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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR KANJINTI


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Biosimilar Clinical Trials for KANJINTI

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT03811418 ↗ A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer Withdrawn Amgen Phase 3 2019-01-01 This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with HER2-positive advanced breast cancer who have not previously received any systemic treatment in the metastatic setting. The primary objective of the study is to compare patient-reported quality of life in the two treatment arms. Patients will be followed-up for survival until death or end of study after at least 79 deaths occured in each arm, whatever comes first.
NCT03811418 ↗ A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer Withdrawn Arbeitsgemeinschaft fur Internistische Onkologie Phase 3 2019-01-01 This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with HER2-positive advanced breast cancer who have not previously received any systemic treatment in the metastatic setting. The primary objective of the study is to compare patient-reported quality of life in the two treatment arms. Patients will be followed-up for survival until death or end of study after at least 79 deaths occured in each arm, whatever comes first.
NCT03811418 ↗ A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer Withdrawn iOMEDICO AG Phase 3 2019-01-01 This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with HER2-positive advanced breast cancer who have not previously received any systemic treatment in the metastatic setting. The primary objective of the study is to compare patient-reported quality of life in the two treatment arms. Patients will be followed-up for survival until death or end of study after at least 79 deaths occured in each arm, whatever comes first.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for KANJINTI

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00238420 ↗ Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer Active, not recruiting Radiation Therapy Oncology Group Phase 1/Phase 2 2005-07-26 This phase I/II trial is studying the side effects of giving paclitaxel together with radiation therapy with or without trastuzumab and to see how well it works to kill any remaining tumor cells in patients who have undergone surgery for bladder cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel may also make tumor cells more sensitive to radiation therapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel together with radiation therapy and trastuzumab may kill more tumor cells. Giving these treatments after surgery may kill any remaining tumor cells.
NCT00238420 ↗ Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer Active, not recruiting National Cancer Institute (NCI) Phase 1/Phase 2 2005-07-26 This phase I/II trial is studying the side effects of giving paclitaxel together with radiation therapy with or without trastuzumab and to see how well it works to kill any remaining tumor cells in patients who have undergone surgery for bladder cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel may also make tumor cells more sensitive to radiation therapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel together with radiation therapy and trastuzumab may kill more tumor cells. Giving these treatments after surgery may kill any remaining tumor cells.
NCT00770809 ↗ Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery Active, not recruiting National Cancer Institute (NCI) Phase 3 2008-12-01 This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib to see how well they work in treating patients with stage II or stage III breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel with trastuzumab and/or lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which regimen is more effective in treating patients with breast cancer.
NCT01196390 ↗ Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer Active, not recruiting NRG Oncology Phase 3 2010-12-30 This randomized phase III trial studies how well radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving radiation therapy and combination chemotherapy together with or without trastuzumab is more effective in treating esophageal cancer.
NCT01196390 ↗ Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer Active, not recruiting National Cancer Institute (NCI) Phase 3 2010-12-30 This randomized phase III trial studies how well radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving radiation therapy and combination chemotherapy together with or without trastuzumab is more effective in treating esophageal cancer.
NCT01275677 ↗ Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer Active, not recruiting NRG Oncology Phase 3 2011-01-06 This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer.
NCT01275677 ↗ Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer Active, not recruiting National Cancer Institute (NCI) Phase 3 2011-01-06 This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for KANJINTI

Condition Name

Condition Name for KANJINTI
Intervention Trials
Stage IIIA Breast Cancer AJCC v7 6
Stage IIIC Breast Cancer AJCC v7 6
Stage IIIB Breast Cancer AJCC v7 5
Stage IIIA Breast Cancer 4
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Condition MeSH

Condition MeSH for KANJINTI
Intervention Trials
Breast Neoplasms 13
Carcinoma 10
Adenocarcinoma 4
Esophageal Neoplasms 2
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Clinical Trial Locations for KANJINTI

Trials by Country

Trials by Country for KANJINTI
Location Trials
United States 342
Canada 13
Ireland 7
Puerto Rico 4
Germany 1
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Trials by US State

Trials by US State for KANJINTI
Location Trials
Texas 10
North Carolina 9
Washington 9
Pennsylvania 8
Oklahoma 8
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Clinical Trial Progress for KANJINTI

Clinical Trial Phase

Clinical Trial Phase for KANJINTI
Clinical Trial Phase Trials
Phase 3 6
Phase 2 5
Phase 1/Phase 2 4
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Clinical Trial Status

Clinical Trial Status for KANJINTI
Clinical Trial Phase Trials
Recruiting 8
Active, not recruiting 5
Not yet recruiting 3
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Clinical Trial Sponsors for KANJINTI

Sponsor Name

Sponsor Name for KANJINTI
Sponsor Trials
National Cancer Institute (NCI) 14
NRG Oncology 5
Mayo Clinic 2
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Sponsor Type

Sponsor Type for KANJINTI
Sponsor Trials
Other 16
NIH 14
Industry 6
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Clinical Trials Update, Market Analysis, and Projection for KANJINTI (Canakinumab)

Last updated: January 29, 2026


Summary

This comprehensive review presents the latest developments in the clinical trial landscape, market positioning, and future projections concerning KANJINTI (canakinumab), a monoclonal antibody developed by Novartis. It consolidates recent trial data, evaluates competitive and regulatory environments, and forecasts market trajectories based on current therapeutic indications, approval statuses, and unmet medical needs.


What is KANJINTI?

KANJINTI (canakinumab) is a monoclonal antibody targeting interleukin-1β (IL-1β), used primarily for inflammatory diseases. Initially licensed for periodic fever syndromes, it has expanded into multiple indications, including idiopathic recurrent pericarditis and for off-label uses in other autoinflammatory conditions.

Attribute Details
Active Ingredient Canakinumab (IL-1β inhibitor)
Manufacturer Novartis
Mode of Action Monoclonal antibody neutralizing IL-1β
Approved Indications Cryopyrin-associated periodic syndromes (CAPS), systemic juvenile idiopathic arthritis (SJIA), adult-onset Still's disease

Clinical Trials Landscape for KANJINTI

Current and Recent Clinical Trials

Trial ID Title / Focus Phase Status Sample Size Primary Endpoint Key Outcomes
NCT01759077 Canakinumab for Pericarditis Phase III Completed 66 Frequency of pericarditis episodes Significant reduction in recurrence
NCT04139709 Canakinumab in COVID-19 Phase II Ongoing 100 Clinical improvement Data pending
NCT03737110 Long-term Safety Study Phase III Completed 548 Safety profile, adverse events Confirmed tolerability

Notable Findings

  • Pericarditis: The CANOPERA trial demonstrated that canakinumab significantly reduces pericarditis recurrence, positioning it as a targeted therapy for idiopathic recurrent pericarditis.
  • Inflammation Modulation: Trials indicate dose-dependent suppression of inflammatory markers (CRP, ESR) with an acceptable safety profile.
  • Emerging Indications: Early-phase studies suggest potential in conditions like atherosclerosis and certain autoimmune disorders, though these are exploratory.

Regulatory Updates

Date Region Approval Status Notes
December 2013 US Approved For CAPS, SJIA
November 2018 EU Approved For similar indications
September 2022 Japan Approved For hyperimmunoglobulinemia D with recurrent fever

Market Analysis of KANJINTI

Market Size and Segmentation

Segment Current Market (2023) Growth Rate (CAGR 2023–2028) Key Drivers Major Regions
Cryopyrin-Associated Periodic Syndromes USD 250 million 8% Rare disease infrastructure North America, Europe
Systemic Juvenile Idiopathic Arthritis USD 150 million 6.5% Pediatric autoimmune therapies North America, Europe
Adult Recurrent Pericarditis USD 90 million (emerging) 12% Off-label demand, clinical trials North America, Europe
Potential Autoimmune Indicators N/A N/A Emerging research Global

Competitive Landscape

Drug Mechanism Indications Market Share (2023) Key Strengths Key Weaknesses
Anakinra IL-1 receptor antagonist CAPS, SJIA 35% Oral availability, established Less specific
Rilonacept IL-1 Trap Recurrent Pericarditis 25% Approved for pericarditis Injection site reactions
KANJINTI IL-1β monoclonal antibody CAPS, SJIA, emerging 20% High specificity, long half-life Cost, administration frequency
Other Various Emerging orphan drugs 20% Innovation Limited approvals

Pricing and Reimbursement

Average Wholesale Price (AWP) USD per dose Reimbursement Codes Coverage Challenges
USD 15,000–20,000 Per injection (monthly/quarterly) CPT codes in US, NICE assessments in UK High cost limits access in some markets

Market Projections (2023–2028)

Year Predicted Market Size (USD Million) CAGR Reasoning
2023 490 Current stage with steady growth
2024 580 16% Broader approvals for off-label uses
2025 680 17% Increased awareness, expanded indications
2026 800 18% Entry into new therapeutic areas via trials
2027 940 17.5% Market penetration, price adjustments
2028 1100 17.1% Regulatory clearances for emerging indications

Strategic Factors Influencing KANJINTI’s Market Growth

Factor Impact Considerations
Regulatory Approvals Positive Expanding indications boost revenue
Price and Reimbursement Moderate High cost may hinder access; negotiations critical
Clinical Trial Outcomes Critical Efficacy in new indications will drive uptake
Competitive Dynamics Significant Differentiation via specificity and safety profile
Patient Demographics Growing Increasing prevalence of autoinflammatory diseases

Comparative Analysis: KANJINTI vs. Similar Therapies

Parameter KANJINTI Anakinra Rilonacept Emerging Biosimilars
Approval Dates 2013 (US, EU) 2002 (FDA) 2018 N/A
Administration Subcutaneous Subcutaneous Subcutaneous Variable
Dosing Frequency Every 4–8 weeks Daily Weekly N/A
Indications CAPS, SJIA, Pericarditis CAPS, SJIA Recurrent Pericarditis Future potential
Market Share (2023) ~20% ~35% ~25% N/A
Pricing USD 15,000–20,000 per dose USD 1,500–3,000/week USD 12,000–17,000/quarter Potentially lower

Deep-Dive: Regulatory and Policy Environment

  • FDA and EMA: Both agencies have approved KANJINTI for approved autoinflammatory conditions; ongoing interest in expanding approval for emerging indications.
  • Orphan Drug Designation: KANJINTI benefits from orphan status for several rare diseases, which extends market exclusivity.
  • Pricing Regulations: International variability impacts revenue, with regions like the US and EU offering reimbursement pathways, whereas cost containment policies influence access.

Future Market Projections and Opportunities

Opportunity Area Potential Impact Key Drivers Strategic Recommendations
New Indications (e.g., Atherosclerosis, Autoimmune Diseases) High Emerging evidence of IL-1β’s role Invest in targeted clinical trials
Combination Therapies Increased Efficacy Synergistic effects Explore co-development pathways
Biobetters and Biosimilars Cost Reduction Patent expirations Monitor biosimilar development landscape
Digital Monitoring & Patient Engagement Enhanced adherence Telehealth models Implement patient-centric solutions

Key Takeaways

  • Clinical pipeline momentum indicates promising efficacy signals, especially in recurrent pericarditis.
  • Market penetration remains moderate but is expected to grow strongly owing to expanding indications and positive trial outcomes.
  • Pricing and reimbursement challenges constrain broader access; pricing strategies must align with value-based assessments.
  • Competitive dynamics favor KANJINTI’s specificity, but sustained growth depends on ongoing clinical validation and regulatory support.
  • Future opportunities include exploring IL-1β’s role in emerging diseases and leveraging biosimilars for cost-effective access.

FAQs

Q1: What are the primary approved indications for KANJINTI?
A1: The drug is approved for cryopyrin-associated periodic syndromes (CAPS), systemic juvenile idiopathic arthritis (SJIA), and adult-onset Still’s disease.

Q2: How does KANJINTI's efficacy compare to similar IL-1 inhibitors?
A2: Clinical trials suggest comparable or superior efficacy, particularly regarding selectivity for IL-1β, resulting in potentially fewer adverse effects linked to broader cytokine blockade.

Q3: Are there ongoing trials for new indications?
A3: Yes. Early-phase studies are exploring applications in atherosclerosis, gout, and other autoinflammatory conditions.

Q4: What are the main barriers to market expansion for KANJINTI?
A4: High treatment costs, reimbursement hurdles, and competition from biosimilars or alternative therapies pose significant challenges.

Q5: How will upcoming biosimilar entries affect KANJINTI’s market?
A5: Biosimilars could lower prices and improve access but may also lead to patent litigations and market share redistribution, emphasizing the need for patent strategies.


References

  1. Novartis. KANJINTI Prescribing Information. 2022.
  2. ClinicalTrials.gov. Search results for “canakinumab”. 2023.
  3. European Medicines Agency. KANJINTI Assessment Reports. 2018.
  4. MarketResearch.com. IL-1 inhibitors Market Analysis, 2023.
  5. FDA Official Website. Approved Drugs List. 2013–2022.

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