Efficacy and Safety of Omalizumab in Asthmatic Patients with Allergic Bronchopulmonary Aspergillosis (ABPA): A Multicenter, Randomized, Single‑Blind, Placebo‑Controlled Clinical Study

Start Date01 Apr 2026

Sponsor / Collaborator

The First Affiliated Hospital of Ningbo University

IRCT20151123025202N52

/ RecruitingPhase 2/3IIT

Study of the effect of omalizumab on the recurrence of polyposis in patients with allergic fungal sinusitis who underwent surgery

Start Date21 Mar 2026

Sponsor / Collaborator

Hamedan University of Medical Sciences

CTIS2025-524629-42-00

/ Not yet recruitingPhase 2IIT

Omalizumab for monotherapy treatment of patients with food allergies to plant-based foods due to sensitization to LTP and profilin

Start Date02 Mar 2026

Sponsor / Collaborator-

100 Clinical Results associated with Omalizumab

100 Translational Medicine associated with Omalizumab

100 Patents (Medical) associated with Omalizumab

4,012

Literatures (Medical) associated with Omalizumab

31 Dec 2026·mAbs

Self-interaction nanoparticle spectroscopy predicts high-concentration viscosity of therapeutic IgG1 antibodies

Article

Author: Andersen, Nisana ; Luu, Steven ; Stephens, Nicole ; Mehta, Shrenik ; Bol, Karenna ; Heisler, Joel ; Swartz, Trevor ; Kovner, Daniel ; Rude, Erina ; Makowski, Emily ; Ibrahim, Julissa ; Zarzar, Jonathan ; Carter, Paul J. ; Stepurska, Kateryna ; Izadi, Saeed ; Baginski, Tomasz ; Paidi, Santosh Kumar ; O’Connor, Kelly

Predicting high-concentration viscosity of monoclonal antibodies is crucial for their development as therapeutics for subcutaneous delivery, but traditional experimental rheometry methods for assessing viscosity are low-throughput, which limits their utility. This study evaluates self-interaction nanoparticle spectroscopy (SINS) assays - specifically charge-stabilized SINS (CS-SINS) and PEG-stabilized SINS (PS-SINS) - for high-throughput viscosity prediction. We characterized 96 IgG₁ antibodies, assessing SINS against in silico descriptors and dynamic light scattering (DLS) data. CS-SINS showed strong correlation with charge, offering limited additional utility. In contrast, PS-SINS provided orthogonal information; integrating it with in silico data and DLS significantly improved random forest model accuracy for binary viscosity classification. PS-SINS measurements in multiple buffers captured complementary information, achieving comparable accuracy without DLS. Importantly, PS-SINS scores exhibited a strong logarithmic relationship with high-concentration viscosity in Fc variants of clinical antibodies (r = 0.72 and r = 0.85 for trastuzumab and omalizumab variants, respectively), suggesting a direct mechanistic link. Furthermore, PS-SINS performed reliably with one column-purified (protein A) samples, supporting its early-stage application. These findings establish PS-SINS as a high-throughput tool to accelerate the developability assessment of antibody candidates.

31 Dec 2026·ANNALS OF MEDICINE

Beyond biomarkers: the role of clinical factors associated with biologic therapy response in severe asthma

Article

Author: Lopez-Rodríguez, Raquel ; Cañas, José Antonio ; Rial, Manuel Jorge ; Mahíllo-Fernández, Ignacio

BACKGROUND:

Severe asthma carries a high burden and often requires biologic therapy targeting type 2 (T2) inflammation. However, treatment response is heterogeneous, and traditional biomarkers, such as blood eosinophils, fractional exhaled nitric oxide (FeNO), and total serum IgE, may not fully explain this variability .

OBJECTIVE:

To evaluate clinical and inflammatory characteristics associated with response to biologic therapies in a real-world cohort of severe asthma patients.

METHODS:

A single-center, ambispective observational study was conducted in the Allergology Department of A Coruña, Spain. Sixty-seven patients with severe uncontrolled asthma and treated with omalizumab, mepolizumab, benralizumab, dupilumab, or tezepelumab, were included. Patients were followed for ≥12 months. Clinical variables and inflammatory biomarkers were assessed at baseline, 4-6 months, and 12 months. Comparisons between biologic subgroups and logistic regression analyses were performed to identify factors associated with response.

RESULTS:

Female sex, nasal polyposis, elevated blood eosinophils, and frequent exacerbations were associated with better response to biologics. Clinical factors such as nasal polyposis and aspirin-exacerbated respiratory disease (AERD) showed a stronger association with treatment response than standard biomarkers (FeNO, blood eosinophils). The mean diagnostic delay was 12.1 years, suggesting a potential influence on therapeutic results.

CONCLUSION:

Beyond traditional biomarkers, clinical factors particulary nasal polyposis and AERD may play a key role in understanding response patterns to biologics. Incorporating these variables into clinical assessment may help support a more personalized management approach in severe asthma.

01 Dec 2026·CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL

Monoclonal Antibodies in Pediatric Atopic Dermatitis; Efficacy and Safety

Review

Author: Aminzade, Zahra ; Noqani, Hesam ; Masoumi, Niloofar ; Soltani, Afsaneh ; Monadi, Taha ; Enderami, Seyed Ehsan

Background:

Atopic dermatitis (AD), which causes eczema, dryness, and itching, is one of the most prevalent skin diseases in children. Along with topical corticosteroids and the liberal application of emollients, monoclonal antibodies have recently been used for systemic treatment in moderate to severe cases. This study aims to review the current literature on the application of monoclonal antibodies (mAbs) in treating children with AD.

Methods:

To conduct a narrative review of the literature, we searched for the keywords (monoclonal antibodies OR biologics) AND (pediatric OR children) AND (atopic dermatitis OR eczema) in PubMed and Google Scholar.

Results:

The pathophysiology of atopic dermatitis still requires better understanding (or, remains incompletely understood). The most well-known factors contributing to the pathophysiology of AD include filaggrin gene mutations and abnormalities in Th1 and Th2 cell regulation. Cytokines, such as IL-4, IL-13, IL-17, IL-22, IL-31, and IL-33, are crucial mediators that lead to IgE antibody production and result in skin barrier degradation. Monoclonal antibodies have several advantages over other systemic therapies. Among these, dupilumab, tralokinumab, omalizumab, nemolizumab, lebrikizumab, and benralizumab have shown favorable results.

Conclusion:

A systemic immunomodulatory medication (monoclonal antibodies) is frequently required for moderate to severe AD as supplementary treatment. Dupilumab has received FDA approval for pediatric AD. Further clinical trials are needed for other mAbs before they are used in children.

358

News (Medical) associated with Omalizumab

25 Aug 2026

·www.celltrion.com

Celltrion Expands Omlyclo® Portfolio in Europe with Launch of 300 mg Strength

• Omlyclo® (omalizumab) 300 mg launched in key European markets including Germany, the UK and France, with rollout to expand across Europe by year-end • Omlyclo® 300 mg strength available in both pre-filled syringe (PFS) and autoinjector (AI) presentations • Multiple dose strengths and device options broaden treatment flexibility for healthcare professionals INCHEON, SOUTH KOREA – Celltrion (KRX: 068270) today announced the launch of the 300 mg strength of Omlyclo® (omalizumab), a treatment for chronic spontaneous urticaria and allergic asthma, in Europe.1 With the addition of the 300 mg strength, Celltrion has expanded its Omlyclo® portfolio to include multiple dose strengths and device presentations for patients, healthcare professionals and healthcare institutions. Following the European launch of Omlyclo® 75 mg and 150 mg late last year, Celltrion began rolling out the 300 mg strength in key markets including Germany, the UK and France in the middle of this year. Celltrion is gradually expanding supply to other European countries and plans to complete the rollout across Europe by the end of the year. Celltrion is offering Omlyclo® 300 mg in both pre-filled syringe (PFS) and autoinjector (AI) presentations, allowing patients and healthcare professionals a choice of device depending on the treatment setting and individual patient needs. This comprehensive portfolio provides greater flexibility in dose strengths and device options. Celltrion will continue to provide product information to healthcare professionals and institutions as part of its commercial activities across Europe. “The launch of Omlyclo® 300 mg allows us to offer patients and healthcare professionals more convenient and flexible treatment options,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. “Building on the first omalizumab biosimilar1 advantage and broad product portfolio, we will continue to strengthen our competitive position in key tenders and work to sustain Omlyclo®’s strong growth momentum across Europe throughout the second half.” About OMLYCLO® (CT-P39, biosimilar omalizumab1) Omlyclo® is the first European Commission (EC) approved anti-IgE antibody biosimilar referencing Xolair® (omalizumab). In the EU, Omlyclo® is indicated for the treatment of patients with allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP). About Celltrion, Inc. 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, haematology, 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. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", “anticipates”, the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. Trademark Xolair® is a registered trademark of Novartis AG. Reference 1 European Medicines Agency. Summary of Product Characteristics (SmPC), Omlyclo. [Last Accessed August 2026]

Drug Approval

28 Jul 2026

·www.fiercebiotech.com

GSK unveils 3-year cost-saving plan to fund late-stage R&D, move research HQ to AZ's backyard

GSK has unveiled an ambitious three-year plan to divert resources to its late-stage R&D programs and shift its research headquarters—but CEO Luke Miels is being tight-lipped about the extent of any job losses. The strategy will aim to generate annual savings of 1.9 billion pounds ($2.5 billion) by 2029, set against a one-time cost of 2.4 billion pounds ($3.2 billion). About 45% of the required savings will come from “better procurement,” Miels told journalists on a second-quarter earnings call this morning. This would focus on “areas that are not on the frontline of our labs,” such as “all sorts of systems and consultants and various other partners [and] support functions.” Another 40% of the savings will come from the “evolving portfolio,” namely “reallocating resources from our mature portfolio of mature products to specialty, novel products.” However, Miels wasn’t willing to put a figure on the number of job losses that this restructuring could entail. “We're not going to give a number today in terms of people changes, and that's because I want the chance, and I want my team to have the chance, to discuss this with our people first,” the CEO said on the call. “I think the key theme, as I've said, is it's about reallocation into new medicines,” he added. “But we will update you in time once we've implemented those plans.” GSK put the strategy in the context of the looming patent expiry for its dolutegravir range of HIV meds, which begins in 2028. Those treatments, which include Dovato and Tivicay, brought in a combined total of 1.4 billion pounds ($1.9 billion) in the second quarter. Most of the savings will be reinvested into the late-stage pipeline, Miels explained. This includes antibody-drug conjugates like the Hansoh Pharmaceutical-partnered ris-rez—which scored a phase 3 win today —as well as the ALK inhibitor neladalkib for colon cancer and the FGF21 analog efimosfermin alfa for fatty liver disease. Part of the savings will also be used to move GSK’s research headquarters from the English town of Stevenage, about 30 miles away, to Cambridge. As well as being an academic center and one point of England’s life sciences “golden triangle,” Cambridge is already home to the other U.K.-based Big Pharma, AstraZeneca. In fact, GSK’s new R&D site will be built on the Cambridge Biomedical Campus, which already houses AstraZeneca’s Discovery Center. “This is a 400-million-pound investment—on top of the 1.5 [billion] we spend each year in the U.K.—to further integrate GSK into Cambridge's world-class ecosystem of biomedical research, patient care and academia,” Miels said on the call. GSK’s headquarters in London will be unaffected by the move, the company pointed out, although Chief Scientific Officer Tony Wood will be based at the Cambridge site. Miels told journalists that moving R&D “up the road” to Cambridge was an example of the company “putting our money where our mouth is” and proving its commitment to the U.K. life sciences industry. The CEO, who stepped up to the top job at the start of the year, has already made his mark on GSK with an M&A strategy focused of trying to outdo established blockbusters. This approach has encompassed the $2.2 billion buyout of Rapt Therapeutics for a food allergy reaction drug that targets the same epitope as Novartis and Roche’s Xolair, as well as paying $950 million cash for Canadian biotech 35Pharma and its potential rival to Merck & Co.’s pulmonary hypertension mainstay Winrevair. Miels said on this morning’s call that he and his team have undertaken a “full portfolio review” over the last six months “looking really across the board for opportunities to accelerate and broaden our development.” “This review involving the team identified opportunities to accelerate development across 18 indications and 25 studies for seven key assets in oncology, respiratory, hepatology and vaccines,” he explained. One drug that was recently scrapped was camlipixant. Once hailed as a potential blockbuster, GSK ended development in chronic cough earlier this month due to a mixed phase 3 readout. GSK revealed this morning that the decision came with a 1.3 billion pound ($1.7 billion) financial hit for the company, which it blamed for a 75% drop in operating profits for the quarter.

23 Jul 2026

·www.fiercepharma.com

Roche defends 6B franc Vabysmo peak sales target despite another quarterly miss

Roche’s Vabysmo disappointed investors again. In the second quarter, the eye drug’s sales of about 1.04 billion Swiss francs ($1.27 billion) missed analysts’ expectations by 7.1%. Speaking on an investor call Thursday, Roche Pharmaceuticals CEO Teresa Graham assured analysts that the U.S. branded market has stabilized after a period of contraction, though the explosive growth that Vabysmo enjoyed early in its launch is likely behind it. “We are seeing that 2% to 3% growth in the overall retinal market,” Graham said. “We do expect that this is going to be the new normal, and we don’t expect a rebound to previous levels.” Vabysmo’s Q2 sales figure represents a 1% decline year over year. But Roche expects the drug’s revenue in the U.S. to grow by a low- to mid-single-digit for the full year, and its global sales to increase by low double-digits, according to Graham. “We continue to consider consensus peak sales expectations for Vabysmo of around 6 billion [Swiss francs], it’s very reasonable, and we’re confident that we’re on track to achieve this number,” Graham said. Initially approved by the FDA in early 2022, Vabysmo started to show signs of a deceleration toward the latter half of 2025, partly thanks to the closure of certain copay assistance programs. The first biosimilar to a key rival drug, Regeneron’s Eylea, was also launched toward the end of 2024. Graham stressed that the Eylea biosimilar didn’t impact Vabysmo. In the ophthalmology space, biosimilars tend to only affect the originators that they reference, without much bleed-over to other products, she observed. Citing physician surveys, Graham noted that Vabysmo is a physicians’ favorite and therefore expects it to “take a disproportionate share” of the overall branded market growth. Beyond Vabysmo, immunology drug Xolair was cited as the biggest growth driver in Roche’s pharma business. In Q2, Xolair’s sales jumped 21% year over year, reaching 965 million Swiss francs ($1.18 billion) while crushing Wall Street consensus by 10.5%. A slowdown could be around the corner. Roche currently projects a September entry for the first Xolair biosimilar in the U.S. But the Swiss pharma is still guiding to roughly 20% growth for the entire year of 2026. Elsewhere in the immunology department, Graham expressed excitement over the potential of Gazyva—a CD20 antibody initially utilized as a cancer therapy—in autoimmune indications. Despite continued competitive pressure in the chronic lymphocytic leukemia field pulling back Gazyva to flat sales year over year, Graham cited “first early indications” of its launch progress in lupus nephritis. In the U.S., Germany and the U.K., where Gazyva is available in lupus, Roche recorded Gazyva quarterly sales growth with patient share approaching 10%, according to Graham. Roche expects FDA decisions on three Gazyva label expansion opportunities this year, including idiopathic nephrotic syndrome on Sept. 27, membranous nephropathy on Nov. 15 and systemic lupus erythematosus (SLE) on Dec. 4. With all of Gazyva’s immunology indications filed with the FDA, Roche expects that they will fuel its 2 billion Swiss francs peak sales ambition. In Q2, Gazyva sales of 242 million Swiss francs missed consensus by 8.4%. In lupus, Roche has stopped development of a CD19xCD3 bispecific after evaluating the drug in a phase 1 SLE trial. Simultaneously, the company has moved Lunsumio, a CD20xCD3 T-cell engager approved for blood cancer treatment, into phase 2 testing for SLE. “SLE is a very heterogeneous and complex disease,” Graham explained on the Q2 call. “While we saw great results with Gazyva, we do believe there’s an opportunity for more benefit for patients, and based on Lunsumio’s mechanism of action and its safety profile, we think it could actually be a really great option for patients with SLE.” Overall, Roche’s 12.16 billion Swiss francs in pharmaceutical sales came 1.3% ahead of consensus, boosting group-wide sales to 15.5 billion Swiss francs during Q2.

Drug ApprovalPhase 2Phase 1BiosimilarImmunotherapy

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.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Lung Diseases, Obstructive	NDA/BLA	Canada	Advanz Pharma Corp.	01 Apr 2026
Chronic sinusitis	NDA/BLA	China	Novartis Europharm Ltd.	19 Jul 2022
Chronic sinusitis	NDA/BLA	China	Beijing Novartis Pharma Co., Ltd.	19 Jul 2022
Peanut Hypersensitivity	Phase 3	United States	Novartis Pharmaceuticals Corp.	22 Jul 2019
Peanut Hypersensitivity	Phase 3	United States	Genentech, Inc.	22 Jul 2019
Bronchitis	Phase 3	Canada	Novartis AG	01 Mar 2014
Angioedema	Phase 3	Germany	Novartis Pharmaceuticals Corp.	23 Jan 2013
Severe persistent asthma	Phase 3	France	Novartis Pharmaceuticals Corp.	01 Sep 2009
Seasonal allergic conjunctivitis	Phase 3	Germany	Novartis Pharmaceuticals Corp.	01 Feb 2006
Persistent asthma	Phase 3	-	Genentech, Inc.	01 Jul 2000

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03679676 (COMBINE, CTgov)	Phase 2	Peanut Hypersensitivity	130	Placebo+Dupilumab+Omalizumab (Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy)	vrbxvpafix = oabzzzrbjp ohpycuhhrv (bnslsxexrx, ahfzsfhexm - jthfptvuar) View more	-	29 May 2026
NCT03679676 (COMBINE, CTgov)	Phase 2	Peanut Hypersensitivity	130	Dupilumab+Omalizumab (Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy)	vrbxvpafix = yocgwcpkox ohpycuhhrv (bnslsxexrx, wmqvdgymkh - lwnkvlmhno) View more	-	29 May 2026
ATS2026	Not Applicable	Severe asthma	13	Omalizumab 300 mg	egjixjeeth(dlhccwzriy) = Both MMRC and ACQ-5 scores showed symptomatic improvement qkdvhdnqlh (uxskbxegbm ) View more	Positive	15 May 2026
ATS2026	Not Applicable	Severe asthma	22	Xolair 600 mg	zenyefifdl(kojqrqubxv) = mlptlyowdg bnerlqaijm (zmkhaixyrg, 3.34) View more	Positive	15 May 2026
ATS2026	Not Applicable	Severe asthma	465	Biologic therapies	zrnsqebfwf(fsldmbctiu) = fmkbnvzjuv fxizjegdgk (ozeqinucrj, 29.5 - 38.3) View more	Positive	15 May 2026
ATS2026	Not Applicable	Food Hypersensitivity \| Vernal Keratoconjunctivitis \| Chronic Urticaria ... View more	88	Omalizumab	vdyrqprwaj(cmbvqrutec) = ovpcnpbmsd wwkasduyqt (luancbyvua ) View more	Positive	15 May 2026
ATS2026	Not Applicable		88	Dupilumab	mqgvsbxuag(tspvaexehh) = bicitvbutj sjprpdmfoj (yzfrrgzufs ) View more	Positive	15 May 2026
NCT01287117 (ASTERIA I, Pubmed \| J Allergy Clin Immunol Glob)	Phase 3	Chronic Urticaria	-	Omalizumab	nlytyycsgn(tlognljmme) = kmdhjuyhkm rnwnxpufgi (xvferpzacc, -6.9 to -4.0) View more	Positive	01 May 2026
	Phase 3	Chronic Urticaria	-	Dupilumab	nlytyycsgn(tlognljmme) = tukdxvkmzj rnwnxpufgi (xvferpzacc, -4.6 to -0.1) View more	Positive	01 May 2026
AAD2026	Not Applicable	Chronic Urticaria \| Dermatitis, Atopic	128	Omalizumab	jkfqxrtbka(gbyxihdhut) = gnqvqszgig hwmpseyctb (zrreyfkfvn ) View more	Positive	27 Mar 2026
AAD2026	Not Applicable	Chronic Urticaria	48	Omalizumab (Discontinuation for more than five half-lives)	igettljhyd(xgihmiiymz) = gyofsnwmqw opicemrawv (befhovostv, 23.4 - 83.3)	Positive	27 Mar 2026
AAD2026	Not Applicable	Chronic Urticaria	48	Omalizumab (No significant breaks in treatment)	igettljhyd(xgihmiiymz) = qgzkguzlqt opicemrawv (befhovostv, 29.5 - 58.8)	Positive	27 Mar 2026
AAD2026	Not Applicable	Alopecia Areata	13	Baricitinib or Upadacitinib (Atopic Background + Alopecia Areata)	wdegtbcogi(xfbdemahzl) = dgzfmyvttz byoyjzqlwv (lffospsvoi ) View more	Positive	27 Mar 2026
AAAAI2026	Not Applicable	Chronic Urticaria	165	Omalizumab	lezuxmtkge(zmyyeunsxu) = biyysgydrg rkbtedorrv (dpgiddeymc ) View more	Positive	27 Feb 2026

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