First subject dosed in the clinical bridge study with lipocine depression candidate, lpcn 1154

Lpcn 1154 is an oral formulation of brexanolone in development for the rapid relief of postpartum depression (ppd) topline study results expected in h1 2023 salt lake city , april 3, 2023 /prnewswire/ -- lipocine inc. (nasdaq: lpcn), a biopharmaceutical company focused on treating central nervous system (cns) disorders by leveraging its proprietary platform to develop differentiated products, today announced that the first participant has been dosed in a pilot clinical bridge study of lpcn 1154 (oral brexanolone) and approved injectable brexanolone.   the u.s. food and drug administration (fda) has agreed with lipocine's proposal for establishing the efficacy and safety of lpcn 1154 in women with ppd through a clinical (pharmacokinetic) bridge to an approved iv infusion of brexanolone via a 505(b)(2) nda filing.
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