Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Albuterol DPI/inh · 1 trial · 1 indication
Serial FEV1 measurements to demonstrate the mean AUC change in percent FEV1 from same-day baseline of A006 versus placebo control
| Arm | Type | Description |
|---|---|---|
| T1 | EXPERIMENTAL | Two inhalations, one of Albuterol DPI 25 mcg/inh and one of Placebo DPI; Total Albuterol dose of 25 mcg |
| T2 | EXPERIMENTAL | Two inhalations of Albuterol DPI 25 mcg/inh; Total Albuterol dose of 50 mcg |
| T3 | EXPERIMENTAL | Two inhalations, one of Albuterol DPI 90 mcg/inh and one of Placebo DPI; Total Albuterol dose of 90 mcg |
| T4 | EXPERIMENTAL | Two inhalations of Albuterol DPI 90 mcg/inh; Total Albuterol dose of 180 mcg |
| P | PLACEBO_COMPARATOR | Two inhalations Placebo DPI; Total Albuterol dose of 0 mcg |
| R1 | ACTIVE_COMPARATOR | One inhalation of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 90 mcg |
| R2 | ACTIVE_COMPARATOR | Two inhalations of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 180 mcg |
| Name | Type | Description |
|---|---|---|
| Albuterol DPI 25 mcg/inh | DRUG | Albuterol DPI with 25 mcg Albuterol/inhalation |
| Albuterol DPI 90 mcg/inh | DRUG | Albuterol DPI with 90 mcg Albuterol/inhalation |
| Placebo DPI | DRUG | Placebo DPI with 0 mcg Albuterol/inhalation |
| Albuterol MDI 90 mcg/inh | DRUG | Albuterol MDI with 90 mcg Albtuerol/inhalation |
Inclusion Criteria: * Generally healthy, male and female adults, 18-55 years of age at screening * With mild-to-moderate persistent asthma for at least 6 months prior to screening and having used a beta-agonist(s) inhaler * Demonstrate a Forced Expiratory Volume (FEV1) at 50-85 percent of predicted...
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 | 27 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | tilrekimig and rHuPH20, 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 |
Albuterol DPI/inh is an inhaled dry powder formulation being studied for the treatment of asthma. It is a small molecule bronchodilator delivered directly to the lungs, and it is being developed as an investigational product rather than a marketed therapy.
Albuterol DPI/inh targets ADRB2, the beta-2 adrenergic receptor. It acts as an agonist at this receptor, which is the same target class as other albuterol formulations. The ChEMBL identifier for this target entry is CHEMBL714.
Albuterol DPI/inh is being developed by Amphastar Pharmaceuticals, Inc., which trades under the ticker AMPH. The company is the sponsor behind the clinical program for this inhaled dry powder albuterol product.
Albuterol DPI/inh is in Phase 2 clinical development. It is an investigational product and is not approved for marketing. The Phase 2 program has completed, and no trials are currently listed as active for this asset.
Albuterol DPI/inh has been studied in one completed Phase 2 trial, NCT01581177, titled Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation. The trial enrolled 23 participants with asthma in the United States and was randomized, double-blind, and placebo-controlled.