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 being studied for use in healthy individuals undergoing third molar extraction, a common dental procedure. It was evaluated in a Phase 2 clinical trial to assess its efficacy and safety in this setting. The drug is not approved and remains in clinical development.
IW-6118 is being developed by Ironwood Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IRWD. The company conducted a Phase 2 trial of the drug in the United States.
IW-6118 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not been approved by regulatory authorities.
IW-6118 has been studied in one completed Phase 2 clinical trial, registered as NCT01107236. The trial, titled 'Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction,' enrolled 90 healthy adult participants in the United States.
IW-6118 is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial. The trial was designed to evaluate its efficacy and safety in healthy individuals undergoing third molar extraction, but the drug remains in clinical development.