletedNov 30, 2021Dec 18, 2023 (actual)
NCT04134091The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic SteatohepatitisPhase 2CompletedAug 27, 2019Jun 24, 2021 (actual)
NCT03868059Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal MenPhase 3CompletedApr 30, 2018Feb 19, 2019 (actual)
NCT03242408Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021)Phase 3Completed2017-012017-05 (actual)
NCT03242590Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).Phase 3Completed2016-122017-03 (actual)
NCT02081300Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or HypogonadismPhase 3Completed2014-022015-05 (actual)
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