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Phase 2 Clinical Trial with an anti-allergy nasal spray confirms Cebina’s drug repurposing discovery research findings on Azelastine as a new antiviral approach

Results from a recently concluded Phase 2, double-blind, placebo-controlled, single-centre trial conducted by a research team at Saarland University demonstrate that a nasal spray containing azelastine reduces the risk of coronavirus and also rhinovirus infections by two-thirds, confirming earlier research findings of Cebina.

Triggered by the onset of the COVID pandemic in March 2020, the CEBINA team, in collaboration with Prof. Robert Konrat (University of Vienna), initiated a drug repurposing project, aiming at the identification of already approved medicines that could counteract SARS-CoV-2 infection and, therefore, be employed to fight COVID.

Using Prof. Konrat’s in-silico prediction method, several known drug candidates were selected for empirical testing in SARS-CoV-2 infection assays, which were subsequently performed in collaboration with the National Virology Laboratory at the University of Pècs, Hungary and the Department of Virology at the University of Innsbruck, Austria.

From the beginning of the project, one of our favourite candidates was azelastine, a generic antihistamine used in nasal sprays all over the world as a medicine for allergy. Since COVID starts with nasal colonization by SARS-CoV-2, we speculated that a nasally applied compound would be the ideal way to stop the virus in the early phase of infection and therefore prevent viral diseases. Indeed, data generated in the VeroE2 cell-based SARS-CoV-2 infection assay demonstrated strong antiviral potency of several candidates, including azelastine, later confirmed in a translational assay using human nasal tissues. Based on our results, which were published first online in September 2020 (Link) and later as a peer-reviewed article (Link), a patent application claiming medical use of azelastine as an antiviral medicine was filed in June 2020. Corresponding patents have meanwhile been granted in Europe and the United States.

To achieve human proof-of-concept, we formed alliance with a German pharma company, UrsaPharm, producing and marketing an azelastine nasal spray (Pollival) as an anti-allergy remedy. Since partnering with UrsaPharm, two Phase 2 efficacy studies proving efficacy in reducing viral load in COVID patients have been conducted (Link1, Link2).

We continued our research on azelastine as an anti-viral drug and proved broad potency against other common upper respiratory viruses, such as influenza, seasonal corona viruses and RSV (Link).

Stimulated by our research results indicating broad antiviral activity of azelastine, UrsaPharm, in collaboration with the University of Saarland, initiated a prophylactic Phase 2 trial to investigate the potential of the azelastine nasal spray to prevent infections by SARS-CoV-2, but also by other upper respiratory viruses. Respective results published on September 2, 2025, in JAMA Internal Medicine by scientists from the University of Saarland and UrsaPharm (Link), demonstrate the prophylactic efficacy of a nasal spray containing azelastine, reducing the risk of coronavirus and rhinovirus infections by two-thirds.

Although it took much longer than expected, finally, the prophylactic value of nasally administered azelastine, is provided. Based on the broad anti-viral effect and favourably side-effect profile, azelastine should further be considered in seasonal viral infections or pandemic situations beyond COVID.

Contact

Vera Baumgartl-Strasser, PhD 
VP Business Development 
vera.baumgartl-strasser(at)cebina.eu  
M: +43 676 363223

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