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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | VX-121/TEZ/D-IVA |
| Sionna Therapeutics, Inc. | SION | 2 | PHASE2 | SION-719 |
| 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 |
| Illumina, Inc. | ILMN | 1 | - | Undisclosed |
AZLI three times a day is an investigational small molecule being studied for the treatment of cystic fibrosis. It is a formulation of aztreonam for inhalation solution designed to be administered three times daily. The drug is being evaluated in patients with cystic fibrosis who have Pseudomonas aeruginosa infection.
AZLI three times a day is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. Gilead is conducting clinical research to evaluate the safety and efficacy of this inhaled aztreonam formulation in cystic fibrosis patients.
AZLI three times a day is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under clinical investigation for cystic fibrosis.
AZLI three times a day has one completed Phase 3 clinical trial, registered as NCT00112359. This was an international, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of the drug in cystic fibrosis patients with Pseudomonas aeruginosa. The trial enrolled 166 participants across the United States, Australia, Canada, and New Zealand.
AZLI three times a day is a formulation of aztreonam for inhalation solution, abbreviated as AZLI. The drug is being studied specifically for administration three times a day in cystic fibrosis patients. The clinical trial NCT00112359 evaluated this inhaled aztreonam formulation in patients with Pseudomonas aeruginosa infection.