Nektar Therapeutics’ Rezpegaldesleukin Approved by FDA to Treat Alopecia Areata

The U.S. Food and Drug Administration (FDA) has granted fast track designation to Nektar Therapeutics’ rezpegaldesleukin to treat alopecia areata (AA) in adult and paediatric patients aged 12 years and older who weigh at least 40 kilograms and are living with severe-to-very severe cases of the autoimmune disease.

Rezpegaldesleukin, which has already been granted FDA fast track designation for moderate-to-severe atopic dermatitis, is designed to target the interleukin-2 receptor complex in the body, stimulating the proliferation of inhibitory immune cells called Tregs and potentially bringing the immune system back into balance.

Currently, the Phase IIb REZOLVE-AA trial is evaluating the drug in patients with severe-to-very severe AA who have at least 50 percent scalp involvement and have not previously been treated with a JAK inhibitor or other biologic. The primary efficacy endpoint of the study will evaluate the mean percent change in the Severity of Alopecia Tool (SALT) score at the end of the 36-week induction period. 

“AA is a chronic, systemic, immune-mediated inflammatory disease, and there is an urgent need for novel mechanistic approaches that could treat the underlying pathogenesis of this disorder,” said Jonathan Zalevsky, senior vice president and chief research and development officer at Nektar. “We remain on track to announce top-line data in December from our ongoing REZOLVE-AA Phase IIb study for rezpegaldesleukin in AA, and we look forward to the opportunity to collaborate quickly with the agency on a potential registrational program following the completion of Phase II.”

References

Kimber, E. FDA Grants Fast Track Designation to Nektar’s Rezpegaldesleukin in Alopecia Areata. PMLive, Aug. 4, 2025. Accessed at pmlive.com/pharma_news/fda-grants-fast-track-designation-to-nektars-rezpegaldesleukin-in-alopecia-areata.

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.