Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA): A Phase 4 Double-Blinded, Parallel-Group, Randomized Control Trial With an Open Label Extension

Adults with severe asthma may have sudden worsening shortness of breath that results in their going to Emergency Department for urgent care. Emergency Room visits for asthma management across Alberta have been reviewed and it has been found that adults frequently need to return for repeated worsening. This is a large drain on health care resources as well as being very distressing for individuals with asthma. Occasionally this results in admission to hospital and rarely may lead to death. People are often treated with steroids to try to prevent the need for Emergency Room visits even though steroid medications have many long term bad side effects.
A new medication for patients considered to have severe asthma has been recently approved by Health Canada. This medication, Tezepelumab, is a monthly injection and it helps control asthma in adults regardless of the underlying cause. The study will examine if starting Tezepelumab, compared with a placebo, in the Emergency Room will help settle symptoms of asthma and prevent future worsening requiring repeated Emergency Room visits or the need for courses of outpatient steroid medications.

Start Date30 Jan 2025

Sponsor / Collaborator

University of Alberta

[+1]

NCT06740045

/ Not yet recruitingPhase 3IIT

Opening the "Black Box" on Tezepelumab's Effect on Chronic Rhinosinusitis With Severe Asthma

The study explores how chronic rhinosinusitis (CRS) and asthma share a common inflammatory process, particularly affecting patients with both conditions. Interaction between immune cells (Interleukins) and Th2 cytokines, such as TSLP, exacerbates asthma control in CRS patients, especially those with nasal polyps (CRSwNP). TSLP plays a pivotal role in initiating and maintaining airway inflammation in both diseases. Tezepelumab, a biologic therapy targeting TSLP, shows promise in reducing inflammation markers in severe asthma but its impact on CRSwNP and quality of life remains unclear. The study proposes investigating Tezepelumab's efficacy in treating CRSwNP and severe asthma to inform future biologic therapies.

Start Date01 Jan 2025

Sponsor / Collaborator

St. Paul's Hospital

[+1]

NCT06706817

/ RecruitingPhase 3

A Multicentre, Single-Arm, Phase 3b Study to Assess Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab (ESSENCE)

The main objective of this study is to evaluate treatment outcomes of tezepelumab among participants with physician-determined surgery-eligible CRSwNP, with or without asthma.
Study details include:
1. The study duration will be up to 40 weeks.
2. The treatment duration will be up to 24 weeks.
3. The visit frequency will be once every 4 weeks (Q4W).

Start Date03 Dec 2024

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with Tezepelumab

100 Translational Medicine associated with Tezepelumab

100 Patents (Medical) associated with Tezepelumab

235

Literatures (Medical) associated with Tezepelumab

01 Dec 2025·Current Allergy and Asthma Reports

Thymic Stromal Lymphopoietin (TSLP): Evidence in Respiratory Epithelial-driven Diseases Including Chronic Rhinosinusitis with Nasal Polyps

Review

Author: Scadding, Glenis K ; Klimek, Ludger ; Lee, Stella E ; De Corso, Eugenio ; Peters, Anju T ; Fokkens, Wytske J ; Mullol, Joaquim ; Desrosiers, Martin ; Hellings, Peter W

PURPOSE OF THE REVIEWThymic stromal lymphopoietin (TSLP) is increasingly recognized for its pivotal role in the pathogenesis of various epithelial-driven chronic inflammatory diseases. This review navigates the existing evidence on TSLP, with a particular focus on asthma, before delving into the current understanding of its role in chronic rhinosinusitis with nasal polyps (CRSwNP). We explore the role of TSLP in the pathogenesis of asthma and CRSwNP, two conditions often interconnected and collectively referred to as"Global Airway Disease". Additionally, this review assesses the therapeutic potential of TSLP inhibition as a treatment option for both CRSwNP and asthma. A systematic literature search was conducted; selected publications were used to describe the biology of TSLP, including its expression and diverse effects on inflammation.RECENT FINDINGSThe role of TSLP in asthma is well established and supported by the efficacy of tezepelumab, the first anti-TSLP monoclonal antibody approved for both type 2 (T2)-high and T2-low severe asthma. TSLP may be a key contributor to CRSwNP pathogenesis as evidenced by genetic and mechanistic studies in which TSLP has been shown to regulate T2 inflammation and influence non-T2 responses. Preliminary data from the NAVIGATOR trial indicate that tezepelumab may reduce CRSwNP symptoms in patients with comorbid asthma. While further research is required to clarify the extent of TSLP contribution in CRSwNP, this review highlights the potential of anti-TSLP therapies as a novel approach for managing severe, uncontrolled CRSwNP. If these preliminary findings are confirmed, targeting TSLP could become a promising strategy to treat CRSwNP with or without comorbid asthma.

01 Feb 2025·Current Opinion in Allergy & Clinical Immunology

Precision medicine and choosing a biologic in asthma: understanding the current state of knowledge for predictors of response and clinical remission

Review

Author: George, Elizabeth K. ; Balasubramanyam, Sadhana ; Wang, Eileen

Purpose of reviewWe review updated key literature on comparative meta-analyses and real-world effectiveness of asthma biologics, with a focus on predictors of response and clinical remission while highlighting ongoing knowledge gaps. We aim to provide insight into the many factors to consider when choosing a biologic to treat uncontrolled moderate to severe asthma.Recent findingsPredictors of response included higher type 2 (T2) biomarkers, shorter duration of asthma, and presence of key T2-related comorbidities. There were outcome-related variations in predictors. Predictors of clinical remission included better controlled asthma, better lung function, and higher T2 biomarkers. Few real-world studies included those treated with tezepelumab, a clear knowledge gap.SummaryAsthma biologics demonstrate clear real-world effectiveness. There have been significant strides in better understanding predictors of response or clinical remission to guide management, yet ongoing knowledge gaps and the heterogeneity of asthma preclude a simple algorithmic approach. Our tools for precision medicine include consideration of clinical phenotypes and shared decision making while striving to achieve clinical remission in all our patients with asthma.

02 Jan 2025·Journal of Asthma

Long-term safety of tezepelumab in patients with asthma: a systematic review and meta-analysis of randomized controlled trials

Review

Author: Han, Dong ; Qin, Jinlv ; Wang, Guizuo

OBJECTIVETezepelumab has demonstrated its effectiveness in patients with asthma, but its safety, especially for long-term use, needs to be further explored. This systematic review and meta-analysis aimed to determine the safety of long-term use of tezepelumab in patients with asthma.DATA SOURCESA systematic search was made of PubMed, Embase, Cochrane Library, and clinicaltrials.gov, without language restrictions.STUDY SELECTIONSRandomized controlled trials (RCTs) on treatment of asthma with tezepelumab, compared with placebo, were reviewed. Studies were pooled to weighted mean differences (WMDs) and risk ratios (RRs), with 95% confidence intervals (CIs).RESULTSSeven RCTs (enrolling 2050 participants) met the inclusion criteria. Serious adverse event (RR 0.74, 95% CI 0.57 to 0.95), upper respiratory tract infection (RR 0.73, 95% CI 0.55 to 0.96), and asthma (RR 0.61, 95% CI 0.48 to 0.76) were more frequent in the placebo groups. There was no statistically significant difference in the proportion of patients with at least one adverse event (AE), AEs leading to discontinuation of study treatment, all-cause death, influenza, bronchitis, nasopharyngitis, headache, and hypertension between the two groups.CONCLUSIONLong-term (12-52 wk) use of tezepelumab in patients with asthma does not increase the incidence of adverse events.

123

News (Medical) associated with Tezepelumab

02 Dec 2024

·endpts.com

Apogee targets Dupixent head-to-head next year as it outlines broad pipeline plans

Apogee Therapeutics, an I&I biologics maker that quickly went public in 2023, said Monday it’s headed toward a Dupixent face-off next year as it looks to become the next “generational” biotech. The San Francisco company expects its lead drug APG777, an IL-13 targeting monoclonal antibody, can eventually generate more than $10 billion in sales, CEO Michael Henderson told Endpoints News in a preview of Apogee’s R&D day on Monday. The plan is to launch the medicine by the end of this decade, Henderson said. “Historically, people have thought about us as a YTE antibody, a longer-acting version of another antibody,” Henderson said, “and we’ve been making investments to become so much more than that, which is what we’re really excited to show at our R&D day.” Part of those grand ambitions are pinned on a combination future in inflammation and immunology. The I&I field has become one of the industry’s fastest-growing areas of R&D as drugmakers sling deals left and right for a market that Henderson said is only second in breadth to obesity. Apogee’s first big combination test will come next year as it pairs APG777 with its OX40L-targeting mAb called APG990. By way of a co-formulation, those experimental medicines will go up against Dupixent in 50 to 75 patients with moderate-to-severe atopic dermatitis in a Phase 1b, Apogee said. The readout is slated for the second half of 2026. “Everyone says, ‘Oh, we’re going to be better. It should be better,’” Henderson said. “No one ever actually runs that head-to-head study.” Dupixent has become a cornerstone of Sanofi and Regeneron’s I&I pipelines, with the medicine projected to break the $14 billion sales milestone this year. It also became the first biologic to get FDA approval for chronic obstructive pulmonary disease, or COPD, this fall. Apogee isn’t daunted. Its half-life technology, born out of its parent company Paragon Therapeutics, could allow for dosing every three or six months versus every two to four weeks for many other I&I therapies like Dupixent and Eli Lilly’s Ebglyss. Eventually, as part of lifecycle management, Henderson envisions a once-yearly dosing schedule. In 12-month Phase 1 data on Monday, Apogee said APG777 had a half-life of 77 days and “near complete” inhibition of pSTAT6 for up to 12 months with just one administration of the drug. “If we look at psoriasis, you have Skyrizi dosed every three months, and that started with an every two-week paradigm with Humira and then the IL-17s came out every four weeks,” Henderson said. “It’s too early to comment on price, of course, but in those cases, you see the price staying the same or even being higher with fewer injections because the better disease control and improved patient experience.” Enrollment is going so much faster than anticipated in Apogee’s Phase 2 trial of APG777 in atopic dermatitis that the company now plans to unveil 16-week Part A data from the study in mid-2025. That’s “months” earlier than the previously guided second half of next year, Henderson said. As a monotherapy, APG777 will also enter a Phase 1b in asthma by next summer, a Phase 2b in asthma in the second half of next year and a Phase 2 in eosinophilic esophagitis in 2026. The company’s combination plans also include pairing up APG777 with APG333, a mAb that goes after TSLP, which is targeted by Amgen’s Tezspire and candidates from a cohort of other biotechs . While Apogee plans to evaluate APG333 alone in a Phase 1b in asthma, its future relies on combinations with APG777 in asthma and COPD. “TSLP as a mono we are not excited about. People are doing that. It’s OK. But it’s crowded. It really is a combination that we get excited” about, Henderson said. Sanofi has an IL-13 and TSLP-targeting bispecific called lunsekimig, and Johnson & Johnson paid $850 million upfront for Proteologix and its bispecific in the arena. Apogee also said its Phase 1 healthy volunteer trial showed its drug APG808 had a half-life of about 55 days, which could translate to every two or three-month maintenance doses. The investigational IL-4Rα drug is also in a Phase 1b in asthma, with a readout planned for the first half of 2025. Apogee raised more than $400 million in a public offering in March on the back of interim Phase 1 healthy volunteer data. Will the company do it again after its R&D day? “We think that we’re incredibly undervalued right now, especially after the recent pullback in the market,” Henderson said. If the Phase 2 data are what Apogee is hoping for, then the company “should be able to access a much lower cost of capital than we’re at today,” he added. Apogee’s share price $APGE is down about 17% over the past month, but up 61% year-to-date. Henderson thinks the biotech is headed toward becoming a “generational” drugmaker like Vertex or Gilead. “They refuse to stop at good enough. They pursue combinations. They look to cannibalize their own markets,” Henderson said.

Phase 1Phase 2Clinical Result

25 Nov 2024

·www.echemi.com

AstraZeneca's New Drug Application Accepted, Expected to Be a Market Focus in 2026

On November 22, 2024, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that the marketing application for Tezeliumab injection jointly submitted by AstraZeneca and Amgen has been officially accepted. According to public information, the drug is a monoclonal antibody targeting against thymic stromal lymphocyte opoietin (TSLP), called tezepelumab (trade name Tezspire). The therapy was approved by the U.S. Food and Drug Administration (FDA) in December 2021 as an add-on maintenance therapy for the treatment of severe asthma in children and adults 12 years and older. According to Clarivate analysis, the treatment is expected to become an important new drug on the market in 2026. According to the registration classification of the declaration, it can be inferred that the indications applied for marketing of the product in China may include the treatment of severe asthma in children and adults aged 12 years and above. At the same time, the product pipeline information on Astrazeneca's official website also indicates that it plans to declare the first indication in the Chinese market for the treatment of severe asthma. The FDA's approval is based on a clinical development program called PATHFINDER, which includes results from the pivotal Phase 3 clinical trial NAVIGATOR. The results of the NAVIGATOR trial were published in the New England Journal of Medicine in May 2021. The results show that tezepelumab met all primary endpoints and key secondary endpoints when treating patients with severe asthma with uncontrolled symptoms. Compared with placebo, the drug reduced the annual rate of acute exacerbations of asthma (AAER) by 56%. In addition to severe asthma, tezepelumab is also in development for the treatment of other potential indications, including chronic obstructive pulmonary disease, chronic sinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis. The product also received breakthrough therapy designation from the FDA in August as an additional maintenance therapy for patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

Drug ApprovalPhase 3Clinical ResultBreakthrough TherapyPriority Review

12 Nov 2024

·www.prnewswire.com

Sanofi/Regeneron Pharmaceuticals' DUPIXENT Approval Marks a Significant Shift in Chronic Obstructive Pulmonary Disease Treatment Landscape | DelveInsight

After over a decade without notable progress in treating chronic obstructive pulmonary disease, patients with this ongoing condition now have two new treatment options, with more expected in the future. Regeneron and Sanofi recently revealed that the FDA has expanded the approved uses of their widely successful drug DUPIXENT to include COPD treatment. This marks the drug's sixth approved indication in the US, following its first approval seven years ago for atopic dermatitis. LAS VEGAS, Nov. 12, 2024 /PRNewswire/ -- Chronic obstructive pulmonary disease (COPD) is a progressive lung condition characterized by obstructed airflow, making breathing difficult. It primarily encompasses two main conditions: chronic bronchitis and emphysema, often coexisting. COPD typically develops due to long-term exposure to irritants such as cigarette smoke, air pollution, or occupational dust. As per DelveInsight analysis, the diagnosed prevalent population of COPD in the 7MM was around 44 million in 2023. These cases of COPD in the 7MM are expected to increase at a significant CAGR of 1.4% throughout the study period (2020–2034). As per the estimates, the majority of cases of COPD are in females as compared to males, in the US. But in EU4 and the UK, and Japan the diagnosed cases of males represent the majority of the cases. Overall, in the 7MM, females are predominantly high in number. In 2023, the US had around 3 million, 9 million, 5 million, and 1 million cases of GOLD 1, GOLD 2, GOLD 3, and GOLD 4, respectively based on the severity of airflow limitation. Estimates suggest that airflow limitation was higher in GOLD 2 severity. Various types of medications are used to manage COPD symptoms and complications, including bronchodilators, which help relax the muscles around the airways. This relaxation opens the airways and makes breathing easier. Most bronchodilators are administered via an inhaler. In more severe cases, the inhaler may also contain steroids to reduce inflammation. Some commonly used short-acting and long-acting bronchodilators for COPD management include Albuterol (ProAir HFA, Ventolin HFA, and others), Ipratropium (Atrovent HFA), Levalbuterol (Xopenex), Aclidinium (Tudorza Pressair), Arformoterol (Brovana), and Formoterol (Perforomist). In the LABA category, medications such as Striverdi Respimat, Arcapta/Onbrez, Serevent, and Brovana are included, while the LAMA class features drugs like Spiriva (available as Spiriva HandiHaler and Spiriva Respimat), Tudorza Pressair, Incruse Ellipta, Yupelri, Seebri Neohaler, and Lonhala Magnair. Since the generic version of Brovana was approved in April 2020, its market share has declined. Additionally, Arcapta Neohaler, Seebri Neohaler, and Utibron Neohaler were discontinued in the US in March 2020, which means they no longer contribute to market size. Patients who do not respond to single therapies are often prescribed double or triple therapy. Among the double therapies, the LABA+ICS combination is widely recommended, with drugs such as Symbicort, Breo Ellipta, and Advair. There are also LABA+LAMA combinations, including Anoro Ellipta, Stiolto Respimat, and Bevespi Aerosphere. In July 2020, the US FDA approved AstraZeneca's BREZTRI AEROSPHERE for the maintenance treatment of patients with COPD. Additionally, in October 2020, TRIXEO AEROSPHERE (a combination of formoterol fumarate, glycopyrronium bromide, and budesonide) received marketing authorization in the EU for the maintenance treatment of adult patients with moderate to severe COPD who are not adequately controlled by either a combination of an ICS and LABA or a LABA and LAMA. Currently, two triple combination therapies are available in the US: BREZTRI and TRELEGY ELLIPTA. Learn more about the FDA-approved COPD drugs @ Drugs for COPD Treatment Recently, Sanofi/Regeneron Pharmaceuticals' DUPIXENT added one more jewel to its crown by getting a label expansion nod for COPD from the FDA, EU, and NMPA. DUPIXENT's approval as the first targeted therapy for COPD represents a significant advancement in the treatment landscape for the disease. Unlike conventional treatments, which largely aim to manage symptoms, DUPIXENT specifically targets the IL-4 and IL-13 pathways linked to type 2 inflammation, a key driver in a subset of COPD patients. This precision in targeting allows for a more tailored treatment, especially for patients with elevated eosinophils, who often experience more frequent exacerbations and worse outcomes. The Phase III BOREAS trial demonstrated that patients treated with DUPIXENT experienced a 30% reduction in moderate-to-severe exacerbations over 52 weeks, significant improvements in lung function, and enhanced quality of life. By Week 52, those on DUPIXENT had improved prebronchodilator FEV1 by 160 mL compared to 77 mL in the placebo group. DUPIXENT was also well-tolerated, with a low frequency of adverse events. These results suggest that DUPIXENT could drastically shift COPD management by reducing exacerbations, improving lung function, and offering a safer, targeted therapy for patients with type 2 inflammation. To know more about COPD treatment options, visit @ New Treatment for COPD The chronic obstructive pulmonary disease pipeline possesses potential drugs in mid-stage developments to be launched in the near future. Itepekimab (Sanofi/Regeneron Pharmaceuticals), Benralizumab (AstraZeneca), Tezepelumab (Amgen/AstraZeneca), Mepolizumab (GSK), and others shall further create a positive impact on the market. Discover which therapies are expected to grab major COPD market share @ COPD Market Report Itepekimab is a fully human monoclonal antibody that targets interleukin-33 (IL-33), a protein involved in both type 1 and type 2 inflammation. The drug is administered via subcutaneous injection. Preclinical studies demonstrated that REGN3500 effectively inhibited several markers of both inflammatory types. Regeneron and Sanofi are investigating REGN3500 in diseases related to respiratory and dermatological inflammation. Currently, REGN3500 is in a Phase III clinical trial for COPD and was developed using Regeneron's VelocImmune technology, which produces optimized fully human antibodies. The development is part of a global collaboration between Regeneron and Sanofi. FASENRA (benralizumab) is a humanized recombinant monoclonal antibody of the IgG1k immunoglobulin type that selectively targets the alpha chain of the interleukin 5 receptor (IL-5R) found on eosinophils and basophils. It prevents IL-5 from binding and stops the hetero-oligomerization of the IL-5R's alpha and beta subunits, thereby inhibiting signal transduction. Additionally, it is an afucosylated IgG, which enhances its affinity for the FcγRIIIα receptor on natural killer cells, macrophages, and neutrophils. Approved by the FDA in November 2017 for severe eosinophilic asthma, benralizumab was developed by MedImmune, AstraZeneca's global biologics R&D division. The company is currently conducting Phase III clinical trials for FASENRA as a treatment for COPD. TEZSPIRE (tezepelumab), a pioneering human monoclonal antibody created by Amgen and AstraZeneca, has shown considerable therapeutic potential for various respiratory conditions. Originally intended for treating COPD, TEZSPIRE has yielded encouraging results in decreasing moderate-to-severe exacerbations in patients with high blood eosinophil counts. Recent findings from the Phase IIa COURSE Trial, unveiled at the ATS 2024 conference, underscored TEZSPIRE's effectiveness in minimizing COPD exacerbations among patients with different eosinophil levels. Mepolizumab is currently undergoing Phase III clinical trials for COPD, particularly in patients with frequent exacerbations and elevated eosinophil levels. It is available as an injectable solution and a powder for reconstitution for subcutaneous administration. The IL-5 receptor complex activates several signaling pathways that lead to the release of cytokines, neuromediators, chemokines, and various kinases, which facilitate eosinophil differentiation, proliferation, recruitment, and degranulation. Mepolizumab works by inhibiting the formation of the IL-5 receptor complex, thereby preventing eosinophil activation. This disruption affects normal eosinophil maturation and function, leading to decreased eosinophilic airway inflammation and reduced eosinophil survival. Discover more about drugs for COPD in development @ COPD Clinical Trials The anticipated launch of these emerging therapies for COPD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the COPD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for COPD in the 7MM is expected to grow from USD 16 billion in 2023 with a significant CAGR of 5% by 2034. This growth is mainly driven by the rise in the number of prevalent cases of COPD, ongoing clinical research, and better diagnostic tools that might improve the prognosis of the disease. DelveInsight's latest published market report titled as Chronic Obstructive Pulmonary Disease Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the COPD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The COPD market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of COPD Subtype-specific Diagnosed Prevalent Cases of COPD Gender-specific Diagnosed Prevalent Cases of COPD Age-specific Diagnosed Prevalent Cases of COPD Diagnosed Prevalent Cases of COPD Based on Severity of Airflow Limitation Diagnosed Prevalent Cases of COPD Based on Symptoms and Exacerbation History The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM COPD market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this COPD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the COPD market. Also, stay abreast of the mitigating factors to improve your market position in the COPD therapeutic space. Related Reports Chronic Obstructive Pulmonary Disease Pipeline Chronic Obstructive Pulmonary Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key COPD companies, including Sanofi, Chiesi Farmaceutici S.p.A., United Therapeutics Corporation, Verona Pharma plc, Immunotek, Yungjin Pharm. Co., Ltd., Pulmotect, Inc., Tetherex Pharmaceutical, CSL Behring, AstraZeneca, Novartis, Genentech, Vertex Pharmaceuticals, EmeraMed, Afimmune, Mereo BioPharma, Synairgen, Adamis Pharmaceuticals, Quercegen Pharmaceuticals LLC, Regend Therapeutics, Meridigen Biotech Co., Ltd., Pulmatrix, Eisai, GlaxoSmithKline, EpiEndo Pharmaceuticals, 3SBio, OmniSpirant, Foresee Pharmaceuticals, Amgen, Organicell Regenerative Medicine, Arrowhead Pharmaceuticals, ProterixBio, RS BioTherapeutics, MitoRx, C4X Discovery, Respiratorius, ARK biosciences, Incannex, GNI Pharma, Celon pharma, Alveolus Bio, Kinaset therapeutics, Landos Biopharma, Parion Sciences, KeyMed Biosciences, Bioneer corporation, AlgiPharma, Palobiofarma, Dimerix Bioscience, Glenmark Pharmaceuticals, among others. Asthma Market Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key asthma companies including GlaxoSmithKline, 4D Pharma plc, AstraZeneca, Suzhou Connect Biopharmaceuticals, Avillion, Pearl Therapeutics, ARS Pharmaceuticals, Sinomab, Avalo Therapeutics, Kymab, Sanofi, Cumberland Pharmaceuticals, Genentech, Inc. , among others. Asthma Pipeline Asthma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key asthma companies, including Jiangsu Hengrui Medicine, GlaxoSmithKline, Immunotek SL, AB Science, EMS, Avalo Therapeutics, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., ARS Pharmaceuticals, Sanofi, Zura Bio Ltd., AstraZeneca, EURRUS Biotech GmbH, T-Balance Therapeutics GmbH, Gossamer Bio, Aldeyra Therapeutics, Inc., Trio Medicines, Janssen Research & Development, Arrowhead Pharmaceuticals, Hoffman-La-Roche, GlaxoSmithKline, Biohaven Pharmaceutical, TAK-Circulator Co., Shanghai Hengrui Pharmaceutical, among others. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ARDS companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, Windtree Therapeutics, Biomarck Pharmaceuticals, Athersys, Healios, Direct Biologics, Biohaven Pharmaceutical, Arch Biopartners, APEPTICO Forschung und Entwicklung GmbH, Staidson (Beijing) Biopharmaceuticals, Veru, Mesoblast Limited, Avalo Therapeutics, Pluristem Therapeutics, ILTOO Pharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3Phase 2

100 Deals associated with Tezepelumab

External Link

KEGG	Wiki	ATC	Drug Bank
D11771	Tezepelumab	-	DB15090

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Severe asthma	US	AstraZeneca AB	17 Dec 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Asthma	NDA/BLA	CN	AstraZeneca AB	22 Nov 2024
Severe asthma	Phase 3	GB	Amgen, Inc.	23 Nov 2017
Severe asthma	Phase 3	ZA	Amgen, Inc.	23 Nov 2017
Severe asthma	Phase 3	BR	AstraZeneca PLC	23 Nov 2017
Severe asthma	Phase 3	US	Amgen, Inc.	23 Nov 2017
Severe asthma	Phase 3	JP	Amgen, Inc.	23 Nov 2017
Severe asthma	Phase 3	AR	Amgen, Inc.	23 Nov 2017
Severe asthma	Phase 3	GB	AstraZeneca PLC	23 Nov 2017
Severe asthma	Phase 3	KR	Amgen, Inc.	23 Nov 2017
Severe asthma	Phase 3	BR	Amgen, Inc.	23 Nov 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04851964 (WAYPOINT, PRNewswire) Manual	Phase 3	Chronic rhinosinusitis with nasal polyps	-	TEZSPIRE	(osnkgcbgvo) = Statistically Significant Reduction Compared to Placebo. rgwjhqgmks (zkiavhtmje ) Met	Positive	08 Nov 2024
NCT04851964 (WAYPOINT, PRNewswire) Manual	Phase 3	Chronic rhinosinusitis with nasal polyps	-	Placebo		Positive	08 Nov 2024
NCT03706079 (Pubmed \| Eur Respir J) Manual	Phase 3	Severe asthma	-	Tezepelumab	(wfxkshnrbs) = qwyuntxmur tknfiqjslc (xxkcmwizkz ) View more	Positive	26 Sep 2024
NCT03706079 (Pubmed \| Eur Respir J) Manual	Phase 3	Severe asthma	-	Placebo	(wfxkshnrbs) = mxnraseafp tknfiqjslc (xxkcmwizkz ) View more	Positive	26 Sep 2024
NCT03347279 (NAVIGATOR, ATS2024) Manual	Phase 3	Severe asthma	165	tezepelumab	(imgekdnzzw) = yzaxwtdtqj tunmqpjpvm (hyrtbnjyxt ) View more	Positive	21 May 2024
NCT05329194 (PASSAGE, ATS2024) Manual	Phase 4	Severe asthma	112	Tezepelumab 210 mg	(xsbtppuzhs) = patients with COPD and Black/African Americans had the highest (3.4) and second highest (2.9) mean number of exacerbations per patient in the past year, respectively. The proportion of patients with exacerbations resulting in hospitalization was 26.7%, 50.0% and 18.2%, and in emergency department/urgent care visits was 40.0%, 83.3% and 45.5% among Black/African American patients, adolescents and those with COPD, respectively. tlfktcgkir (jyvhwegrfb )	Positive	21 May 2024
NCT04039113 (COURSE, Biospace) Manual	Phase 2	Pulmonary Disease, Chronic Obstructive	-	tezepelumab	auzoybdaem(lgnhysdmgc) = ctusvoikbx xevgkbqwgq (rcqgkuycor )	Positive	19 May 2024
NCT04833855 (INCEPTION, CTgov)	Phase 2	Chronic Urticaria	183	placebo (Placebo)	uivqfifegn(qzyqbhhrwr) = hkmsbdtiao stdrewgnab (ladjftkmqo, aaxzhqmech - vdooetosiq) View more	-	01 May 2024
NCT04833855 (INCEPTION, CTgov)	Phase 2	Chronic Urticaria	183	Omalizumab (Omalizumab 300 mg SC Q4W)	uivqfifegn(qzyqbhhrwr) = ttfybnptvx stdrewgnab (ladjftkmqo, nfkjmpjjhn - qnyroqopkr) View more	-	01 May 2024
AAAAI2024 Manual	Not Applicable	Asthma	20	Tezepelumab-ekko 210mg	msnucrejde(fgqlsnnktt) = hridrsltih sjzyyetcfm (vjktlfkxwz ) View more	Positive	23 Feb 2024
NCT03347279 (NAVIGATOR, AAAAI2024) Manual	Phase 3	Asthma, Nasal Polyps, and Aspirin Intolerance \| Severe asthma	43	Tezepelumab 210 mg	oxwtrzoimf(zbqtdaxaqt) = mlugbzsmxx tqarlwazum (xneyxhofks ) View more	Positive	23 Feb 2024
NCT04673630 (TRAILHEAD, CTgov)	Phase 1	Asthma	18	Tezepelumab	ilyzqddmsa(ojouygywqt) = omtvwxcfyw vaictdepvd (tmewoemxfe, sthpbpqxui - drbseaizgk) View more	-	08 Jan 2024
NCT05062759 (VECTOR, CTgov)	Phase 3	Asthma \| Influenza, Human	70	Tezepelumab	lhxruiyovh(xlgtbyvfiv) = nccyndqsie rpkhvxkiom (yjjdxihawb, xzbrxuizlo - lljskdmzxw) View more	-	21 Apr 2023

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