Delving into the Latest Updates on Clazakizumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Clazakizumab (USAN/INN), ALD 518, ALD-518

+ [4]

Target

IL-6

Action

inhibitors

Mechanism

IL-6 inhibitors(Interleukin-6 inhibitors)

Therapeutic Areas

Cardiovascular DiseasesUrogenital Diseases

Active Indication

Myocardial InfarctionAtherosclerosisKidney Failure, Chronic

Inactive Indication

Antibody-mediated rejectionArthritis, PsoriaticCachexia+ [10]

Originator Organization

Lundbeck Seattle BioPharmaceuticals, Inc.

Active Organization

CSL Behring LLC

Inactive Organization-

License Organization

Vitaeris, Inc.

Eli Lilly & Co.

CSL Behring LLC

+ [3]

Drug Highest PhasePhase 2/3

First Approval Date-

RegulationOrphan Drug (United States)

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Structure/Sequence

Sequence Code 125583L

Source: *****

Sequence Code 125589H

Source: *****

The goal of this clinical trial is to learn about the effects of inflammation-lowering therapy on mobility and disability in older adults. The main questions it aims to answer are:
* Will therapy improve walking speed/pace?
* Will therapy improve levels of blood inflammation markers and other indicators of physical, cognitive and immune function?
Participants will be asked to receive injections of drug or placebo every 4 weeks for 24 weeks. They will also be asked to undergo testing that assesses physical function, thinking ability and brain health, breathing capacity, and blood vessel stiffness, and will have blood samples collected to measure immune function and to create a bank of samples for future testing. Comparisons will be made between those who receive drug and those who receive placebo.

Start Date01 Aug 2023

Sponsor / Collaborator

University of Pittsburgh

[+1]

NCT05485961

/ RecruitingPhase 2/3

A Phase 2b / 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis

This is a 2-part (phase 2b/3) prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1 (phase 2b) is a dose-finding study for CSL300 vs placebo. Part 2 (phase 3) aims to assess the efficacy of CSL300 on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.

Start Date21 Oct 2022

Sponsor / Collaborator

CSL Behring LLC

100 Clinical Results associated with Clazakizumab

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100 Translational Medicine associated with Clazakizumab

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100 Patents (Medical) associated with Clazakizumab

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44

Literatures (Medical) associated with Clazakizumab

01 Nov 2025·Kidney International Reports

The Effects of Clazakizumab on Peripheral Blood and Kidney Transcriptomes in Patients With Late Antibody-Mediated Rejection

Article

Author: Böhmig, Georg A ; Budde, Klemens ; Schatzl, Martina ; Chang, Jessica ; Halloran, Philip ; Lee, Colin Y C ; Zhang, Roy ; Clatworthy, Menna R ; Halleck, Fabian ; Jilma, Bernd

Introduction:

There are no licensed treatments for antibody-mediated rejection (AMR), a major cause of late kidney allograft loss. Clazakizumab (CLZ), an interleukin (IL)-6-neutralizing antibody, showed potential efficacy in a phase 2 trial in late AMR, with a reduction in donor-specific antibodies (DSAs) and kidney molecular microscope diagnostic system (MMDx) AMR score, but the underpinning mechanisms are unclear.

Methods:

Using peripheral blood transcriptomics, we identified a decrease in IL-6-associated "JAK-STAT signaling" pathway genes with CLZ, and a reduction in gene modules that enriched for T follicular helper cell and activated platelet signatures, cells that contribute to DSA generation and inflammatory responses to DSA respectively. However, responses were variable, and some patients showed a rebound in the expression of inflammatory signatures with long-term CLZ treatment, indicating variability in the efficacy of IL-6 antagonism. One peripheral blood gene module significantly correlated with kidney MMDx AMR score and enriched for monocyte signature genes, as well as "Fc gamma receptor-mediated phagocytosis" and "leukocyte transendothelial migration" gene sets, suggesting that cells activated by DSAs can be detected in peripheral blood. In the kidney, CLZ-treatment was associated with a significant reduction in a damaged tubule gene signature and preservation of podocyte signatures. We also found a kidney plasma cell gene-rich module that positively correlated with circulating DSAs; however, this was not significantly downregulated by CLZ.

Conclusion:

Overall, our results provide mechanistic insights into the effects and limitations, of IL-6 neutralization in humans in the context of AMR.

01 Nov 2025·CTS-Clinical and Translational Science

Population Pharmacokinetic and Pharmacokinetic‐Pharmacodynamic Analysis for Clazakizumab in Patients With End‐Stage Kidney Disease Undergoing Dialysis

Article

Author: Nandy, Partha ; Kerbusch, Thomas ; Chang, Anna Marie ; Strong, Laura E. ; Muthukrishnan, Venkateswari Y. ; McCune, Jeannine S. ; Pfister, Marc ; Kleijn, Huub Jan ; Acharya, Milin

ABSTRACT:

The inflammatory cytokine interleukin‐6 (IL‐6) plays a significant role in the progression of cardiovascular disease (CVD). We evaluated the impact of clazakizumab, a monoclonal antibody targeting the IL‐6 ligand, upon high‐sensitivity C‐reactive protein (hs‐CRP) as part of the dose‐finding phase 2b trial. In this randomized, double‐blind trial, adults with cardiovascular disease and/or diabetes receiving maintenance dialysis and having hs‐CRP ≥ 2 mg/L at baseline received clazakizumab (2.5 mg, 5 mg, or 10 mg, n = 32 per dose group) or placebo ( n = 31) every 4 weeks. These data were used to develop a population pharmacokinetics (popPK) and a longitudinal PK‐pharmacodynamic (PK‐PD) model to characterize the relationship between clazakizumab and hs‐CRP to support Phase 3 dose selection. A 2‐compartment model with linear elimination well described clazakizumab PK. PK‐PD was best described by an indirect‐response inhibitory model, where clazakizumab concentrations inhibited the kin (zero‐order rate of production) of hs‐CRP. Simulations predicted that all doses (2.5, 5, and 10 mg IV every 4 weeks) would result in the majority (> 80%) of subjects experiencing at least an 80% decrease in baseline hs‐CRP (80.9%, 83.4%, and 88.1%, respectively). In addition, the proportion of subjects with hs‐CRP concentrations below 2 mg/L at Week 12 was predicted to be 67.7%, 76.7%, and 82.6%, respectively, for these 3 dose groups. These modeling and simulation results support the dose selection of clazakizumab 5 mg IV every 4 weeks in the phase 3 placebo‐controlled trial to evaluate the impact of IL‐6 inhibition via clazakizumab administration upon cardiovascular events.

01 May 2025·JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY

Effects of Clazakizumab on Anemia and Iron Metabolism in Patients with Kidney Failure

Article

Author: Chertow, Glenn M. ; Neuen, Brendon L. ; Wolf, Myles ; Chang, Annamarie ; Heise, Mark ; Felker, G. Michael ; Mahaffey, Kenneth W. ; Tricoci, Pierluigi ; Catanese, Benjamin ; Eckardt, Kai-Uwe

Neuen, Brendon L.; Catanese, Benjamin; Chang, Annamarie; Heise, Mark; Tricoci, Pierluigi; Felker, G. Michael; Mahaffey, Kenneth W.; Wolf, Myles; Chertow, Glenn M.; the POSIBIL6ESKD Investigators Author Information

10

News (Medical) associated with Clazakizumab

18 Feb 2026

·www.fiercebiotech.com

Lilly pays CSL $100M upfront for IL-6 antibody that flunked a phase 3 organ transplant study

CSL will continue to explore clazakizumab for preventing cardiovascular events in kidney disease patients, while Lilly can develop and the therapy in “additional indications.”\n Eli Lilly is paying $100 million upfront (PDF) for the right to develop CSL’s phase 3-stage IL-6 antibody that had previously been explored for organ transplant rejection.Australia-based CSL picked up the anti-interleukin-6 monoclonal antibody, called clazakizumab, as part of its acquisition of Vitaeris in 2020. Clazakizumab was designed to treat chronic antibody-mediated organ rejection (AMR), and CSL oversaw a phase 3 trial for the drug as a treatment for AMR in kidney transplant patients.But that trial was terminated early for futility during a planned interim analysis, CSL explained to Fierce.Despite the setback in AMR, the company has continued to assess clazakizumab in a phase 3 study for the prevention of cardiovascular events in patients on dialysis with end-stage kidney disease (ESKD). That trial kicked off in 2022 and is due to wrap up in 2029, according to the trial database. CSL will be hoping this study has better luck than the AMR trial, and the company highlighted to Fierce that “trials evaluating the role of IL-6 in cardiovascular risk are supported by genetic and pharmacological evidence.”“Cardiovascular outcome trials ... have a very distinct rationale from the Imagine study in chronic antibody-mediated rejection,” a spokesperson added.This morning’s deal allows CSL to continue to develop clazakizumab for the specific indication of prevention of cardiovascular events in ESKD patients. Meanwhile, Lilly will be able to develop and commercialize the therapy in “additional indications,” according to a Feb. 18 release.Beyond the $100 million upfront payment, CSL will be eligible for clinical, regulatory and commercial milestones as well as royalties on global net sales—although the companies didn’t offer a ballpark figure for these potential payouts. “This agreement marks a significant step forward in our mission to bring innovative therapies to patients worldwide,” CSL’s head of R&D Bill Mezzanotte said in the release.“Clazakizumab is a promising therapeutic candidate with the potential to significantly impact the treatment landscape for various immuno-inflammatory and cardiovascular conditions,” Mezzanotte added. “Lilly is another patient-focused organization, and we look forward to working with them to maximise the potential of this important medicine.”Buoyed with cash from its blockbuster diabetes and obesity franchise, Lilly has been on a dealmaking spree over recent months, including buying gene editing partner Verve Therapeutics for $1 billion, inflammation biotech Ventyx Biosciences for $1.2 billion and in vivo CAR-T player Orna Therapeutics for up to $2.4 billion.This story was amended Thursday Feb. 19, 2026 to include additional information provided by CSL

Phase 3Acquisition

18 Feb 2026

·endpoints.news

Lilly licenses CSL’s IL-6 immuno-inflammatory antibody for $100M upfront

CSL will need more than $100 million to recover from its current difficulties , but it’s a start. Eli Lilly has paid the nine-figure sum upfront for rights to the Australian company’s anti-IL-6 monoclonal antibody in unspecified indications. The drug is called clazakizumab, and CSL is developing it for patients with end-stage kidney disease who are on dialysis and at risk of major cardiovascular events. A placebo-controlled Phase 2/3 trial in more than 2,000 patients is ongoing, but will not generate data until 2029. CSL is keeping exclusive rights to develop and sell clazakizumab in this indication. What Lilly is planning for the molecule is less clear. CSL’s head of R&D Bill Mezzanotte said in a Wednesday press release that the drug has potential in “various immuno-inflammatory and cardiovascular conditions,” but the US drugmaker has not set out its development plans. Lilly could make further payments to CSL if the drug hits clinical, regulatory and commercial milestones, as well as royalties on global sales. These amounts were not specified, but CSL’s investors will have to hope the payments are frequent and generous. A week ago, the company released its financials for the six months ended Dec. 31, and they made for tough reading. Its net profit collapsed 81% from the prior year and it took $1.1 billion in write-downs, including for its $200 million upfront licensing agreement with Arcturus Therapeutics for Covid-19 and other vaccines. CSL’s CEO Paul McKenzie had left the day before , with the company’s chair saying McKenzie “didn’t have the skills that we wanted for the future.” IL-6-targeting antibodies have been the subject of dealmaking elsewhere. Last fall, Novartis bought Tourmaline Bio to get a hold of pacibekitug, which had shown promise in atherosclerotic cardiovascular disease. Pacibekitug is also in a mid-stage trial in thyroid eye disease, so perhaps this could be an avenue for Lilly to explore. Novo Nordisk also has an IL-6 candidate, which is called ziltivekimab. CSL obtained clazakizumab through its acquisition of Vitaeris for an unspecified amount in 2020.

License out/inVaccineAcquisitionmRNAClinical Study

18 Feb 2026

·www.biospace.com

Lilly Fronts $100M for CSL’s IL-6 Blocker to Bolster I&I, Cardiovascular Pipeline

iStock, jozefmicic CSL is advancing clazakizumab for the treatment of cardiovascular events in end-stage kidney disease and will retain rights over the asset in this indication. Lilly will explore other conditions. Eli Lilly has snagged a new immune-inflammatory and cardiovascular program thanks to a $100 million upfront licensing deal with Australia’s CSL. The pharma has fronted the cash for access to the anti-IL-6 monoclonal antibody clazakizumab, according to a Tuesday press release . CSL will also be eligible for clinical, regulatory and commercial milestones, plus royalties if the antibody hits the market. The companies did not specify how much Lilly has committed for these future contingent payments. By targeting the IL-6 cytokine, clazakizumab addresses several key biological pathways, including the regulation of the immune system, the inflammation of blood vessels and the production of new blood cells. Excessive production of IL-6 has been linked to several chronic inflammatory conditions, CSL said. A subsidiary of the company, CSL Behring, had previously terminated a Phase 3 study of clazakizumab for transplant rejection because of lack of efficacy. CSL’s R&D Head Bill Mezzanotte said in a statement that clazakizumab has “the potential to significantly impact the treatment landscape for various immune-inflammatory and cardiovascular conditions.” The Australian biotech is currently running a Phase 3 study to test clazakizumab for the prevention of cardiovascular events in end-stage kidney disease. Under Tuesday’s agreement, CSL will retain exclusive developmental and commercialization rights over the antibody in this indication. Lilly, meanwhile, will explore clazakizumab’s therapeutic potential in other conditions, though the companies did not specify what these indications are. 2026 has already been a busy year for Lilly on the dealmaking front. Last week, the pharma dropped $2.4 billion to acquire Orna Therapeutics, gaining entry into the CAR T space. Lead asset Orna-252 is poised to enter the clinic and is being proposed for B cell-driven autoimmune diseases. Lilly also absorbed Ventyx Biosciences last month for $1.2 billion, gaining two NLRP3 assets, both in Phase 2 development, targeting the inflammatory cascade. Other deals that Lilly has signed this year so far include its $1.12-billion bet with Seamless Therapeutics, centered on the biotech’s drug design engine to develop gene editors for hearing loss. The pharma has also joined hands with Ventyx Biosciences, pledging up to $1.84 billion in payments, to advance tolerizing therapies for autoimmune diseases.

License out/inPhase 2AcquisitionPhase 3

100 Deals associated with Clazakizumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D10312	Clazakizumab	-	DB12849

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Myocardial Infarction	Phase 3	Japan	CSL Behring LLC	27 Apr 2024
Myocardial Infarction	Phase 3	Argentina	CSL Behring LLC	27 Apr 2024
Myocardial Infarction	Phase 3	Australia	CSL Behring LLC	27 Apr 2024
Myocardial Infarction	Phase 3	Austria	CSL Behring LLC	27 Apr 2024
Myocardial Infarction	Phase 3	Belgium	CSL Behring LLC	27 Apr 2024
Myocardial Infarction	Phase 3	Brazil	CSL Behring LLC	27 Apr 2024
Myocardial Infarction	Phase 3	Bulgaria	CSL Behring LLC	27 Apr 2024
Myocardial Infarction	Phase 3	Denmark	CSL Behring LLC	27 Apr 2024
Myocardial Infarction	Phase 3	France	CSL Behring LLC	27 Apr 2024
Myocardial Infarction	Phase 3	Germany	CSL Behring LLC	27 Apr 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03744910 (IMAGINE, CTgov)	Phase 3	Graft Rejection \| Antibody-mediated rejection	194	Clazakizumab (Clazakizumab)	opqbtefbub(askinjrpgd) = bdnyorcvmn fufojbvetn (xfsfzsemwe, ayzhywnbkr - ayzccdgrsm) View more	-	23 Jul 2025
				Physiologic saline solution (Placebo)	opqbtefbub(askinjrpgd) = ieoaorezna fufojbvetn (xfsfzsemwe, wnumqrumav - rfxzqucext) View more
NCT03380377 (CTgov)	Phase 1/2	Transplant complication \| Antibody-mediated rejection \| Renal transplant rejection ... View more	10	Clazakizumab	apcboiefgr = brabeaqcov uuzadbhojy (ndtglsbuyg, gfavziabsb - xnqyisokdh) View more	-	06 May 2025
NCT05485961 (phase 2b, Pubmed \| Nat Med)	Phase 2	Maintenance high-sensitivity C-reactive protein (hs-CRP)	-	Clazakizumab 2.5 mg	kvpipxvfjs(hxbfktyjfx) = mitdcofntd yyvicpyhfg (topttlgoii )	Positive	01 Aug 2024
				Clazakizumab 5 mg	kvpipxvfjs(hxbfktyjfx) = zgocjjfqbj yyvicpyhfg (topttlgoii )
NCT03444103 (Pubmed \| Transplant Direct)	Phase 2	Renal transplant rejection	20	Clazakizumab	ymgwsnfpgv(xgqomqjqgy) = tqgpflefne dvctspltqd (iaunhqqqbf, 0.91% - 2.78%) View more	-	01 Dec 2022
				Placebo	ymgwsnfpgv(xgqomqjqgy) = jjdydmwmbc dvctspltqd (iaunhqqqbf, 0.56% - 2.30%) View more
NCT03744910 (Pubmed)	Phase 2	Renal transplant rejection	-	Clazakizumab	wlutyhaaee(qgvxtwofxw) = cspyazvmpm mszwrafyfq (qhmwoysbyk ) View more	-	15 Aug 2022
NCT04381052 (CTgov)	Phase 2	COVID-19	1	Clazakizumab (Clazakizumab 25 mg)	mqwilktygu(fsnyhxkomc) = lajerdrkxm lvvnawyrnl (nshrgtyuhk, oxnecwjlhz - fehtcihdwm) View more	-	08 Apr 2022
				Placebo (Placebo)	mqwilktygu(fsnyhxkomc) = jxxpnlpbtn lvvnawyrnl (nshrgtyuhk, jjzcgyjgqa - zjrurlbxvu) View more
NCT03744910 (Pubmed \| Kidney Int Rep)	Phase 2	-	10	Clazakizumab 25 mg	nrapkqfhvz(sjxgysdfoo) = claztrdugc iiwwylqoca (jiysdrbbck )	Positive	01 Apr 2022
NCT04343989 (CTgov)	Phase 2	COVID-19	178	Clazakizumab 25 mg (Clazakizumab 25 mg)	rehcyvfoqn = kqtuyrlyjt dpavblmcyz (xplvxjrnvi, kuerhxbrnj - gddbwhubca) View more	-	15 Feb 2022
				Clazakizumab 12.5 mg (Clazakizumab 12.5 mg)	rehcyvfoqn = bzitxxtjrb dpavblmcyz (xplvxjrnvi, wvprsqxhyb - uwwkwolnwz) View more
NCT01373151 (CTgov)	Phase 2	Rheumatoid Arthritis	418	Placebo+MTX (Placebo+MTX)	zzjeaabnlx = bafvrrtmmv bcwbkrzoax (aazqacbwbg, xkdvjkujjq - pikqwjcuod) View more	-	06 Dec 2021
				Clazakizumab+MTX (Clazakizumab(25)+MTX)	zzjeaabnlx = ftpefcnndq bcwbkrzoax (aazqacbwbg, csplulsiya - lxorbgkrxv) View more
NCT04348500 (CTgov)	Phase 2	COVID-19	17	Clazakizumab (Clazakizumab)	xhpconidhg = xusnqykrpd gcposekfny (ymaurflgvj, bbytiukdev - xmiqhzslan) View more	-	02 Dec 2021
				Clazakizumab (Placebo)	xhpconidhg = hrgqsuccdj gcposekfny (ymaurflgvj, ouualdezgz - jeonvsbdql) View more

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Biosimilar

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Clazakizumab

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation