Fda clears lpcn 1154 ind application for a phase 2 postpartum depression study

Salt lake city, june 14, 2021 /prnewswire/ -- lipocine inc. (nasdaq: lpcn), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the u.s. food and drug administration ("fda") has cleared the company's investigational new drug application ("ind") to initiate a phase 2 study to evaluate the therapeutic potential of lpcn 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression ("ppd") in adults. a pharmacokinetic ("pk") study to assess dose proportionality is planned to start in july 2021 with top-line results expected in the third quarter of 2021.
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