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BLU-5937

Phase 3

Cough | Small molecule | Respiratory |GSK plc|Last Updated: Jul 14, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment2,044

FDA Designations

No designations recorded

Clinical trial landscape

BLU-5937 · 8 trials · 5 indications

Phase 3 3Phase 2 2Phase 1 3
NCT07650084A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough - China ExtensionRefractory Chronic Cough
RECRUITING75 Analytics
NCT05600777A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic CoughCough
ACTIVE NOT_RECRUITING997 Analytics
NCT05599191A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic CoughCough
COMPLETED957 Analytics
PHASE3RECRUITING
A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough - China Extension
Refractory Chronic Cough
NCT0765008475
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PHASE3ACTIVE NOT_RECRUITING
A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
Cough
NCT05600777997
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PHASE3COMPLETED
A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
Cough
NCT05599191957
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Study Endpoints

Primary Endpoints

24-Hour Cough Frequency
Week 24

Assessed using an ambulatory cough monitor

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 24
Up to Week 24

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.

Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 24
Up to Week 24

An AEMI is an event of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring is appropriate. The following are AEMIs for this study: taste disturbance, oral hypoesthesia, oral paresthesia, and new or worsening findings of the cornea.

Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 24
Up to Week 24

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.

Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 24
Up to Week 24

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.

Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 24
Baseline, Week 24
Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 24
Baseline, Week 24
Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 24
Baseline, Week 24
Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 24
Baseline, Week 24
Change from Baseline in Vital Sign: Weight (kilograms [kg]) at Week 24
Baseline, Week 24
Change from Baseline in Male Reproductive Hormone: Total Testosterone (nanomoles per liter [nmol/L]) at Week 24
Baseline, Week 24
Change from Baseline in Male Reproductive Hormones: Follicle-Stimulating Hormone [FSH] and Luteinizing Hormone [LH] (international units per liter [IU/L]) at Week 24
Baseline, Week 24
Change from Baseline in Male Reproductive Hormone: Inhibin B (nanograms per liter [ng/L]) at Week 24
Baseline, Week 24
Change from Baseline in Hematology Parameter: Red Blood Cell (RBC) Count (10^12 cells per liter) at Week 24
Baseline, Week 24
Change from Baseline in Hematology Parameters: Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) (grams per liter [g/L]) at Week 24
Baseline, Week 24
Change from Baseline in Hematology Parameter: Hematocrit (percentage) at Week 24
Baseline, Week 24
Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) (femtoliters [fL]) at Week 24
Baseline, Week 24
Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) (picograms per cell [pg/cell]) at Week 24
Baseline, Week 24
Change from Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) (percentage) at Week 24
Baseline, Week 24
Change from Baseline in Hematology Parameters: White Blood Cell (WBC) Count (neutrophils, lymphocytes, monocytes, eosinophils, and basophils) and Platelet Count (10^9 cells per liter) at Week 24
Baseline, Week 24
Change from Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-Glutamyl Transferase (GGT) (units per liter [U/L]) at Week 24
Baseline, Week 24
Change from Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase (ALP) and Creatine Kinase (CK) (international units per liter [IU/L]) at Week 24
Baseline, Week 24
Change from Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct and Indirect Bilirubin, and Creatinine (micromoles per liter) at Week 24
Baseline, Week 24
Change from Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Calcium, Magnesium, Bicarbonate, Glucose, and Blood Urea Nitrogen (BUN) (millimoles per liter [mmol/L]) at Week 24
Baseline, Week 24
Change from Baseline in Clinical Chemistry Parameters: Protein and Albumin (grams per liter [g/L]) at Week 24
Baseline, Week 24
Change from Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) (milliliters per minute per 1.73 meters squared [mL/min/1.73 m^2]) at Week 24
Baseline, Week 24
Change from Baseline in Clinical Chemistry Parameters: Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) (seconds) at Week 24
Baseline, Week 24
Change from Baseline in Electrocardiogram (ECG) Value: Heart Rate (beats per minute) at Week 24
Baseline, Week 24
Change from Baseline in ECG Value: PR Interval, QT Interval, RR Interval, QRS Interval, and Corrected QT Interval Using Fridericia's Formula (QTcF) (milliseconds) at Week 24
Baseline, Week 24
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 52
Up to Week 52

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.

Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 52
Up to Week 52

An AEMI is an event of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring is appropriate. The following are AEMIs for this study: taste disturbance, oral hypoesthesia, oral paresthesia, and new or worsening findings of the cornea.

Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 52
Up to Week 52

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.

Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 52
Up to Week 52

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.

Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 52
Baseline, Week 52
Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 52
Baseline, Week 52
Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 52
Baseline, Week 52
Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 52
Baseline, Week 52
Change from Baseline in Vital Sign: Weight (kilograms [kg]) at Week 52
Baseline, Week 52
Change from Baseline in Male Reproductive Hormone: Total Testosterone (nanomoles per liter [nmol/L]) at Week 52
Baseline, Week 52
Change from Baseline in Male Reproductive Hormones: Follicle-Stimulating Hormone [FSH] and Luteinizing Hormone [LH] (international units per liter [IU/L]) at Week 52
Baseline, Week 52
Change from Baseline in Male Reproductive Hormone: Inhibin B (nanograms per liter [ng/L]) at Week 52
Baseline, Week 52
Change from Baseline in Hematology Parameter: Red Blood Cell (RBC) Count (10^12 cells per liter) at Week 52
Baseline, Week 52
Change from Baseline in Hematology Parameters: Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) (grams per liter [g/L]) at Week 52
Baseline, Week 52
Change from Baseline in Hematology Parameter: Hematocrit (percentage) at Week 52
Baseline, Week 52
Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) (femtoliters [fL]) at Week 52
Baseline, Week 52
Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) (picograms per cell [pg/cell]) at Week 52
Baseline, Week 52
Change from Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) (percentage) at Week 52
Baseline, Week 52
Change from Baseline in Hematology Parameters: White Blood Cell (WBC) Count (neutrophils, lymphocytes, monocytes, eosinophils, and basophils) and Platelet Count (10^9 cells per liter) at Week 52
Baseline, Week 52
Change from Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-Glutamyl Transferase (GGT) (units per liter [U/L]) at Week 52
Baseline, Week 52
Change from Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase (ALP) and Creatine Kinase (CK) (international units per liter [IU/L]) at Week 52
Baseline, Week 52
Change from Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct and Indirect Bilirubin, and Creatinine (micromoles per liter) at Week 52
Baseline, Week 52
Change from Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Calcium, Magnesium, Bicarbonate, Glucose, and Blood Urea Nitrogen (BUN) (millimoles per liter [mmol/L]) at Week 52
Baseline, Week 52
Change from Baseline in Clinical Chemistry Parameters: Protein and Albumin (grams per liter [g/L]) at Week 52
Baseline, Week 52
Change from Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) (milliliters per minute per 1.73 meters squared [mL/min/1.73 m^2]) at Week 52
Baseline, Week 52
Change from Baseline in Clinical Chemistry Parameters: Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) (seconds) at Week 52
Baseline, Week 52
Change from Baseline in Electrocardiogram (ECG) Value: Heart Rate (beats per minute) at Week 52
Baseline, Week 52
Change from Baseline in ECG Value: PR Interval, QT Interval, RR Interval, QRS Interval, and Corrected QT Interval Using Fridericia's Formula (QTcF) (milliseconds) at Week 52
Baseline, Week 52
Change from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score
Week 4

Assessed by Worst Itch Numeric Rating Scale \[WI-NRS\] The WI-NRS is a single item questionnaire assessing the patient-reported severity of itch at its most intense during the previous 24-hour period on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'the worst itch imaginable'. Higher scores indicate worse severity.

Change from baseline in the 24-hour cough frequency
Week 4

Assessed using an ambulatory cough monitor

Assessment of ECG QTcF interval (ms) change
Pre-dose up to 48 hours post-dose for both single and multiple administration
Assessment of diastolic and systolic blood pressure (mmHg) change
Pre-dose up to 48 hours post-dose for both single and multiple administration
Assessment of heart rate (BPM) change
Pre-dose up to 48 hours post-dose for both single and multiple administration
Number of participants with clinically significant changes in Clinical laboratory tests
Pre-dose up to 48 hours post-dose for both single and multiple administration
Number of participants with clinically significant changes in Physical Examination
Pre-dose up to 48 hours post-dose for both single and multiple administration
Adverse Event and Adverse Event of medical interest monitoring
Pre-dose up to 48 hours post-dose for both single and multiple administration and again at follow-up call (1 week after discharge)
Measurement of the area under the plasma concentration by time curve (AUC)
Pre-dose up to 48 hours post-dose for both single and multiple administration
Measurement of the maximum observed plasma drug concentration (Cmax)
Pre-dose up to 48 hours post-dose for both single and multiple administration
Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]-BLU-5937
168 hour

Mass balance recovery of total radioactivity in all excreta by analysing the total radioactivity and metabolic profile in blood, urine and faeces samples.

Number and severity of treatment emergent adverse events (TEAEs)
up to 48 hours after the last dose

Number and severity of TEAEs collected from dosing until follow up 48 hours after last dose

Secondary Endpoints

Change from Baseline in Cough Severity Visual Analogue Scale at Week 24
Baseline, Week 24
Percentage of Participants With Greater than or Equal to (>=) 30 mm Reduction From Baseline in Cough Severity Visual Analog Scale at Week 24
Baseline, Week 24
Awake Cough Frequency at Week 24
Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BLU-5937 25 mgEXPERIMENTALBLU-5937 oral dose 25 mg twice a day.
BLU-5937 50 mgEXPERIMENTALBLU-5937 oral dose 50 mg twice a day.
PlaceboPLACEBO_COMPARATORMatching Placebo for BLU-5937 oral dose twice a day.
BLU-5937 oral tabletEXPERIMENTALEligible participants will receive BLU-5937 twice a day (BID) orally for 4 weeks.
Placebo oral tabletPLACEBO_COMPARATOREligible participants will receive matching Placebo BID orally for 4 weeks.
BLU-5937 Dose AEXPERIMENTALBLU-5937 oral dose A twice a day.
BLU-5937 Dose BEXPERIMENTALBLU-5937 oral dose B twice a day.
BLU-5937 Dose CEXPERIMENTALBLU-5937 oral dose C twice a day.
BLU-5937 Dose A (Population with baseline cough < 25 coughs/hour)EXPERIMENTALBLU-5937 oral dose A twice a day.
Placebo (Population with baseline cough < 25 coughs/hour)PLACEBO_COMPARATORMatching Placebo for BLU-5937 oral dose twice a day.
Cohort 1EXPERIMENTAL10 Japanese and 8 Caucasian subjects. 8 out of 10 Japanese subjects will receive BLU-5937 Dose A and 2 will receive placebo. All Caucasian subjects will receive BLU-5937 Dose A.
Cohort 2EXPERIMENTAL8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose B and 2 will receive placebo.
Cohort 3EXPERIMENTAL8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose C and 2 will receive placebo.
Arm 1EXPERIMENTALSingle oral dose of \[14C\]-BLU-5937
Single Ascending DosesEXPERIMENTALSingle ascending doses, 6 dose levels
Multiple Ascending DosesEXPERIMENTALMultiple ascending doses, 3 dose levels

Interventions

NameTypeDescription
BLU-5937DRUGOral administration of BLU-5937 Tablets.
PlaceboDRUGOral administration of matching placebo for BLU-5937 Tablets.
[14C]-BLU-5937DRUGEach subject will receive a single oral administration of \[14C\]-BLU-5937 capsule, in the fasted state.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: * Capable of giving signed informed consent * Refractory chronic cough (including unexplained chronic cough) for at least one year * Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose...

Countries:ChinaUnited StatesAustraliaCanadaCzechiaGermanyIndiaJapanNew ZealandSlovakiaSouth KoreaTaiwanUnited KingdomArgentinaBelgiumColombiaFranceHungaryIsraelNetherlandsPolandSouth AfricaSpainTurkey (Türkiye)
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Recent Changes (Last 90 Days)

MEDIUMAug 14, 2026NCT05599191TRIAL_REMOVED: changed
MEDIUMAug 14, 2026NCT05599191TRIAL_REMOVED: changed
MEDIUMAug 14, 2026NCT05599191TRIAL_REMOVED: changed
LOWJul 14, 2026NCT05600777Enrollment: 975 → 997
HIGHJul 14, 2026NCT05599191Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWJul 14, 2026NCT05600777Enrollment: 975 → 997
HIGHJul 14, 2026NCT05599191Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWJun 16, 2026NCT07650084NEW_TRIAL: changed
LOWJun 16, 2026NCT07650084NEW_TRIAL: changed
LOWJun 16, 2026NCT07650084NEW_TRIAL: changed

Frequently asked questions about BLU-5937

What is BLU-5937 used for?

BLU-5937 is an investigational small molecule being studied for refractory chronic cough, chronic pruritus associated with atopic dermatitis, and cough. It is developed by GSK plc (GSK) and is currently in Phase 2 and Phase 3 clinical trials for these conditions.

What does BLU-5937 target?

BLU-5937 is a small molecule that targets the P2X3 receptor, which is involved in sensory nerve signaling. By modulating this receptor, it aims to reduce the hypersensitivity that drives chronic cough and pruritus. This mechanism is being evaluated in clinical trials for refractory chronic cough and chronic pruritus.

Who makes BLU-5937?

BLU-5937 is developed by GSK plc, a global biopharmaceutical company listed on the New York Stock Exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the safety and efficacy of BLU-5937 for chronic cough and pruritus indications.

What phase is BLU-5937 in?

BLU-5937 is in Phase 2 and Phase 3 clinical development. It has completed Phase 1 and Phase 2 trials, and two Phase 3 trials for refractory chronic cough have been completed or are active but not recruiting. It is not yet approved by regulatory authorities.

What clinical trials is BLU-5937 in?

BLU-5937 has been studied in several trials. NCT03638180 was a Phase 1 first-in-human study in healthy volunteers. NCT04693195 was a Phase 2 trial in chronic pruritus with atopic dermatitis. NCT05599191 and NCT05600777 are Phase 3 trials in refractory chronic cough, with the latter active but not recruiting.

Is BLU-5937 the same as other names?

BLU-5937 is the primary name used in clinical trials and development. No alternative names have been reported for this investigational drug. It is consistently referred to as BLU-5937 across all registered studies and communications from the developer GSK.