The goal of this interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC). The main question it aims to answer is whether these skin barrier abnormalities can be reversed by omalizumab.
If there is a comparison group: Researchers will compare non-food allergic participants (who do not receive omalizumab) to see if they experience skin barrier abnormalities.
All food allergic participants will receive 4 months of Omalizumab treatment as well as two Oral Food Challenges. Participants will all undergo skin barrier assessments.

Start Date01 Oct 2024

Sponsor / Collaborator

National Jewish Health, Inc.

[+1]

NCT06437171

/ RecruitingPhase 4IIT

The Use of Exhaled Nitric Oxide as a Predictive Marker of Allergic Reactions to Oral Food Challenge and Clinical Response of Omalizumab Treatment in Subjects With Multiple Food Allergies

This is a Phase IV, open-label, single-center study to evaluate the change in FeNO as a marker of clinical response to OMA in participants with multiple FA.

Start Date03 Jun 2024

Sponsor / Collaborator-

NCT06771934

/ Active, not recruitingNot ApplicableIIT

Efficacy and Safety Evaluation of Omalizumab Combined With Standardized Allergen Specific Immunotherapy in Moderate to Severe Allergic Asthma

The combined treatment of anti-IgE monoclonal antibody and standardized allergen immunotherapy has good efficacy and safety in allergic diseases. However, the efficacy and safety of the combined treatment for allergic asthma in the Chinese population have not been fully elucidated yet.This study is a prospective observational study designed to evaluate the efficacy and safety of omalizumab combined with allergen immunotherapy (AIT) in patients with moderate to severe asthma in the Chinese population.

Start Date01 Jun 2024

Sponsor / Collaborator

Qianfoshan Hospital of Shandong Province

100 Clinical Results associated with Omalizumab

100 Translational Medicine associated with Omalizumab

100 Patents (Medical) associated with Omalizumab

3,712

Literatures (Medical) associated with Omalizumab

01 Dec 2025·Current Allergy and Asthma Reports

Olfactory Dysfunction in Chronic Rhinosinusitis with Nasal Polyps: Effect of Treatment with Emphasis on Biological Therapy

Review

Author: Reitsma, Sietze ; Fokkens, Wytske Johanna ; Otten, Josje Janna

PURPOSE OF REVIEWOlfactory dysfunction significantly impacts quality of life that affects a majority of the patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The aim of this review is to explore the impact of various treatment regimens on olfactory dysfunction in patients diagnosed with CRSwNP.RECENT FINDINGSAccurate assessment of olfactory dysfunction remains challenging and should incorporate both psychophysical tests and patient-reported outcomes. Patients with CRSwNP appear capable of reliably evaluating their olfactory function. Standard treatment such as intranasal corticosteroids and surgery have limited capability of restoring the sense of smell. Oral corticosteroids have a far greater potency, albeit short-lived and at the cost of adverse events and side effects. Recent studies on registered biological agents- specifically dupilumab, mepolizumab, and omalizumab- indicate their effectiveness in restoring olfactory function in severe CRSwNP. According to meta-analyses and indirect comparisons, dupilumab shows superiority; however, direct comparative studies are necessary.

01 Apr 2025·Current Opinion in Allergy & Clinical Immunology

The ethics of food allergy

Review

Author: Singh, Tarandeep ; Buckey, Timothy M. ; Sacta, Maria A.

Purpose of reviewEthical dilemmas are a common occurrence in the provision of care to individuals with food allergies. Thus, an understanding of medical ethics is essential for allergists/immunologists.Recent findingsDespite the importance of medical ethics in the clinical practice of food allergy, there has been little published on this topic. Some international allergy societies have published ethical guidelines. Further investigation on medical ethics in food allergy is required.SummaryThis review describes key ethical principles in relation to food allergy testing, oral food challenges, and various management strategies, including avoidance, omalizumab and oral immunotherapy. This review demonstrates the necessity for education and research on medical ethics in food allergy.

01 Apr 2025·Current Opinion in Allergy & Clinical Immunology

New approaches in childhood IgE-mediated food allergy treatment

Review

Author: Sharon, Chinthrajah ; Arasi, Stefania ; Sahiner, Umit ; Sindher, Sayantani ; Anagnostou, Aikaterini ; Fiocchi, Alessandro ; Gurel, Deniz Ilgun

Purpose of reviewThis review aims to provide an overview of the current and future treatment options for children with food allergies (FAs), highlighting the latest research findings and the potential impact of these new approaches on improving patients’ and caregivers’ quality of life.Recent findingsIn the last decade, many promising approaches have emerged as an alternative to the standard avoidance of the culprit food with the risk of severe accidental reactions. Desensitization through oral immunotherapy has been introduced in clinical settings as a therapeutic approach, and more recently also omalizumab. In addition, alternative routes of administration for immunotherapy, other biologics, small molecules, probiotics or prebiotics, microbiota transplantation therapy, IGNX001, and PVX108 are being investigated.SummaryThe portfolio of available treatment options for food allergies is increasing but several relevant unmet needs remain. This review aims to provide a brief overview of the existing and future treatment options for IgE-mediated food allergies.

179

News (Medical) associated with Omalizumab

17 Mar 2025

·www.echemi.com

Novartis Targets $830 Million CSU Market with New Drug Developments

Recently, Novartis has made significant strides in the chronic spontaneous urticaria (CSU) market, announcing a priority review application for its BTK inhibitor Remibrutinib and a $830 million deal to acquire Kyorin's clinical-stage MRGPRX2 antagonist. The announcement highlights Novartis' commitment to maintaining its leadership position in the CSU treatment landscape, which is marked by a prevalence rate of approximately 0.05% to 3%, with CSU accounting for about 68% of chronic urticaria cases. The condition primarily manifests as hives and itching, and can lead to deeper systemic issues, increasing the risk of autoimmune diseases and cancers. First-line treatment typically involves H1 antihistamines, but nearly half of patients struggle to achieve adequate control, necessitating additional therapies. The global CSU market is projected to grow from $779.28 million in 2024 to $1.54141 billion by 2032, with a compound annual growth rate (CAGR) of 8.90% from 2025 to 2032. As awareness and treatment demands increase, this market is poised for continued growth. As a market leader, Novartis has long relied on its collaboration with Roche to dominate the CSU field with Xolair (omalizumab), an anti-IgE drug that has generated over $4.3 billion in sales in 2024, despite emerging competition. However, with the expiration of Xolair's compound patent and an impending expiry of its formulation patent in November 2025, Novartis faces pressure from competitors like Sanofi/Regenron's Dupixent (dupilumab), which has recently gained approval for CSU in Japan and is challenging Xolair's dominance. In light of these developments, Novartis has shifted its focus to exploring next-generation therapies, particularly BTK inhibitors. Bruton’s tyrosine kinase (BTK) plays a crucial role in CSU's pathogenesis, and inhibiting BTK can prevent mast cell activation and the production of autoantibodies, addressing two primary pathological mechanisms of CSU. Last year, Novartis reported positive results from two pivotal Phase III trials of Remibrutinib, demonstrating significant symptom improvement over 52 weeks. The recent submission of its New Drug Application (NDA) positions Remibrutinib as a potential successor to Xolair, aiming to solidify Novartis' standing in the CSU market. In addition to Remibrutinib, Novartis is strategically acquiring promising candidates like KRP-M223, an MRGPRX2 antagonist, which is anticipated to enhance its portfolio in this therapeutic area. MRGPRX2, a G protein-coupled receptor expressed predominantly on mast cells, is activated during allergic responses, leading to the release of mediators such as histamine. Although KRP-M223 is still in preclinical stages, its unique mechanism holds the potential for significant advancements in treating CSU and related allergic conditions. In the domestic market, several promising therapies targeting CSU are advancing through clinical trials. Notably, Tianchen Biotech's LP-003, a next-generation anti-IgE antibody, recently reported mid-stage Phase II clinical data that surpassed Xolair's efficacy. With a dosing regimen of every 8 weeks, LP-003 could significantly improve patient compliance compared to Xolair's more frequent administration. Another contender is Jimin Xinke's JYB1904, a long-acting anti-IgE antibody that boasts a half-life more than twice that of Xolair, reducing injection frequency and potentially enhancing patient adherence to treatment. As Novartis strengthens its position in the CSU market with innovative therapies and strategic acquisitions, the competitive landscape continues to evolve. The battle for dominance in this lucrative market is intensifying, with Novartis poised to defend its title against emerging threats while exploring new growth avenues.

Clinical ResultPhase 3Phase 2Priority ReviewNDA

14 Mar 2025

·www.prnewswire.com

Weekly Roundup: 15 Health Press Releases You Need to See

A roundup of the most newsworthy healthcare press releases from PR Newswire this week, including business acquisition news from Sun Pharma and Labcorp as well as new research from the National Sleep Foundation. NEW YORK, March 14, 2025 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major stories from the week that shouldn't be missed. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Weekly Health Press Release Roundup, March 10-14, 2025. Sun Pharma to Acquire Checkpoint Therapeutics "We are excited to enter this transaction with Sun Pharma as the next step to bringing UNLOXCYT to cSCC [metastatic cutaneous squamous cell carcinoma] patients in need of a differentiated immunotherapy treatment option," said James Oliviero, President and Chief Executive Officer of Checkpoint. Labcorp Announces Acquisition of Select Assets of BioReference Health's Innovative Oncology and Related Clinical Testing Services Businesses Labcorp will acquire BioReference Health's laboratory testing businesses focused on oncology and oncology-related clinical testing services across the United States. The assets that Labcorp will be acquiring currently generate approximately $85 million to $100 million in annual revenue. National Sleep Foundation Research Reveals Nearly 1/3 of Americans Diagnosed with Sleep Apnea are Not Receiving Treatment Despite Health Risks Findings revealed 78% of Americans aren't aware of all the treatment options available for sleep apnea and only 1 in 4 Americans can identify the health consequences of untreated sleep apnea. Amgen and Kyowa Kirin Provide Top-Line Results from Rocatinlimab Phase 3 Ignite Study in Adults with Moderate to Severe Atopic Dermatitis The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths versus placebo. Celebrating the Best in Patient Safety: Healthgrades Announces 2025 Top Hospitals for Patient Safety This year's recipients include 442 hospitals from 40 states and represent the top 10% of hospitals in the nation for patient safety. Patient safety is a vital component of achieving the best possible health outcomes, ensuring that serious injuries and complications are minimized for patients during hospital stays. U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR® The availability of the first omalizumab biosimilar will help increase access and potentially lower the healthcare cost for people with asthma and allergic diseases. Make-A-Wish Receives $250,000 Grant from U.S. Bank Foundation to Help Support Life-Changing Wishes Nationwide "Together with the U.S. Bank Foundation, we look forward to granting wishes that can replace fear with hope and transform the lives of wish kids and their families," said Leslie Motter, president and CEO of Make-A-Wish America. Health is Wealth: MyFitnessPal's Third Annual Nutrition IQ Survey Exposes Americans' Nutritional Blind Spots Amid Rising Food Prices While the new year traditionally inspires health-oriented resolutions, current economic pressures are adding a layer of complexity. Rising food prices further complicate efforts to prioritize nutrient-dense options in grocery carts, creating a substantial barrier for many. Clayman Thyroid Center Launches Inaugural Hashimoto's Disease Awareness Day on March 12 Hashimoto's Disease Awareness Day, to be observed annually on the second Wednesday in March, is designed to bring much-needed attention to Hashimoto's thyroiditis, an autoimmune condition that affects millions yet remains misunderstood, underdiagnosed, and often dismissed. The American Diabetes Association Announces the 2025 National Scientific and Health Care Achievement Award Winners "The diligent work of these passionate professionals is moving us closer to a world free of diabetes. Their contributions to research, prevention, and treatment are creating lasting change and improving the lives of people affected by diabetes," said Charles "Chuck" Henderson, the ADA's chief executive officer. Lilly's baricitinib delivered high rates of hair regrowth for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS study "With these data, baricitinib is the most well-studied JAK inhibitor in severe alopecia areata, a chronic immune system disorder that can have an especially devastating social and emotional impact on adolescent patients and their families," said Anabela Cardoso, senior vice president, Lilly Immunology Medical Affairs. Informa Connect Celebrates Successful HIMSS25, Announces Dates for HIMSS26 The conference featured 600+ educational sessions, 950+ exhibitors, numerous networking opportunities and a highly attended hosted buyer program that facilitated crucial conversations about the future of healthcare technology and delivery models. Data Shows Quality of Life Improves for Spouses of Hip and Knee Replacement Patients When spouses were surveyed about their own quality of life compared to before their spouse's surgery, 70% said their quality of life was slightly or significantly better, 28% noted no change and 2% reported a slightly worse quality of life. Sesame Place Philadelphia Is First Theme Park in North America to Launch Hidden Disabilities Sunflower Program Part of a global initiative designed to support people with non-visible disabilities and conditions, the program consists of a wearable Sunflower-branded tool that discreetly signals to Sesame Place Ambassadors that a guest may need extra help, understanding, or time due to a disability or condition that may not be immediately apparent. Count Me In Launches New Patient-Partnered Research Project for Translocation Renal Cell Carcinoma tRCC is a unique type of kidney cancer caused by specific genetic changes called translocations, where parts of chromosomes s or rearrange. Due to its rarity, research on tRCC has historically been limited, leaving patients and families with few therapeutic options and many unanswered questions. For more news like this, check out all of the latest health-related releases from PR Newswire. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultAcquisitionPhase 3Drug Approval

10 Mar 2025

·pipelinereview.com

U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®

JERSEY CITY, NJ, USA I March 9, 2025 I Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO ® (omalizumab-igec) as the first and only biosimilar designated as interchangeable with XOLAIR ® (omalizumab) for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU). [2] “We are proud to achieve the approval of the first biosimilar to omalizumab in the U.S., which will help broaden access to this important medicine for patients with allergic and respiratory conditions, as well as for physicians, payers and providers,” said Hetal Patel, Vice President of Medical Affairs at Celltrion USA. “The interchangeability designation of OMLYCLO reinforces confidence among physicians and patients that there is no decrease in effectiveness or increase in safety risk associated with switching between OMLYCLO and the reference product.” The FDA approval and designation of interchangeability are based on comprehensive clinical evidence, including results from a global Phase III clinical trial involving 619 adult patients with CSU up to Week 40. Patients were randomized to receive 300 mg or 150 mg of OMLYCLO or reference product every 4 weeks. From Week 12, patients who received OMLYCLO were continued on OMLYCLO, and patients who received 300mg of the reference product were re-randomized in a 1:1 ratio to switch to OMLYCLO or to continue reference product. From Week 24, patients were followed up until Week 40 without dosing. The result demonstrated the comparable efficacy and safety of OMLYCLO to reference product during both treatment and off-dose periods. [1] An interchangeable biosimilar is a biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable biosimilar medications. [3] “The approval of OMLYCLO could have a meaningful impact for the medical community and patients, offering a high quality and affordable treatment option, while reducing the burden of healthcare costs,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “With our integrated development, manufacturing, and commercialization platform, Celltrion remains committed to alleviating treatment costs and delivering life-changing medicines to support patients with allergic conditions in the U.S.” About OMLYCLO ® (omalizumab-igec) OMLYCLO ® (omalizumab-igec) is the first U.S. Food and Drug Administration (FDA)-approved anti-IgE antibody biosimilar referencing XOLAIR ® (omalizumab). OMLYCLO 75 mg/0.5 mL and 150 mg/mL solution in a single-dose prefilled syringe is approved as interchangeable with reference product for all indications based on comprehensive data and clinical evidence confirming the therapeutic equivalence to XOLAIR. [1],[2] OMLYCLO was also approved by the European Commission (EC) in May 2024. INDICATION OMLYCLO® (omalizumab-igec) injection, is an anti-IgE antibody indicated for: Limitations of Use: Not indicated for: acute bronchospasm or status asthmaticus; emergency treatment of allergic reactions, including anaphylaxis; other forms of urticaria. IMPORTANT SAFETY INFORMATION WARNING: ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early as after the first dose of omalizumab products, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate OMLYCLO therapy in a healthcare setting and closely observe patients for an appropriate period of time after OMLYCLO administration. Health care providers administering OMLYCLO should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of OMLYCLO should be based on criteria to mitigate risk from anaphylaxis. Contraindications: Severe hypersensitivity reaction to OMLYCLO or any ingredient of OMLYCLO. Anaphylaxis. Omalizumab products, including OMLYCLO, have been associated with anaphylaxis, reported in both clinical trials and postmarketing data. Patients with a history of anaphylaxis to foods, medications, or other causes face an increased risk. Initiate OMLYCLO only in a healthcare setting with anaphylaxis management capabilities. Patients should be monitored for an appropriate period post-administration, informed of symptoms, and instructed to seek immediate medical care if they occur. Malignancy. Malignancies have been observed in clinical studies, with various cancer types reported. The long-term risk, especially in high-risk groups, is unknown. Acute Asthma Symptoms and Deteriorating Disease. Omalizumab products have not been shown to alleviate asthma exacerbations acutely. Do not use OMLYCLO to treat acute bronchospasm or status asthmaticus. Corticosteroid Reduction. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of OMLYCLO therapy for asthma or CRSwNP. Eosinophilic Conditions. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids. Fever, Arthralgia, and Rash. Stop OMLYCLO if a patient develops this constellation of signs and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy. Parasitic (Helminth) Infection. Monitor patients at high risk of geohelminth infection while on OMLYCLO therapy. Laboratory Tests. Omalizumab increases serum total IgE due to drug:IgE complexes. Do not use serum total IgE levels within one year of discontinuation to reassess dosing regimen, as they may not reflect steady-state free IgE. Potential Medication Error Related to Emergency Treatment of Anaphylaxis. OMLYCLO should not be used for the emergency treatment of allergic reactions, including anaphylaxis. Instruct patients that OMLYCLO is for maintenance use to reduce allergic reactions, including anaphylaxis, while avoiding food allergens. Most Common Adverse Reactions For more information, see Full Prescribing Information . About Celltrion Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us . and stay updated with our latest news and events on our social media: LinkedIn , Instagram , X , and Facebook . About Celltrion USA Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has nine biosimilar products approved by the U.S. FDA: INFLECTRA ® (infliximab-dyyb), TRUXIMA ® (rituximab-abbs), HERZUMA ® (trastuzumab-pkrb), VEGZELMA ® (bevacizumab-adcd), YUFLYMA ® (adalimumab-aaty), AVTOZMA ® (tocilizumab-anho), STEQEYMA ® (Ustekinumab-stba) STOBOCLO ® (denosumab-bmwo) and OSENVELT ® (denosumab-bmwo) as well as a novel biologic ZYMFENTRA ® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com , and stay updated with our latest news and events on our social media: LinkedIn . References [1] Sarbjit Singh Saini et al., CT-P39 Compared With Reference Omalizumab in Chronic Spontaneous Urticaria: Results From a Double-Blind, Randomized, Active-Controlled, Phase 3 Study. Available at: https://onlinelibrary-wiley-com.libproxy1.nus.edu.sg/doi/pdf/10.1111/all.16446?msockid=30d535870b30638b14c920090a18627c [Last accessed March 2025] [2] OMLYCLO U.S. prescribing information (2025) [3] U.S. Food and Drug Administration (FDA). Available at: https://www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars [Last accessed March 2025] SOURCE: Celltrion

Phase 3Drug ApprovalClinical Result

100 Deals associated with Omalizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D05251	Omalizumab	R03DX05	DB00043

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Food Hypersensitivity	United States	Genentech, Inc.	16 Feb 2024
Nasal Polyps	United States	Genentech, Inc.	30 Nov 2020
Rhinitis, Allergic, Seasonal	Japan	Novartis Pharmaceuticals KK	11 Dec 2019
Asthma	United States	Genentech, Inc.	20 Jun 2003
Allergic asthma	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	13 Jun 2002
Chronic rhinosinusitis with nasal polyps	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	13 Jun 2002
Chronic Urticaria	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	13 Jun 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic sinusitis	NDA/BLA	China	Beijing Novartis Pharma Co. Ltd.	19 Jul 2022
Chronic sinusitis	NDA/BLA	China	Novartis Europharm Ltd.	19 Jul 2022
Chronic Urticaria	Phase 3	Switzerland	Genentech, Inc.	01 Feb 2011
Seasonal allergic conjunctivitis	Phase 3	Germany	Novartis Pharmaceuticals Corp.	01 Feb 2006
Allergic asthma	Phase 3	-	Genentech, Inc.	01 May 2003
Allergic asthma	Phase 3	-	Novartis AG	01 May 2003
Asthma	Phase 3	-	Novartis AG	01 Oct 2002
Persistent asthma	Phase 3	-	Genentech, Inc.	01 Jul 2000
Food Hypersensitivity	Phase 3	-	Novartis AG	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01287117 \| NCT01292473 (ASTERIA I and ASTERIA II, Pubmed \| World Allergy Organ J)	Phase 3	Chronic Urticaria	-	Omalizumab 300 mg	nosfvmyjrn(anvioszidk) = kxufnwcicj ztgrtvozry (otpyuegrra )	Positive	01 Aug 2024
	Phase 3	Chronic Urticaria	-	Omalizumab 150 mg	nosfvmyjrn(anvioszidk) = vlwhtkhfas ztgrtvozry (otpyuegrra )	Positive	01 Aug 2024
NCT05813470 (Pubmed \| Front Immunol) Manual	Phase 3	Allergic asthma Add-on	256	P043 (Zerafil®)	cdwrybxdex(nckwmxvtcj) = btmlaejxbo bynwoyswsc (biktqvvlvf ) View more	Positive	29 Jul 2024
NCT05813470 (Pubmed \| Front Immunol) Manual	Phase 3	Allergic asthma Add-on	256	omalizuma	cdwrybxdex(nckwmxvtcj) = yhdlpbywux bynwoyswsc (biktqvvlvf ) View more	Positive	29 Jul 2024
AAAAI2024	Not Applicable	serum total IgE levels	-	YH35324 6 mg/kg	vflhglntxn(ckuazaaqpv) = There were no anaphylaxis after the YH35324 treatment falvsdnhpo (qgjgdhfcse ) View more	Positive	23 Feb 2024
AAAAI2024	Not Applicable	serum total IgE levels	-	Omalizumab 300 mg		Positive	23 Feb 2024
AAAAI2024	Not Applicable	Food Hypersensitivity Maintenance IgE antibody	533	Omalizumab	poihrxyxot(kmnxrgmgig) = eesuayarwf yedflvntxt (bmrjyxftvp ) View more	Positive	23 Feb 2024
NCT03881696 (OUtMATCH, FDA) Manual	Phase 3	Food Hypersensitivity	165	XOLAIR	(tizlbzovrd) = dvbajwvvap fwyxuuhpvi (vthmrtgtsj ) View more	Positive	16 Feb 2024
NCT03881696 (OUtMATCH, FDA) Manual	Phase 3	Food Hypersensitivity	165	Placebo	(tizlbzovrd) = pjrucrkrir fwyxuuhpvi (vthmrtgtsj ) View more	Positive	16 Feb 2024
EADV2023	Not Applicable	Pemphigoid, Bullous IgE levels	36	Omalizumab 300 mg	nppzmbenpy(qdzzbaetqh) = dygcowphqe sffmihfpmd (uqwxwgtciu )	Positive	11 Oct 2023
EADV2023	Not Applicable	Chronic Urticaria	93	Omalizumab	rpjrzkfrbt(wttndcegqu) = maxmlmjidd ifwxluqttk (euknstksyb )	-	11 Oct 2023
WCD2023	Not Applicable	Sunburn	100	Omalizumab	(jagusxnuck) = Periorbital edema, short term asthenia, mild local site reaction and gastrointestinal intolerance were the adverse events reported across 4% of patients cuxbndypll (hcoqgbetvx )	Positive	07 Jul 2023
WCD2023	Not Applicable	Urticaria	-	Omalizumab	prmgfekwpu(bapgpfcujb) = jiifxzwljv ddyhjmqfvw (lzgwjbmemm )	Positive	04 Jul 2023
WCD2023	Not Applicable	Chronic Urticaria	-	Omalizumab	(fcaxkbmltm) = He developed rash with burning sensation affecting the photosensitive areas of the face, extensor upper limbs, v of the neck and nape on exposure to sunlight after the 4th dose yfpiljwdln (zbgneflnug )	-	03 Jul 2023

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