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Lipocine (LPCN) FDA Events

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FDA Events for Lipocine (LPCN)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Lipocine (LPCN). Over the past two years, Lipocine has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as LPCN, LPCN, LPCN, LPCN, and TLANDO. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Lipocine's Drugs in FDA Review

LPCN 1148 - FDA Regulatory Timeline and Events

LPCN 1148 is a drug developed by Lipocine for the following indication: Liver cirrhosis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LPCN 1154 - FDA Regulatory Timeline and Events

LPCN 1154 is a drug developed by Lipocine for the following indication: Postpartum depression (PPD). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LPCN 2101 - FDA Regulatory Timeline and Events

LPCN 2101 is a drug developed by Lipocine for the following indication: Epilepsy. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LPCN 2401 - FDA Regulatory Timeline and Events

LPCN 2401 is a drug developed by Lipocine for the following indication: receptor aganist and α-alpha tocopherol, an antioxidant metabolic modifier. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

TLANDO - FDA Regulatory Timeline and Events

TLANDO is a drug developed by Lipocine for the following indication: Oral testosterone. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Lipocine FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Lipocine (LPCN) has reported FDA regulatory activity for the following drugs: LPCN 1154, LPCN 1148, TLANDO, LPCN 2101 and LPCN 2401.

The most recent FDA-related event for Lipocine occurred on June 26, 2025, involving LPCN 1154. The update was categorized as "Top-line results," with the company reporting: "Lipocine Inc announced that Phase 3 Top Line Results Expected Q2 2026"

Current therapies from Lipocine in review with the FDA target conditions such as:

  • Postpartum depression (PPD) - LPCN 1154
  • Liver cirrhosis - LPCN 1148
  • Oral testosterone - TLANDO
  • Epilepsy - LPCN 2101
  • receptor aganist and α-alpha tocopherol, an antioxidant metabolic modifier. - LPCN 2401

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:LPCN) was last updated on 7/9/2025 by MarketBeat.com Staff
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