Cyrano Therapeutics, Inc. recently announced positive topline results from its Phase 2 FLAVOR trial of CYR-064, an innovative, intranasal soft-mist spray for the treatment of persistent post-viral loss of smell (hyposmia).

The randomized, double-blind, placebo-controlled study enrolled 151 patients with persistent hyposmia, lasting at least 6 months, across 14 clinical sites in the U.S. and met its primary endpoint demonstrating the safety and tolerability of CYR-064 with no treatment-related serious adverse events. CYR-064 also demonstrated durable improvements in smell function across multiple, prespecified, secondary efficacy endpoints. The company intends to present detailed trial data at an upcoming medical conference in 2026.

“This is the first randomized, controlled trial to show a pharmaceutical agent can safely improve smell function in patients with persistent post-viral hyposmia,” said Rick Geoffrion, President and CEO of Cyrano Therapeutics. “Once a person has lost their sense of smell for as long as 6 months, the chances become extremely small that their sense of smell will return.  Also, when the sense of smell is lost, people also lose up to 80% of their perception of taste.  So in general we are talking about the impairment of as many as 2 out of the main 5 human senses. CYR-064 has the potential to be the first approved therapy for millions suffering from this serious condition, one with no effective treatment today.”

“We now have the first randomized clinical trial data evaluating a targeted regenerative therapy for post-viral smell loss,” said Mas Takashima, MD, FACS, Chairman of the Department of Otolaryngology – Head and Neck Surgery at Houston Methodist Hospital and Primary Investigator for the FLAVOR trial. “We currently have no effective options for the tens of millions of patients in the U.S. and worldwide experiencing post-viral smell loss and its associated impact on taste.  The results of this trial show that CYR-064 may one day become the first front-line treatment for this serious condition.”

CYR-064 is a patent-protected, intranasal formulation of a broad-spectrum phosphodiesterase (PDE) inhibitor with a patent-protected targeted delivery system designed to enhance olfactory neuron excitability and restore the sense of smell.

Hyposmia, including post-viral hyposmia, is a decreased sense of smell after a viral infection, an increasingly prevalent and serious chronic sensory condition for which there is no approved drug therapy and limited treatment options. Hyposmia is commonly associated with a decreased sense of both smell and taste.  People with post-viral hyposmia which persists for more than several months often do not recover, causing significant impairment in quality of life, nutritional deficits, depression, safety risks, and increased risk of cognitive decline and mortality in older adults. More than 60 million people in the U.S., Europe and Japan currently suffer from persistent post-viral hyposmia.

Cyrano Therapeutics is a private, venture-backed clinical stage regenerative medicine company. Since its foundation, Cyrano has been working diligently to develop therapies for people struggling with the loss of smell and taste. To learn, more please visit https://cyranotherapeutics.com/.