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FDA Grants Fast Track Designation to Rezpegaldesleukin for Alopecia Areata
FDA grants Fast Track designation to rezpegaldesleukin for severe alopecia areata, highlighting its potential to meet critical treatment needs.
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The US Food and Drug Administration (FDA) has granted Fast Track designation to rezpegaldesleukin, an investigational biologic therapy, for the treatment of severe-to-very severe alopecia areata (AA) in adults and pediatric patients aged ≥12 years and weighing 40 kg or more, according to a July 29 announcement from Nektar Therapeutics.
Rezpegaldesleukin is designed to selectively stimulate proliferation of regulatory T cells (Tregs) by targeting the interleukin-2 receptor complex. In clinical studies, the agent has been shown to dose-dependently increase Tregs, which play a role in modulating immune system activity.
The Fast Track designation was granted based on the serious nature of alopecia areata, a chronic immune-mediated condition that causes patchy to total scalp hair loss, and the potential of rezpegaldesleukin to address unmet medical need in this population. According to the company, current treatments for AA are not durable and are associated with high relapse rates.
Nektar is currently evaluating rezpegaldesleukin in the REZOLVE-AA Phase 2b trial (NCT06340360), a randomized, placebo-controlled study enrolling approximately 90 patients with severe-to-very severe alopecia areata who have not been previously treated with Janus kinase (JAK) inhibitors or other biologics. Patients were randomized across two dose regimens of rezpegaldesleukin or placebo. The primary endpoint is mean percent change in Severity of Alopecia Tool (SALT) score at week 36. Secondary endpoints include the proportion of participants achieving SALT-50 (50% or greater reduction in SALT score) and SALT-20 (absolute score 20 or less.) Results from the trial are expected in December 2025.
The REZOLVE-AA trial enrolled participants across approximately 30 global sites, with 62% of patients enrolled in Poland, 24% in Canada, and 14% in the United States. Patients with unstable AA, diffuse alopecia, or other forms of alopecia were excluded.
Rezpegaldesleukin previously received Fast Track designation in February 2025 for the treatment of moderate-to-severe atopic dermatitis.
References
Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Severe-to-Very Severe Alopecia Areata. News release. Nektar Therapeutics. July 29, 2025. Accessed July 30, 2025. https://ir.nektar.com/news-releases/news-release-details/nektar-therapeutics-receives-fast-track-designation-0
