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AZD4604

Phase 2

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Nov 17, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials4
Total Enrollment411

FDA Designations

No designations recorded

Clinical trial landscape

AZD4604 · 5 trials · 2 indications

Phase 2 2Phase 1 3
NCT06435273Phase II Study to Evaluate the Effect of AZD4604 on Airway Inflammation and Biomarkers in Adults With AsthmaAsthma
COMPLETED36 Analytics
NCT06020014Phase 2a Study to Assess the Efficacy and Safety of AZD4604 in Adult Patients With Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABAAsthma
COMPLETED339 Analytics
PHASE2COMPLETED
Phase II Study to Evaluate the Effect of AZD4604 on Airway Inflammation and Biomarkers in Adults With Asthma
Asthma
NCT0643527336
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PHASE2COMPLETED
Phase 2a Study to Assess the Efficacy and Safety of AZD4604 in Adult Patients With Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA
Asthma
NCT06020014339
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Study Endpoints

Primary Endpoints

Change from baseline to end of investigational medicinal product (IMP) administration in expression of T2 and non-T2, and JAK1-related genes and gene signatures in bronchial brushings
4 weeks

Gene expression in airway epithelial cells

Time to first CompEx Asthma event
12 weeks

CompEx Asthma is a composite surrogate endpoint for exacerbations that captures: - acute worsening events based on a combination of events based on ePRO data (asthma symptoms and rescue medication use), PEF data, and severe asthma exacerbation events.

Maximum observed drug concentration (Cmax) of AZD4604
Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)

The Cmax of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.

Time to reach maximum observed concentration (tmax) of AZD4604
Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)

The tmax of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.

Area under concentration-time curve in the dosing interval (AUCtau) of AZD4604
Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)

The AUCtau of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.

Apparent total body clearance (CL/F) of AZD4604
Day 10 (Pre-dose and Post-dose)

The CL/F of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.

Apparent volume of distribution based on the terminal phase (VZ/F) of AZD4604
Day 10 (Pre-dose and Post-dose)

The VZ/F of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.

Dose normalised AUCtau (AUCtau/D) of AZD4604
Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)

The AUCtau/D of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.

Dose normalised Cmax (Cmax/D) of AZD4604
Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)

The Cmax/D of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.

Number of participants with adverse event (AEs)
From Day -28 to 5 weeks (Parts 1a and 2a); Day -28 to 6 weeks (Parts 1b and 2b)

To assess the safety and tolerability of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).

Amount of AZD4604 excreted (Ae) - Part 1
Urine and faecal sample collection from pre-dose to 336 hours post-dose

Mass balance of total radioactivity (TR) of \[14C\]AZD4604 in urine and faeces

Amount of AZD4604 excreted expressed as a fraction of dose excreted (Fe) - Part 1
Urine and faecal sample collection from pre-dose to 336 hours post-dose

Mass balance of total radioactivity (TR) of \[14C\]AZD4604 in urine and faeces

The cumulative amount of AZD4604 excreted (CumAe) - Part 1
Urine and faecal sample collection from pre-dose to 336 hours post-dose

Mass balance of total radioactivity (TR) of \[14C\]AZD4604 in urine and faeces

Cumulative amount of AZD4604 excreted expressed as a fraction of dose excreted (CumFe) - Part 1
Urine and faecal sample collection from pre-dose to 336 hours post-dose

Mass balance of total radioactivity (TR) of \[14C\]AZD4604 in urine and faeces

Time to maximum concentration (tmax) for AZD4604 and total radioactivity - Part 1
Plasma sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 and \[14C\]AZD4604 in plasma

Area under the curve from time 0 extrapolated to infinity for AZD4604 and total radioactivity (AUC-inf) - Part 1
Plasma sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 and \[14C\]AZD4604 in plasma

Maximum observed concentration (Cmax) for AZD4604 and total radioactivity - Part 1
Plasma sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 and \[14C\]AZD4604 in plasma

Area under the curve from time 0 to the time of the last measurable concentration for AZD4604 and total radioactivity (AUC0-t) - Part 1
Plasma sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 and \[14C\]AZD4604 in plasma

Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) and total radioactivity - Part 1
Plasma sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 and \[14C\]AZD4604 in plasma

Terminal elimination half-life of AZD4604 (t1/2) and total radioactivity - Part 1
Plasma sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 and \[14C\]AZD4604 in plasma

First order rate constant associated with the terminal (log-linear) portion of the curve for AZD4604 (λz) and total radioactivity - Part 1
Plasma sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 and \[14C\]AZD4604 in plasma

Total body clearance calculated after a single IV administration (CL) - Part 1
Plasma sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 and \[14C\]AZD4604 in plasma

Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) - Part 1
Plasma sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 and \[14C\]AZD4604 in plasma

Volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single IV administration (Vz) - Part 1
Plasma sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 and \[14C\]AZD4604 in plasma

Volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) - Part 1
Plasma sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 and \[14C\]AZD4604 in plasma

Assessment of metabolites in plasma, urine and faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry - Part 1
Plasma, urine and faces sample collection from pre-dose to 336 hours post-dose

Metabolite profiling and structural identification from plasma, urine and faecal samples

Amount of AZD4604 excreted (Ae) - Part 2
Urine and faecal sample collection from pre-dose to 336 hours post-dose

Mass balance of total radioactivity (TR) of \[14C\]AZD4604 in urine and faeces

Amount of AZD4604 excreted expressed as a fraction of dose excreted (Fe) - Part 2
Urine and faecal sample collection from pre-dose to 336 hours post-dose

Mass balance of total radioactivity (TR) of \[14C\]AZD4604 in urine and faeces

The cumulative amount of AZD4604 excreted (CumAe) - Part 2
Urine and faecal sample collection from pre-dose to 336 hours post-dose

Mass balance of total radioactivity (TR) of \[14C\]AZD4604 in urine and faeces

Cumulative amount of AZD4604 excreted expressed as a fraction of dose excreted (CumFe) - Part 2
Urine and faecal sample collection from pre-dose to 336 hours post-dose

Mass balance of total radioactivity (TR) of \[14C\]AZD4604 in urine and faeces

Time to maximum concentration (tmax) for AZD4604 and total radioactivity - Part 2
Plasma and whole blood sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 in plasma and whole blood

Area under the curve from time 0 extrapolated to infinity for AZD4604 and total radioactivity (AUC-inf) - Part 2
Plasma and whole blood sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 in plasma and whole blood

Maximum observed concentration (Cmax) for AZD4604 and total radioactivity - Part 2
Plasma and whole blood sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 in plasma and whole blood

Area under the curve from time 0 to the time of the last measurable concentration for AZD4604 and total radioactivity (AUC0-t) - Part 2
Plasma and whole blood sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 in plasma and whole blood

Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) and total radioactivity - Part 2
Plasma and whole blood sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 in plasma and whole blood

Terminal elimination half-life of AZD4604 (t1/2) and total radioactivity - Part 2
Plasma and whole blood sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 in plasma and whole blood

First order rate constant associated with the terminal (log-linear) portion of the curve for AZD4604 (λz) and total radioactivity - Part 2
Plasma and whole blood sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 in plasma and whole blood

Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) - Part 2
Plasma and whole blood sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 in plasma and whole blood

Volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) - Part 2
Plasma and whole blood sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 in plasma and whole blood

Renal clearance calculated using plasma AUC of AZD4604 and total radioactivity - Part 2
Plasma and whole blood sample collection from pre-dose to 336 hours post-dose

PK of AZD4604 in plasma and whole blood

Assessment of metabolites in plasma, urine and faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry - Part 2
Plasma, urine and faces sample collection from pre-dose to 336 hours post-dose

Metabolite profiling and structural identification from plasma, urine and faecal samples

Secondary Endpoints

Change from baseline to end of IMP administration in STAT phosphorylation in bronchial biopsies
4 weeks
Change in number of airway cells, including but not limited to inflammatory cells, airway smooth muscle cells, and goblet cells from baseline to end of IMP administration in bronchial biopsies (cells per mm² determined by microscopic evaluation)
4 weeks
Pre-BD FEV1
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD4604EXPERIMENTALAZD4604
Placebo to AZD4604PLACEBO_COMPARATORPlacebo to AZD4604
Arm 1EXPERIMENTALAZD4604
Arm 2PLACEBO_COMPARATORPlacebo
AZD4604 dose A via GenuairEXPERIMENTALParticipants will receive dose A of AZD4604 via Genuair device twice daily
AZD4604 dose A via TurbuhalerEXPERIMENTALParticipants will receive dose A of AZD4604 via Turbuhaler device twice daily
AZD4604 dose B via TurbuhalerEXPERIMENTALParticipants will receive dose B of AZD4604 via Turbuhaler device twice daily
Placebo via GenuairPLACEBO_COMPARATORParticipants will receive placebo via Genuair device twice daily
Placebo via TurbuhalerPLACEBO_COMPARATORParticipants will receive placebo via Turbuhaler device twice daily
Part 1a: AZD4604 (Dose 1) SADEXPERIMENTALJapanese participants will receive single dose of AZD4604 (Dose 1) via inhalation on Day 1.
Part 1a: AZD4604 (Dose 2) SADEXPERIMENTALJapanese participants will receive single dose of AZD4604 (Dose 2) via inhalation on Day 1.
Part 1a: AZD4604 (Dose 3) SADEXPERIMENTALJapanese participants will receive single dose of AZD4604 (Dose 3) via inhalation on Day 1.
Part 1a: PlaceboPLACEBO_COMPARATORJapanese participants will receive single dose of matching placebo to AZD4604 on Day 1.
Part 1b: AZD4604 (Dose 4) Multiple dose cohortEXPERIMENTALJapanese participants will receive AZD4604 (Dose 4) via inhalation twice daily (BID) from Day 1 to Day 6 and a single dose on Day 7.
Part 1b: PlaceboPLACEBO_COMPARATORJapanese participants will receive matching placebo to AZD4604 BID from day 1 to day 6 and a single dose of placebo on Day 7.
Part 2a: AZD4604 (Dose 1) SADEXPERIMENTALChinese participants will receive single dose of AZD4604 (Dose 1) via inhalation on Day 1.
Part 2a: AZD4604 (Dose 3) SADEXPERIMENTALChinese participants will receive single dose of AZD4604 (Dose 3) via inhalation on Day 1.
Part 2a: PlaceboPLACEBO_COMPARATORChinese participants will receive single dose of matching placebo to AZD4604 on Day 1.
Part 2 b: AZD4604 (Dose 4) Multiple dose cohortEXPERIMENTALChinese participants will receive AZD4604 (Dose 4) via inhalation BID from Day 1 to Day 6 and a single dose on Day 7.
Part 2b: PlaceboPLACEBO_COMPARATORChinese participants will receive placebo via inhalation BID from Day 1 to Day 6 and a single dose on Day 7.

Interventions

NameTypeDescription
AZD4604DRUGJanus kinase 1 (JAK1) inhibitor
Placebo to AZD4604DRUGPlacebo to AZD4604
PlaceboOTHERPlacebo
GenuairDEVICEParticipants will either receive AZD4604 or placebo via Genuair device.
TurbuhalerDEVICEParticipants will receive either AZD4604 or placebo via Turbuhaler device.
AZD4604 Inhalation Powder, 1 mgDRUG3 mg dose, inhaled, fasted
[14C]AZD4604 Solution for Infusion 6 μg/mL (NMT 37.0 kBq/5 mL)DRUG30 μg, intravenous, fasted
[14C]AZD4604 Oral Solution, 4 mg (NMT 37.0 kBq)DRUG4 mg, oral, fasted
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Documented physician-diagnosed asthma ≥ 12 months prior to screening (Visit 1). * Participants treated with medium-to-high dose ICS in combination with LABA at a stable dose for at least 2 months prior to Visit 1 (the ICS can be contained within an ICS-LABA fixed dose combinat...

Countries:CanadaDenmarkGermanySpainUnited KingdomUnited StatesArgentinaBrazilBulgariaFranceIndiaMalaysiaPhilippinesSouth AfricaSouth KoreaSwedenTaiwanThailandVietnam
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Competitive Landscape -Asthma 76 trials

CompanyTickerTrialsLead PhaseDrugs
Teva Pharmaceutical Industries Limited Sponsored ADRTEVA4PHASE3Fp/ABS, ABS
Novartis AG Sponsored ADRNVS5PHASE3QVM149, Salmeterol Xinafoate/ Fluticasone Propionate
GSK plc Sponsored ADRGSK5PHASE3FF/UMEC/VI
Sanofi SA Sponsored ADRSNY7PHASE3Dupilumab
AstraZeneca PLCAZN27PHASE3Benralizumab
Generate Biomedicines, Inc.GENB3PHASE3GB-0895
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Incyte CorporationINCY1PHASE2povorcitinib, ICS-LABA
Pfizer Inc.PFE1PHASE2PF-07275315
Kymera Therapeutics, Inc.KYMR1PHASE2KT-621
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE2ARO-RAGE
Upstream Bio, Inc.UPB1PHASE2Verekitug
Sunshine Biopharma IncorporatedSBFM2PHASE3610
Amgen Inc.AMGN1PHASE1AMG 691
Apogee Therapeutics, Inc.APGE1PHASE1APG777
Celldex Therapeutics, Inc.CLDX1PHASE1CDX-622
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Frequently asked questions about AZD4604

What is AZD4604 used for?

AZD4604 is an investigational small molecule being developed for asthma. It has been studied in adult patients with moderate-to-severe asthma uncontrolled on medium-high dose ICS-LABA, as well as in healthy participants and adults with mild asthma. It is administered via inhalation.

Who is developing AZD4604?

AZD4604 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The drug is currently in clinical development for respiratory conditions, specifically asthma.

What phase is AZD4604 in?

AZD4604 is in Phase 2 clinical development. A Phase 2a study in adult patients with moderate-to-severe asthma has been completed. Phase 1 studies have also been completed to evaluate safety, tolerability, pharmacokinetics, and bioavailability in healthy participants and patients with mild asthma.

What clinical trials has AZD4604 been in?

AZD4604 has been studied in four completed clinical trials. These include a Phase 2a efficacy and safety study (NCT06020014) in patients with moderate-to-severe asthma, an ADME and bioavailability study (NCT06157255), a safety and pharmacokinetics study in healthy Japanese and Chinese participants (NCT06519968), and a pharmacokinetics and pharmacodynamics study using the Turbuhaler device in mild asthma (NCT06732882).

Is AZD4604 FDA approved?

AZD4604 is not FDA approved. It is an investigational drug that has completed Phase 1 and Phase 2 clinical trials, but it remains in clinical development and has not been approved for any use.

How is AZD4604 administered?

AZD4604 is administered via inhalation. One clinical trial evaluated the drug given via the Turbuhaler device in adults with mild asthma. Other studies used inhaled administration to assess safety, tolerability, and pharmacokinetics in healthy participants and asthma patients.