HyposmiaPhase 2NCT06019000
Study of CYR-064 Versus Placebo in Patients.
A Phase 2 study testing CYR-064 in people with Hyposmia, run by Cyrano Therapeutics, Inc. at 14 sites in United States.
Trial summary
Randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR-064. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyposmia
- What is being tested?
- CYR-064
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 14 sitesUnited States
- Study dates
- 26 Sep 2023to 21 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Centers for Advanced ENT
Baltimore, Maryland, 21204
Specialty Physician Associates
Bethlehem, Pennsylvania, 18017
ENTAAFL
Boca Raton, Florida, 33487
Medical University of South Carolina-MUSC
Charleston, South Carolina, 29425
Rush University Medical Center
Chicago, Illinois, 60612
Colorado ENT & Allergy
Colorado Springs, Colorado, 80923
Houston Methodist
Houston, Texas, 77030
KU Medical Center-University of Kansas
Kansas City, Kansas, 66160-8500
Advanced ENT and Allergy
Louisville, Kentucky, 40220
Tandem Clinical Research
Marrero, Louisiana, 70072
Charleston ENT and Allergy
North Charleston, South Carolina, 29406
ENTAAFL
Plantation, Florida, 33324
ENTAAFL
Port Saint Lucie, Florida, 34952
Ear Nose Throat & Allergy Associates
Puyallup, Washington, 98374
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled Trial to Determine The Safety and Efficacy of CYR-064
Randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR-064.
Read the detailed description
The purpose of this study is to determine the safety and effectiveness of CYR-064 in a randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR064.
The study will take approximately 32 weeks which will include a 4-week screening period to evaluate if participants are right for the Study, followed by a 24-week Treatment Period, and a 1 week follow up after participants have completed the Study. About 150 subjects will participate in this study in about 25 research sites in the United States.
- Conditions
- Hyposmia
- Being tested
- CYR-064
- Keywords
- post viral smell loss
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYR-064Combination product
CYR-064 is a nasal solution.
| Study group | Role | What they receive |
|---|---|---|
| CYR-064 dose 1 | Active comparator | Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients. Receives: Combination Product: CYR-064 |
| CYR-064 dose 2 | Experimental | Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients. Receives: Combination Product: CYR-064 |
| Placebo | Placebo comparator | Treatment with Placebo nasal solution for 24 weeks. CYR-064 will be self-administered by patients. Receives: Combination Product: CYR-064 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome - Safety and Tolerability
The count and percentage of patients reporting AEs, SAEs, and SUSARs will be summarized overall, by System Organ Class, Preferred Term within the System Organ Class, maximum severity, and relationship to study drug. All other safety parameters, including clinical laboratory values through blood draws, will be summarized using descriptive statistics for continuous variables and counts and percentages for categorical variables. All changes in nasal mucosal appearance will be noted.
Measured: Approximately 32 weeks
Secondary outcomes (5)
Change in Visual Rating Scale (VRS) scores
The Main Secondary Outcome Measure is Change in Visual Rating Scale (VRS) scores in CYR-064 low dose and high dose groups as compared with placebo from Baseline to Week 24.
- VRS high dose versus placebo
- VRS low dose versus placebo
- VRS low and high dose combined versus placebo
Measured: Approximately 24 weeks
Secondary Outcome-improvement on NRS-11 Smell-PRO
Improvement in patient reported NRS-11 Smell-PRO (scale of 0-10) in CYR-064 low dose and high dose groups as compared with placebo from Baseline to Week 24.
Measured: Approximately 24 weeks
Secondary Outcome-improvement on NRS-11 Taste-PRO
Improvement in patient reported NRS-11 Taste-PRO (scale of 0-10) in CYR-064 low dose and high dose groups as compared with placebo from Baseline to Week 24.
Measured: Approximately 24 weeks
Secondary Outcome-Mean Change in NRS-11 Smell-PRO
Mean Change in NRS-11 Smell-PRO from Baseline to Week 24 between CYR-064 low and high dose and placebo from Baseline to Week 24
Measured: Approximately 24 weeks
Secondary Outcome-Mean Change in NRS-11 Taste-PRO
Mean Change in NRS-11 Taste-PRO from Baseline to Week 24 between CYR-064 low and high dose and placebo from Baseline to Week 2
Measured: Approximately 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start26 Sep 2023
- Primary completion11 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HyposmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study treatment of CYR-064 is administered for a 24-week Treatment Period. Patients who meet all study criteria and have consented to participation will be randomized (1:1:1) to three parallel study arms, with two different dose strengths and a placebo group over 24 weeks. CYR-064 dose 1 CYR-064 dose 2 Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyrano Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mas Takashima, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019000
- Sponsor's protocol ID
- CYR-064-01
- Status last verified
- Feb 2026
- First submitted
- 11 May 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Descriptive statistics
Publications
Henkin RI. Growth Factors in Olfaction. In: Preedy VR, editor. Handbook of Growth and Growth Monitoring in Health and Disease. New York, NY: Springer New York; 2012. p. 1417-36.
Henkin RI, Abdelmeguid M. Improved Smell and Taste Dysfunction with Intranasal Theophylline. Am J Otolaryngol Head Neck Surg. 2019;2(9):1070.
Henkin RI, Levy LM, Fordyce A. Taste and smell function in chronic disease: a review of clinical and biochemical evaluations of taste and smell dysfunction in over 5000 patients at The Taste and Smell Clinic in Washington, DC. Am J Otolaryngol. 2013 Sep-Oct;34(5):477-89. doi: 10.1016/j.amjoto.2013.04.006. Epub 2013 Jun 2.
PubMed 23731850Henkin RI. Comparative monitoring of oral theophylline treatment in blood serum, saliva, and nasal mucus. Ther Drug Monit. 2012 Apr;34(2):217-21. doi: 10.1097/FTD.0b013e3182492a20.
PubMed 22377744Henkin RI, Hosein S, Stateman WA, Knoppel AB, Abdelmeguid M. Improved smell function with increased nasal mucus sonic hedgehog in hyposmic patients after treatment with oral theophylline. Am J Otolaryngol. 2017 Mar-Apr;38(2):143-147. doi: 10.1016/j.amjoto.2016.11.010. Epub 2016 Nov 23.
PubMed 27923495Henkin RI, Schultz M, Minnick-Poppe L. Intranasal theophylline treatment of hyposmia and hypogeusia: a pilot study. Arch Otolaryngol Head Neck Surg. 2012 Nov;138(11):1064-70. doi: 10.1001/2013.jamaoto.342.
PubMed 23165381Henkin RI, Velicu I. cAMP and cGMP in nasal mucus related to severity of smell loss in patients with smell dysfunction. Clin Invest Med. 2008;31(2):E78-84. doi: 10.25011/cim.v31i2.3367.
PubMed 18377764Henkin RI, Velicu I, Schmidt L. An open-label controlled trial of theophylline for treatment of patients with hyposmia. Am J Med Sci. 2009 Jun;337(6):396-406. doi: 10.1097/MAJ.0b013e3181914a97.
PubMed 19359985Henkin RI, Velicu I, Schmidt L. Relative resistance to oral theophylline treatment in patients with hyposmia manifested by decreased secretion of nasal mucus cyclic nucleotides. Am J Med Sci. 2011 Jan;341(1):17-22. doi: 10.1097/MAJ.0b013e3181f1fdc8.
PubMed 21191261
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled Trial to Determine The Safety and Efficacy of CYR-064
- ClinicalTrials.gov ID
- NCT06019000
- Acronym / sponsor ID
- CYR-064-01
- Conditions
- Hyposmia
- Keywords
- post viral smell loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Cyrano Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR-064.
Detailed description
The purpose of this study is to determine the safety and effectiveness of CYR-064 in a randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR064.
The study will take approximately 32 weeks which will include a 4-week screening period to evaluate if participants are right for the Study, followed by a 24-week Treatment Period, and a 1 week follow up after participants have completed the Study. About 150 subjects will participate in this study in about 25 research sites in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study treatment of CYR-064 is administered for a 24-week Treatment Period. Patients who meet all study criteria and have consented to participation will be randomized (1:1:1) to three parallel study arms, with two different dose strengths and a placebo group over 24 weeks. CYR-064 dose 1 CYR-064 dose 2 Placebo
| Arm | Type | Receives |
|---|---|---|
| CYR-064 dose 1 | Active comparator | Combination Product: CYR-064Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients. |
| CYR-064 dose 2 | Experimental | Combination Product: CYR-064Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients. |
| Placebo | Placebo comparator | Combination Product: CYR-064Treatment with Placebo nasal solution for 24 weeks. CYR-064 will be self-administered by patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYR-064CYR-064 is a nasal solution. | Combination product | CYR-064 dose 1, CYR-064 dose 2, Placebo |
Primary outcome
Primary Outcome - Safety and Tolerability
Time frame: Approximately 32 weeks
The count and percentage of patients reporting AEs, SAEs, and SUSARs will be summarized overall, by System Organ Class, Preferred Term within the System Organ Class, maximum severity, and relationship to study drug. All other safety parameters, including clinical laboratory values through blood draws, will be summarized using descriptive statistics for continuous variables and counts and percentages for categorical variables. All changes in nasal mucosal appearance will be noted.
5 secondary outcomes
Change in Visual Rating Scale (VRS) scores
Time frame: Approximately 24 weeks
Secondary Outcome-improvement on NRS-11 Smell-PRO
Time frame: Approximately 24 weeks
Secondary Outcome-improvement on NRS-11 Taste-PRO
Time frame: Approximately 24 weeks
Secondary Outcome-Mean Change in NRS-11 Smell-PRO
Time frame: Approximately 24 weeks
Secondary Outcome-Mean Change in NRS-11 Taste-PRO
Time frame: Approximately 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- BackgroundHenkin RI. Growth Factors in Olfaction. In: Preedy VR, editor. Handbook of Growth and Growth Monitoring in Health and Disease. New York, NY: Springer New York; 2012. p. 1417-36.
- BackgroundHenkin RI, Abdelmeguid M. Improved Smell and Taste Dysfunction with Intranasal Theophylline. Am J Otolaryngol Head Neck Surg. 2019;2(9):1070.
- Results publication: PubMed 23731850Henkin RI, Levy LM, Fordyce A. Taste and smell function in chronic disease: a review of clinical and biochemical evaluations of taste and smell dysfunction in over 5000 patients at The Taste and Smell Clinic in Washington, DC. Am J Otolaryngol. 2013 Sep-Oct;34(5):477-89. doi: 10.1016/j.amjoto.2013.04.006. Epub 2013 Jun 2.
- Results publication: PubMed 22377744Henkin RI. Comparative monitoring of oral theophylline treatment in blood serum, saliva, and nasal mucus. Ther Drug Monit. 2012 Apr;34(2):217-21. doi: 10.1097/FTD.0b013e3182492a20.
- Results publication: PubMed 27923495Henkin RI, Hosein S, Stateman WA, Knoppel AB, Abdelmeguid M. Improved smell function with increased nasal mucus sonic hedgehog in hyposmic patients after treatment with oral theophylline. Am J Otolaryngol. 2017 Mar-Apr;38(2):143-147. doi: 10.1016/j.amjoto.2016.11.010. Epub 2016 Nov 23.
- Results publication: PubMed 23165381Henkin RI, Schultz M, Minnick-Poppe L. Intranasal theophylline treatment of hyposmia and hypogeusia: a pilot study. Arch Otolaryngol Head Neck Surg. 2012 Nov;138(11):1064-70. doi: 10.1001/2013.jamaoto.342.
- Results publication: PubMed 18377764Henkin RI, Velicu I. cAMP and cGMP in nasal mucus related to severity of smell loss in patients with smell dysfunction. Clin Invest Med. 2008;31(2):E78-84. doi: 10.25011/cim.v31i2.3367.
- Results publication: PubMed 19359985Henkin RI, Velicu I, Schmidt L. An open-label controlled trial of theophylline for treatment of patients with hyposmia. Am J Med Sci. 2009 Jun;337(6):396-406. doi: 10.1097/MAJ.0b013e3181914a97.
- Results publication: PubMed 21191261Henkin RI, Velicu I, Schmidt L. Relative resistance to oral theophylline treatment in patients with hyposmia manifested by decreased secretion of nasal mucus cyclic nucleotides. Am J Med Sci. 2011 Jan;341(1):17-22. doi: 10.1097/MAJ.0b013e3181f1fdc8.
- Individual participant dataSharing planned: No. Descriptive statistics
Related trials for Hyposmia
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
SniffTrain: Effectiveness of Sniff Training in the Treatment of Post-Viral Anosmia
Post-viral Anosmia, Anosmia
RecruitingPhase 3
Topical Versus Injection PRP for Olfactory Dysfunction
Olfactory Dysfunction, Anosmia
Not yet recruitingObservational study
Artificial Intelligence-based Parkinson's Disease Risk Assessment (AI-PRA) Study
Parkinson Disease (PD), REM Sleep Behavior Disorder (iRBD)
Recruiting
Olfactory Training as a Treatment for Olfactory Dysfunction Post COVID-19
Hyposmia, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mas Takashima, MD principal investigator
The Methodist Hospital Research Institute
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CYR-064 in people with Hyposmia, run by Cyrano Therapeutics, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome - Safety and Tolerability (time frame: Approximately 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06019000, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.