Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZLI three times a day · 1 trial · 1 indication
The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R respiratory symptoms scale (RSS; range of scores: 0-100; higher scores indicate fewer symptoms).
| Arm | Type | Description |
|---|---|---|
| Placebo three times a day (TID) | PLACEBO_COMPARATOR | - |
| AZLI 75 mg three times a day (TID) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AZLI 75 mg three times a day (TID) | DRUG | - |
| Placebo three times a day (TID) | DRUG | - |
Inclusion Criteria: * Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria: * Sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT); * Two well-cha...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-581, VX-272 |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Roivant Sciences Ltd. | ROIV | 1 | PHASE1 | SP-101 |
AZLI three times a day is an inhaled small molecule antibiotic regimen being studied in cystic fibrosis. It is designed to treat cystic fibrosis patients with Pseudomonas aeruginosa lung infection. Gilead Sciences is developing it as a Phase 3 candidate, and the completed trial enrolled 166 participants aged 6 years and older.
AZLI three times a day is being developed by Gilead Sciences, Inc., which trades on Nasdaq under the ticker GILD. The company sponsored the Phase 3 program evaluating this inhaled antibiotic regimen in cystic fibrosis patients with P. aeruginosa infection.
AZLI three times a day is in Phase 3 development. The single registered trial, NCT00112359, is a completed Phase 3 study. AZLI three times a day is investigational and has not been established as an approved therapy based on the information available.
AZLI three times a day has been evaluated in one registered clinical trial, NCT00112359, titled International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa. It was a completed Phase 3 randomized, double-blind, placebo-controlled study with 166 participants across the United States, Australia, Canada, and New Zealand.