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LPCN Lipocine

Lipocine Inc is a clinical-stage biopharmaceutical company that is engaged in research and development for the delivery of drugs using its proprietary delivery technology. Its principal operation is to provide oral delivery solutions for existing drugs. Lipocine develops its drug candidates, or it develops drug candida…

Assets on file: LPCN 1154, testosterone undecanoate

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Catalyst calendar

Dated catalysts for LPCN, including recently decided ones.

September 2027

Sep 2027

Sep 30, 2027

in 334 days

LPCNLipocine Inc.

LPCN 1154: Phase 2 trial NCT06580444 expected to finish collecting primary-endpoint data (topline results usually follow)

Rescheduled — was Feb 26, 2027

Trial primary completionClinicalTrials.gov

September 2029

Sep 2029

Sep 30, 2029

in 1065 days

LPCNLipocine Inc.

testosterone undecanoate: Phase 2 trial NCT07512323 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

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Decision-gradeMaterialNotableMinor

Oct 7, 2026

10:10 AM

LPCNLipocine Inc.

Lipocine Announces Health Canada Approval of TLANDO for Male Hypogonadism

Health Canada has approved TLANDO (testosterone undecanoate) capsules for testosterone replacement therapy in adult males with male hypogonadism. This provides a new oral fixed-dose option without titration in Canada, where Verity Pharma holds exclusive commercial rights and plans launch by end of 2026.

FDA label updateSEC 8-K Open record1 update

Sep 21, 2026

03:22 PM

LPCNLipocine Inc.

LPCN 1154 · NCT06580444 registry update

primary_completion: 2027-02-26 → 2027-09-30; completion: 2027-03-19 → 2027-12-31

Trial registry changeClinicalTrials.gov

Sep 14, 2026

10:15 AM

LPCNLipocine Inc.

Lipocine initiates BLOOM Phase 3 study of LPCN 1154 in PPD

Lipocine has started the BLOOM Phase 3 trial of LPCN 1154 (oral brexanolone) for postpartum depression. First participant dosing is expected in early Q4 2026. The study is designed to generate prospective efficacy and safety data to support a potential 505(b)(2) NDA.

Trial registry changeSEC 8-K

Mar 10, 2026

10:13 AM

LPCNLipocine Inc.

Lipocine LPCN 1154 Phase 3 topline readout expected early April 2026

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.

Topline resultsSEC 8-K Open record3 updates