EKTERLY Market Summary

Key Factors Driving EKTERLY Growth

1. Market Share Gains and New Patient Starts

• EKTERLY (sebetralstat) is rapidly capturing share in the hereditary angioedema (HAE) on-demand treatment segment, driven by its status as the first and only oral acute attack therapy.
• New patient starts have risen quickly since launch, with early commercial data reporting hundreds of patient start forms in the US within months of approval, reflecting strong unmet need and prescription uptake.
• KalVista’s commercial strategy, including targeted physician education and patient support, is helping drive awareness and adoption among HAE specialists and general immunologists.

2. Expansion Across Key Indications

• Hereditary Angioedema (HAE) Acute Attacks: EKTERLY is approved for treating acute HAE attacks in adults and adolescents aged 12 years and older, offering a new first-line oral option.
• Pediatric Expansion: Ongoing studies are exploring EKTERLY’s use in younger pediatric populations (ages 2–11), which could expand the label and patient pool.
• Broader HAE Use: As clinical and real-world data accumulate, guidelines may increasingly recommend early on-demand oral therapy, further broadening the drug’s clinical reach.
• Future Indications: Additional regulatory submissions under review in key markets may support expanded access globally.

3. Geographic Expansion

• United States: FDA approval has enabled immediate commercial launch, with early uptake demonstrating meaningful demand.
• Europe and UK: EKTERLY received marketing authorization in the European Union and Switzerland, with planned launches starting in Germany in late 2025 and follow-on availability in additional European markets.
• Global Filings: Additional regulatory applications and licensing agreements (e.g., Japan, Canada) are advancing, positioning EKTERLY for broader international presence.

4. New Indication Approvals

• EKTERLY has achieved major regulatory approvals across the US, EU, UK, and Switzerland, significantly expanding the on-demand HAE treatment landscape.
• Pediatric studies and expanded registrations are underway, potentially broadening the indicated age range and reinforcing KalVista’s competitive footprint.
• EKTERLY’s orphan designation across multiple regions supports long-term market exclusivity in rare disease settings.

5. Strong Acute HAE Volume Momentum

• Given the rarity and episodic nature of HAE attacks, acute on-demand therapies are critical to patient care, and EKTERLY’s oral form meets a significant unmet preference compared to injectables.
• Early commercial data suggest robust start rates and prescriber interest, particularly among patients who find injectable therapies burdensome.
• The convenience and rapid symptomatic relief demonstrated in large Phase III data support ongoing volume momentum.

6. Competitive Differentiation and Market Trends

• First-and-only oral on-demand HAE option: EKTERLY’s pill formulation differentiates it from traditional injectable or IV acute therapies, improving convenience and potentially adherence.
• Favorable clinical profile: Phase III KONFIDENT data showed rapid onset of relief and significant attack resolution, with a tolerability profile similar to placebo.
• Rare disease dynamics: Personalized, guideline-driven care models in rare disease and growing clinician comfort with oral therapies support EKTERLY’s positioning.
• Real-world evidence (RWE): Early real-world use will further inform safety, utilization patterns, and payer confidence, enhancing value-based care integration.

 

EKTERLY Recent Developments

In November 2025, KalVista Pharmaceuticals announced new patient satisfaction and pediatrics data from its clinical studies of EKTERLY (sebetralstat), the first and only oral on-demand treatment for hereditary angioedema (HAE), as well as physician and patient survey and consensus study data highlighting the substantial unmet need for safe, effective and easy-to-use on-demand treatments, presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2025 Annual Scientific Meeting.

 

“EKTERLY Sales Forecast, and Market Size Analysis - 2034” report provides comprehensive insights of EKTERLY for approved indication like Hereditary angioedema in the 7MM. A detailed picture of EKTERLY’s existing usage in anticipated entry and performance in approved indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020-2034 is provided in this report along with a detailed description of the EKTERLY for approved indications. The EKTERLY market report provides insights about EKTERLY’s sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current EKTERLY performance, future market assessments inclusive of the EKTERLY market forecast analysis for approved indications in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of EKTERLY sales forecasts, along with factors driving its market.

 

EKTERLY Drug Summary

EKTERLY is an oral plasma kallikrein inhibitor containing sebetralstat, designed as the first on-demand pill for treating acute attacks of hereditary angioedema (HAE) in adults and pediatric patients aged 12 years and older. It works by competitively and reversibly blocking plasma kallikrein, a serine protease that cleaves high molecular weight kininogen to release bradykinin, which causes vascular permeability and swelling; this inhibition halts bradykinin production, prevents attack progression, and disrupts the positive feedback in the kallikrein-kinin system. FDA-approved on July 2025, it is supplied as 300 mg film-coated tablets, with a recommended dose of 600 mg (two tablets) taken orally at the onset of an attack, demonstrating rapid symptom relief within 12 hours and complete resolution in clinical trials like KONFIDENT. The report provides EKTERLY’s sales, growth barriers and drivers, post usage and approvals in multiple indications.

 

Scope of the EKTERLY Market Report

The report provides insights into:

• A comprehensive product overview including the EKTERLY MoA, description, dosage and administration, research and development activities in approved indication like Hereditary angioedema.
• Elaborated details on EKTERLY regulatory milestones and other development activities have been provided in EKTERLY market report.
• The report also highlights EKTERLY‘s cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved indications across the United States, Europe, and Japan.
• The EKTERLY market report also covers the patents information, generic entry and impact on cost cut.
• The EKTERLY market report contains current and forecasted EKTERLY sales for approved indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The EKTERLY market report also features the SWOT analysis with analyst views for EKTERLY in approved indications.

 

Methodology

The EKTERLY market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

 

EKTERLY Analytical Perspective by DelveInsight

In-depth EKTERLY Market Assessment

This EKTERLY sales market forecast report provides a detailed market assessment of EKTERLY for approved indication like Hereditary angioedema in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted EKTERLY sales data uptil 2034.

EKTERLY Clinical Assessment

The EKTERLY market report provides the clinical trials information of EKTERLY for approved indications covering trial interventions, trial conditions, trial status, start and completion dates.

EKTERLY Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

 

EKTERLY Market Potential & Revenue Forecast

Projected market size for the EKTERLY and its key indications

• Estimated EKTERLY sales potential (EKTERLY peak sales forecasts)
• EKTERLY Pricing strategies and reimbursement landscape

 

EKTERLY Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• EKTERLY Market positioning compared to existing treatments
• EKTERLY Strengths & weaknesses relative to competitors

 

EKTERLY Regulatory & Commercial Milestones

• EKTERLY Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

 

EKTERLY Clinical Differentiation

• EKTERLY Efficacy & safety advantages over existing drugs
• EKTERLY Unique selling points

 

EKTERLY Market Report Highlights

• In the coming years, the EKTERLY market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The EKTERLY companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence EKTERLY’s dominance.
• Other emerging products for Hereditary angioedema are expected to give tough market competition to EKTERLY and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of EKTERLY in approved indications.
• Analyse EKTERLY cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted EKTERLY sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of EKTERLY in approved indications.

 

Key Questions

What is the class of therapy, route of administration and mechanism of action of EKTERLY? How strong is EKTERLY’s clinical and commercial performance?

What is EKTERLY’s clinical trial status in each individual indications such as Hereditary angioedema and study completion date?

What are the key collaborations, mergers and acquisitions, licensing and other activities related to the EKTERLY Manufacturers?

What are the key designations that have been granted to EKTERLY for approved indications? How are they going to impact EKTERLY’s penetration in various geographies?

What is the current and forecasted EKTERLY market scenario for approved indications? What are the key assumptions behind the forecast?

What are the current and forecasted sales of EKTERLY in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan? 

What are the other emerging products available and how are these giving competition to EKTERLY for approved indications?

Which are the late-stage emerging therapies under development for the treatment of approved indications?

How cost-effective is EKTERLY? What is the duration of therapy and what are the geographical variations in cost per patient?