Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.
Study StatusStudy PhaseStudy Title and Summary
Currently Enrolling PatientsPhase 3A Pivotal Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
[Referred to as the "FLASH" Study]


The purpose of this study is to evaluate the use of SGX301, a novel topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Learn more about SGX301 trial(s) on ClinicalTrials.gov
Study to Begin 2017Phase 3A Pivotal, Double-Blind, Randomized, Controlled, Multicenter, Multi-National Study Assessing the Ability of an 8-Week Treatment with SGX203 (Oral Beclomethasone 17,21-Dipropionate) to Induce Symptomatic Improvement in Pediatric Patients with Mild to Moderate Crohn's Disease

The purpose of this study is to evaluate the safety and efficacy of low and high dose SGX203, a steroid formulated to deliver therapeutic doses to the intestinal lining but reduced systemic levels of the drug, in eliminating the signs and symptoms of Crohn's disease in children 6-17 years of age with active, mild-to-moderate disease with a 8-week treatment course.

More details to come.
Study to Begin 2017Phase 3A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study of SGX942 for the Treatment of Oral Mucositis in Patients Being Treated with Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to evaluate the safety and efficacy of SGX942 in reducing the duration of severe oral mucositis associated with chemoradiation therapy in patients receiving these treatments for the treatment of head and neck cancer.

More details to come.
Patient Enrollment CompletePhase 2A Double-Blind, Randomized, Placebo-Controlled, Dose Escalating, Multicenter Study of SGX942 for the Attenuation of Oral Mucositis in Patients Being Treated with Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

The purpose of this exploratory study is to evaluate the safety and efficacy of SGX942, a unique innate immune modulator, in reducing severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer.

Learn more about SGX942 trial(s) on ClinicalTrials.gov

Study Status: Currently Enrolling Patients

Study Phase: Phase 3

Study Title and Summary: A Pivotal Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
[Referred to as the "FLASH" Study]


The purpose of this study is to evaluate the use of SGX301, a novel topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Learn more about SGX301 trial(s) on ClinicalTrials.gov
Study Status: Study to Begin 2017

Study Phase: Phase 3

Study Title and Summary: A Pivotal, Double-Blind, Randomized, Controlled, Multicenter, Multi-National Study Assessing the Ability of an 8-Week Treatment with SGX203 (Oral Beclomethasone 17,21-Dipropionate) to Induce Symptomatic Improvement in Pediatric Patients with Mild to Moderate Crohn's Disease

The purpose of this study is to evaluate the safety and efficacy of low and high dose SGX203, a steroid formulated to deliver therapeutic doses to the intestinal lining but reduced systemic levels of the drug, in eliminating the signs and symptoms of Crohn's disease in children 6-17 years of age with active, mild-to-moderate disease with a 8-week treatment course

More details to come.
Study Status: Study to Begin 2017

Study Phase: Phase 3

Study Title and Summary: A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study of SGX942 for the Treatment of Oral Mucositis in Patients Being Treated with Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to evaluate the safety and efficacy of SGX942 in reducing the duration of severe oral mucositis associated with chemoradiation therapy in patients receiving these treatments for the treatment of head and neck cancer.

More details to come.
Study Status: Patient Enrollment Complete

Study Phase: Phase 2

Study Title and Summary: A Double-Blind, Randomized, Placebo-Controlled, Dose Escalating, Multicenter Study of SGX942 for the Attenuation of Oral Mucositis in Patients Being Treated with Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

The purpose of this exploratory study is to evaluate the safety and efficacy of SGX942, a unique innate immune modulator, in reducing severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer.

Learn more about SGX942 trial(s) on ClinicalTrials.gov

For more information regarding our current and upcoming clinical trials, please contact us. (Select “Clinical Trials” in the Contact page dropdown menu.)