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Last update 10 Jun 2025

Itepekimab

Last update 10 Jun 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-IL-33 mAb(Regeneron Pharmaceuticals), Immunoglobulin igg4 (230-proline), anti-(human interleukin 33) (human monoclonal regn3500 .gamma.4-chain), disulfide with human monoclonal regn3500 .kappa.-chain, dimer, REGN-3500

+ [1]

Target

IL-33

Action

inhibitors

Mechanism

IL-33 inhibitors(Interleukin-33 inhibitors)

Therapeutic Areas

Respiratory DiseasesInfectious DiseasesOtorhinolaryngologic Diseases

Active Indication

Chronic rhinosinusitis without nasal polypsChronic rhinosinusitis with nasal polypsModerate chronic obstructive pulmonary disease+ [4]

Inactive Indication

Allergic asthmaAsthmaInflammation+ [3]

Originator Organization

Regeneron Pharmaceuticals, Inc.

Active Organization

SanofiGenzyme Ireland Ltd.

Regeneron Pharmaceuticals, Inc.

+ [2]

Inactive Organization-

License Organization

Regeneron Pharmaceuticals, Inc.

Sanofi

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Structure/Sequence

Sequence Code 17746027H

Source: *****

Sequence Code 17746031L

Source: *****

Clinical Trials associated with Itepekimab

CTIS2024-515576-12-00

/ RecruitingPhase 2

A randomized, double blind, placebo controlled, Proof of Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab in participants with inadequately controlled chronic rhinosinusitis without nasal polyps - ACT18421

Start Date20 Mar 2025

Sponsor / Collaborator

Sanofi-Aventis Recherche & Développement SA

NCT06834347

/ RecruitingPhase 3

A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

EFC18418 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo as add-on therapy to intranasal corticosteroids (INCS) in male and female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years of age and older.
Study details include:
* The study duration per participant (4-week screening, 52-week treatment, 20-week safety follow-up) will be up to 76 weeks. For participants transitioning to the LTS18420 study, the study duration will be 56 weeks.
* The treatment duration will be up to 52 weeks.
* The number of visits will be 9 site visits and 20 phone/home visits.

Start Date12 Feb 2025

Sponsor / Collaborator

Sanofi

[+1]

NCT06834360

/ RecruitingPhase 3

EFC18419 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo as add-on therapy to intranasal corticosteroids (INCS) in male and female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years of age and older.
Study details include:
* The study duration per participant (4-week screening, 52-week treatment, 20-week safety follow-up) will be up to 76 weeks. For participants transitioning to the LTS18420 study, the study duration will be 56 weeks.
* The treatment duration will be up to 52 weeks.
* The number of visits will be 9 site visits and 20 phone/home visits.

Start Date06 Feb 2025

Sponsor / Collaborator

Sanofi

[+1]

100 Clinical Results associated with Itepekimab

100 Translational Medicine associated with Itepekimab

100 Patents (Medical) associated with Itepekimab

Literatures (Medical) associated with Itepekimab

01 May 2025·Annals of the American Thoracic Society

Role of Monoclonal Antibodies in the Management of Eosinophilic Chronic Obstructive Pulmonary Disease: A Meta-analysis of Randomized Controlled Trials

Review

Author: Kamel, Ghassan ; Charbek, Edward ; Mohamed, Mohamed M. G.

Rationale: Chronic obstructive pulmonary disease (COPD) remains a leading cause of morbidity and mortality worldwide. Acute exacerbations are associated with progressive decline in lung function and quality of life. After recognition of the role of type 2 inflammation in the pathogenesis of eosinophilic COPD, there was increased interest in studying monoclonal antibodies as a therapeutic agent. Multiple randomized controlled trials showed promising results, yet no consensus exists. Objectives: Our study aims to summarize the current evidence regarding the role of monoclonal antibodies in the management of patients with eosinophilic COPD. Methods: We systematically searched multiple databases using prespecified search terms. We included only randomized controlled trials that compared monoclonal antibodies versus placebo in patients with objective evidence of eosinophilic COPD receiving standard-of-care therapy. The primary outcome of interest was the annualized rate of COPD exacerbation. Absolute changes in forced expiratory volume in 1 second and St. George's Respiratory Questionnaire scores were secondary outcomes. We also reported serious adverse effects and all-cause mortality. Statistical analysis was conducted via random effects model using RevMan software. Results: We identified and included eight double blinded, placebo-controlled trials with a total of 4,512 patients and a median follow up of 52 weeks. The patients' mean age was 65 ± 8 years, with 85% male. Seventy percent of patients were former smokers, with a mean of 43 ± 25 pack-years of smoking history. The majority of patients were receiving triple inhaled therapy. The mean serum eosinophil count at enrollment was 398 ± 297 cells/μl. The monoclonal antibodies studied were dupilumab, mepolizumab, benralizumab, astegolimab, and itepekimab. Compared with placebo, patients who received monoclonal antibodies had a significantly decreased annualized COPD exacerbation rate (rate ratio, 0.79; 95% confidence interval [CI], 0.73-0.86; P < 0.001). The serious adverse effect rate was significantly lower in the monoclonal antibody arm compared with placebo (odds ratio, 0.80; 95% CI, 0.69-0.93; P = 0.004). The all-cause mortality rates were not statistically different between the groups (odds ratio, 0.91; 95% CI, 0.63-1.3; P = 0.6). Dupilumab showed a trend of improved efficacy over mepolizumab and benralizumab. Conclusions: In patients with eosinophilic COPD receiving standard-of-care therapy, the use of monoclonal antibodies led to a significant reduction in annualized COPD exacerbation rate compared with placebo. Monoclonal antibodies have an acceptable tolerability and safety profile.

03 Jan 2025·COPD-Journal of Chronic Obstructive Pulmonary Disease

Biologic Therapies for Chronic Obstructive Pulmonary Disease: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials

Review

Author: Stanbrook, Matthew ; Ho, Terence ; Blazer, Alina ; Zeraatkar, Dena ; Lupas, Daniel ; Mah, Jasmine ; Pitre, Tyler

BACKGROUND:

Despite limited breakthroughs in COPD pharmacotherapy, recent trials have shown promising results for biologics in COPD patients. However, robust evidence synthesis in this area is currently lacking.

METHODS:

We conducted a systematic review of MEDLINE, EMBASE, and Cochrane CENTRAL from inception to July 17, 2024, to identify randomized trials of biologic medications in patients with COPD. We performed a random effects frequentist network meta-analysis and present the results using relative risk (RR) and 95% confidence intervals (CI). We used the GRADE framework to rate the certainty of the evidence. Outcomes of interest included exacerbations, change in FEV1, change in quality of life, and serious adverse events.

RESULTS:

Dupilumab reduced exacerbations as compared to placebo (RR 0.68 [95% CI 0.59 to 0.79]) (high certainty). Benralizumab (RR 0.89 [95% CI 0.78 to 1]), itepekimab (RR 0.81 [95% CI 0.61 to 1.07]) and tezepelumab (RR 0.83 [95% CI 0.61 to 1.12]) may reduce exacerbations as compared to placebo (all low certainty). Dupilumab probably reduced exacerbations more than mepolizumab (RR 0.74 [95% CI 0.62 to 0.89]) (moderate certainty). Dupilumab may reduce exacerbations more than tezepelumab (RR 0.82 [95% CI 1.14]) (low certainty). For all patients, no treatment improved FEV1 above the pre-specified minimal clinically important difference (MCID) of 0.1 L. Dupilumab probably has no meaningful effect on FEV1 compared to placebo (MD 0.07 [95% CI 0.02 to 0.13]) (moderate certainty). However, in the subgroup of patients with blood eosinophils ≥300/mcL, both tezepelumab (MD 0.15 [95% CI 0.05 to 0.26]) and dupilumab (MD 0.13 [95% CI 0.06 to 0.19]) probably improved FEV1 above the MCID.

CONCLUSION:

Dupilumab is effective at improving patient-relevant outcomes in COPD with higher eosinophil levels. Other biological therapies, including tezepelumab, have no important effect on patient-relevant outcomes.

01 Nov 2024·Clinical Pharmacology in Drug Development

Pharmacokinetics of Subcutaneous Itepekimab Injection With an Autoinjector Device and Prefilled Syringe in Healthy Participants

Article

Author: Nivens, Michael C. ; Kosloski, Matthew P. ; Xu, Christine ; Xin, Kong ; Goulaouic, Helene ; Butler, Allison ; Kanamaluru, Vanaja

Abstract:

Itepekimab, a monoclonal antibody against interleukin‐33, has demonstrated clinical utility in previous studies in patients with asthma and chronic obstructive pulmonary disease. An autoinjector (AI) has been developed for administering itepekimab to facilitate further development. This study compared pharmacokinetics of single 300‐mg itepekimab subcutaneous administration via an AI versus a prefilled syringe (PFS). Of 90 healthy volunteers enrolled in this Phase 1, parallel‐design, randomized study and stratified by body weight (50 to <70 kg, ≥70 to <80 kg, ≥80 to 100 kg) and injection site (abdomen, thigh, or arm), 84 completed the study. Systemic exposure of itepekimab was similar for both groups. Point estimates for geometric mean ratios of pharmacokinetic parameters for AI versus PFS groups were 1.01 for maximum serum concentration, 1.06 for area under the serum concentration‐time curve to the last quantifiable concentration, and 1.04 for area under the serum concentration‐time curve extrapolated to infinity. The exposure was similar for both devices in each body weight and injection site subgroup. Overall, systemic exposure of 300‐mg single‐dose itepekimab in healthy participants was comparable when administered subcutaneously via an AI device and PFS, with an acceptable safety profile in both device groups.

News (Medical) associated with Itepekimab

02 Jun 2025

·www.fiercepharma.com

With Opella proceeds burning a hole in its pocket, Sanofi snaps up Blueprint for $9.1B

Sanofi has made its largest acquisition in seven years, buying up Massachusetts rare disease specialist Blueprint Medicines for $9.5 billion. In late April, when Sanofi revealed that it was selling a controlling stake in its consumer health business Opella for 10 billion euros ($11.4 billion), chief financial officer Francois Roger said that the French drugmaker would “explore external growth opportunities for bolt-on acquisitions.”Just five weeks later, Sanofi has made a deal few would describe as “bolt-on,” as it has bought out Massachusetts-based Blueprint Medicines for up to $9.5 billion.With the deal, Sanofi gains Blueprint’s portfolio of rare immunological disease treatments, including systemic mastocytosis (SM) pill Ayvakit, which generated sales of $479 million last year and has peak sales potential of $2 billion, the 14-year-old company projected last year.Blueprint also brings a next-generation SM candidate in elenestinib, a KIT D816V inhibitor which is the subject of a phase 2/3 study, and an early-stage KIT inhibitor BLU-808. KIT plays a central role in mast cell activation, Sanofi said, which is implicated in a broad range of inflammatory diseases.Sanofi is paying $129 per share for the drugmaker, which is a 27% premium over Blueprint’s closing price on May 30 and 34% above its average price over the previous 30 days.The acquisition includes contingent value rights (CVRs) tied to the advancement of BLU-808, which could expand payments to Blueprint shareholders by $2 and $4 per share, bringing the total equity value of the deal from $9.1 billion to $9.5 billion.The Blueprint buyout "complements recent acquisitions of early-stage medicines that remain our main field of interest,” Sanofi CEO Paul Hudson said in a release. “Sanofi still retains a sizeable capacity for further acquisitions.”While Blueprint’s shares jumped by 26% on Monday, Sanofi’s dropped by less than 1%.It is Sanofi’s largest acquisition since its 2018 buyout of hemophilia specialist Bioverativ for $11.8 billion. The Blueprint deal comes after Sanofi made an unsuccessful play in 2022 for another rare disease specialist, Horizon Therapeutics. In that case, Amgen took the prize with its $27.8 billion offer. Sanofi said it anticipates completing the deal in the third quarter and that it will not impact its 2025 financial guidance. The company said in April that it expects (PDF) sales to increase by mid-to-high single digits this year on top of a 9% year-over-year increase in 2024 to 41.1 billion euros ($44.5 billion).The acquisition will help revitalize Sanofi’s portfolio, which has taken a few hits recently. Last week, Sanofi and Regeneron reported the failure of a phase 3 trial of their chronic obstructive pulmonary disorder (COPD) candidate itepekimab. In February, Sanofi revealed a phase 3 trial of its invasive E. coli vaccine came up short. The candidate had been acquired from Johnson & Johnson for $250 million. Sanofi has been active in the M&A market this year, picking up Dren Bio’s clinical-stage bispecific antibody, DR-0201, for $600 million upfront and another $1.3 billion in milestones. Last month, Sanofi spent $470 million for Vigil Neuroscience and its investigative Alzheimer’s disease candidate. And in January, Sanofi paid $2.2 billion for Inbibrx and its human recombinant protein rare disease drug.Other recent Sanofi deals include a $3.2 billion acquisition of Translate Bio in 2021 and a $2.9 billion buyout of Provention Bio in 2023.

AcquisitionPhase 3Vaccine

02 Jun 2025

·www.pharmaceutical-technology.com

Sanofi and Regeneron report results from two Phase III trials of COPD treatment

Itepekimab is currently being assessed in studies for other respiratory conditions. Credit: Momentum studio/Shutterstock. Sanofi and Regeneron have reported that the Phase III AERIFY-1 trial of the fully human monoclonal antibody itepekimab in former smokers who have inadequately controlled chronic obstructive pulmonary disease (COPD), met the primary goal. Former smokers are said to be those who remain unsmoked for a minimum of six months. The trial, which included 1,127 subjects, has achieved the primary endpoint, with a significant decrease of 27% in moderate or severe acute exacerbations against placebo at week 52. Other Phase III study, AERIFY-2 in 953 subjects, however, did not meet the same primary goal, despite showing an earlier benefit in the trial. These randomised, double-blind, placebo-controlled trials assessed the safety and efficacy of the antibody in adult patients aged 40-85 years. Subjects in both studies were given itepekimab every two or four weeks, or a placebo, in addition to standard-of-care therapy. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence The companies noted that the total number of exacerbations in both trials was lower than expected, potentially due to enrolment during the Covid pandemic globally, which may have influenced the overall exacerbation rates. The safety profile of the antibody was found to be consistent across dosing regimens. Sanofi Research and Development head and executive vice-president Houman Ashrafian said: “While we are encouraged by the results of AERIFY-1, the results of both studies merit further exploration to have a full understanding of the data and the role that interleukin-33 (IL33) plays in this complex disease.” In AERIFY-1, the overall rates of adverse events (AEs) were observed as 67% and 68% for itepekimab every two weeks and every four weeks, respectively, against 68% for placebo. AERIFY-2 showed similar results, with overall rates of AEs at 64% and 71% for the respective itepekimab dosing schedules, against 64% for placebo. The rate of serious infections was slightly lower in the antibody arms than in the placebo in AERIFY-1, but similar in AERIFY-2. Deaths due to AEs were low across both trials, with anti-drug antibodies being uncommon and without any apparent impact on drug levels. In 2023, the companies reported positive interim data from the Phase III NOTUS trial with Dupixent (dupilumab), showing a 34% decrease in exacerbations in COPD patients. Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

Clinical ResultPhase 3

30 May 2025

·www.fiercebiotech.com

Sanofi, Regeneron\'s IL-33 drug fails one of 2 COPD studies as FDA timeline thrown in doubt

Sanofi said it will take itepekimab data to regulators to \"evaluate our path forward.\"\n Sanofi’s plans to submit itepekimab to regulators for approval this year have been thrown into doubt after the Regeneron-partnered drug failed one of a pair of phase 3 chronic obstructive pulmonary disease (COPD) trials.Both of the studies, dubbed Aerify-1 and Aerify-2, evaluated administering the IL-33 drug itepekimab subcutaneously every two weeks or four weeks across a combined total of more than 2,000 former smokers with moderate to severe COPD. Both trials were designed to demonstrate a statistically significant reduction in moderate or severe exacerbations of COPD compared to placebo after 52 weeks.Aerify-1 hit this endpoint by demonstrating a 27% relative reduction in exacerbations among patients who received itepekimab every two weeks and a 21% reduction among those who received the drug every four weeks.But Aerify-2 was less successful, producing just a 2% reduction at two-week dosing and a 12% reduction at four-week dosing.Sanofi partly blamed the results on the lower total number of exacerbations “than prospectively anticipated,” which the company said had “decreas[ed] the power of both trials.”“Enrollment largely occurred during the time of the global COVID pandemic, which could have contributed to the overall lower exacerbation rates,” the pharma explained.Adverse events were “generally comparable” between the itepekimab and placebo cohorts, Sanofi said in its May 30 release. In the failed Aerify-2 trial, adverse events that led to death were 3% for each of the itepekimab cohorts compared to 2% for the placebo group.The failure of that trial is a significant setback for a drug that was listed in Sanofi’s most recent earnings presentation in April as being lined up for a regulatory filing in the second half of this year. At the time, Houman Ashrafian, Ph.D., Sanofi’s head of R&D, described the COPD readouts as “significant” and told analysts they could potentially lead to itepekimab’s market launch in 2026.In a statement attached to this morning’s data, Ashrafian sounded more muted on the drug’s near-term plans.“While we are encouraged by the results of AERIFY-1, the results of both studies merit further exploration to have a full understanding of the data and the role that IL-33 plays in this complex disease,” Ashrafian said. “Certain people with COPD are in desperate need of new treatment options, especially those who continue to experience exacerbations despite being on maximal therapy, and we remain committed to discussing these data with regulatory agencies to evaluate our path forward.”Sanofi declined to confirm to Fierce Biotech that its previous FDA timeline remains on track. The French Big Pharma had been developing itepekimab in collaboration with Regeneron. The two companies have seen blockbuster success with their immunology drug Dupixent and had previously evaluated the two therapies in combination as an asthma treatment in a phase 2 trial before halting that work in 2021. Separate phase 2 and 3 trials of itepekimab in COPD remain ongoing. Even if today’s unimpressive results mark the end of the road for itepekimab in that respiratory indication, the drug is still being evaluated in trials for rhinosinusitis with nasal polyps and bronchiectasis.“We are encouraged by the initial results from AERIFY-1 and are carefully reviewing the results from both itepekimab trials to inform next steps,” Regeneron Chief Scientific Officer George Yancopoulos, M.D., Ph.D., said in today’s release.“We remain committed to our broader itepekimab development program,” Yancopoulos added. “The learnings will be invaluable as we continue to advance itepekimab in respiratory diseases with unmet need.”The Aerify-2 fail continues a run of bad luck for Sanofi this year. The Paris-based pharma has also seen its psoriasis drug balinatunfib, its asthma hopeful amlitelimab and its Johnson & Johnson-sourced E. coli vaccine all underwhelm in the clinic in 2025.

$Sanofi, Regeneron\'s IL-33 drug fails one of 2 COPD studies as FDA timeline thrown in doubt$

Phase 2Phase 3VaccineClinical Result

100 Deals associated with Itepekimab

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16206

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic rhinosinusitis without nasal polyps	Phase 3	United States	Sanofi	12 Feb 2025
Chronic rhinosinusitis without nasal polyps	Phase 3	Japan	Sanofi	12 Feb 2025
Chronic rhinosinusitis without nasal polyps	Phase 3	Argentina	Sanofi	12 Feb 2025
Chronic rhinosinusitis without nasal polyps	Phase 3	Canada	Sanofi	12 Feb 2025
Chronic rhinosinusitis without nasal polyps	Phase 3	Chile	Sanofi	12 Feb 2025
Chronic rhinosinusitis without nasal polyps	Phase 3	Finland	Sanofi	12 Feb 2025
Chronic rhinosinusitis without nasal polyps	Phase 3	Hungary	Sanofi	12 Feb 2025
Chronic rhinosinusitis without nasal polyps	Phase 3	Israel	Sanofi	12 Feb 2025
Chronic rhinosinusitis without nasal polyps	Phase 3	Netherlands	Sanofi	12 Feb 2025
Chronic rhinosinusitis without nasal polyps	Phase 3	United Kingdom	Sanofi	12 Feb 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03546907 (CTgov)	Phase 2	Pulmonary Disease, Chronic Obstructive	343	Any short-acting β agonist as prescribed by treating physician as standard of care (Placebo)	rasigmvkrf = rcwujdaebt qqxqygpwis (gsmzaqtvsl, rbhluvblhe - utjkfewhdn) View more	-	22 Nov 2022
				Any short-acting β agonist as prescribed by treating physician as standard of care+SAR440340 (SAR440340)	rasigmvkrf = svqbmrrfkl qqxqygpwis (gsmzaqtvsl, xkepohdgyu - qulazbyjxt) View more
NCT03738423 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	129	Placebo (Placebo Q2W)	kfdrgiyrsq(yqhqsaogss) = nhklorlgnh ivxalqhzfj (qvpaepgdgo, 41.81) View more	-	10 Jun 2022
				REGN3500 (REGN3500 30 mg Q8W)	kfdrgiyrsq(yqhqsaogss) = jjlpogzmmx ivxalqhzfj (qvpaepgdgo, 31.65) View more
NCT03387852 (CTgov)	Phase 2	Asthma	296	Placebo for dupilumab+Fluticasone+Fluticasone/salmeterol (Placebo)	mynnnesfyh = spzwnbzftw fhawgnlevl (ioqaiktlns, yyihabufqn - tmwgkxdueg) View more	-	29 Mar 2022
				Dupilumab+Fluticasone+SAR440340+Fluticasone/salmeterol (SAR440340 + Dupilumab)	mynnnesfyh = fdiaggzhvo fhawgnlevl (ioqaiktlns, yijysjpmhi - dkgrmosajz) View more
NCT03736967 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	206	Placebo (Placebo Q2W)	pxylggzkdh(pgkhhjqfty) = dnpgvhhlfb gwfltknrgo (pqyobpclgv, 31.86) View more	-	01 Nov 2021
				REGN3500 (REGN3500 300 mg Q2W)	pxylggzkdh(pgkhhjqfty) = ilvtojiwxg gwfltknrgo (pqyobpclgv, 22.46) View more

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