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canakinumab

Generic: canakinumab·Brand: Ilaris

canakinumab: developed by 1 company · 7 clinical trials tracked · 1 FDA decision.

canakinumab evidence translation

What we can confirm

1 FDA record · 7 tracked trials

What it means

Source-backed records connect canakinumab to NVS; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could canakinumab → NVS affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence6 indications · 0 study sponsors

Related indications

Hereditary Periodic Fever SyndromesMild Cognitive Impairment; Non-small Cell Lung CancerMild Cognitive Impairment; Non-small Cell Lung Cancer; Adult Onset Still's DiseaseAlzheimer DiseaseChronic Myelomonocytic LeukemiaMild Cognitive Impairment

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (3)
CompanyPhase
Novartis AG (NVS)
Hereditary Periodic Fever Syndromes
Phase 4
Novartis AG (NVS)
Mild Cognitive Impairment; Non-small Cell Lung Cancer
Phase 4
Novartis AG (NVS)
Mild Cognitive Impairment; Non-small Cell Lung Cancer; Adult…
Phase 4
Clinical Trials (7)

Real Life Non-interventional Study on Safety and Effectiveness of Ilaris® (Canakinumab) 150 mg for Subcutaneous Injection in Hereditary Periodic Fever Syndrome (CAPS, crFMF, TRAPS and HIDS/MKD) Patients and sJIA Patients (REASSURE)

Recruiting

Primary endpoint: Incidence of adverse events and serious adverse events

Observational25 targetStarted 2025-03Completion 2028-091 site · South KoreaNovartis Pharmaceuticals

Exploratory PLatform Trial on Anti-Inflammatory Agents in Alzheimer's Disease (EXPLAIN-AD): A Randomized, Placebo-controlled, Multicenter Platform Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Various Anti-inflammatory Agents in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease

NCT04795466·Phase 2·NVS
Terminated

Primary endpoint: Change From Baseline in Cognition as Measured by the Neuropsychological Test Battery (NTB) Z-scores

InterventionalRandomizedquadruple34 targetStarted 2021-10Completion 2024-0310 sites · Finland, Iceland, United Kingdom, United StatesNovartis Pharmaceuticals

Phase I/II Study of Canakinumab With Chemoradiation and Durvalumab for Unresected Locally-Advanced Non-Small Cell Lung Cancer (CHORUS)

NCT04905316·Phase 2
Completed

Primary endpoint: progression-free survival

Interventionalopen41 enrolledStarted 2021-05Completion 2026-077 sites · United StatesMemorial Sloan Kettering Cancer Center

An Open-label, Single-arm, Active-treatment Study to Evaluate Efficacy and Safety of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Adult Onset Still's Disease (AOSD)

NCT04717635·Phase 3·NVS
Completed

Primary endpoint: Percentage of Participants Who Achieved Adapted American College of Rheumatology (ACR) 30 Response at Week 8

Interventionalopen14 enrolledStarted 2021-03Completion 2025-049 sites · JapanNovartis Pharmaceuticals

A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS/IPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia

NCT04239157·Phase 2
Recruiting

Primary endpoint: Hematological improvement (HI)

Interventionalopen76 targetStarted 2020-08Completion 2026-121 site · United StatesM.D. Anderson Cancer Center

A Pilot Study of Neoadjuvant Combination Spartalizumab and Canakinumab Prior to Radical Nephrectomy in Patients With Localized Clear Cell Renal Cell Carcinoma (SPARC-1 Trial)

NCT04028245·Early Phase 1
Completed

Primary endpoint: Percentage of subjects who proceed to radical nephrectomy

Interventionalopen17 enrolledStarted 2019-08Completion 2026-031 site · United StatesColumbia University

A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)

NCT03631199·Phase 3·NVS
Terminated

Primary endpoint: Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs)

InterventionalRandomizedquadruple673 targetStarted 2018-12Completion 2026-0150 sites · Argentina, Australia, Austria, Brazil…Novartis Pharmaceuticals
FDA Decisions1 records
Approval(NVS)FDA ↗
BLA125319Type 1 - New Molecular EntityOrphan DrugPrioritySubcutaneousInjectable

Frequently asked questions

Who is developing canakinumab?

canakinumab is being developed by Novartis AG.

How many clinical trials involve canakinumab?

BioSniper tracks 7 clinical trials involving canakinumab.

What is canakinumab's latest FDA decision?

The most recent tracked FDA decision for canakinumab is Approval, dated June 17, 2009.