How LP-10 Could Transform Treatment for Oral Lichen Planus

In a recent interview with Dermatology Times, Michael Chancellor, MD, Chief Medical Officer of Lipella Pharmaceuticals, discussed the company’s promising investigational treatment, LP-10, for oral lichen planus (OLP)—a chronic inflammatory condition affecting over 6 million Americans, yet lacking any FDA-approved therapies.

Chancellor emphasized the therapeutic gap in OLP management, noting that current off-label treatments, such as topical tacrolimus creams, are not ideal for intraoral use. These formulations were never studied for mucosal application, and concerns around systemic absorption and toxicity remain significant. LP-10 addresses these challenges through a novel liposomal tacrolimus mouth rinse designed specifically for mucosal surfaces. Patients rinse with a 10 mL solution twice daily for 3 minutes and then spit it out, minimizing systemic exposure while delivering therapeutic concentrations directly to the oral lesions.

The recently completed phase 2a dose-ranging trial, conducted at 7 US sites with both dermatologists and oral medicine specialists, evaluated three tacrolimus doses: 0.25, 0.5, and 1.0 mg. Across over 1,500 total rinses, the treatment demonstrated excellent safety and tolerability. Importantly, all doses showed statistically significant improvement in both clinician-assessed endpoints (ulceration and erythema) and patient-reported outcomes, including pain, sensitivity, and symptom severity scores. Notably, the efficacy appeared similar across all doses, consistent with the known pharmacodynamics of tacrolimus, where receptor saturation occurs at relatively low concentrations.

“That was a very exciting finding; the global response rate was that no patient reported any worsening or even staying the same,” Chancellor noted. “It was either mild, moderate, or much better after the LP-10.”

A critical safety outcome was the minimal systemic exposure: 76% of blood samples had tacrolimus levels below the detection threshold, and peak levels remained far below nephrotoxic thresholds. This supports LP-10’s targeted delivery approach of local efficacy without systemic risk.

Looking ahead, Lipella is preparing for a phase 2b trial, using the lowest effective dose to align with FDA expectations. Chancellor identified regulatory clarity and funding as the primary hurdles. However, with compelling efficacy and safety data and ongoing discussions around breakthrough therapy designation, the company is optimistic about advancing LP-10. He closed by acknowledging the interdisciplinary collaboration driving this progress and expressed gratitude to trial investigators and patients.

“I feel very humbled that I trained as a urologist and now I get the opportunity to learn about oral mouth disease,” Chancellor said. “I want to thank the dermatologists and the dentists who are part of the trials, and the patients that participated and work with me.”