Lipocine Inc.
Lipocine Inc. is a biopharmaceutical company leveraging proprietary technology to develop patient-friendly oral therapies targeting large unmet medical needs, especially in CNS disorders and hormonal conditions. The company’s pipeline includes candidates for postpartum depression, epilepsy, liver cirrhosis, and other CNS disorders, with a focus on innovative oral delivery systems. Lipocine aims to provide rapid, effective treatments with improved safety profiles and convenience.
Industries
Nr. of Employees
small (1-50)
Lipocine Inc.
675 Arapeen Drive, Suite 202, Salt Lake City, Utah-84108
Patents
Products
TLANDO (oral testosterone replacement therapy)
An orally administered testosterone prodrug approved for testosterone replacement in adult males with specific forms of hypogonadism; label includes requirements for blood pressure and hematocrit monitoring.
LPCN 1154 (oral brexanolone candidate)
Oral formulation of a neuroactive steroid developed to provide rapid outpatient treatment for postpartum depression via a pharmacokinetic exposure‑bridge to an approved IV reference product.
LPCN 1148 (oral androgen receptor agonist prodrug)
Oral prodrug of a bioidentical testosterone derivative targeted for management of symptoms and sarcopenia in patients with decompensated liver cirrhosis; has received Fast Track designation for a relevant indication.
LPCN 1144 (oral prodrug for metabolic/NASH indications)
Oral prodrug candidate developed for treatment of non‑cirrhotic non‑alcoholic steatohepatitis (NASH) and related metabolic conditions.
LPCN 1111 (once‑daily oral testosterone candidate)
Next‑generation oral testosterone prodrug candidate developed for potential once‑daily dosing in testosterone replacement therapy.
LPCN 1107 (oral 17‑alpha hydroxy‑progesterone caproate candidate)
Oral candidate of 17‑alpha hydroxy‑progesterone caproate developed for prevention of recurrent preterm birth; has received orphan drug designation for the indication.
TLANDO (oral testosterone replacement therapy)
An orally administered testosterone prodrug approved for testosterone replacement in adult males with specific forms of hypogonadism; label includes requirements for blood pressure and hematocrit monitoring.
LPCN 1154 (oral brexanolone candidate)
Oral formulation of a neuroactive steroid developed to provide rapid outpatient treatment for postpartum depression via a pharmacokinetic exposure‑bridge to an approved IV reference product.
LPCN 1148 (oral androgen receptor agonist prodrug)
Oral prodrug of a bioidentical testosterone derivative targeted for management of symptoms and sarcopenia in patients with decompensated liver cirrhosis; has received Fast Track designation for a relevant indication.
LPCN 1144 (oral prodrug for metabolic/NASH indications)
Oral prodrug candidate developed for treatment of non‑cirrhotic non‑alcoholic steatohepatitis (NASH) and related metabolic conditions.
LPCN 1111 (once‑daily oral testosterone candidate)
Next‑generation oral testosterone prodrug candidate developed for potential once‑daily dosing in testosterone replacement therapy.
LPCN 1107 (oral 17‑alpha hydroxy‑progesterone caproate candidate)
Oral candidate of 17‑alpha hydroxy‑progesterone caproate developed for prevention of recurrent preterm birth; has received orphan drug designation for the indication.
Services
Structuring, negotiating and executing licensing and alliance agreements, and managing milestones, royalties and commercialization transfers to partners.
Design and execution of clinical programs including PK‑bridge and pivotal PK studies, and preparation and management of IND and NDA/505(b)(2) submissions with agency interactions.
Structuring, negotiating and executing licensing and alliance agreements, and managing milestones, royalties and commercialization transfers to partners.
Design and execution of clinical programs including PK‑bridge and pivotal PK studies, and preparation and management of IND and NDA/505(b)(2) submissions with agency interactions.
Expertise Areas
- Clinical trial management (Phase 1–3 and pivotal PK studies)
- Formulation and oral drug delivery for poorly water‑soluble APIs
- Regulatory strategy and submissions (IND, NDA, 505(b)(2), Fast Track)
- CMC, process development and manufacturing scale‑up
Key Technologies
- Oral prodrug and oral formulation technologies
- Solubility enhancement methods for poorly water‑soluble APIs
- Pharmacokinetic (PK) bridging study design
- PK/PD modeling and clinical pharmacology analyses
News & Updates
Lipocine Inc. announced financial results for the second quarter ended June 30, 2025, including updates on clinical trials and pipeline progress.
Lipocine announced the dosing of the first patient in a Phase 3 trial for LPCN 1154, a treatment for postpartum depression.
The FDA has accepted Lipocine's IND application for LPCN 2101, a neuroactive steroid candidate for epilepsy.
Lipocine entered into an exclusive licensing agreement with Verity Pharma for the marketing of TLANDO in the U.S. and Canada.
Lipocine announced the transition of TLANDO's commercialization to Verity Pharma, ensuring continued patient access.
The FDA agreed with Lipocine's pathway for LPCN 1154 to establish efficacy through a PK bridge to IV brexanolone.
Lipocine Inc. announced financial results for the second quarter ended June 30, 2025, including updates on clinical trials and pipeline progress.
Lipocine announced the dosing of the first patient in a Phase 3 trial for LPCN 1154, a treatment for postpartum depression.
The FDA has accepted Lipocine's IND application for LPCN 2101, a neuroactive steroid candidate for epilepsy.
Lipocine entered into an exclusive licensing agreement with Verity Pharma for the marketing of TLANDO in the U.S. and Canada.
Lipocine announced the transition of TLANDO's commercialization to Verity Pharma, ensuring continued patient access.
The FDA agreed with Lipocine's pathway for LPCN 1154 to establish efficacy through a PK bridge to IV brexanolone.