Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD4604 for inhalation via DPI
AZD4604 for via DPI · 1 trial · 1 indication
Safety and tolerability of AZD4604 following inhaled administration of single ascending doses to healthy volunteers.
Safety and tolerability of AZD4604 following inhaled administration of multiple ascending doses to healthy volunteers.
Cmax of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
tmax of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
λz of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
t1/2λz of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
AUC (0 - 12) of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
AUC (0 - 24) of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
AUClast of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
AUClast of AZD4604 following PO administration of a single dose to healthy volunteers.
CL of AZD4604 following IV administration of a single dose to healthy volunteers.
Vz/F of AZD4604 following PO administration of a single dose to healthy volunteers.
Vz of AZD4604 following IV administration of a single dose to healthy volunteers.
AUClast/D of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
AUCinf of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
AUCinf/D of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
Cmax/D of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
tlast of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
Safety and tolerability of AZD4604 following inhaled administration of multiple ascending doses to patients.
| Arm | Type | Description |
|---|---|---|
| Part 1a (SAD): AZD4604 for inhalation via DPI (Dose 1) | EXPERIMENTAL | Healthy volunteers will receive a single inhaled dose of AZD4604 Dose 1 administered with a DPI. |
| Part 1a (SAD): AZD4604 for inhalation via DPI (Dose 2) | EXPERIMENTAL | Healthy volunteers will receive a single inhaled dose of AZD4604 Dose 2 administered with a DPI. |
| Part 1a (SAD): AZD4604 for inhalation via DPI(Dose 3) | EXPERIMENTAL | Healthy volunteers will receive a single inhaled dose of AZD4604 Dose 3 administered with a DPI. |
| Part 1a (SAD): AZD4604 for inhalation via DPI (Dose 4) | EXPERIMENTAL | Healthy volunteers will receive a single inhaled dose of AZD4604 Dose 4 administered with a DPI. |
| Part 1a (SAD): AZD4604 for inhalation via DPI (Dose 5) | EXPERIMENTAL | Healthy volunteers will receive a single inhaled dose of AZD4604 Dose 5 administered with a DPI. |
| Part 1a (SAD): AZD4604 for inhalation via DPI (Dose 6) | EXPERIMENTAL | Healthy volunteers will receive a single inhaled dose of AZD4604 Dose 6 administered with a DPI. |
| Part 1a (SAD): AZD4604 for inhalation via DPI (Dose 7) | EXPERIMENTAL | Healthy volunteers will receive a single inhaled dose of AZD4604 Dose 7 administered with a DPI. |
| Part 1a (SAD): AZD4604 for inhalation via DPI | EXPERIMENTAL | An additional cohort of healthy volunteers will receive a single inhaled dose of AZD4604 administered with a DPI. |
| Part 1a (SAD): Placebo for AZD4604 for inhalation via DPI | PLACEBO_COMPARATOR | Healthy volunteers will receive placebo administered with a DPI. |
| Part 1b: AZD4604 for intravenous administration | EXPERIMENTAL | Healthy volunteers will receive a single IV dose of AZD4604 administered as a 20 minute infusion. |
| Part 1b: AZD4604 for oral administration | EXPERIMENTAL | Healthy volunteers will receive a single PO dose of AZD4604. |
| Part 2 (MAD): AZD4604 for inhalation via DPI (Dose 8) | EXPERIMENTAL | Healthy volunteers will receive multiple inhaled dose of AZD4604 administered with a DPI. |
| Part 2 (MAD): AZD4604 for inhalation via DPI (Dose 9) | EXPERIMENTAL | Healthy volunteers will receive multiple inhaled dose of AZD4604 administered with a DPI. |
| Part 2 (MAD): AZD4604 for inhalation via DPI (Dose 10) | EXPERIMENTAL | Healthy volunteers will receive multiple inhaled dose of AZD4604 administered with a DPI. |
| Part 2 (MAD): Placebo for AZD4604 for inhalation via DPI | PLACEBO_COMPARATOR | Healthy volunteers will receive placebo administered with a DPI. |
| Part 3 (MAD): AZD4604 for inhalation via DPI (Dose 9) | EXPERIMENTAL | Patients will receive multiple inhaled dose of AZD4604 administered with a DPI. |
| Part 3 (MAD): AZD4604 for inhalation via DPI (Dose 10) | EXPERIMENTAL | Patients will receive multiple inhaled dose of AZD4604 administered with a DPI. |
| Part 3 (MAD): Placebo for AZD4604 for inhalation via DPI | PLACEBO_COMPARATOR | Patients will receive placebo administered with a DPI. |
| Part 3 (PoM): AZD4604 for inhalation via DPI (Dose 9 or Dose 10) | EXPERIMENTAL | Patients will receive multiple inhaled dose of AZD4604 administered with a DPI. |
| Name | Type | Description |
|---|---|---|
| AZD4604 for inhalation via DPI | DRUG | Healthy volunteers will receive AZD4604 administered with a DPI. The dose is expected to be administered between 10 to 45 minutes, depending upon dose. The dose will be administered after an overnight fast of at least 10 hours. Healthy volunteers will be allowed to drink water to prevent dehydration until 1 hour before dosing. |
| Placebo for AZD4604 for inhalation via DPI | DRUG | Part 1a: An additional cohort of healthy volunteers will receive a placebo administered with a DPI. Part 2: Healthy volunteers will receive placebo administered with a DPI. They will receive BID doses on Day 1 to Day 6, and a single dose will be administered on Day 7. Part 3: Patients will receive placebo administered with a DPI. They will receive BID doses on Day 1 to Day 9, and a single dose will be administered on Day 10. |
| AZD4604 for IV administration | DRUG | Healthy volunteers will receive a single IV dose of AZD4604 administered over 20 minutes. The dose will be administered after an overnight fast of at least 10 hours. Healthy volunteers will be allowed to drink water to prevent dehydration until 1 hour before dosing. |
| AZD4604 for oral administration | DRUG | Healthy volunteers will receive a single PO dose of AZD4604. The dose will be administered after an overnight fast of at least 10 hours. Healthy volunteers will be allowed to drink water to prevent dehydration until 1 hour before dosing. |
Inclusion criteria: All Study Parts: * Provision of signed and dated, written informed consent prior to any study specific procedures. * Female subjects must have a negative pregnancy test at the Screening Visit and on admission to the Study Center or prior to randomization for Part 3 (Day -1 or D...
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| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
AZD4604 for inhalation via DPI is an investigational small molecule developed by AstraZeneca PLC for the treatment of asthma. It is delivered by dry powder inhaler and has been studied in a Phase 1 clinical trial that enrolled 110 participants, including healthy volunteers and patients with mild asthma.
AZD4604 is being developed as an inhaled treatment for asthma. AstraZeneca studied it in a Phase 1 trial that included healthy volunteers and patients with mild asthma, evaluating the medicine given through a dry powder inhaler. It is investigational and has not been established as a marketed therapy.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of AZD4604 for inhalation via DPI. The company sponsored the Phase 1 clinical trial of the inhaled small molecule in asthma conducted in the United Kingdom.
AZD4604 is in Phase 1 development. The single recorded trial, NCT04769869, was a Phase 1 study in healthy volunteers and patients with mild asthma, and it has been completed. The program remains investigational and is not an approved asthma treatment.
AZD4604 has been studied in one clinical trial, NCT04769869, titled a clinical trial in healthy volunteers and patients with mild asthma to investigate a new medicine (AZD4604) for the treatment of asthma. The Phase 1 study enrolled 110 participants in the United Kingdom and is completed.
Yes, AZD4604 for via DPI and AZD4604 for inhalation via DPI refer to the same AstraZeneca asthma candidate. Both names describe the small molecule AZD4604 delivered as a dry powder inhaler, the formulation studied in the completed Phase 1 trial NCT04769869.