WAYNE, Pa., August 6, 2026
Aclaris Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to modzatinib (ATI-2138) for the treatment of moderate to severe lichen planus (LP), including oral erosive lichen planus, cutaneous lichen planus, and lichen planopilaris. The designation represents an important regulatory milestone for the company’s immuno-inflammatory disease pipeline and is intended to accelerate the development of therapies addressing serious diseases with significant unmet medical needs. Aclaris expects to initiate a phased multi-part Phase 2b clinical trial during the fourth quarter of 2026, marking the next step in advancing modzatinib toward potential regulatory approval. Currently, there are no FDA-approved therapies for lichen planus, highlighting the importance of developing new treatment options for patients living with this chronic inflammatory condition.
Fast Track Designation Supports Accelerated Development
The FDA Fast Track Designation is designed to facilitate the development and review of investigational therapies that address serious conditions and fill unmet medical needs. The designation enables more frequent interactions with the FDA regarding clinical development strategies and trial design, potentially reducing development timelines. It also allows for rolling review of a future New Drug Application (NDA), enabling completed sections of the application to be reviewed before the full submission is finalized. In addition, Fast Track programs may qualify for Priority Review if regulatory criteria are met. According to Dr. Jesse Hall, Chief Medical Officer of Aclaris Therapeutics, lichen planus is a debilitating disease that significantly impacts patients’ quality of life, and the company looks forward to working closely with the FDA as modzatinib advances into Phase 2b development later this year.
Modzatinib Targets Significant Unmet Need in Lichen Planus
Lichen planus is a chronic inflammatory disorder affecting the skin, mucous membranes, scalp, and other tissues, often causing persistent pain, itching, inflammation, and long-term complications. Patients with oral erosive lichen planus frequently experience painful mouth ulcers that interfere with eating and speaking, while lichen planopilaris can result in permanent hair loss due to inflammation of hair follicles. Because no approved therapies currently exist, treatment options remain limited and are largely based on symptom management rather than disease modification. Modzatinib (ATI-2138) is being developed to provide a targeted therapeutic option capable of addressing the underlying immune-driven mechanisms involved in the disease, with the Phase 2b program expected to further evaluate its safety and clinical efficacy.
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Aclaris Expands Immuno-Inflammatory Pipeline
The FDA’s Fast Track decision strengthens Aclaris Therapeutics’ strategy of developing innovative treatments for patients with immuno-inflammatory diseases lacking satisfactory therapeutic options. The company’s research pipeline includes multiple investigational programs supported by its internal research and development platform. With regulatory momentum now established for modzatinib, Aclaris aims to accelerate clinical development while maintaining close collaboration with regulators throughout the process. Successful Phase 2b results could position the therapy for later-stage clinical development and potentially provide the first FDA-approved treatment specifically for lichen planus, addressing a major unmet need for patients affected by this chronic and often disabling inflammatory disease.
Source:Aclaris Therapeutics press release
