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FDA Clears Investigational New Drug Application for Lipella’s Oral Lichen Planus Treatment


LP-310 designated as an oral formulation of company’s LP-10 asset.

Taking a smear for a disease in the tongue of a woman. Glossitis and gingivitis tongue disease research concept, medical. Image Credit: Adobe Stock Images/HENADZY

Image Credit: Adobe Stock Images/HENADZY

Lipella Pharmaceuticals announced that the FDA has approved an investigational new drug (IND) application for a multi-center, Phase IIa, dose-escalation clinical trial to assess the safety and efficacy of LP-310 in patients with symptomatic oral lichen planus (OLP). In March of this year, the organization created a scientific advisory board to focus on the development of LP-310.

"OLP is a painful oral mucosal disease that currently has no approved therapy. We look forward to the opportunity to develop an effective treatment,” said Michael Chancellor, MD, chief medical officer, Lipella, in a company press release.

Reference: Lipella Pharmaceuticals Announces FDA Clearance of IND for LP-310 for Oral Lichen Planus. PR Newswire. October 20, 2023. Accessed October 20, 2023. https://www.prnewswire.com/news-releases/lipella-pharmaceuticals-announces-fda-clearance-of-ind-for-lp-310-for-oral-lichen-planus-301962718.html

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