Drugs / Dusquetide
Dusquetide
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT06386744 | Nov 2024 → May 2025 | Behcet disease | Soligenix | Completed | No outcome recorded |
| Phase 2 | NCT02013050 | Dec 2013 → Dec 2015 | chemotherapy-induced oral mucositis | Soligenix | Completed | Met primary |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT03237325 | Dec 2017 → Jun 2020 | head and neck squamous cell carcinoma, mucositis | Soligenix | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2025-08-18 | Soligenix | Regulatory FDA Grants Soligenix Orphan Drug Designation for the Treatment of Behçet's Disease after Reviewing Recent Phase 2 Clinical Study Results soligenix.com ↗
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to dusquetide, the active ingredient in SGX945, for "treatment of Behçet's Disease" following review of recent Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet's Disease. |
| 2024-01-08 | Soligenix | Regulatory FDA Grants Soligenix "Fast Track" Designation for Dusquetide in the Treatment of Oral Lesions of Behçet's Disease soligenix.com ↗
announced today that its SGX945 (dusquetide) development program for the treatment of oral lesions of Behçet's Disease has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA). |
| 2023-11-30 | Soligenix | Regulatory Soligenix Receives FDA IND Clearance for Phase 2 Clinical Trial of Dusquetide in the Treatment of Aphthous Ulcers in Behçet's Disease soligenix.com ↗
We are pleased to have received FDA clearance on our SGX945 Phase 2 pilot trial in aphthous ulcers of Behçet's disease, |
| 2020-12-22 | Soligenix | Results Soligenix Announces Topline Results from its Phase 3 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients soligenix.com ↗
The primary endpoint of median duration of SOM did not achieve the pre-specified criterion for statistical significance (p≤0.05); although biological activity was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group. |
| 2019-08-28 | Soligenix | Results Soligenix Announces Positive Recommendation by Independent Data Monitoring Committee on its Phase 3 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer soligenix.com ↗
Following its prospectively defined interim analysis, including unblinded assessment of the study's primary efficacy endpoint, the DMC recommended that approximately 70 additional subjects be randomized into the trial, increasing the study sample size from 190 to 260 evaluable subjects. |
| 2019-04-09 | Soligenix | Regulatory Soligenix and the European Medicines Agency Pediatric Committee Reach Agreement on the Pediatric Investigation Plan for SGX942 soligenix.com ↗
announced today that the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) agreed to the Company’s Pediatric Investigation Plan (PIP) for SGX942 (dusquetide). |
| 2018-09-13 | Soligenix | Regulatory NIH selects Soligenix’s SGX942 in the Treatment of Oral Mucositis for the Commercialization Accelerator Program soligenix.com ↗
the National Institutes of Health (NIH) selected Soligenix’s SGX942 (dusquetide) development program for the treatment of oral mucositis in head and neck cancer (HNC) patients as a Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) Commercialization Accelerator Program (CAP) Phase II awardee for 2018-2019. |
| 2017-10-05 | Soligenix | Results Dusquetide Technology Platform to be Presented at the 2nd World Congress and Expo on Immunology soligenix.com ↗
Dusquetide has been demonstrated to be clinically effective in modulating the innate immune system. |
| 2017-07-06 | Soligenix | Results Dusquetide Technology Platform to be Presented at the 2017 Drug Discovery and Therapy World Congress soligenix.com ↗
Dusquetide is an Innate Defense Regulator (IDR) and the active ingredient in the drug SGX942, which yielded positive results in a Phase 2 clinical trial in oral mucositis. |
| 2017-06-19 | Soligenix | Results Complete Efficacy and Long-Term Follow-Up Safety Results from SGX942 Phase 2 Oral Mucositis Clinical Trial to be Presented at the 2017 Multinational Association for Supportive Care in Cancer Conference soligenix.com ↗
In this clinical trial that enrolled 111 patients, SGX942 (1.5 mg/kg dusquetide) demonstrated a positive, clinically meaningful reduction in the median duration of severe oral mucositis, ranging from 50% in all patients, to 67% in patients receiving the most aggressive chemoradiation therapy (CRT) for treatment of their head and neck cancer (HNC). |
| 2017-05-18 | Soligenix | Results Soligenix Announces Publication of its Phase 2 Long-Term Follow-Up Results of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients soligenix.com ↗
These 12-month data further support the safety and tolerability of SGX942, with the 1.5 mg/kg treatment group demonstrating accelerated tumor resolution and a decreased mortality rate relative to the placebo group. |
| 2017-05-03 | Soligenix | Regulatory Soligenix Receives FDA Protocol Clearance of Pivotal Phase 3 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients soligenix.com ↗
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received US Food and Drug Administration (FDA) clearance to advance a pivotal Phase 3 clinical trial evaluating SGX942 (dusquetide) for the treatment of oral mucositis in head and neck cancer (HNC) patients being treated with chemoradiation (CRT). |
| 2017-01-05 | Soligenix | Regulatory Soligenix Receives Positive Scientific Advice from the European Medicines Agency for SGX942 in the Treatment of Oral Mucositis in Head and Neck Cancer Patients soligenix.com ↗ |
| 2016-12-12 | Soligenix | Regulatory Soligenix Announces SGX942 Receives Promising Innovative Medicine Designation from the UK Medicines and Healthcare Products Regulatory Agency soligenix.com ↗ |
| 2016-10-18 | Soligenix | Results Soligenix Announces Publication of its Phase 2 Clinical Trial Results of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients soligenix.com ↗
Soligenix, Inc. (OTCQB: SNGXD) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today the publication of the positive interim results from its recent Phase 2 clinical trial in which SGX942 (dusquetide) demonstrated a statistically significant reduction in the median duration of severe oral mucositis by 50% in all patients and by 67% in patients at the highest risk for developing severe oral mucositis. |
| 2016-10-11 | Soligenix | Results Soligenix Announces Poster Presentation of its Ricin Vaccine and Dusquetide Orphan Programs at the 2016 NORD Rare Diseases and Orphan Products Breakthrough Summit soligenix.com ↗
As will be presented, the drug is effective in a preclinical model of MAS. |
| 2016-08-18 | Soligenix | Regulatory FDA Grants Soligenix Orphan Drug Designation for Dusquetide for Treatment of Macrophage Activation Syndrome soligenix.com ↗
Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient dusquetide for treatment of macrophage activation syndrome (MAS). |
| 2016-05-31 | Soligenix | Regulatory FDA Grants Soligenix “Fast Track” Designation for SGX943 for the Treatment of Melioidosis soligenix.com ↗
Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its SGX943 (dusquetide) development program has received “Fast Track” designation from the US Food and Drug Administration (FDA) as adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis, a serious and potentially life-threatening condition. |
| 2016-03-29 | Soligenix | Results Soligenix Announces Publication of Preclinical Efficacy Results with Dusquetide in Infectious Disease soligenix.com ↗
The preclinical results were published online in the Journal of Biotechnology and are available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.03.032. |
All press releases naming this drug 40 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dusquetide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06386744 ↗ |
| Known as | Arg-ile-val-pro-ala-nh2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545314 ↗ |
| Known as | Dusquetida | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545314 ↗ |
| Known as | IMX-942 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545314 ↗ |
| Known as | SGX-94 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545314 ↗ |
| Known as | SGX942 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02013050 ↗ |
| Modality | Protein / enzyme biologic | — CHEMBL3545314 ↗ |
| Route | Intravenous | “administered as a 4 minute IV infusion” NCT03237325 ↗ |