Lipella Pharmaceuticals Announces Successful Completion of Pre-IND Type B FDA Meeting Regarding Oral Lichen Planus Drug Candidate

Lipella Pharmaceuticals Announces Successful Completion of Pre-IND Type B FDA Meeting Regarding Oral Lichen Planus Drug Candidate

United States, Pennsylvania, Pittsburgh - 05/11/2021 — Lipella Pharmaceuticals’ LP-310 asset has the potential to become the first oral drug treatment for oral lichen planus

Pittsburgh, PA – (May 11, 2021) – Lipella Pharmaceuticals Inc., a clinical stage pharmaceutical company based in Pittsburgh, PA, announced today that the company has successfully concluded a Type B pre-Investigational New Drug (IND) meeting communication with the U.S. Food and Drug Administration (FDA) for LP-310, a drug candidate for treating oral lichen planus (OLP).   

Oral lichen planus is a chronic inflammatory mucosal disease that affects more than 6 million people in the U.S. and Europe.  The disease is typically characterized by ulcerative lesions in the oral cavity, accompanied by inflammation and severe pain. Also, patients with OLP have a higher frequency of transformation into oral cancer, making early detection and treatment an imperative.  There are currently no approved drug treatments for OLP.   

“Meeting with the FDA for this pre-IND application was an important step toward allowing a Phase II clinical trial to assess both the safety and efficacy of LP-310,” stated Jonathan Kaufman, Ph.D., Chief Executive Officer of Lipella. “We are very excited because this progress advances our capacity to develop a safe and effective therapy a serious disease with great unmet need.”

About LP-310

LP-310 is a liposomal tacrolimus formulation for local oral rinse administration to treat OLP.  

About Lipella Pharmaceuticals Inc.

Lipella Pharmaceuticals Inc. is a clinical stage pharmaceutical company with a focus on capital efficient therapeutic development opportunities, including the proprietary repositioning of generics for rare, morbid diseases that currently have no adequate treatments.  Additional information is available at 

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are only predictions and involve known and unknown risks, uncertainties, and other factors.


Allison Houck

Lipella Pharmaceuticals Inc.


Source: Lipella Pharmaceuticals Inc.

Key words: pharmaceutical, drug, LP-10, Lipella, lichen planus, IND, 505(b)(2), liposomal tacrolimus, therapeutic

Caution: LP-310 is currently not approved for commercial use in any indication in the United States and is limited by U.S. Federal Law to investigational use only.

Media Contacts:

Company Name: Lipella Pharmaceuticals, Inc.
Full Name: Allison Houck
Phone: 4128941853
Email Address: Send Email