Soligenix, Inc. announced on August 18, 2025, that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to dusquetide, the active ingredient in SGX945, for the treatment of Behçet's Disease. This designation follows the review of recent Phase 2a clinical results demonstrating biological efficacy and safety.
Orphan Drug Designation provides seven years of U.S. market exclusivity upon final FDA approval, a significant commercial advantage. Additionally, it offers a range of financial and regulatory benefits, including government grants for clinical trials, waiver of expensive FDA user fees for New Drug Application (NDA) submission, and certain tax credits.
Behçet's Disease is a rare inflammatory disorder affecting up to 18,000 people in the U.S. and 1 million worldwide, representing a substantial unmet medical need. This ODD significantly strengthens the intellectual property and commercial potential of SGX945, positioning it favorably against existing treatments.
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