KLKB1 Inhibitors Market to Reach New Heights by 2034 Owing to the Launch of Novel Therapies | DelveInsight
The outlook for the KLKB1 inhibitors market is increasingly positive, driven by growing recognition of the kallikrein–kinin pathway's pivotal role in inflammatory, cardiovascular, and rare disease mechanisms. Recent product approvals, such as TAKHZYRO, EKTERLY, KALBITOR, ORLADEYO, and DAWNZTERA, along with emerging therapies such as Lonvoguran ziclumeran (Intellia Therapeutics), Navenibart (Astria Therapeutics), RZ402 (Rezolute), and others, underscore both the scientific validation and accelerating commercial potential of this therapeutic area.
LAS VEGAS, Nov. 19, 2025 /PRNewswire/ -- DelveInsight's KLKB1 Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Hereditary Angioedema, Diabetic Macular Edema, and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging KLKB1 inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets (the US, EU4, UK, and Japan).
Key Takeaways from the KLKB1 Inhibitors Market Report
- The total market size of KLKB1 inhibitors in the leading markets is expected to surge significantly by 2034.
- The report provides the total potential number of patients in the indications, such as Hereditary Angioedema, Diabetic Macular Edema, and others.
- Leading KLKB1 inhibitor companies, such as Intellia Therapeutics, Astria Therapeutics, Rezolute, and others, are developing novel KLKB1 inhibitors that can be available in the KLKB1 inhibitors market in the coming years.
- Some of the key KLKB1 inhibitors in clinical trials include Lonvoguran ziclumeran, Navenibart (STAR-0215), RZ402, and others.
Discover which indication is expected to grab the major KLKB1 inhibitors market share @ KLKB1 Inhibitors Market Report
Key Factors Driving the KLKB1 Inhibitors Market
Rising Prevalence of Hereditary Angioedema
The increasing number of patients diagnosed with HAE, a rare genetic disorder that causes severe swelling attacks, is a primary driver. KLKB1 inhibitors target plasma kallikrein, a key enzyme in HAE pathology, providing effective treatment options for the prevention and management of attacks.
Growing Demand for Targeted and Personalized Medicine
KLKB1 inhibitors represent precision therapies that specifically target disease pathways, aligning with the trend toward personalized medicine in rare diseases and inflammatory conditions, which increases their appeal.
Advancements in Drug Development
Ongoing research and development focus on creating novel KLKB1 inhibitors such as Lonvoguran ziclumeran (Intellia Therapeutics), Navenibart (Astria Therapeutics), RZ402 (Rezolute), and others with improved efficacy, safety profiles, oral administration options, and combination therapies. These innovations address unmet medical needs and patient convenience, fostering market growth.
KLKB1 Inhibitors Market Analysis
KLKB1 inhibitors, including TAKHZYRO (lanadelumab), ORLADEYO (berotralstat), EKTERLY (sebetralstat), and DAWNZTERA (donidalorsen), have swiftly established themselves as standard-of-care treatments for hereditary angioedema (HAE), offering both prophylactic and acute attack management through diverse delivery routes such as oral, injectable, and RNA-based formulations.
The recent approvals of EKTERLY as the first oral on-demand therapy and DAWNZTERA as the first RNA-based prophylactic, along with NTLA-2002 advancing into Phase III as a gene-editing therapy, underscore a shift in the pipeline toward greater treatment convenience, sustained efficacy, and the potential for curative solutions.
Elevated plasma kallikrein levels have been associated with heightened cardiovascular risks, including myocardial infarction and stroke in men. Similarly, children with abnormal lipid profiles or metabolic syndrome exhibit higher kallikrein levels, linking the enzyme to vascular inflammation and cardiovascular disease progression.
Thus, inhibiting plasma kallikrein (PKal) has been validated as a promising therapeutic approach for managing HAE, diabetic microvascular complications, and cardiovascular disorders. Emerging candidates such as RZ402 for diabetic macular edema (DME) represent the next wave of KLKB1 inhibitors targeting more prevalent indications, significantly broadening commercial opportunities beyond rare diseases like HAE.
Overall, kallikrein inhibitors, while currently centered on HAE treatment, are increasingly being explored for DME, diabetic retinopathy (DR), and other vascular and inflammatory conditions.
Learn more about the KLKB1 inhibitors @ KLKB1 Inhibitors Analysis
KLKB1 Inhibitors Competitive Landscape
Some of the KLKB1 inhibitors in clinical trials include Lonvoguran ziclumeran (Intellia Therapeutics), Navenibart (Astria Therapeutics), RZ402 (Rezolute), and others.
Intellia Therapeutics' Lonvo-z, previously known as NTLA-2002, is an investigational in vivo CRISPR-based gene editing therapy designed to prevent hereditary angioedema (HAE) attacks by inactivating the KLKB1 gene, which encodes prekallikrein, the precursor to kallikrein. The therapy has earned five key regulatory designations, including Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) status from the U.S. FDA, the Innovation Passport from the UK MHRA, PRIME (Priority Medicines) designation from the EMA, and Orphan Drug Designation (ODD) from the European Commission.
Astria Therapeutics' Navenibart is a monoclonal antibody that inhibits plasma kallikrein and is being developed for the treatment of HAE. The objective with navenibart is to deliver fast-acting and long-lasting prevention of HAE attacks through a well-established mechanism and trusted antibody modality, administered subcutaneously every 3 to 6 months. The ultimate goal is to enable people living with HAE to lead lives free from the constraints of their condition.
The anticipated launch of these emerging therapies are poised to transform the KLKB1 inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the KLKB1 inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about KLKB1 inhibitors clinical trials, visit @ KLKB1 Inhibitors Treatment
Recent Developments in the KLKB1 Inhibitors Market
- In September 2025, Intellia Therapeutics announced it had completed enrollment in the global Phase III HAELO study of lonvoguran ziclumeran for the treatment of hereditary angioedema. Topline data are expected to be available in the first half of 2026. Intellia is on track to submit a Biologics License Application (BLA) in the second half of 2026 to support the company's plans for a US launch in the first half of 2027.
- In September 2025, KalVista Pharmaceuticals announced that the European Commission and Swissmedic approved EKTERLY for the symptomatic treatment of acute attacks of HAE in adults and adolescents aged 12 years and older.
- In August 2025, Ionis Pharmaceuticals announced that the FDA had approved DAWNZERA for the prophylaxis of HAE attacks in adult and pediatric patients 12 years of age and older. DAWNZERA is the first and only RNA-targeted medicine approved for the treatment of hereditary angioedema.
- In August 2025, Astria Therapeutics announced that it had exclusively licensed development and commercialization rights in Japan to Kaken Pharmaceutical for navenibart, a Phase III development candidate for the preventive treatment of HAE.
- In July 2025, KalVista Pharmaceuticals announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK granted marketing authorization, and the US FDA had approved EKTERLY for the treatment of HAE attacks in adults and adolescents aged 12 years and older.
- In June 2025, Intellia Therapeutics announced three-year follow-up data from the Phase I portion of the ongoing Phase I/II study in patients with HAE after receiving a single dose of lonvo-z (NTLA-2002). Results were presented orally at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025.
- In June 2025, Astria Therapeutics announced positive initial results from the target enrollment group in the ongoing ALPHA-SOLAR long-term open-label trial evaluating navenibart in HAE patients. These results demonstrated robust overall reduction in the monthly attack rate (92% mean and 97% median) and further supported its favorable safety and tolerability profile, and potential every three-month (Q3M) and every six-month (Q6M) dosing regimens.
What are KLKB1 Inhibitors?
KLKB1 inhibitors act on plasma kallikrein, a pivotal enzyme in the kallikrein–kinin system (KKS) that cleaves high-molecular-weight kininogen to produce bradykinin, a key mediator of vasodilation, vascular permeability, pain, and inflammation. Dysregulation of this pathway is linked to various inflammatory, cardiovascular, metabolic, and thrombotic conditions, positioning KLKB1 as an essential regulator of vascular function and immune activity. In addition to suppressing bradykinin generation, KLKB1 inhibition affects coagulation pathways and interacts with the complement system, suggesting a broader role in maintaining vascular balance and regulating inflammatory processes. Emerging research underscores its therapeutic potential in retinal vascular leakage, diabetic complications, and thrombosis prevention, highlighting its broader relevance beyond hereditary angioedema.
KLKB1 Inhibitors Epidemiology Segmentation
The KLKB1 inhibitors market report is a comprehensive and specialized analysis, offering in-depth epidemiological insights for the study period 2020–2034 across the leading markets. As per DelveInsight's assessment, the total diagnosed prevalent cases of HAE in the 7MM in 2024 were ~14,000, which is expected to increase by 2034, at a considerable CAGR.
The KLKB1 inhibitor target patient pool is segmented into:
- Total Cases of Selected Indications For KLKB1 Inhibitors
- Total Eligible Patient Pool of Selected Indications
- Total Treated Cases in the Selected Indication For KLKB1 Inhibitors
| KLKB1 Inhibitors Report Metrics |
Details |
| Study Period |
2020–2034 |
| KLKB1 Inhibitors Report Coverage |
7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
| Key Indications Covered in the Report |
Hereditary Angioedema, Diabetic Macular Edema, and others |
| Key KLKB1 Inhibitor Companies |
Intellia Therapeutics, Astria Therapeutics, Rezolute, Ionis Pharmaceuticals, KalVista Pharmaceuticals, BioCryst Pharmaceuticals, Takeda Pharmaceuticals, and others |
| Key KLKB1 Inhibitors |
Lonvoguran ziclumeran, Navenibart (STAR-0215), RZ402, DAWNZERA, EKTERLY, ORLADEYO, TAKHZYRO, and others |
Scope of the KLKB1 Inhibitors Market Report
- KLKB1 Inhibitors Therapeutic Assessment: KLKB1 Inhibitors current marketed and emerging therapies
- KLKB1 Inhibitors Market Dynamics: Conjoint Analysis of Emerging KLKB1 Inhibitors Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, KLKB1 Inhibitors Market Access and Reimbursement
Discover more about KLKB1 inhibitors in development @ KLKB1 Inhibitors Clinical Trials
Table of Contents
| 1 |
KLKB1 Inhibitor Market Key Insights |
| 2 |
KLKB1 Inhibitor Market Report Introduction |
| 3 |
Executive Summary of KLKB1 Inhibitors |
| 4 |
Key Events |
| 5 |
Epidemiology and Market Forecast Methodology |
| 6 |
KLKB1 Inhibitors Market Overview at a Glance in the 7MM |
| 6.1 |
KLKB1 Inhibitor Market Share (%) Distribution by Indication in 2024 |
| 6.2 |
KLKB1 Inhibitor Market Share (%) Distribution by Indication in 2034 |
| 7 |
KLKB1 Inhibitors: Background and Overview |
| 8 |
Treatment and Management |
| 9 |
Target KLKB1 Inhibitor Patient Pool |
| 9.1 |
Key Findings |
| 9.2 |
Assumptions and Rationale: 7MM |
| 9.3 |
Epidemiology Scenario in the 7MM |
| 9.3.1 |
Total Cases of Selected Indication for KLKB1 Inhibitors in the 7MM |
| 9.3.2 |
Total Eligible Patient Pool for KLKB1 Inhibitors in Selected Indications in the 7MM |
| 9.3.3 |
Total Treatable Cases in Selected Indications for KLKB1 Inhibitors in the 7MM |
| 10 |
Marketed KLKB1 Inhibitor Therapies |
| 10.1 |
Key Competitors |
| 10.2 |
EKTERLY (sebetralstat): KalVista Pharmaceuticals |
| 10.2.1 |
Product Description |
| 10.2.2 |
Regulatory milestones |
| 10.2.3 |
Other developmental activities |
| 10.2.4 |
Clinical development |
| 10.2.5 |
Safety and efficacy |
| 10.2.6 |
Analyst Views |
| 10.3 |
TAKHZYRO (lanadelumab-flyo): Takeda Pharmaceutical |
| List to be continued in the report… |
|
| 11 |
Emerging KLKB1 Inhibitor Therapies |
| 11.1 |
Key Competitors |
| 11.2 |
Lonvoguran ziclumeran (lonvo-z): Intellia Therapeutics |
| 11.2.1 |
Product Description |
| 11.2.2 |
Other developmental activities |
| 11.2.3 |
Clinical development |
| 11.2.4 |
Safety and efficacy |
| 11.2.5 |
Analyst Views |
| 11.3 |
Navenibart (STAR-0215): Astria Therapeutics |
| List to be continued in the report… |
|
| 12 |
KLKB1 Inhibitors Market: Seven Major Market Analysis |
| 12.1 |
Key Findings |
| 12.2 |
KLKB1 Inhibitor Market Outlook |
| 12.3 |
Key KLKB1 Inhibitor Market Forecast Assumptions |
| 12.4 |
Total Market Size of KLKB1 Inhibitors in the 7MM |
| 12.5 |
The United States KLKB1 Inhibitor Market Size |
| 12.5.1 |
Market Size of KLKB1 Inhibitors by Indication in the United States |
| 12.5.2 |
Market Size of KLKB1 Inhibitors by Therapies in the United States |
| 12.6 |
EU4 and the UK KLKB1 Inhibitor Market Size |
| 12.7 |
Japan KLKB1 Inhibitor Market Size |
| 13 |
SWOT Analysis of KLKB1 Inhibitors |
| 14 |
KOL Views of KLKB1 Inhibitors |
| 15 |
Unmet Needs of KLKB1 Inhibitors |
| 16 |
Market Access and Reimbursement |
| 16.1 |
United States |
| 16.2 |
EU4 and the UK |
| 16.3 |
Japan |
| 16.4 |
Summary and Comparison of Market Access and Pricing Policy Developments in 2025 |
| 16.5 |
KLKB1 Inhibitors: Market Access and Reimbursement |
| 17 |
Bibliography |
| 18 |
KLKB1 Inhibitor Market Report Methodology |
Related Reports
Hereditary Angioedema Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key HAE companies, including Shire, Takeda Pharma, CSL Behring, Pharming Group, BioCryst Pharmaceuticals, Ionis Pharmaceuticals, KalVista Pharmaceuticals, among others.
Hereditary Angioedema Clinical Trial Analysis
Hereditary Angioedema Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HAE companies, including BioCryst Pharmaceuticals, KalVista Pharmaceuticals, Pharvaris, BioMarin Pharmaceutical, Ionis Pharmaceuticals, Inc., Intellia Therapeutics, among others.
Diabetic Macular Edema Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key DME companies, including Adverum Biotechnologies, Graybug Vision, Roche, Novartis, KalVista Pharmaceuticals, Ocuphire Pharma, Oxurion, YD Life Science, Allergan (AbbVie), Molecular Partners, Allergo Ophthalmics, Bausch Health, Kodiak Sciences, Clearside Biomedical, among others.
Diabetic Macular Edema Clinical Trial Analysis
Diabetic Macular Edema Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key diabetic macular edema companies, including Mylan Pharmaceuticals, Kodiak Sciences, Celltrion, Exonate, Opthea, AsclepiX Therapeutics, Allgenesis Biotherapeutics, Ascentage Pharma, Rezolute, Ocuphire Pharma, Oxurion, MingSight Pharmaceuticals, Adverum Biotechnologies, among others.
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