A Randomised Double-blind Placebo-controlled Phase III Field Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Chinese Participants Aged 12-65 Years With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma

A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.

Start Date01 Sep 2025

Sponsor / Collaborator

ALK-Abello A/S

NCT07013123

/ Not yet recruitingPhase 3IIT

Potency of HDM Sublingual AIT Tablets in Assuring the Persistency of Asthma Control in HDM Allergic Patients With Severe Asthma, Treated With Tezepelumab

The aim of this drug trial is to evaluate the annualized asthma exacerbation rate under treatment with Acarizax versus placebo. The trial is intended for adults aged 18 to 65 with severe uncontrolled asthma and a house dust mite allergy. The study will involve 32 patients (up to 38 with study dropouts) recruited from French hospitals, in pulmonology and allergology departments.
Initially, all participants will receive Tezepelumab for 3 to 6 months (M-3/-6) to control asthma symptoms. If asthma is not controlled after 6 months, the participant will be excluded from the study and will continue on standard treatment.
Once their asthma is controlled, patients will be randomized in two groups:
* Group A: Tezepelumab + Acarizax®
* Group B: Tezepelumab + Placebo After 6 months of treatment with Acarizax or placebo (M6), Tezepelumab will be stopped and participants will continue treatment with Acarizax or placebo alone for a further 12 months (up to M18/End of search).
The study will include 5 visits during regular consultations (M-3/M-6, D0, M6, M12 and M18), as well as 2 follow-up telephone calls M3 and M9).

Start Date15 Jul 2025

Sponsor / Collaborator

University Hospital of Montpellier

[+4]

TCTR20250107010

/ Not yet recruitingPhase 2

Efficacy of Alternate-Day Dosing House dust mite Sublingual Immunotherapy Compared to Daily Dosing in Allergic Rhinitis Patients

Start Date13 Jan 2025

Sponsor / Collaborator

Abbott Laboratories (Pakistan) Ltd.

100 Clinical Results associated with House dust mites allergenics extract(ALK-Abello A/S)

100 Translational Medicine associated with House dust mites allergenics extract(ALK-Abello A/S)

100 Patents (Medical) associated with House dust mites allergenics extract(ALK-Abello A/S)

Literatures (Medical) associated with House dust mites allergenics extract(ALK-Abello A/S)

01 Jan 2025·CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL

The Efficacy of Sublingual Immunotherapy in Patients With House Dust Mite Allergic Asthma—A Systematic Review

Review

Author: Rysgaard, Anne Sofie ; Ulrik, Charlotte Suppli ; Rovsing, Alma Holm ; Hegner, Pernille Vigand

Background and objective:

Patients' with allergy-driven symptoms of asthma may not achieve adequate symptom control on inhaled pharmacotherapy alone, therefore, allergen-immunotherapy may be a relevant add-on treatment. The aim of the present review is to provide an update on the current evidence of efficacy of sublingual immunotherapy (SLIT) for the treatment of house dust mite (HDM)-driven allergic asthma.

Methods:

Systematic review performed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses-Statement (PRISMA) guidelines.

Results:

A total of 15 studies fulfilled the predefined criteria and were included, all assessing the efficacy of the HDM SLIT-tablet in patients with HDM-driven asthma. Of the 15 studies, 13 reported significant improvements in asthma symptoms, while 2 found no changes. Ten studies assessed lung function (that is FEV₁, PEF and FEV₁/FVC) with 6 reporting significant improvements and 4 reporting no significant changes. Eight of the 15 studies measured the impact on prescribed asthma controller medication, of which 6 studies reported a significant reduction in daily mean dose of inhaled corticosteroid (ICS) (up to a reduction of 300+ µg/day), 1 found a significant reduction in medication use (according to the GINA steps), while 1 showed no significant reduction.

Conclusion:

In the majority of studies, HDM SLIT was associated with improvements in asthma symptom control and a reduction in daily dose of ICS. On the other hand, the findings addressing treatment induced changes in lung function are conflicting.

01 Jan 2025·PEDIATRIC PULMONOLOGY

Effect and mechanism of allergen‐specific immunotherapy on small airway dysfunction in children with asthma

Article

Author: Lin, Jie ; Dong, Wenfang ; Yin, Yong ; Wu, Jinhong ; Hong, Li ; Zhong, Wenwei ; Zhang, Lei ; Ying, Xiaolan ; Yang, Lin

Abstract:

Background:

The purpose of this study was to investigate the effectiveness of allergen‐specific immunotherapy (AIT) on small airway dysfunction (SAD) and the underlying mechanism with a special focus on basophils.

Methods:

Sixty‐five children with mild to moderate asthma who were under regular inhaled corticosteroid (ICS) treatment for more than 1 year but whose FEF75 remained below 65% of the predicted value and had positive results for serum Der p or Der f were enrolled. Children with asthma underwent house dust mite (HDM) subcutaneous immunotherapy (SCIT) treatment for 1 year. Clinical symptoms and lung function were evaluated every 3 months during HDM SCIT treatment. Basophil activation test (BAT) was carried out before and after HDM SCIT treatment. RNA sequencing was performed in isolated basophils from peripheral blood after 6 months of HDM SCIT treatment, followed by GO term and KEGG pathway enrichment analysis between patients with and without HDM SCIT treatment.

Results:

HDM AIT treatment ameliorated clinical symptoms while concurrently improved lung function parameters, such as FEV1/FVC, FEF75, FEF50 and MMEF (p < .05). It is worth noting that FEF75 values showed a highly significant, gradual and persistent increase (from 49.55 ± 1.27% at baseline to 71.89 ± 2.64% after 1 year of therapy) and 22 of 35 patients no longer had SAD after 1 year of treatment. BAT results revealed that AIT treatment significantly reduced basophil activity to the inhalant allergen mixtures containing HDM in vitro challenge from baseline. GO term and KEGG pathway enrichment analysis of basophils revealed that downregulated genes were mainly involved in immune cell activation, antigen presentation, and Th2 cell differentiation.

Conclusions:

Our study demonstrated that HDM AIT not only improved SAD related lung function parameters, but also reduced basophil activity. RNA sequencing revealed the inhibition of phagocytosis and the phagosome pathway in basophils which may affect the polarization of Th2 cell differentiation after HDM AIT.

01 Jan 2025·Lancet Regional Health-Europe

Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trial

Article

Author: Gagnon, Remi ; Emeryk, Andrzej ; Caimmi, Davide ; Schuster, Antje ; Pfaar, Oliver ; Nolte, Hendrik ; Foss-Skiftesvik, Majken Hougaard ; Østerdal, Anne Sofie ; Mikler, Jan ; Novakova, Silviya

Background:

Allergic rhinitis/rhinoconjunctivitis (AR/C) induced by house dust mites (HDM) often begins in childhood and negatively impacts a child's quality of life. The daily burden can be further compounded by comorbid asthma. Allergen immunotherapy is the only available treatment targeting the underlying cause of allergic disease. Efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT)-tablet has been demonstrated in adults and adolescents with HDM AR/C with or without asthma, but data are lacking for younger children.

Methods:

Phase III, randomised, double-blind, placebo-controlled trial in younger children (5-11 years) with HDM AR/C with or without asthma. Eligible subjects were randomised 1:1 to SQ HDM SLIT-tablet or placebo for ∼1 year and had free access to AR/C symptom-relieving medications. The primary outcome was the total combined rhinitis score (TCRS) during the final 8 weeks of the treatment period (∼1 year). Secondary outcomes included the rhinitis daily symptom score (DSS) and medication score (DMS), the rhinoconjunctivitis total combined score (TCS), and the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) score. Efficacy analyses were conducted on the full analysis set (observed cases). Asthma-related outcomes were also explored. The trial was registered on ClinicalTrials.gov: NCT04145219 and EudraCT: 2019-000560-22.

Findings:

A total of 1460 subjects were randomised to SQ HDM SLIT-tablet (n = 729) or placebo (n = 731). The primary outcome, TCRS, was statistically significantly different for SQ HDM SLIT-tablet (n = 693) versus placebo (n = 706), with an absolute difference of 1.0 (95% CI: 0.5, 1.4; p < 0.0001) corresponding to a relative reduction of 22.0% (95% CI: 12.0, 31.1). Key secondary outcomes (DSS, DMS, TCS, PRQLQ) showed statistically significant reductions in symptoms and medication use, and improved disease-related quality of life for SQ HDM SLIT-tablet versus placebo. Improvements in asthma symptoms and reduced asthma medication use indicated an additional effect of SQ HDM-SLIT tablet versus placebo. The SQ HDM SLIT-tablet showed a higher event rate for treatment-related adverse events (AEs) than placebo. Most events were of mild or moderate severity and few subjects discontinued due to AEs (2.5%).

Interpretation:

The trial confirmed the efficacy and safety of the SQ HDM SLIT-tablet for treating HDM AR/C in younger children (5-11 years) with or without asthma. The safety profile supports daily self-administration of the SQ HDM SLIT-tablet in children.

Funding:

ALK-Abellό, Hørsholm, Denmark.

News (Medical) associated with House dust mites allergenics extract(ALK-Abello A/S)

17 Sep 2025

·ir.alk.net

ALK and GenSci partner to expand the AIT market in China

Inside Information GenSci is granted exclusive rights to ALK’s house dust mite AIT products in China. ALK will be eligible for upfront and milestone payments of up to DKK 1.3 billion in addition to income from supplying GenSci with products. Partnership also aims to accelerate the introduction of a broader portfolio in China. Partnership is projected to become accretive to earnings margin in the medium term but is not expected to materially impact ALK’s revenue and earnings (EBIT) in 2025. ALK (ALKB:DC / OMX: ALK B) today announced a partnership agreement with China-based Changchun GeneScience Pharmaceutical Co. Ltd. (“GenSci”) to develop and commercialise ALK’s house dust mite (“HDM”) allergy immunotherapy (AIT) products in Mainland China. Under the agreement, GenSci is granted exclusive rights to ALK’s injectable Alutard® HDM product, skin prick tests, and the ACARIZAX® SLIT-tablet in Mainland China until the end of 2039. GenSci will incur all costs related to marketing and sales and the majority of costs for the remaining clinical development and registration of the products, while ALK will be responsible for production and supply. GenSci will take over sales and marketing activities of Alutard® immediately and add ACARIZAX® to the portfolio upon regulatory approval of the tablet. ALK and GenSci will co-operate to finalise the ongoing clinical development to facilitate the approval of ACARIZAX® for adults and children. GenSci is a leading biopharmaceutical company in China with extensive experience in the paediatric field, strong presence at Chinese hospitals, and ambitions to expand in respiratory diseases. The company employs 9,000 people, including around 4,000 in the sales force and 1,500 in R&D. Commenting on the partnership, ALK’s CEO Peter Halling says: “We’re very excited about the prospects of speeding up market uptake of ALK’s evidence-based AIT products in China. We partner for strength, and GenSci has a well-proven track record of navigating this important market and intends to deploy significant resources, including a sizeable sales force, to succeed with our AIT products. We see a strong strategic fit and look forward to co-operating with GenSci to benefit even more patients and healthcare professionals.“ World-wide, China is the country with the highest number of people suffering from HDM allergy, however, the market is significantly underpenetrated with less than 1 million people estimated to undergo treatment with AIT products, primarily drop-based products. ALK is currently number two in the market with its Alutard® products. To unlock the potential and become AIT market leader, GenSci plans to allocate a significant sales force to promote ALK’s products and conduct a wide range of market building activities spanning education of healthcare professionals, collaborations with hospitals, allergy centres, online pharmacies, and telemedicine service providers, as well as campaigns to raise awareness of allergy and AIT treatment. GenSci is expected to take over the majority of ALK’s organisation in China, whereas ALK will maintain a small local organisation to support the partnership. In addition, ALK and GenSci plan to explore collaboration on innovation for other allergic diseases, with GenSci focusing on the Chinese market and ALK targeting markets outside China, leveraging both parties’ technology and commercial platforms. The parties have agreed on a reciprocal right of first negotiation for related R&D projects, which could further support ALK’s strategic ambitions of building additional revenue streams through innovation and partnerships. Terms and financial implications The partnership is not expected to materially impact ALK’s revenue and earnings (EBIT) in 2025 as savings are expected to offset one-off costs associated with the transition. The partnership is projected to become accretive to ALK’s earnings margin in the medium term, largely driven by savings on ALK’s capacity costs, clinical expenses, and market building activities in China. These savings, combined with income from upfront and milestone payments as well as product supply, allow ALK to reallocate funds to strategic projects with high-growth potential, including R&D, business development, and market expansion. ALK’s long-term financial ambitions remain unchanged. Under the terms of the partnership, effective 1 October 2025, ALK will supply Alutard® and ACARIZAX® products to GenSci at agreed transfer prices reflecting a profit on cost of manufacturing. ALK will receive an upfront payment of DKK ~245 million from GenSci and is further eligible for DKK ~300 million in milestone payments related to regulatory progress of ACARIZAX® for use in adults and children, expected during 2028-30. Additionally, ALK may receive commercial milestone payments of up to DKK ~780 million, subject to future in-market sales in Mainland China. All upfront and milestone payments will be recognised as revenue over the partnership's expected duration. During a short-term transition period, ALK will continue to recognise sales from Alutard® based on the current import and distribution setup and will pay GenSci a service fee for handling the sales and marketing activities. ALK’s tablet for HDM allergy is marketed as ACARIZAX® in Europe and international markets, ODACTRA® in the USA, MITICURE™ in Japan, and Sensimune™ in India. The tablet is approved for all age groups in most markets. ALK-Abelló A/S For further information please contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Maiken Riise Andersen, tel. +45 5054 1434 This announcement contains inside information. This is information that ALK-Abelló A/S is obliged to make public pursuant to the EU Market Abuse Regulation. About ALKALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. ALK manufactures and markets allergy immunotherapy (‘AIT’) treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net. About Changchun GeneScience Pharmaceutical Co., Ltd. (“GenSci”)GenSci is a leading biopharmaceutical company in China, specialising in pediatric and women's health. Additionally, GenSci is active in four other therapeutic areas: Oncology, Endocrinology, Immunology/Respiratory, and Metabolic. The company has over 9,000 employees, and integrates research, development, production, and marketing of innovative therapies in its value chain. Established in 1997, the company is a subsidiary of Changchun High-Tech Industries (Group) and is headquartered in Changchun, China. Find more information at www.genscigroup.com/en. Attachment Company release_15_25UK_170925_Partnership in China

License out/inDrug ApprovalImmunotherapy

21 Jul 2025

·ir.alk.net

ALK’s tree pollen tablet (ITULAZAX®) now recommended by NICE for use in the UK health system

ALK (ALKB:DC / OMX: ALK B) today announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of the company’s tree pollen tablet ITULAZAX® for the treatment in adults. The recommendation allows for patients to gain access to ITULAZAX® through the National Health Service (NHS) systems in England, Wales, and Northern Ireland by making it eligible for general reimbursement. The recommendation of ITULAZAX® is another significant milestone for ALK, marking the second NICE approval of ALK’s sublingual allergy immunotherapy (AIT) products received in 2025. Being the first-ever of their kinds to become widely accessible through the National Health Service (NHS) systems, ACARIZAX® (final approval obtained in March 2025) and ITULAZAX® are now available treatment options to address the significant underutilisation of AIT in the UK compared to other European countries. ALK’s Executive Vice President of Commercial Operations, Søren Niegel, says: “Today’s approval emphasises a remarkable achievement by ALK with now two of our sublingual allergy immunotherapy tablets being recommended by NICE within less than six months. We appreciate the endorsement from a highly respected institute like NICE which improves the treatment accessibility for patients impacted by allergy”. Scientists warn that this year's tree pollen season has started early due to warm weather, leading to higher pollen counts. This is bad news for the approximately 16 million people who are affected by hay fever in the UK, and while many manage symptoms with over-the-counter medicines, the consequences can be more challenging for the 4 million people with moderate to severe tree pollen hay fever. NICE conducts reviews to assess the clinical benefits and cost-effectiveness of healthcare interventions, treatments, and technologies. The institute published a Final Draft Guidance on 21 July 2025, appraising the clinical benefits and cost-effectiveness of ITULAZAX® in the treatment of uncontrolled tree pollen allergy. NICE is expected to publish a Final Guidance in August, after which the NHS systems in England, Wales and Northern Ireland are required to implement ITULAZAX® in the treatment practices. Following the approved applications of ACARIZAX® and ITULAZAX® for adults and adolescents, submissions will also be made to extend the approvals to include children as well as for the grass tablet GRAZAX®. ALK’s current business in the UK mainly focuses on anaphylaxis (treatment of severe allergic reactions) with the adrenaline pen Jext® on the market and the recently approved nasal spray EURneffy® due for launch later this year. AIT tablet sales are currently modest, but ALK expects the combination of its anaphylaxis treatments and the tablets to create long-term synergies in parallel with an expanded infrastructure and as more patients become aware of these treatment options. The NICE approval does not affect ALK’s financial guidance for 2025. ALK-Abelló A/S For further information please contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Maiken Riise Andersen, tel. +45 5054 1434 About ALKALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net. Attachment InvestorNews_21July25_ITULAZAX recommended by NICE

ImmunotherapyDrug Approval

06 May 2025

·ir.alk.net

Three-month interim report (Q1) 2025 (unaudited)

ALK delivers 12% organic revenue growth with operating profit up 50% in Q1 Q1 results were strong as expected. Revenue increased on double-digit sales growth in all sales regions, including 22% growth in tablet sales. The operating profit margin of 31% partly reflected seasonality in ALK’s earnings. Free cash flow almost tripled. Outlook remains unchanged. Performance highlights Comparative figures for Q1 2024 are shown in brackets. Growth rates are stated in local currencies, unless otherwise indicated. Total revenue increased by 12% to DKK 1,522 million (1,351). Europe and International markets delivered growth rates of 10% and 24% respectively. Revenue in North America bounced back with growth of 14%. Global tablet sales grew by 22% to DKK 857 million (706) on double-digit growth in all sales regions. European tablet sales grew by 17%, largely due to increase in new patients, while the positive growth impact of pricing decreased as anticipated compared to last year. Global SCIT and SLIT drops sales were unchanged at DKK 500 million (500), while sales of Other products and services was up 11% to DKK 165 million (145). Operating profit (EBIT) increased by 50% to DKK 469 million (316), driven by sales growth, improved gross margin, and cost savings after last year’s optimisation initiatives. The capacity cost-to-revenue ratio was down to 36% (42%). The EBIT margin of 31% (23%) partly reflected that Q1 typically is ALK’s most profitable quarter. Free cash flow almost tripled to DKK 330 million (111) mainly driven by increased earnings. CAPEX was unchanged at DKK 57 million (59). Financial highlights Allergy+ strategy highlights The launch of the house dust mite tablet for children positively impacted sales growth in Q1, and initial market response exceeded expectations. The tablet is currently available for young children in 12 countries. The tree tablet ITULAZAX® has recently been approved in Europe for treatment of young children and adolescents aged five to 17. Efforts to secure market access for the neffy®adrenaline nasal spray is progressing well, and ALK expects the first launches in Europe to start in Q3 2025. Initial market feedback has been encouraging. ALK has entered into a four-year agreement with US-based ARS Pharma to co-promote the neffy® adrenaline (epinephrine) nasal spray in the USA. The clinical phase 2 of the peanut allergy tablet is on track and patient recruitment continues. 2025 full-year outlook The full-year outlook remains unchanged, demonstrating a continuous, robust improvement in profitability: Revenue is still expected to grow by 9-13% driven by growth across all sales regions and product groups. Growth will predominantly be attributable to higher volumes, as ALK expects to treat more patients with its allergy immunotherapy (AIT) and anaphylaxis products. The EBIT margin is still expected to improve by 5 percentage points to around 25%, driven by revenue growth, improving gross margin, and optimisation efforts. Commenting on the Q1 results, CEO Peter Halling said: “ALK is off to a very good start in 2025, with sustained revenue growth, a significant increase in operating profit, and steady progress on our strategic agenda. The initial market response to the launch of our house dust mite tablet, ACARIZAX®, for use in young children has been encouraging, and we are excitedly preparing to launch neffy®, the new adrenaline nasal spray. Despite the turmoil in the markets from trade wars and tariffs, we remain optimistic about the year ahead, anticipating only a modest impact from tariffs considering our current business footprint." Hørsholm, 6 May 2025 ALK-Abelló A/S For further information, contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525Media: Maiken Riise Andersen, tel. +45 5054 1434 ALK is hosting a conference call for analysts and investors at 11.00 a.m. (CEST) on 6 May 2025 at which Management will review the financial results and the outlook. The conference call will be audio cast on https://ir.alk.net where the relevant presentation will be available shortly before the call begins. To register for the conference call, please use this link and follow the registration instructions. You will receive an email from diamondpass@choruscall.com with dial-in details, including a passcode and a pin code. Please make sure to whitelist diamondpass@choruscall.com and/or check your spam filter. We advise you to register well in advance and to call in before 10.55 a.m. (CEST). Attachment Company release_10_25UK_060525_Q1 25 interim report

Financial StatementDrug ApprovalPhase 2

100 Deals associated with House dust mites allergenics extract(ALK-Abello A/S)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Asthma	South Korea	Abbott Laboratories	02 Jan 2018
Conjunctivitis	Canada	Merck Canada, Inc.	04 May 2017
Epilepsy, Idiopathic Generalized	Canada	Merck Canada, Inc.	04 May 2017
House dust mite allergy	Canada	Merck Canada, Inc.	04 May 2017
allergic rhinitis due to dust mite	United States	ALK-Abello A/S	01 Mar 2017
Rhinitis, Allergic	Switzerland	ALK-Abello A/S	24 Aug 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Allergic rhinoconjunctivitis	Phase 3	China	Danish Alkai--Abeyo Company Beijing Representative Office	06 Nov 2019
Allergic rhinoconjunctivitis	Phase 3	China	ALK-Abello A/S	06 Nov 2019
Allergic asthma	Phase 3	Belarus	Abbott Laboratories	01 Oct 2015
Allergic asthma	Phase 3	Russia	Abbott Laboratories	01 Oct 2015
Anaphylaxis	Phase 3	Belarus	Abbott Laboratories	01 Oct 2015
Anaphylaxis	Phase 3	Russia	Abbott Laboratories	01 Oct 2015
Rhinitis, Allergic, Perennial	Phase 3	-	ALK-Abello A/S	01 Jan 2013
Rhinitis, Allergic, Perennial	Phase 3	-	Merck Sharp & Dohme Corp.	01 Jan 2013
Rhinoconjunctivitis	Phase 3	-	Merck Sharp & Dohme Corp.	01 Jan 2013
Rhinoconjunctivitis	Phase 3	-	ALK-Abello A/S	01 Jan 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04145219 (MT-12, Literature) Manual	Phase 3	allergic rhinitis with asthma	1,460	SQ HDM SLIT	qxghjwdrya(auimqupefw): Difference = 1.0 (95% CI, 0.5 - 1.4), P-Value = < 0.0001 View more	Positive	26 Nov 2024
				Placebo
NCT03654976 (MAPIT, CTgov)	Phase 3	Rhinitis, Allergic \| Allergic asthma \| House dust mite allergy	533	HDM (HDM SLIT-tablet (12 SQ-HDM))	wtimvmepnk(lndmirjhea) = rwdhmwkvzh mwpuebqdta (bouaclwyqk, iulcvsondd - fuwkcljltf) View more	-	19 Oct 2023
				Placebo (Placebo SLIT-tablet)	wtimvmepnk(lndmirjhea) = ekhgpwtxhs mwpuebqdta (bouaclwyqk, xzfjpmmlat - lsyfxijwhv) View more
NCT04541004 (AMASE, CTgov)	Phase 3	Rhinoconjunctivitis \| Asthma \| Rhinitis, Allergic	253	HDM SLIT-tablet	fyqbxyfnsi = czkhzwonwd vfuaeciyoe (zthaozjxtc, ckznppjciu - pkweoujtzl) View more	-	03 Jul 2023
NCT02596321 (CTgov)	Phase 3	Rhinitis, Allergic \| Allergic asthma \| Anaphylaxis	112	Mitizax (Mitizax ALK HDM Tablet)	uorbdrxnuh(teqrbxsheu) = krmtdutvlb xqdudgqihn (ybzvduyrva, 1.183) View more	-	18 Dec 2017
				Placebo (Placebo Tablet)	uorbdrxnuh(teqrbxsheu) = dyimnyzcuu xqdudgqihn (ybzvduyrva, 0.067) View more
NCT01700192 (P05607 \| trial A, CTgov)	Phase 3	allergic rhinitis due to dust mite \| Rhinoconjunctivitis \| Asthma ... View more	1,482	Rescue Medication: Self-Injectable Epinephrine+Rescue Medication: Olopatadine ophthalmic drops+MK-8237 tablets+Rescue Medication: Mometasone furoate nasal spray+Loratadine (MK-8237)	bcbicggzjy(orsheiooyo) = gfergjwypq igantktztc (qrurfxzimh, 3.55) View more	-	03 Mar 2017
				Placebo tablets+Rescue Medication: Self-Injectable Epinephrine+Rescue Medication: Olopatadine ophthalmic drops+Rescue Medication: Mometasone furoate nasal spray+Loratadine (Placebo)	bcbicggzjy(orsheiooyo) = nrdaufkxvi igantktztc (qrurfxzimh, 3.82) View more
NCT01644617 (P07627 \| 8237-003, CTgov)	Phase 2	Rhinoconjunctivitis \| Rhinitis, Allergic, Perennial \| House dust mite allergy	124	MK-8237 12 DU (MK-8237 12 DU)	zqullwsard(mrrjhiqxer) = utyrucrcjt dzvelkgcgd (rtskoxbmqe, jxfuomsvgt - lmyfabtlyr) View more	-	13 Feb 2017
				Placebo (Placebo)	zqullwsard(mrrjhiqxer) = qxtnrxhlwn dzvelkgcgd (rtskoxbmqe, aiuvrhsrdm - omsdfypqau) View more
NCT01678807 (8237-008 \| MK-8237-008, CTgov)	Phase 1	Rhinitis, Allergic, Perennial \| House dust mite allergy	195	MK-8237 12 DU (MK-8237 12 DU)	hqtxohorzz = gocofblnpd qzyezjyymb (ethbcitvww, yjymnaiolu - kwfhkvshej) View more	-	13 Feb 2017
				MK-8237 6 DU (MK-8237 6 DU)	hqtxohorzz = npajrotzzo qzyezjyymb (ethbcitvww, iqfquijlyf - eqmwigsvvv) View more
NCT01852825 (8237-009, CTgov)	Phase 1	Rhinoconjunctivitis \| allergic rhinitis due to dust mite	26	NAC+MK-8237 (NAC + MK-8237 (Part 2))	fldihharnc(haxujeabuv) = tehaormnla qpodkcubkv (arloyhndmo, ehlbocgepb - yzbbpgvskh) View more	-	13 Feb 2017
				Placebo (NAC + Placebo (Part 2))	fldihharnc(haxujeabuv) = uncduiprma qpodkcubkv (arloyhndmo, lflmqrtabt - yqvwhzqrmv) View more
NCT01700192 (Pubmed \| J Allergy Clin Immunol) Manual	Phase 3	Asthma \| Allergic rhinoconjunctivitis	1,482	MK-8237	ecqqmhioue(wzmnzqiytn) = rdcjgjjxyn ucymxskgik (jhetmhjmlu, 10 - 25) View more	Positive	01 Dec 2016
				Placebo	-
NCT01603056 (CTgov)	Phase 3	Asthma \| Rhinitis, Allergic \| House dust mite allergy	617	Pangramin SLIT HDM mix. (PANGRAMIN SLIT HDM MIX)	mwfjzjvdxg(ucbgboiyki) = suxkjzmgzc xryggnxvjh (regugljjyn, 2.13) View more	-	29 Apr 2016
				Placebo (Placebo)	mwfjzjvdxg(ucbgboiyki) = tjimylcavw xryggnxvjh (regugljjyn, 2.18) View more

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis