Danegaptide Shows Promise in Reducing Diabetic Retinopathy Leakage | Healio

Early results from a phase 1b clinical trial suggest that the oral medication danegaptide may reduce vascular leakage and macular exudation in patients with nonproliferative diabetic retinopathy (NPDR), according to a press release from Breye Therapeutics issued February 7, 2026.

The study, conducted across sites in the United Kingdom, Germany, and the United States, involved 24 adults with NPDR and diabetic macular edema. Participants received either one or two doses of danegaptide daily for 28 days, followed by a 14-day follow-up period to assess safety and how the drug moved through the body.

According to Carl D. Regillo, MD, director of the retina service at Wills Eye Hospital and a member of Breye’s scientific advisory board, the trial demonstrated a positive biological effect in 55% of patients. Analysis using fluorescein angiography and high-definition optical coherence tomography (OCT) revealed reduced vascular leakage and/or decreased macular exudation – indicated by decreased macular thickness, macular volume, and fewer intraretinal cysts – in more than half of those treated.

“Danegaptide has the potential to be a medicine capable of treating diabetic retinopathy from its earlier [nonproliferative diabetic retinopathy] stages,” Regillo stated in the press release. “This would create new options for how diabetic retinopathy is treated — opening the door to halting or even reversing disease and treating it before the risk emerges of disease progression to advanced forms.”

Importantly, the trial showed no clinical safety signals, and plasma levels of the drug remained within the targeted range. Breye Therapeutics announced completion of the phase 1b trial in June 2025 and is currently seeking funding for a phase 2 randomized clinical trial to further evaluate danegaptide’s efficacy and safety.