New drug aims to restore lost smell in clinical trial
NCT ID NCT06019000
First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times
Summary
This study tested a new drug called CYR-064 in 151 adults aged 18-70 who have a reduced sense of smell (hyposmia). The goal was to see if the drug is safe and if it can improve smell and taste over 24 weeks compared to a placebo. Participants had no other nasal issues like polyps or sinusitis.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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151 people
The number who actually took part.
- Started
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Sep 2023
- Finished
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Nov 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Able to provide written informed consent. * Male or female 18-70 years of age. * Endoscopy of the nasal cavity showing no structural or pathologic issues leading to hyposmia (nasal polyps, sinusitis, infection, etc.) that in the opinion of the Investigator, believes would hinder the delivery of study drug to the olfactory receptors. * CT scan of the nasal cavity after the onset of hyposmia (within prior 2 years) prior to Baseline showing no structural or pathologic issue leading to hyposmia that in the opinion of the Investigator, believes would hinder the delivery of study drug to the olfactory receptors. * Willing and able to self-administer the study drug, follow the study drug administration instructions, comply with study procedures, and participate in the scheduled study visits specified in this protocol. Exclusion Criteria: * History of traumatic brain injury, Parkinson's disease, early dementia, Alzheimer's disease, or any other condition in which hyposmia is not expected to improve in the opinion of the Investigator, such as history of congenital or idiopathic hyposmia or a surgical procedure that led to hyposmia. * History of surgery that led to hyposmia. * Concomitant Medical Conditions * Current symptoms or signs of an acute respiratory viral illness at Screening or Baseline. * Chronic viral infection or immunodeficiency condition (e.g., medical history of human immunodeficiency virus) based on medical records. * Any active malignancy. * Any concomitant medical condition that in the opinion of the Investigator, compromises patient safety or compliance with the study protocol or collected data. * History of moderate to severe Substance Use Disorder within the past 3 years as assessed by the Investigator. * History of persistent chronic sinusitis without polyps or chronic sinusitis with polyps. * Use or planned use of tobacco or nicotine-containing products, including smoking, smokeless tobacco, e-cigarettes, or nicotine replacement products within 3 months prior to Screening through EOS. * Unwilling or unable to discontinue current or planned use of over the counter or prescription medication administered intranasally, with the exception of nasal saline. * Use or planned use of another investigational drug within 4 weeks prior to Screening through Follow-Up. * Receiving any concomitant medication/therapy that would, in the opinion of the Investigator, compromise patient safety or compliance with the study protocol or collected data. * General Exclusions Any female who is pregnant, planning to become pregnant during the study, or who is lactating. Vulnerable patients. Any condition or abnormality (including clinical laboratory, physical examination, or vital sign abnormalities), current or past, that, in the opinion of the Investigator, would compromise the efficacy evaluation, safety of the patient, or would interfere with or complicate study procedures or assessments.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Advanced ENT and Allergy
Louisville, Kentucky, 40220, United States
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Centers for Advanced ENT
Baltimore, Maryland, 21204, United States
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Charleston ENT and Allergy
North Charleston, South Carolina, 29406, United States
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Colorado ENT & Allergy
Colorado Springs, Colorado, 80923, United States
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ENTAAFL
Boca Raton, Florida, 33487, United States
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ENTAAFL
Plantation, Florida, 33324, United States
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ENTAAFL
Port Saint Lucie, Florida, 34952, United States
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Ear Nose Throat & Allergy Associates
Puyallup, Washington, 98374, United States
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Houston Methodist
Houston, Texas, 77030, United States
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KU Medical Center-University of Kansas
Kansas City, Kansas, 66160-8500, United States
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Medical University of South Carolina-MUSC
Charleston, South Carolina, 29425, United States
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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Specialty Physician Associates
Bethlehem, Pennsylvania, 18017, United States
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Tandem Clinical Research
Marrero, Louisiana, 70072, United States
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Other studies related to the condition(s) this trial covers.
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