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Last update 28 Oct 2026

Cendakimab

Last update 28 Oct 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Cendakimab (USAN/INN), ABT-308, BMS-986355

+ [2]

Target

IL-13

Action

inhibitors

Mechanism

IL-13 inhibitors(Interleukin-13 inhibitors)

Therapeutic Areas

Immune System DiseasesDigestive System DisordersHemic and Lymphatic Diseases+ [1]

Active Indication

Eosinophilic EnteropathyEosinophilic Esophagitis

Inactive Indication

AsthmaDermatitis, AtopicEczema+ [2]

Originator Organization

Active Organization

Inactive Organization

Celgene International II SARL

Bristol-Myers Squibb (China) Investment Co. Ltd.

Sino-American Shanghai Squibb Pharmaceuticals Ltd.

+ [1]

License Organization

Receptos LLC

AbbVie, Inc.

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (Japan)

Structure/Sequence

Sequence Code 616724128H

Source: *****

Sequence Code 616724130L

Source: *****

Clinical Trials associated with Cendakimab

NCT05638282

/ CompletedPhase 1

A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Subcutaneous Doses of Cendakimab in Chinese Healthy Participants

The purpose of this study is to assess the drug levels, safety, and tolerability of cendakimab in healthy male and female Chinese participants.

Start Date15 Feb 2023

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT04991935

/ CompletedPhase 3

A Phase 3, Multicenter, Multinational, Open-Label Extension Study to Evaluate the Long-Term Safety of CC-93538 in Adult and Adolescent Subjects With Eosinophilic Esophagitis

This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies.

Start Date09 Aug 2022

Sponsor / Collaborator

Celgene Corp.

NCT05175352

/ CompletedPhase 1

A Phase 1, Open-label, Single-sequence Study to Evaluate Potential Disease-mediated Drug-drug Interaction With Selected Cytochrome P450 Substrates in Adult Subjects With Active Eosinophilic Esophagitis Receiving Cendakimab

The purpose of this study to evaluate the potential for disease-mediated drug-drug interactions between cendakimab and selected substrates of metabolic enzymes in eosinophilic esophagitis participants.

Start Date07 Jun 2022

Sponsor / Collaborator

Celgene Corp.

100 Clinical Results associated with Cendakimab

100 Translational Medicine associated with Cendakimab

100 Patents (Medical) associated with Cendakimab

Literatures (Medical) associated with Cendakimab

01 Sep 2026·Clinical Gastroenterology and Hepatology

Efficacy of Biological and Steroid Therapies in Adolescent and Adult Patients With Eosinophilic Esophagitis: A Systematic Review and Network Meta-Analysis With Meta-Regression

Review

Author: Laine, Loren ; Savarino, Edoardo Vincenzo ; Al Hayek, Mohammad ; Gyawali, C Prakash ; Chan, Walter W ; Visaggi, Pierfrancesco ; Barberio, Brigida ; McCoul, Edward D ; Najah, Qasi ; Lucendo, Alfredo J ; Yadlapati, Rena ; Elhadi, Muhammed

BACKGROUND & AIMS:

The therapeutic hierarchy of current pharmacologic options for eosinophilic esophagitis (EoE) has not been established. We performed a network meta-analysis to evaluate the comparative efficacy of pharmacological therapies for EoE.

METHODS:

PubMed, Scopus, Web of Science, and the Cochrane Library were searched from inception to May 25, 2025, for randomized controlled trials (RCTs) ≥12 weeks in duration comparing corticosteroids, biologics, or proton pump inhibitors with placebo or active comparators in participants aged ≥12 years. Key outcomes included changes in dysphagia from baseline and histologic remission (≤6 eosinophils/high-power field) at 12, 24, and 48 weeks. Treatments were ranked using the surface under the cumulative ranking curve (SUCRA). Certainty of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework.

RESULTS:

Thirteen RCTs were included. For dysphagia improvement compared with placebo and active comparators, dupilumab 300 mg and cendakimab 360 mg demonstrated moderate-to-high-certainty benefit at 12 and 24 weeks, whereas budesonide oral suspension (BOS) 2 mg demonstrated moderate-to-high-certainty benefit at 12 weeks; no 24-week data were available for BOS. At 48 weeks, budesonide orodispersible tablets (BOT) 0.5 and 1 mg demonstrated high certainty benefits for dysphagia improvement compared with placebo and active comparators. SUCRA ranked dupilumab highest for dysphagia improvement at 12 and 24 weeks (92% and 97%), and BOT 1 mg highest at 48 weeks (96%). For histologic remission, all agents except etrasimod showed moderate certainty benefits vs placebo across time points. SUCRA ranked BOS 2 mg highest at 12 weeks (78%), benralizumab 30 mg at 24 weeks (80%), and BOT 1 mg at 48 weeks (79%).

CONCLUSIONS:

All evaluated therapies except etrasimod achieved histologic remission, whereas only dupilumab, cendakimab, BOS, and BOT were associated with symptomatic improvement in EoE, highlighting dissociations between histologic and symptomatic responses. Most corticosteroid trials were short-term and lacked direct comparisons with biologics. Robust head-to-head trials are needed to define optimal treatment strategies, assess long-term outcomes, and clarify the role of symptom, endoscopic, and histologic endpoints in therapeutic decision-making.

01 Sep 2026·CTS-Clinical and Translational Science

Evaluation of the Effect of Cendakimab on the Pharmacokinetics of CYP Probe Drugs in Patients With Eosinophilic Esophagitis

Article

Author: De Oliveira, Claudia H. M. C. ; Murthy, Bindu ; Wang, Yanying ; Basdeo, Shenita ; Zhang, Peijin ; Charriez, Christina M. ; Kandoussi, Hamza ; Li, Jie ; Leiman, David A. ; Aras, Urvi ; Villa‐Caballero, Leonel

ABSTRACT:

Cendakimab is a humanized monoclonal antibody that inhibits interleukin‐13 binding to its receptors. Although not expected to share clearance pathways with small molecules, its use in eosinophilic esophagitis, a type 2 inflammatory disease, may indirectly affect cytochrome P450 activity by modulating cytokine signaling affecting certain cytochrome P450 enzymes. This open‐label, single‐sequence study evaluated the pharmacokinetics of cytochrome P450 substrates in adults with active eosinophilic esophagitis, evidenced by a peak eosinophil count of ≥ 15 per high‐power field in esophageal biopsies and clinical symptoms of esophageal dysfunction, before and after 16 weeks of cendakimab treatment. Patients received a cocktail of probe substrates (caffeine 200 mg, warfarin 10 mg + vitamin K 10 mg, omeprazole 40 mg, dextromethorphan 30 mg, midazolam 5 mg) for cytochrome P450 1A2, 2C9, 2C19, 2D6, and 3A in two sequential periods, separated by 16 weeks of cendakimab treatment. Blood samples were analyzed to assess pharmacokinetics. Sixteen patients were treated; 15 completed the study. Exposures (AUC and Cmax ) of caffeine, S‐warfarin, midazolam, and omeprazole were comparable before and after treatment. Dextromethorphan exposure showed no clinically meaningful change, although interpretation is limited by small sample size. Cendakimab was well tolerated. All adverse events were mild to moderate, with no serious adverse events, deaths or discontinuations from adverse events. No clinically relevant changes in laboratory tests, vital signs, or electrocardiograms were observed. Cendakimab had no clinically meaningful effects on cytochrome P450 enzyme activities and was generally safe and well tolerated with or without probe substrates in adults with active eosinophilic esophagitis.

01 Feb 2026·CPT-Pharmacometrics & Systems Pharmacology

Latent Variable Indirect Response Modeling of Cendakimab Exposure–Response for Longitudinal Dysphagia Days Using a Combined Uniform‐Binomial Likelihood Framework

Article

Author: Murthy, Bindu ; Du, Shengnan ; Hu, Chuanpu ; Kondic, Anna ; Wojciechowski, Jessica ; Aras, Urvi ; Shen, Jun ; Zhang, Peijin

ABSTRACT:

To characterize the relationship between cendakimab exposure and the longitudinal efficacy endpoint dysphagia days (DD), E–R analyses were performed using data from the EE‐001 study ( N = 427) with eosinophilic esophagitis. DD—a bounded, discrete endpoint assessed over 14‐day period via modified daily symptom diary (mDSD)—was modeled using a latent variable indirect response (IDR) model coupled with a combined uniform‐binomial (CUB) distribution. The latent variable, representing the underlying disease status, was dynamically modulated by placebo and drug effects (a function of individual‐predicted exposure) to govern the binomial probability of DD, while the uniform component captured the residual variability in patient‐reported outcomes. Inter‐individual variability was estimated for baseline DD, maximum placebo effect, and maximum drug effect. Covariates, including steroid inadequate response or intolerance (Steroid IR/I) status and baseline DD, were incorporated in the final model based on the clinical relevance. The estimated placebo half‐life was ~28 weeks, estimated EC 50 was 76.5 μg/mL, corresponding to an EC 90 of ~688 μg/mL, indicating steepness of the Emax curve. Model‐based simulations showed that both 360 mg QW and QW‐to‐Q2W regimens reduced DD compared to placebo at Week 48, with mean reductions of ~1.65 and ~1.36 days, respectively. Covariate‐stratified simulations suggested consistent responses across sex, age, and race. Steroid IR/I and baseline DD influenced treatment response magnitude but did not warrant dose modification. These findings support QW‐to‐Q2W as an effective maintenance posology and the utility of latent variable IDR models with appropriate likelihoods for modeling bounded, discrete longitudinal endpoints in E–R analyses.

News (Medical) associated with Cendakimab

27 Aug 2026

·allsci.com

Amgen/AZ's Tezspire extends TSLP platform to eosinophilic esophagitis with Phase III win

Tezepelumab has met both co-primary and all key secondary endpoints in eosinophilic esophagitis, Amgen (Nasdaq: AMGN) and AstraZeneca reported on August 27, extending the anti-thymic stromal lymphopoietin (TSLP) antibody's demonstrated efficacy to a third epithelial-driven inflammatory disease after severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). The Phase III CROSSING trial enrolled 368 patients aged 12–80 years with symptomatic, histologically active eosinophilic esophagitis (EoE) uncontrolled on maintenance therapy, randomized 1:1:1 to low-dose tezepelumab, high-dose tezepelumab, or placebo, all administered subcutaneously every four weeks. Co-primary endpoints at week 24 were histologic remission — defined as a peak esophageal eosinophil count of six or fewer per high-power field — and mean change from baseline in the patient-reported Dysphagia Symptom Questionnaire (DSQ) score. Both were met with statistically significant and clinically meaningful improvements versus placebo, the companies said, and those improvements were sustained through week 52. All key secondary endpoints, including endoscopic disease features, histologic severity, and total endoscopic remission at week 52, were also met. Specific numerical results have not been disclosed; full data will be presented at an upcoming medical meeting. The safety profile was described as generally consistent with tezepelumab's approved indications. Tezepelumab (Tezspire) is currently approved for severe asthma in the US, EU, China, Japan, and more than 70 countries, and received FDA approval for CRSwNP in October 2025 based on the Phase III WAYPOINT trial, which showed a 98% reduction in surgery need and 88% reduction in systemic corticosteroid use versus placebo. Tezepelumab blocks TSLP, an epithelial cytokine that sits upstream of multiple inflammatory cascades. In EoE, TSLP is preferentially secreted by terminally differentiated esophageal epithelial cells and is believed to initiate the eosinophilic inflammation that drives dysphagia, food impaction, and esophageal remodeling. By acting at this upstream checkpoint rather than targeting downstream mediators such as IL-5 or IL-13, tezepelumab intervenes earlier in the inflammatory cascade rather than targeting individual effector pathways — a distinction the companies have consistently emphasized across indications. The EoE market currently has one approved biologic: Sanofi and Regeneron's Dupixent (dupilumab), which blocks IL-4 receptor alpha signaling and was first approved by the FDA for EoE in May 2022, with a pediatric expansion to children aged one year and older in January 2024. Takeda's Eohilia (budesonide oral suspension) received FDA approval in February 2024 as the first oral pharmacotherapy for EoE, though it is indicated only for a 12-week course rather than chronic maintenance. Bristol Myers Squibb's cendakimab, an anti-IL-13 antibody that completed a positive Phase III trial in EoE, was discontinued in February 2025 as part of pipeline cost-cutting. Tezepelumab's upstream TSLP mechanism differentiates it from the approved and discontinued agents, which target downstream type 2 cytokines; whether that translates to a clinical advantage over dupilumab will require head-to-head data that do not yet exist. For Amgen and AstraZeneca, a positive EoE filing would extend tezepelumab's label across three distinct epithelial-driven conditions and reinforce the commercial and scientific rationale for the TSLP platform. The drug also holds FDA Orphan Drug Designation for EoE, granted in October 2021. Phase III COPD trials — JOURNEY and EMBARK — are ongoing, and the FDA granted a Breakthrough Therapy Designation for tezepelumab in eosinophilic COPD in July 2024, meaning EoE would represent one of potentially four approved indications if both programs succeed. The companies said they will submit the CROSSING data to regulatory authorities as quickly as possible. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article

Phase 3Drug ApprovalOrphan DrugClinical ResultBreakthrough Therapy

07 Feb 2025

·www.fiercebiotech.com

Bristol Myers backs out of Dupixent fight, axing allergy asset despite phase 3 win

Bristol Myers Squibb remains open to deals amid the cost-cutting. \n Bristol Myers Squibb has continued its ruthless cost-cutting push, dropping plans to commercialize a rival to Dupixent despite meeting its phase 3 goals and pumping the brakes on a would-be Sotyktu successor.The Big Pharma has dropped a series of internal and partnered programs since Chris Boerner, Ph.D., took over as CEO. Boerner initially targeted $1.5 billion in savings. With that cost-cutting push underway, the CEO added another $2 billion to the target this week. BMS is looking to make some of the savings by setting a higher bar for investments.Cendakimab fell short of the bar. The antibody hits IL-13, one of the interleukins targeted by Regeneron and Sanofi’s blockbuster Dupixent. Last year, BMS reported a phase 3 trial in eosinophilic esophagitis met both co-primary endpoints, positioning the drugmaker to challenge Dupixent and Takeda’s Eohilia for the market.Yet, BMS quietly removed cendakimab from the pipeline in its fourth-quarter update. Adam Lenkowsky, chief commercialization officer at BMS, explained the removal on an earnings call with analysts Thursday. “Given the data that we have seen, we\'ve made the decision not to commercialize cendakimab,” Lenkowsky said. “We\'re going to continue to prioritize investments and opportunities where we have a competitive advantage. We can deliver the highest return for the company in areas where we believe that we have an opportunity to deliver potentially transformational outcomes for patients.”Similar thinking underpinned BMS’ decision on investing in TYK2. BMS completed a phase 2 trial of its second-generation TYK2 inhibitor BMS-986322 in psoriasis in August. The drug candidate is still listed in BMS’ pipeline but an analyst questioned the lack of progress since the phase 2 trial wrapped up, leading Samit Hirawat, M.D., head of development at BMS, to explain why the program has stalled.“We have to decide within our pipeline where we are going to really focus and prioritize,” Hirawat said. “At the current time, our focus is truly squarely on Sotyktu and maximizing that opportunity from a development and commercial perspective. So, at this time, that TYK2 is not in development.”BMS is barreling ahead in other areas, pulling forward an anticipated readout from a phase 3 study of iberdomide in multiple myeloma after adding minimal residual disease (MRD) as a co-primary endpoint. Hirawat said BMS discussed the switch with the FDA and will talk to regulators once it has results to learn “how they will see that data and what else they would need.” Further use of MRD is on the cards. “Newer endpoints are needed,” Hirawat said. “We are continuing to evaluate the potential to leverage an earlier MRD endpoint readout to accelerate the development of our multiple myeloma assets across the board, but it will all depend on the timing, the population, as well as how the event accrual is occurring.”BMS remains open to deals amid the cost cutting. The drugmaker moved into radiopharmaceuticals as part of a deal spree, inking a deal to buy RayzeBio for $4.1 billion late in 2023, and Boerner said the team is looking for opportunities to enhance the acquisition. BMS will consider business development to achieve that goal if “it makes sense for us, both financially and scientifically,” the CEO said.

Phase 3Phase 2AcquisitionExecutive ChangeClinical Trial Failure

06 Feb 2025

·endpts.com

Bristol Myers prunes pipeline amid new round of cost cuts

Bristol Myers Squibb is ending work on a handful of assets, including an immunology medication that was in two Phase 3 trials. The pipeline cuts disclosed Thursday follow news of a wider $2 billion cost-saving initiative , the pharma’s second large restructuring in less than a year. Those reductions are set to impact the workforce and operating costs involving marketing, clinical trials and supply chains. The most consequential pipeline decision was culling cendakimab, an IL-13 inhibitor that was in two Phase 3 studies to treat esophagus and gastrointestinal inflammation, respectively. Chief commercialization officer Adam Lenkowsky told analysts on the company’s earnings call that “we’ve made the decision not to commercialize cendakimab.” A readout last year from the drug’s pivotal study in eosinophilic esophagitis found that it hit both of its primary endpoints, with statistically significant reductions in white blood cell counts in the esophagus and patients reporting fewer instances of food getting stuck in their throats. Bristol Myers did not expand on a commercialization timeline when it reported the data in late July. The Sotyktu makers are also putting plans for a backup TYK2 asset on ice, according to medical chief Samit Hirawat, saying the priority is commercializing the first-gen product. “At the current time, our focus is truly squarely on Sotyktu and maximizing that opportunity from a development and commercial perspective,” he told analysts. The second-generation candidate, BMS-986322, wrapped up a Phase 2 study in patients with moderate-to-severe psoriasis in August 2024, according to the clinical trial record . Hirawat said that it’s no longer currently in development. A smattering of other Phase 1 drugs were culled as well, including two solid tumor drugs, an NK cell engager to treat leukemia, and another TYK2 inhibitor aimed at neuroinflammatory conditions. BMS also removed an obstructive hypertrophic cardiomyopathy indication for MYK-224, a drug acquired from MyoKardia. A spokesperson for Bristol Myers confirmed the pipeline cuts, saying “as a standard practice, we regularly evaluate our pipeline to ensure we are prioritizing the assets that will have the greatest clinical benefit to impact areas of high unmet need and where BMS can deliver these medicines.” The changes, and select explanations by execs, further demonstrate BMS’ effort to double down on its existing portfolio — and invest in and maximize revenue from those medicines. Schizophrenia drug Cobenfy, the prize drug from BMS’ acquisition of Karuna Therapeutics, was in the spotlight after earning $10 million in its first two months on the market, in line with investor expectations, according to Leerink analysts. The company said they’re tracking ahead of expectations on access for patients on Medicare and Medicaid, which combined represent about 80% of the covered patients that BMS is targeting. A ramp-up is expected in the back half of 2025. Lenkowsky said that feedback from prescribers has been positive, and that most are starting patients on the lowest 50 mg dose and taking “a week or two” before titrating up to the next dose, which is likely mitigating GI side effects. Instructions for Cobenfy ask that patients take it at least one hour before a meal or two hours after, but a study testing the drug with food is set to read out this year. Lenkowsky said that should make it even easier to prescribe.

Phase 2Phase 1Phase 3Financial Statement

100 Deals associated with Cendakimab

External Link

KEGG	Wiki	ATC	Drug Bank
D11843	-	L04AC27	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Eosinophilic Enteropathy	Phase 3	Japan	Celgene Corp.	04 Mar 2022
Eosinophilic Enteropathy	Phase 3	-	Celgene Corp.	04 Mar 2022
Eosinophilic Esophagitis	Phase 3	United States	Celgene Corp.	22 Feb 2021
Eosinophilic Esophagitis	Phase 3	Japan	Celgene Corp.	22 Feb 2021
Eosinophilic Esophagitis	Phase 3	Argentina	Celgene Corp.	22 Feb 2021
Eosinophilic Esophagitis	Phase 3	Australia	Celgene Corp.	22 Feb 2021
Eosinophilic Esophagitis	Phase 3	Austria	Celgene Corp.	22 Feb 2021
Eosinophilic Esophagitis	Phase 3	Belgium	Celgene Corp.	22 Feb 2021
Eosinophilic Esophagitis	Phase 3	Canada	Celgene Corp.	22 Feb 2021
Eosinophilic Esophagitis	Phase 3	Germany	Celgene Corp.	22 Feb 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04991935 (CTgov)	Phase 3	Eosinophilic Esophagitis	367	CC-93538	ojgsdsiriu = dcuhyhmwst tzompznogl (wbtercuxea, lvhusenacy - vpmfblubql) View more	-	06 Apr 2026
NCT04753697 (Pubmed \| NEJM Evid)	Phase 3	Eosinophilic Esophagitis	430	Cendakimab 360 mg once weekly for 48 weeks	mktlwgrcgu(dnoyorauzc) = fmgqfvpjxm zguoxtuoag (nendpjrglt ) View more	Positive	23 Sep 2025
				Cendakimab 360 mg once weekly for 24 weeks, then 360 mg every other week for weeks 24 to 48	owoncfueio(ruzxqiorvn) = efqnoftmmd hdznsnmdwk (mvkbqdbomp )
NCT05214768 (CTgov)	Phase 3	Eosinophilic Enteropathy	48	Placebo	mrnahbosse(fccigszqij) = zlmmlcrwmr xwrxdhfooa (wuotckazlq, 60.27) View more	-	18 Sep 2025
NCT04753697 (DDW2025)	Phase 3	Eosinophilic Esophagitis	427	Cendakimab 360 mg (Eosinophilic Esophagitis)	zvhsoqjucq(caknqkktro) = ytlwhkjdlw wiknwmexvx (gneblioysq )	Positive	03 May 2025
				Placebo (Eosinophilic Esophagitis)	-
NCT04753697 (DDW2025)	Phase 3	Eosinophilic Esophagitis	427	Cendakimab 360 mg SC weekly	oldlrxpgvh(xicmvqzfre): P-Value = 0.05	Positive	03 May 2025
				Placebo
NCT04753697 (CTgov)	Phase 3	Eosinophilic Esophagitis	430	CC-93538 (Induction Phase - CC-93538 360 mg QW)	cmrxasdsry(iwmhxwwvba) = bbfgianfpq eyurinscnn (kgtnciocbo, 5.259) View more	-	13 Mar 2025
				placebo+CC-93538 (Induction Phase - Placebo)	cmrxasdsry(iwmhxwwvba) = nkolxtgglf eyurinscnn (kgtnciocbo, 5.075) View more
UEGW2023	Not Applicable	Eosinophilic Esophagitis	-	Cendakimab 180 mg	psgyhlqhhz(hjceoqqadq) = avqisxdehq azywowhltc (qjjnxhtnrm, 3.6Ã10 - 11) View more	-	15 Oct 2023
				Cendakimab 360 mg	psgyhlqhhz(hjceoqqadq) = mwrxphxghu azywowhltc (qjjnxhtnrm, 4.9Ã10 - 18) View more
UEGW2018	Not Applicable	Eosinophilic Esophagitis	-	RPC4046 360 mg	ivohkcovoa(uolykrqwnz) = gueaechydn rugnsqgxxi (pwdhlcvoni )	-	01 Oct 2018
				RPC4046 180 mg	ivohkcovoa(uolykrqwnz) = hyrkmwzzzq rugnsqgxxi (pwdhlcvoni )
UEGW2016	Not Applicable	Eosinophilic Esophagitis	-	RPC4046 180 mg	xsadynosjg(klzkeirpnj) = PBO 0%, LD 12.9%, HD 5.9% xctmigcwar (viszmnibur ) View more	-	01 Oct 2016
				RPC4046 360 mg

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