Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IW-3300 · 2 trials · 1 indication
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is lifethreatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; or other situations such as important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. An SAE was considered a treatment-emergent SAE (serious TEAE) if the SAE started after initial study drug administration and within 1 day of the last dose of study drug.
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: 100 μg IW-3300 | EXPERIMENTAL | 100 μg dose of active drug (IW-3300) once daily for 7 days |
| Cohort 1: Placebo | PLACEBO_COMPARATOR | matching placebo once daily for 7 days |
| Cohort 2: 300 μg IW-3300 | EXPERIMENTAL | 300 μg dose of active drug (IW-3300) once daily for 7 days |
| Cohort 2: Placebo | PLACEBO_COMPARATOR | matching placebo once daily for 7 days |
| Cohort 3 (optional): Dose 3 | EXPERIMENTAL | Active drug (IW-3300) once daily for 7 days |
| Cohort 3 (optional): Placebo | PLACEBO_COMPARATOR | Matching placebo once daily for 7 days |
| Cohort 3: 900 μg IW-3300 | EXPERIMENTAL | Dose 3: within the cohort, 6 participants receive active drug (IW-3300) |
| Cohort 3: Placebo | PLACEBO_COMPARATOR | Within the cohort, 2 participants will receive the matching placebo dose |
| Cohort 4: 2500 μg IW-3300 | EXPERIMENTAL | Dose 4: within the cohort, 6 participants receive active drug (IW-3300) |
| Cohort 4: Placebo | PLACEBO_COMPARATOR | Within the cohort, 2 participants will receive the matching placebo dose |
| Name | Type | Description |
|---|---|---|
| IW-3300 | DRUG | A dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema). |
| Placebo | DRUG | A dose of placebo administered rectally (as a low-volume \[20 mL\] enema). |
Inclusion Criteria: * Males and female subjects of non-childbearing potential * Ages 18 to 60 years * Medically healthy with no clinically significant findings during medical evaluation including physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests. * Body mass index...
IW-3300 is an investigational small molecule being developed by Ironwood Pharmaceuticals, Inc. It has been studied in Phase 1 clinical trials in healthy volunteers. No approved indication has been announced for IW-3300, and it remains in early clinical development.
IW-3300 is being developed by Ironwood Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker IRWD. Ironwood is the sponsor of the clinical program for this investigational small molecule.
IW-3300 is in Phase 1 development. Two Phase 1 trials have been completed, and no active trials are currently listed. The program has not advanced beyond early-stage clinical testing, and IW-3300 is not approved for any indication.
IW-3300 has been evaluated in two completed Phase 1 trials. NCT05188261 studied single ascending doses in healthy volunteers with 32 participants, and NCT05362695 studied multiple ascending doses in healthy subjects with 18 participants. Both trials were conducted in the United States.
Yes. The IW-3300 Phase 1 trials were randomized, double-blind, and placebo-controlled. Together they enrolled 50 healthy adult volunteers aged 18 years and older in the United States. NCT05188261 tested single ascending doses, and NCT05362695 tested multiple ascending doses.