RINVOQ: A Promising New Treatment Option for Alopecia Areata

RINVOQ, a JAK inhibitor, is under investigation for multiple immune-mediated inflammatory conditions. In human leukocyte assays, it demonstrated more potent inhibition of cytokine-driven STAT phosphorylation via JAK1 and JAK1/JAK3 compared to JAK2-mediated pathways. However, the clinical significance of targeting specific JAK enzymes for efficacy and safety remains uncertain.

Initially approved in 2019 for rheumatoid arthritis, RINVOQ has since expanded into several other indications, including psoriatic arthritis, atopic dermatitis, Crohn’s disease, and ulcerative colitis. RINVOQ is currently in Phase III trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. AbbVie recently reported Q2 sales of $2.03 billion, reflecting 42% growth year over year, with total 2024 revenues reaching $5.97 billion.

What do RINVOQ Positive Top Results Mean for Alopecia Areata?

AbbVie is expanding its presence with RINVOQ, a JAK1-selective oral inhibitor. The company reported positive topline results from the second of two pivotal Phase III UP-AA studies evaluating upadacitinib (RINVOQ; 15 mg and 30 mg, once daily) for adult and adolescent patients with severe alopecia areata, who had an average baseline SALT score of 84.0 (around 16% scalp hair coverage).

In the first study, both upadacitinib doses met the primary endpoint: 45.2% of patients on 15 mg and 55.0% on 30 mg achieved 80% or greater scalp hair coverage (SALT score ≤ 20) at week 24, compared to 1.5% in the placebo group (p<0.001). These findings align with the results from the parallel replicate study in the Phase 3 UP-AA program. Additionally, in the recent trial, 35% of patients on 15 mg and 46% on 30 mg reached 90% or more scalp coverage at week 24, versus just 0.7% for placebo.

Regarding secondary endpoints, both studies showed improvements in eyebrow and eyelash growth, as well as the proportion of patients achieving complete scalp coverage at week 24 in each dosing group. The safety profile for both doses of RINVOQ was consistent with what has been observed in other approved uses.

Heading Toward Regulatory Submissions

AbbVie has indicated it intends to submit these data to regulatory bodies. If approved, upadacitinib could become one of the first systemic JAK inhibitors specifically approved for alopecia areata, opening a new therapeutic path for patients.

Discover how RINVOQ will shape the alopecia treatment landscape @ RINVOQ Medication

How Will RINVOQ Compete with Existing Alopecia Areata Therapy

While cross-trial comparisons should be approached with caution, RINVOQ appears to outperform three other JAK inhibitors currently approved for this indication. The latest alopecia therapy to gain approval is Sun Pharma’s LEQSELVI, evaluated in two trials involving 1,220 patients with an average baseline scalp coverage of just 13%. After 24 weeks, over 30% of participants achieved at least 80% scalp coverage.

Eli Lilly’s OLUMIANT, approved in 2022, demonstrated in clinical studies that 17–22% of patients on a 2 mg daily dose reached 80% scalp coverage at 36 weeks, while 32–35% of those on a 4 mg dose achieved the same benchmark. In 2023, Pfizer’s LITFULO received approval following trial results showing that 23% of patients attained 80% or greater scalp coverage after six months of treatment.

Targeted Patient Pool of Alopecia Areata

In 2024, the major markets, the US, EU5, and Japan, reported roughly 2.2 million prevalent cases of alopecia areata, of which 1.7 million were diagnosed. These figures are expected to increase between 2025 and 2034. The patient pool of alopecia areata is driven by factors such as improved awareness and diagnostics, an aging population, genetic susceptibility, environmental triggers, and rising stress levels. Enhanced healthcare access and better reporting also contribute to the growing number of diagnosed cases.

Current Alopecia Areata Treatment Landscape

The current alopecia areata treatment market landscape includes corticosteroids, immunosuppressants, immunomodulators, topical sensitization, and irritation therapies. Corticosteroids remain a mainstay due to their anti-inflammatory effects, helping to suppress immune attacks on hair follicles. Immunosuppressants and immunomodulators are generally reserved for more severe or treatment-resistant cases to modulate immune activity and prevent further hair loss.

Key pharmaceutical companies in the alopecia areata therapy market include Eli Lilly, Incyte, Pfizer, and Sun Pharmaceuticals, offering approved therapies such as OLUMIANT (available in the US, EU, and Japan), LITFULO (US, EU, and Japan), and LEQSELVI (US).

Find out more about alopecia areata therapy @ Alopecia Areata Medications

Other Key Emerging Therapies in the Alopecia Areata Market

There remains a notable gap in treatments specifically targeting mild alopecia areata, as most available therapies focus on moderate to severe cases. This highlights an unmet need for practical, accessible solutions for early-stage or less severe conditions. The growing demand for safer, more efficacious treatments presents opportunities for the development of innovative therapies that can achieve remission without long-term use or serious risks such as black box warnings. Pharmaceutical companies are actively pursuing new treatment for alopecia areata to address these unmet needs.

Apart from AbbVie, key players developing next-generation alopecia areata therapies include Legacy Healthcare (Coacillium [LH-8]), Soterios (STS01), Sanofi (Amlitelimab), Q32 Bio (Bempikibart), Nektar Therapeutics (Rezpegaldesleukin), and others.

Rezpegaldesleukin is being developed as a potential first-in-class therapy designed to correct immune system imbalances seen in various autoimmune and inflammatory diseases. The treatment works by engaging the interleukin-2 receptor complex to promote the growth of regulatory T cells, a type of immune cell that helps suppress excessive immune activity. Through this mechanism, rezpegaldesleukin may help restore immune balance. In July 2025, Nektar Therapeutics reported that the FDA granted Fast Track designation to rezpegaldesleukin for the treatment of severe to very severe alopecia areata in adults and in pediatric patients aged 12 years and older who weigh at least 40 kilograms.

Bempikibart is a fully human monoclonal antibody that targets both the Interleukin-7 Receptor Alpha subunit (IL-7Rα) and Thymic Stromal Lymphopoietin (TSLP), aiming to modulate adaptive immune responses in autoimmune disorders. The IL-7 and TSLP pathways are biologically and genetically associated with T cell–driven disease mechanisms and are key contributors to multiple autoimmune conditions. In April 2025, Q32 Bio Inc. reported that the FDA granted Fast Track designation (FTD) to bempikibart (ADX-914) for the treatment of alopecia areata.

Legacy Healthcare has developed Coacillium, a botanical therapy that shows strong potential in managing pediatric alopecia areata. Clinical trials demonstrated significant hair regrowth, with lasting benefits even after treatment stopped. In June 2023, the EMA validated the Marketing Authorization Application (MAA) for Coacillium, which the CHMP is now reviewing for use in children and adolescents with moderate to severe alopecia areata. A recent study reported that 82% of patients experienced hair regrowth, along with marked improvements in SALT scores.

The anticipated launch of these new treatments for alopecia areata are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the alopecia areata market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

To know about what is the current status of research on alopecia areata, visit @ Alopecia Areata Cure Research

Where is the Alopecia Areata Market Headed?

DelveInsight estimates that the alopecia areata market size is expected to grow from ~USD 400 million in 2024 at a significant CAGR by 2034. This growth is mainly attributed to the increasing awareness about alopecia areata, which may increase market size in the coming years, assisted by an increase in the prevalence of alopecia areata.

DelveInsight’s latest published market report, titled as Alopecia Areata Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the alopecia areata country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market’s underlying potential. The alopecia areata market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:

• Prevalent Cases of Alopecia Areata

• Diagnosed Prevalent Cases of Alopecia Areata

• Gender-specific Diagnosed Prevalent Cases of Alopecia Areata

• Age Onset-based Diagnosed Prevalent Cases of Alopecia Areata

• Severity-specific Diagnosed Prevalent Cases of Alopecia Areata

The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM alopecia areata market. Highlights include:

• 10-year Forecast

• 7MM Analysis

• Epidemiology-based Market Forecasting

• Historical and Forecasted Market Analysis upto 2034

• Emerging Drug Market Uptake

• Peak Sales Analysis

• Key Cross Competition Analysis

• Industry Expert’s Opinion

• Access and Reimbursement

Download the alopecia areata market report to assess epidemiology forecasts, understand patient journeys, understand KOLs’ opinions on upcoming treatment paradigms, and determine the factors contributing to the shift in the alopecia areata market. Also, stay abreast of the mitigating factors to improve your market position in the alopecia areata therapeutic space.

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