Trial Profile

Phase 3 trial of LPCN 1144

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 16 May 2022

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At a glance

Drugs LPCN-1144 (Primary)
Indications Non-alcoholic steatohepatitis
Focus Registrational; Therapeutic Use
Sponsors Lipocine

Most Recent Events

09 May 2022 According to a Lipocine media release, the company has requested an End of Phase 2 meeting to discuss the Phase 3 study and confirmatory trial design.
08 Mar 2022 New trial record
01 Mar 2022 According to a Lipocine media release, The FDA provided a written response in which it acknowledged that the New Drug Application ("NDA") submission of LPCN 1144 would be via 505(b)2 regulatory pathway

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