Solrikitug (formerly known as MK-8226), developed initially by Merck & Co. and now advanced by Uniquity Bio with funding from Blackstone Life Sciences, is currently in Phase II clinical development for multiple inflammatory conditions, including chronic obstructive pulmonary disease (COPD), asthma, and eosinophilic esophagitis. The severe asthma market, which is already dominated by major players such as AstraZeneca, Sanofi, Teva, GSK, Regeneron, Amgen, Ellodi, Bristol Myers Squibb, Revolo, EsoCap, and Pfizer, is expected to transform with the introduction of Solrikitug in the coming months.
According to DelveInsight’s comprehensive report, “Severe Asthma Market Insights, Epidemiology, and Market Forecast–2034”, the global burden of asthma remains substantial, with approximately 43 million diagnosed cases in adults and 11 million in the pediatric population across the 7MM in 2023. The United States alone accounts for about 26 million diagnosed cases. Of particular concern is severe asthma, which affects more than 5 million individuals across these markets.
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The severe asthma market in the 7MM is currently valued at nearly USD 8 billion and is highly competitive. Biologic therapies dominate the severe asthma treatment space, particularly those targeting type 2 inflammation pathways. Key players include AstraZeneca’s FASENRA, Sanofi and Regeneron’s DUPIXENT, and Teva’s CINQAIR. Emerging therapies like GSK’s depemokimab and AstraZeneca’s PT010 are also competing in this landscape.
Solrikitug, an anti-TSLP monoclonal antibody currently in Phase II trials, is an interesting candidate among emerging therapies for asthma and other chronic inflammatory conditions such as COPD and eosinophilic esophagitis. Originally developed by Merck & Co., it has been in-licensed by Uniquity Bio, a clinical-stage drug development company focused on immunology and inflammation.
The solrikitug mechanism of action targets TSLP, a critical epithelial cell-derived cytokine expressed in the barrier surfaces of the body, including the lungs, skin, and gut tissues. TSLP acts as a “master switch” cytokine at the top of the inflammatory cascade. By preventing TSLP from binding to its receptors, Solrikitug has the potential to disrupt multiple inflammatory pathways simultaneously, presenting a therapeutic advantage over existing biologics that target single mediators such as IL-5 or IgE.
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It is noteworthy that tezepelumab (AstraZeneca) is the first anti-TSLP agent approved for severe asthma in 2021. However, solrikitug recognizes a different epitope compared to tezepelumab and demonstrated superior potency in preclinical studies. Solrikitug also appears to have a longer circulating half-life, which could be advantageous for patient convenience and adherence by potentially allowing for less frequent administration.
As of early 2025, several clinical trials for Solrikitug are either underway or planned to evaluate its safety, efficacy, and optimal dosing regimens across different patient populations.
The RAINIER Study (NCT06496607) is an ongoing Phase IIa clinical trial investigating Solrikitug for adults with asthma. This randomized, double-blind, placebo-controlled study evaluates three dose levels, focusing on changes in blood eosinophil counts and the therapy’s safety profile. The study is estimated to be completed by August 2025.
Concurrently, the ZION Study (NCT06496620) is exploring solrikitug’s potential in COPD, the third leading cause of death worldwide, while the ALAMERE Study (NCT06598462) is investigating its efficacy in Eosinophilic Esophagitis, thereby broadening the potential applications of this promising therapy.
Additionally, a Phase I study was planned to investigate the safety, tolerability, and pharmacokinetics of Solrikitug in both Japanese and non-Japanese participants, reflecting efforts to understand potential ethnic differences in drug response. This study aims to enroll 32 participants and is scheduled to start in May 2025, with an estimated completion by December 2025.
Uniquity Bio has also indicated plans to expand its immunology and inflammation pipeline with additional programs in the near future, potentially leveraging Solrikitug as a platform for developing bispecific antibodies or combination approaches. The company’s pipeline already includes “Solrikitug-Based Bispecific 1” and “Solrikitug-Based Bispecific 2”, suggesting ongoing innovation based on this molecular platform.
The development of solrikitug represents part of a broader trend in precision medicine approaches for inflammatory conditions, where targeting specific cytokines and inflammatory mediators can potentially offer more effective and personalized treatment options, addressing significant unmet needs. The substantial investment of $300 million by Blackstone Life Sciences into Uniquity Bio underscores the significant commercial potential seen in Solrikitug.
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Table of Contents
1
Key Insights
2
Report Introduction
3
Severe Asthma Market Overview at a Glance
4
Severe Asthma Epidemiology and Market Methodology
5
Executive Summary of Severe Asthma
6
Key Events
7
Severe Asthma Background and Overview
8
Severe Asthma Epidemiology and Patient Population
9
Severe Asthma Patient Journey
10
Severe Asthma Marketed Drugs
11
Severe Asthma Emerging Drugs
12
Severe Asthma: Seven Major Market Analysis
13
Key Opinion Leaders’ Views
14
SWOT Analysis
15
Severe Asthma Unmet Needs
16
Reimbursement and Market Access
17
Appendix
18
DelveInsight Capabilities
19
Disclaimer
20
About DelveInsight
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DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
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