Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD3199 · 4 trials · 5 indications
Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.
Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7.
change from baseline
change from baseline
Maximum FEV1 value
Residual FEV1 24 h post-dose
Minimum S-potassium concentration (A well-known effect of beta2-agonists (AZD3199 is a beta2-agonist) is a reduction in serum potassium levels. The minimum value has therefore been evaluated.
Average S-potassium concentration
QTcF or QTcI (algorithm based decision)
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | AZD3199 800 µg inhaled via single inhaler device (SID), single dose |
| 2 | EXPERIMENTAL | AZD3199 880 µg inhaled via SID, single dose |
| 3 | EXPERIMENTAL | AZD3199 1400 µg inhaled via SID, single dose |
| 4 | EXPERIMENTAL | AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose |
| 5 | EXPERIMENTAL | AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose |
| 6 | PLACEBO_COMPARATOR | Placebo inhaled via Turbuhaler inhaler and SID, single dose |
| crossover dose 1 | EXPERIMENTAL | AZD3199 120 microgram |
| crossover dose 2 | EXPERIMENTAL | AZD3199 480 microgram |
| crossover dose 3 | EXPERIMENTAL | AZD3199 1920 microgram |
| crossover dose 4 | PLACEBO_COMPARATOR | Placebo |
| crossover dose 5 | ACTIVE_COMPARATOR | Formoterol 9 microgram |
| crossover dose 6 | ACTIVE_COMPARATOR | Formoterol 36 microgram |
| Name | Type | Description |
|---|---|---|
| AZD3199 | DRUG | Inhaled via single inhaler device (SID) |
| AZD3199 Placebo | OTHER | Inhaled via Turbuhaler inhaler and SID |
| formoterol | DRUG | Dry powder for inhalation, b.i.d., 4 weeks |
| Placebo | DRUG | Dry powder for inhalation, b.i.d., 4 weeks |
| Moxifloxacin | DRUG | Single dose, oral encapsulated tablet |
| Placebo comparator | OTHER | Single dose, oral inhalation |
Inclusion Criteria: * Provision of signed and dated written informed consent prior to any study specific procedures * Men or women, age ≥ 18 years. Women must be of non-childbearing potential or stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing ...
Top 16 of 18 competitors
| 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 |
AZD3199 was developed for the treatment of respiratory conditions, specifically asthma and chronic obstructive pulmonary disease (COPD). It is an inhaled small molecule studied as a bronchodilator therapy. All clinical trials of AZD3199 have been completed, and the program reached Phase 2 testing in both asthma and COPD patient populations.
AZD3199 targets ADRB2, the beta-2 adrenergic receptor. It acts as an agonist at this receptor, a mechanism that produces bronchodilation in the airways. This target class is well established in respiratory medicine for relieving airway constriction in conditions such as asthma and COPD.
AZD3199 was developed by AstraZeneca PLC, which trades under the ticker AZN. The compound, identified by ChEMBL ID CHEMBL3545103, was studied as an inhaled small molecule for respiratory indications. AstraZeneca sponsored the clinical trial program evaluating the drug in asthma and COPD.
AZD3199 reached Phase 2 clinical development. It is an investigational drug and is not approved for any indication. The Phase 2 program evaluated the drug in asthma and COPD, and all listed trials for AZD3199 have been completed, with no active trials currently reported.
AZD3199 has been studied in completed trials including NCT00929708, a Phase 2 efficacy study in COPD with 329 patients, and NCT01348139, a Phase 2 pharmacokinetic and pharmacodynamic study in asthma. Earlier studies included NCT01222442, a Phase 1 cardiac safety trial, and NCT00736489, a Phase 2 pharmacodynamic study in asthma.
Across the reported AZD3199 trials, total enrollment was 329 patients in the largest study, NCT00929708, which evaluated efficacy in COPD. Other completed studies enrolled smaller numbers, including 39 patients in the asthma pharmacokinetic trial NCT01348139, 40 in the Phase 1 cardiac safety trial NCT01222442, and 37 in the asthma pharmacodynamic study NCT00736489.