COMPANY

Lipocine

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

2026-09 Trial start Phase 3: Brexanolone Lifting Outcomes Of Moms source ↗
Jun 16, 2025 Trial start Phase 3: A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD source ↗
May 6, 2025 Partnership Partnership / licensing announced May 6, 2025. Source: SEC filing. source ↗
Oct 31, 2024 Partnership Partnership / licensing announced Oct 31, 2024. Source: SEC filing. source ↗
Nov 30, 2021 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 ↗
Nov 11, 2020 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 ↗
Aug 27, 2019 Trial start Phase 2: The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis source ↗
Apr 30, 2018 Trial start Phase 3: Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men source ↗
2017-01 Trial start Phase 3: Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) source ↗
2016-12 Trial start Phase 3: Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021). source ↗
2014-02 Trial start Phase 3: Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism source ↗

Upcoming milestones

2027-08 (ESTIMATED) · Phase 3 · Brexanolone Lifting Outcomes Of Moms · NCT07822321

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Last 2 years.

May 6, 2025 Partnership / licensing announced May 6, 2025. Source: SEC filing. source ↗
Oct 31, 2024 Partnership / licensing announced Oct 31, 2024. Source: SEC filing. source ↗

Clinical trials (lead sponsor) 9

Record	Title	Phase	Status	Start	Primary completion
NCT07822321	Brexanolone Lifting Outcomes Of Moms	Phase 3	Recruiting	2026-09	2027-08 (estimated)
NCT06979544	A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD	Phase 3	Completed	Jun 16, 2025	Jan 16, 2026 (actual)
NCT04685993	A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial	Phase 2	Completed	Nov 11, 2020	Mar 1, 2022 (actual)
NCT04874350	A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia	Phase 2	Completed	Nov 30, 2021	Dec 18, 2023 (actual)
NCT04134091	The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis	Phase 2	Completed	Aug 27, 2019	Jun 24, 2021 (actual)
NCT03868059	Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men	Phase 3	Completed	Apr 30, 2018	Feb 19, 2019 (actual)
NCT03242408	Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021)	Phase 3	Completed	2017-01	2017-05 (actual)
NCT03242590	Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).	Phase 3	Completed	2016-12	2017-03 (actual)
NCT02081300	Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism	Phase 3	Completed	2014-02	2015-05 (actual)