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AZD4604

Phase 2

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Trials Updated: Nov 13, 2025

AZD4604 development status

Highest phase Phase 2
Registered trials 4 across 1 sponsor since Aug 2023

AZD4604 target and mechanism

ModalitySmall molecule

Also known as Londamocitinib

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

AZD4604 clinical trials

AZD4604 · 4 trials · 1 indication

Phase 2 2Phase 1 2
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.

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

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 101 trials

Top 16 of 18 competitors

CompanyTickerTrialsLead PhaseDrugs
Novartis AG Sponsored ADRNVS5PHASE3QVM149, QMF149, Glycopyrronium bromide
GSK plc Sponsored ADRGSK10PHASE3Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin
Teva Pharmaceutical Industries Limited Sponsored ADRTEVA4PHASE3TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab
Sanofi SA Sponsored ADRSNY8PHASE3Dupilumab, Lunsekimig
AstraZeneca PLCAZN28PHASE3Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007
Pfizer Inc.PFE4PHASE3Tilrekimig, PF-07275315, PF-08103402
Generate Biomedicines, Inc.GENB3PHASE3GB-0895
Kymera Therapeutics, Inc.KYMR1PHASE2KT-621
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Incyte CorporationINCY1PHASE2povorcitinib
Upstream Bio, Inc.UPB1PHASE2Verekitug
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE2ARO-RAGE
Amgen Inc.AMGN1PHASE1AMG 691
Johnson & JohnsonJNJ1PHASE2JNJ-95597528
Apogee Therapeutics, Inc.APGE1PHASE1APG777
Celldex Therapeutics, Inc.CLDX1PHASE1CDX-622
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Frequently asked questions about AZD4604

What is AZD4604?

AZD4604 is an investigational inhaled small molecule developed by AstraZeneca PLC for the treatment of asthma. It is being studied as an inhalation powder and has completed four clinical trials, including Phase 1 and Phase 2 studies, in adults with asthma. It is not yet approved for commercial use.

What is AZD4604 used for in asthma?

AZD4604 is being developed to treat asthma, including moderate-to-severe asthma that is uncontrolled on medium-to-high dose inhaled corticosteroids plus long-acting beta agonists. Clinical studies have evaluated its effects on airway inflammation and biomarkers in adults with asthma. It remains investigational and is not approved for prescribing.

Who makes AZD4604?

AstraZeneca PLC, which trades under the ticker AZN, is the developer of AZD4604. The company sponsors the clinical program evaluating the inhaled small molecule in asthma, including Phase 1 pharmacokinetic and ADME studies and Phase 2 efficacy and biomarker studies.

What phase is AZD4604 in?

AZD4604 has completed Phase 2 clinical development for asthma. Four trials have been completed, including two Phase 1 studies and two Phase 2 studies, with no trials currently active. It is an investigational drug and has not been approved by the FDA.

What clinical trials is AZD4604 in?

AZD4604 has been studied in four completed trials: NCT06020014, a Phase 2a efficacy and safety study in moderate-to-severe asthma; NCT06435273, a Phase 2 airway inflammation and biomarker study; NCT06732882, a Phase 1 pharmacokinetic study using the Turbuhaler device; and NCT06157255, a Phase 1 ADME and bioavailability study.

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