Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IW-6118 · 1 trial · 1 indication
Adverse events, vital signs, laboratory parameters, and ECGs will be assessed.
| Arm | Type | Description |
|---|---|---|
| IW-6118 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Naproxen Sodium | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| IW-6118 | DRUG | Single dose |
| Matching Placebo | DRUG | Single dose of matching placebo for IW-6118 and/or matching placebo for naproxen sodium |
| Naproxen Sodium | DRUG | Single dose |
Inclusion Criteria: * Between 18 and 30 years old at time of screening; * BMI \> 18.5 and \< 30.0; * In overall good health with no clinically-significant laboratory, ECG, or physical exam findings; * Patient requires two ipsilateral third molar extractions of which one must be a full or partial bo...
IW-6118 is an investigational small molecule developed by Ironwood Pharmaceuticals, Inc. (ticker IRWD). It has been studied in a Phase 2 clinical trial in patients undergoing third molar extraction. The specific therapeutic indication for IW-6118 has not been publicly disclosed.
IW-6118 is being developed by Ironwood Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol IRWD. Ironwood is the sponsor of the clinical program for this investigational small molecule.
IW-6118 has completed a Phase 2 clinical trial. It is an investigational drug and is not approved by the FDA. No active trials of IW-6118 are currently listed, and the completed Phase 2 study represents the only registered clinical trial for this asset.
IW-6118 has been evaluated in one registered clinical trial: NCT01107236, titled "Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction." This Phase 2 trial was completed, enrolled 90 participants, and was conducted in the United States.
The Phase 2 trial NCT01107236 was a randomized, double-blind, placebo-controlled study of IW-6118 in patients undergoing third molar extraction. It enrolled 90 participants aged 18 years and older, included both sexes, and was conducted in the United States. The trial has been completed.