The biopharmaceutical company Sitryx Therapeutics,from Oxford, UK, has received FDA approval to begin testing its new drug SYX-5219 in patients with moderate to severe atopic dermatitis (AD). This allows the company to start a Phase 1b clinical trial in the U.S. in early 2026.
What Is SYX-5219?
SYX-5219 is a first-of-its-kind oral anti-inflammatory medicine.SYX-5219 is an investigational drug and has not yet been approved by regulatory authorities for commercial use. Clinical trials are ongoing to evaluate its safety and effectiveness. It works by targeting an enzyme called pyruvate kinase M2 (PKM2), which controls energy use in immune cells. By adjusting this enzyme’s activity, the drug aims to:
- Reduce skin inflammation
- Relieve itching
- Help repair the skin barrier
According to Dr. Ravi Rao, Chief Medical Officer of Sitryx, this drug could offer a long-lasting oral treatment for patients who need better control of their disease.
Why It is benefecial?
Atopic dermatitis affects over 200 million people worldwide. Many current treatments—like creams, biologics, and immune-suppressing drugs—have side effects or don’t work for everyone.
SYX-5219 could be a more convenient and long-term option since it is taken orally and works on the root causes of the disease.
Sitryx CEO Iain Kilty said the FDA’s approval is an important step toward bringing a new treatment to patients who still have limited options.
Early Results So Far
SYX-5219 is already being tested in healthy volunteers in the UK under approval from the MHRA. Early lab and animal studies have shown that the drug can:
- Lower inflammatory signals that cause itching
- Strengthen the skin’s protective layer
These encouraging results support moving forward with human trials in patients with AD.
What’s Next future perspective ?
Sitryx plans to start a Phase 1b study in early 2026 in U.S. patients with moderate to severe atopic dermatitis. The study will test both the safety and effectiveness of SYX-5219 and measure biological markers that show how the drug works.
If successful, the drug may later be studied for other autoimmune and inflammatory diseases.
What about Sitryx Therapeutics?
Sitryx Therapeutics is a clinical-stage biotech company from Oxford, UK. The company focuses on immunometabolism—how immune cells use energy—to develop new oral medicines for autoimmune and inflammatory disorders.
For more updates, visit the Sitryx website https://www.sitryx.com/ or follow the company on https://www.linkedin.com/company/sitryx-therapeutics-limited/
References
- Sitryx Therapeutics. Press Release: FDA Clears IND Application for SYX-5219 in Atopic Dermatitis. October 4, 2025.
- Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66 Suppl 1:8-16.
- Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122.
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