US FDA Accepts Levi-04 IND for Osteoarthritis Treatment

U.S. Food and Drug Administration has accepted the Investigational New Drug application for Levi-04, an investigational therapy developed by Levicept for the treatment of osteoarthritis. The acceptance allows the company to initiate clinical studies in the US, marking a key regulatory milestone in advancing Levi-04 into human trials.

Regulatory Clearance Enables Clinical Progress

The IND acceptance confirms that preclinical data submitted for Levi-04 met regulatory requirements for safety and scientific rationale. This clearance enables Levicept to proceed with planned clinical trials evaluating the therapy’s potential to address pain and disease progression in osteoarthritis patients, a condition with significant unmet medical need.

Strengthening Innovation in Osteoarthritis R&D

Osteoarthritis remains a large and underserved market with limited disease-modifying treatment options. The FDA’s decision highlights growing regulatory openness to novel, non-opioid and targeted approaches, positioning Levi-04 as part of a broader wave of innovation aimed at improving long-term outcomes for patients with chronic joint disease.