Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GS-9411 · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | GS-9411 9.6 mg |
| 2 | EXPERIMENTAL | GS-9411 4.8 mg |
| 3 | EXPERIMENTAL | GS-9411 2.4 mg |
| 4 | PLACEBO_COMPARATOR | Saline Placebo |
| 5 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| GS-9411 | DRUG | Inhaled GS-9411 dissolved in sterile saline |
| Placebo | DRUG | Inhaled Placebo, sterile saline |
Inclusion Criteria: * Males and females, 18 to 65 years of age * No clinically important abnormal physical findings at Screening * No clinically relevant abnormalities in the results of laboratory evaluation at Screening * Must test negative for hepatitis B virus (HBV), hepatitis C virus (HCV), and...
| 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 |
GS-9411 is an investigational small molecule being developed for cystic fibrosis. It is being studied for its potential effects on mucociliary clearance and airway hydration, which are relevant to the respiratory manifestations of the disease. The drug is in Phase 1 clinical development.
GS-9411 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. The company has sponsored Phase 1 clinical trials of the drug in healthy volunteers.
GS-9411 is in Phase 1 clinical development. All three completed trials of the drug were Phase 1 studies. It is an investigational agent and has not been approved by regulatory authorities for any use.
GS-9411 has completed three Phase 1 trials: NCT00800579, NCT00951522, and NCT00999531. These studies assessed safety, tolerability, and pharmacokinetics in healthy volunteers, with the third being a randomized, double-blind, placebo-controlled multiple-dose trial.
No alternative names for GS-9411 have been reported. The drug is identified solely by its code name GS-9411 in clinical trial records and development documentation.