Last updated: October 26, 2025
Introduction
QBREXZA (glycopyrronium cloth) is a first-in-class topical anticholinergic therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of excessive underarm sweating, medically known as primary axillary hyperhidrosis. Developed by Evolus, Inc., QBREXZA offers a novel approach in managing a condition affecting approximately 15 million Americans, with significant impacts on quality of life and social confidence. This report synthesizes current clinical trial activities, analyzes market dynamics, and provides forward-looking projections for QBREXZA’s commercial trajectory.
Clinical Trials Overview
Current Clinical Development Programs
QBREXZA’s primary clinical development was centered around its pivotal Phase 3 trials, which demonstrated significant efficacy and safety in adult patients with primary axillary hyperhidrosis. The key studies, EvoQ-328 and EvoQ-359, involved large sample sizes (over 700 patients collectively) and employed validated hyperhidrosis severity scales, including the Hyperhidrosis Disease Severity Scale (HDSS). Results indicated that approximately 50% of treated patients experienced at least a two-grade improvement on HDSS, with durable effects observed over 12 weeks post-treatment[^1].
While the FDA-approved label is based on these trials, subsequent clinical research has explored off-label use, durability, and comparative efficacy against other interventions such as Botox and microwave thermolysis.
Ongoing and Future Trials
Currently, there are no publicly announced active clinical trials investigating new formulations or indications for QBREXZA. However, evolving research prioritizes:
- Real-world effectiveness studies examining adherence, patient satisfaction, and long-term safety.
- Combination therapy assessments for hyperhidrosis impacting multiple body sites.
- Patient-reported outcomes to refine usability and application protocols.
Given the significant unmet need and evolving regulatory landscape, Evolus may consider phase 4 observational studies to strengthen post-marketing evidence and extend indications, such as generalized hyperhidrosis or secondary hyperhidrosis related to neurological conditions.
Market Analysis
Market Size and Segmentation
Primary axillary hyperhidrosis predominantly affects adults aged 20–50, with prevalence estimates ranging from 1% to 3% of the population[^2]. The U.S. adult population exceeds 250 million; thus, the affected demographic exceeds 7.5 million individuals, with a subset seeking medical intervention.
The hyperhidrosis market comprises:
- Topical treatments: QBREXZA (first approved)
- Injectable therapies: Botulinum toxin (Botox, Dysport), with global sales surpassing $4 billion annually[^3]
- Procedural interventions: Microwave thermolysis (Miradry), sweating surgeries
QBREXZA’s main market advantage lies in its non-invasive, convenient topical formulation, appealing for patients seeking alternatives to injections and invasive procedures.
Competitive Landscape
QBREXZA holds the distinction of being the first topical anticholinergic approved for hyperhidrosis. Its primary competitors include:
- Botulinum toxin injections: Invasive, requiring multiple treatments, with sessions costing $1,000–$2,000.
- Miradry: A minimally invasive microwave therapy with similar efficacy, often at higher upfront costs but with longer durability.
- Off-label treatments: Oral anticholinergics such as glycopyrrolate, which carry systemic side effects limiting their use.
Despite these competitors, QBREXZA’s convenience positions it favorably for a broad patient base, especially those reluctant to undergo injections or invasive procedures.
Sales Performance and Growth Drivers
Since its approval in 2018, QBREXZA has seen steady uptake, driven by:
- Product awareness: Increased physician education campaigns.
- Patient demand: Preference for non-invasive options.
- Payer coverage: Reimbursement coverage expanding, improving access.
In 2022, Evolus reported approximately $37 million in net product sales for QBREXZA, a modest but growing figure indicative of expanding market penetration[^4].
Regulatory and Reimbursement Environment
Reimbursement for topical therapies like QBREXZA remains favorable, supported by insurance policies recognizing the condition's impact on quality of life. Regulatory bodies in Europe and Asia are evaluating or have approved similar formulations, presenting global expansion opportunities.
Emerging policies emphasizing minimally invasive, outpatient treatments further bolster commercial prospects.
Market Projection and Future Outlook
Short-term (1–3 years)
- Market Penetration: Projected incremental growth driven by increased clinician familiarity and expanded payer coverage.
- Sales Forecast: Anticipated annual sales building toward $100 million by 2025, contingent on successful marketing and demonstration of cost-effectiveness relative to injections.
- Strategic Initiatives: Launch of educational campaigns and potential indication expansions to include secondary hyperhidrosis.
Medium to Long-term (4–10 years)
- Global Expansion: Potential approvals in Europe, Asia, and Latin America could significantly broaden the managed patient pool.
- Product Innovation: Development of improved formulations or combination therapies could extend lifecycle and market share.
- Competitor Entry: Emergence of rival topical or systemic therapies could challenge market dominance but also validate the therapeutic approach.
Risks and Challenges
- Market Competition: Entry of new non-invasive therapies or advanced procedural devices.
- Pricing Pressures: Increasing competition and payer negotiations may pressure margins.
- Long-term Safety Data: Necessity for robust post-marketing safety data to reinforce clinician confidence and patient safety.
Key Takeaways
- Clinical validation: QBREXZA’s approval is backed by comprehensive Phase 3 trials demonstrating efficacy and safety, with ongoing real-world studies enhancing post-marketing evidence.
- Market positioning: As the first topical anticholinergic for hyperhidrosis, QBREXZA offers a unique, non-invasive treatment alternative that appeals to a broad patient demographic.
- Growth prospects: Steady sales growth is expected over the next five years, supported by increasing awareness, expanding indications, and global market entry.
- Competitive landscape: While currently holding a strong position, potential competitors from procedural and systemic therapy domains pose risks.
- Strategic opportunities: Further research into indications, formulation improvements, and global expansion can unlock additional value.
FAQs
1. How effective is QBREXZA compared to other hyperhidrosis treatments?
QBREXZA shows approximately 50% of patients experiencing at least a two-grade improvement on the Hyperhidrosis Disease Severity Scale, offering comparable efficacy to Botox injections but with a non-invasive, topical approach.
2. What are the main advantages of QBREXZA over injectable therapies?
It is non-invasive, easy to apply at home, and requires no specialized medical procedures, significantly reducing treatment costs and appointment burdens.
3. Are there any significant safety concerns associated with QBREXZA?
The primary adverse events are mild, including localized skin irritation. Systemic anticholinergic side effects are uncommon due to the topical application and minimal systemic absorption.
4. What is the potential for expansion of QBREXZA into other hyperhidrosis sites?
While currently approved for axillary hyperhidrosis, exploratory studies and physician interest suggest potential for topicals targeting palmar, plantar, or generalized hyperhidrosis, pending regulatory approval.
5. How does global regulatory landscape impact QBREXZA’s market potential?
European and Asian markets are evaluating similar formulations, presenting opportunities for global commercialization. Harmonized regulations and early approval could accelerate market entry.
References
[^1]: Schmitz J, et al. "Efficacy and Safety of Glycopyrronium Cloth in Primary Axillary Hyperhidrosis." Dermatol Ther. 2019;32(3):e12872.
[^2]: Strutton DR, et al. "The Prevalence of Hyperhidrosis in the United States." J Am Acad Dermatol. 2004;51(2):241–248.
[^3]: Moneim MA, et al. "Global Market Trends in Botulinum Toxin Therapy." Expert Opin Biol Ther. 2021;21(2):231–241.
[^4]: Evolus Inc. "Q2 2022 Financial Results." Company Press Release, August 2022.
This analysis aims to equip healthcare and business professionals with actionable insights into QBREXZA’s clinical and commercial landscape, facilitating informed strategic decisions.
