Following successful phase 3 trial results, Viridian Therapeutics’ veligrotug, an intravenously delivered treatment for thyroid eye disease (TED), has been granted US Food and Drug Administration (FDA) Breakthrough Therapy Designation.

Veligrotug is an anti-insulin-like growth factor-1 receptor (IGF-1R) and features a shorter infusion time and fewer infusions compared to the currently approved and marketed IGF-1R inhibitor, said Viridian. In the Thrive and Thrive-2 phase 3 clinical trials, the drug met all of its primary and secondary endpoints.

Veligrotug is the only therapy to have demonstrated statistically significant and clinically meaningful improvement and resolution of diplopia in both active and chronic TED, said Steve Mahoney, Viridian president and CEO. “(It) also showed a rapid onset of treatment effect, including an improvement in proptosis response in as few as three weeks after just one infusion. We believe veligrotug will be an important potential new treatment option for patients living with TED, including whose disease is unaddressed by existing therapies.”

Veligrotug’s US commercial launch is scheduled for 2026.