SGX945 FDA Approval Status

FDA Approved: No
Brand name: SGX945
Generic name: dusquetide
Company: Soligenix, Inc.
Treatment for: Behcet's Disease

SGX945 (dusquetide) is an innate defense regulator (IDR) in development for the treatment of oral lesions of Behçet's Disease.

Behçet's Disease is an inflammatory disorder of the blood vessels characterized by mouth sores, skin rashes and lesions, genital sores, leg ulcers, and eye inflammation. It is thought to be an autoimmune disease with both genetic and environmental factors.
Dusquetide works by modulating the innate immune system and influencing the body’s response to injury and infection by promoting anti-inflammatory, anti-infective, and tissue-healing properties.
Dusquetide is also being studied as SGX942 for the treatment of Severe Oral Mucositis (SOM) and SGX943 for the treatment of melioidosis.

Development timeline for SGX945

Date	Article
Aug 18, 2025	FDA Grants Soligenix Orphan Drug Designation for the Treatment of Behçet's Disease after Reviewing Recent Phase 2 Clinical Study Results
Jul 31, 2025	Biological Efficacy Demonstrated in a Phase 2 Clinical Trial of SGX945 for the treatment of Behçet's Disease
Nov 14, 2024	Soligenix Initiates a Phase 2 Clinical Trial of SGX945 (dusquetide) for the treatment of Behçet's Disease
Jan 8, 2024	FDA Grants Soligenix Fast Track Designation for Dusquetide in the Treatment of Oral Lesions of Behçet's Disease

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