Alopecia in 2025: Year in Review

In 2025, the HCPLive team covered a variety of dermatology news and developments related to alopecia, including important regulatory updates from the US Food and Drug Administration (FDA) and the release of influential clinical study fndings that continued to advance understanding of options for hair loss disorders.

Alongside regulatory and research milestones, the year also saw several HCPLive podcast episodes connected to hair loss disorders. These podcasts featured emerging science and expert perspectives on alopecia's diagnosis, disease mechanisms, and management. In this Year in Review summary, the HCPLive team included some of the most notable alopecia-related headlines featured in coverage of the disease this year, providing a comprehensive look back at key developments:

FDA News

FDA Grants Fast Track Designation to Bempikibart for Alopecia Areata

The FDA’s Fast Track designation was granted to bempikibart (ADX-914) as a treatment for individuals living with alopecia areata, according to an April 2025 announcement by Q32 Bio Inc. The Fast Track designation, a process designed to facilitate the development of newer drugs and allow for expedited review of medications, was granted to this fully human anti-interleukin (IL)-7Rα antibody. The decision follows the positive findings seen in Part A of the SIGNAL-AA clinical study and the initiation of dosing in the Part A open-label extension and Part B portions of the SIGNAL-AA trial. Bempikibart is now being assessed for patients with alopecia areata.

Trial Updates and New Guidelines

BRAVE-AA-PEDS: Baricitinib Leads to Hair Regrowth in Adolescents with Alopecia Areata

In 1 notable study from 2025, presented at the 2025 Fall Clinical Dermatology conference and announced by Eli Lilly and Incyte, investigators found oce-daily oral baricitinib (Olumiant) led to significant hair regrowth on the scalp, eyelashes, and eyebrows in adolescents with severe alopecia areata after 1 year of medication use. The 52-week data on baricitinib 4 mg’s use and its hair regrowth effects resulted from the phase 3 BRAVE-AA-PEDS study (NCT05723198).

Upadacitinib Improves Scalp Hair Coverage in Phase 3 UP-AA Trial for Alopecia Areata

Positive topline findings were announced by AbbVie from the first of 2 pivotal phase 3 analyses in the UP-AA clinical trial program. These data highlight the safety and efficacy of upadacitinib (Rinvoq) 15 mg and 30 mg, once-per-day, among adults and adolescents with severe alopecia areata, a mean baseline Severity of Alopecia Tool (SALT) score of 83.8, and approximately 16% scalp hair coverage. In study 2, both doses of upadacitinib were shown to have attained the investigators’ primary endpoint, with 44.6% and 54.3% of patients treated with upadacitinib 15 mg and 30 mg, respectively, achieving 80% or more scalp hair coverage (SALT score ≤ 20) at the 24-week mark, compared with 3.4% of those in the placebo arm (P <.001).

ALLEGRO 3-Year Data Demonstrate Effectiveness in Alopecia Areata for Adults, Adolescents

In recent 3-year data on ritlecitinib (Litfulo), presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in France, ritlecitinib demonstrated long-term efficacy in both adult and pediatric patients. The investigators noted nearly 90% of those attaining SALT scores of 20 or less maintained these benefits out to 36-38 months. Additionally, almost 30% attained complete scalp hair regrowth.

REZOLVE-AA: Phase 2b Data Released on Rezpegaldesleukin for Alopecia Areata

In December 2025, topline, phase 2b study results were released, highlighting investigational rezpegaldesleukin and demonstrating the drug’s meaningful level of clinical effect in those with severe-to-very-severe alopecia areata. This Nektar Therapeutics announcement followed the conclusion of the 36-week induction treatment period of the REZOLVE-AA analysis of investigational rezpegaldesleukin. The drug is a first-in-class IL-2 pathway agonist and regulatory T-cell (Treg) proliferator. While the trial's main endpoint was not statistically significant overall, the study achieved significance when excluding protocol violations.

Feature Content/Podcasts

Skin of Color Savvy: Hair Loss Misconceptions, Clinical Insights, and Management, with Janiene Luke, MD, and Victoria Barbosa, MD, MPH

During this Savvy Conversations episode of Skin of Color Savvy, Victoria Barbosa, MD, MPH, MBA, an associate professor of dermatology at the University of Chicago and president of SOCS, was joined by Janiene Luke, MD, clinical professor of dermatology at Loma Linda University. The 2 experts held a comprehensive discussion regarding common habits of patients, hair care myths, and the management of hair loss in individuals with skin of color. Both speakers gave a deep dive into common misconceptions about alopecia, noting the term’s common misunderstanding among patients. They also noted challenges of educating patients who self-diagnose and stressed the importance of accurate clinical evaluation.

Skin of Color Savvy: Hair-Care Challenges in Dermatology, With Amy McMichael, MD, and Kayla Taylor, MD

In this episode, 2 experts spoke on the topic of hair loss. Amy McMichael, MD, of Wake Forest School of Medicine, spoke with Kayla Taylor, MD, of Atrium Health Dermatology, for an in-depth discussion on hair loss differentials, scarring alopecia, and hair-care–related issues impacting individuals with skin of color. Taylor’s background and long-term clinical and academic focus on hair loss disorders was discussed in this podcast episode, with special focus on her work on scarring alopecias disproportionately affecting patients of African descent.

The Medical Sisterhood: From MD to Medical Director—A Real Talk on Industry Careers

This July 2025 episode of The Medical Sisterhood, host Mona Shahriari, MD, of the Yale School of Medicine, spoke with Amal Elkady, MBBCh, a physician-leader with experience in dermatology, immunology, and the pharmaceutical industry. Elkady highlighted her research experience alongside Emma Guttman-Yassky, MD, PhD, at Mount Sinai, sharing how a single case report on a patient with overlapping vitiligo, psoriasis, psoriatic arthritis, and alopecia helped lead her into the global pharmaceutical spotlight. That experience ultimately led to Elkady’s key role in developing what would become an FDA-approved treatment.