Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06384157 | Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder | PHASE2 | COMPLETED | 300 | — | — | Jun 10, 2024 | Nov 3, 2025 | Dec 16, 2025 | 35 | United States |
The treatment failure is defined as meeting either one of the two criteria. 1. Urine Drug Screen (UDS, dipstick) positive for opioids, or fentanyl on 4 consecutive assessments while participants on the Investigational Medicinal Product (IMP) (INDV-2000 or placebo) alone (after Day 8 visit). 2. Discontinued the IMP (INDV-2000 or placebo) prematurely.
| Arm | Type | Description |
|---|---|---|
| 100 mg INDV-2000 QD dosed by two 50 mg extended-release tablets | EXPERIMENTAL | - |
| 200 mg INDV-2000 QD dosed by two 100 mg extended-release tablets | EXPERIMENTAL | - |
| 400 mg INDV-2000 QD dosed by two 200 mg extended-release tablets | EXPERIMENTAL | - |
| Placebo dose | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| INDV-2000 | DRUG | INDV-2000 is a highly potent and selective OX1R antagonist that is being developed as a therapy for the treatment of OUD. |
| Placebo | OTHER | This is a randomized, double-blind, placebo-controlled study. |
Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant must be 18 or the legal age of consent in the jurisdiction in which the study is taking place to 65 years of age inclusive, at the time of signing the informed ...