Lipocine、LPCN 1154の第3相トップライン結果を2026年4月上旬に発表予定

The last patient completed the final study visit in the confirmatory Phase 3 safety and efficacy trial of LPCN 1154 for postpartum depression in February 2026. Topline results are now expected early April 2026. If positive, the data are intended to support a 505(b)(2) NDA submission in mid-2026.

主要事実

提出: 2026年3月10日 10:13
イベント: トップライン結果
方向: 中立
企業: LPCNLipocine Inc.
アセット: LPCN 1154
出典: SEC 8-K
信頼度: 出典あり
N: 90
phase: 3
post hoc N: 54
primary result: not met
post hoc day 30: -5.3 (P < 0.05)
post hoc hour 12: -7.2 (P < 0.001)
post hoc hour 60: -6.1 (P < 0.01)
primary endpoint: HAM-D17 total score at hour 60

出典の抜粋

EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Lipocine Announces Financial Results for the Full Year Ended December 31, 2025 SALT LAKE CITY, March 10, 2026 — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the full year ended December 31, 2025 and provided a corporate update. “We believe 2025 was a pivotal year for Lipocine as we continue to advance our pipeline and expand our market presence. The progress we’ve made, especially with our postpartum depression therapeutic, LPCN 1154, demonstrates the strength of our science and our team’s commitment to delivering more effective treatments for patients in need,” said Dr Mahesh Patel, Lipocine

SEC 8-K

このアセットの詳細

注目

2026年9月14日

10:15

LPCNLipocine Inc.

Lipocine、LPCN 1154のPPDを対象としたBLOOM第3相試験を開始

試験登録の変更SEC 8-K