Introduction.
Alphyn Biologics has officially dosed the first patient in its Phase 2b trial for Zabalafin Hydrogel. This drug is being developed to treat mild to moderate atopic dermatitis, commonly known as eczema. The trial, called CLEAR-AD1, is taking place in Australia and will soon expand to the U.S. and Europe. It represents a big step in bringing an innovative topical treatment to patients worldwide.
What Is Zabalafin Hydrogel?
Zabalafin Hydrogel is a botanical-based topical drug from Alphyn’s Multi-Target Therapeutics® platform. It combines anti-inflammatory, antibacterial, and anti-itch properties to treat the root causes of atopic dermatitis. Unlike conventional treatments, this hydrogel targets both symptoms and the bacterial imbalances that worsen eczema. It uses multiple bioactive compounds, offering a broad and effective response with fewer side effects.
About the CLEAR-AD1 Trial.
CLEAR-AD1 is a randomized, double-blind, vehicle-controlled clinical study to test Zabalafin’s safety and efficacy. It involves two groups of patients—those with bacterial impact but no infection, and those with progressing bacterial infection. The trial will measure outcomes like itch relief, inflammation reduction, and bacterial balance improvement. Participants will use the hydrogel twice daily over a fixed treatment period under medical supervision.
Results from Phase 2a Trials.
In previous Phase 2a trials, Zabalafin Hydrogel met all primary and secondary endpoints successfully. Patients reported improved skin conditions, reduced itching, and visible relief from redness and swelling. The product was well tolerated, with no significant adverse effects reported by participants or researchers. These early results encouraged Alphyn to fast-track its Phase 2b trial to validate findings on a larger scale.
Global Expansion and Regulatory Steps.
Alphyn has received approval from the U.S. FDA for its investigational new drug application.
The company will soon begin enrolling U.S. patients and plans to move into Europe shortly after. With positive results, the hydrogel could enter Phase 3 trials and eventually reach the commercial market. Regulatory interest and patient demand are expected to fuel further development and adoption.
Conclusion.
Zabalafin Hydrogel offers hope to millions living with eczema through a natural, science-backed, multi-action treatment. The CLEAR-AD1 trial marks a critical milestone in proving the hydrogel’s safety, effectiveness, and market readiness.
