Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INDV-2000 · 4 trials · 5 indications
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.
An adverse event (AE) was considered related to study drug if it could not reasonably be explained by other factors. A serious AE is any event that met any of the following criteria: * Death * Life-threatening * In-patient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other important medical event that may have jeopardized the participant or required an intervention to prevent an above outcome. A severe AE describes the intensity of an AE, defined as causing marked limitation in activity; medical intervention or therapy or hospitalization required. For vital sign and laboratory abnormalities assessed as AEs, intensity was graded in accordance with the Food and Drug Administration Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, where Grade 3 = serious and Grade 4 = potentially life-threatening.
| 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 | - |
| INDV-2000 BID + Midazolam | EXPERIMENTAL | Participants will receive a single oral dose of 5 mg midazolam on Day 1. Participants will receive a dose of INDV-2000 twice a day (BID) from Days 2 to 15. On Day 15 participants will also receive a single oral dose of 5 mg midazolam co-administered with the INDV-2000 morning dose. |
| Part I Cohort 1 INDV-2000 100 mg QD | EXPERIMENTAL | Healthy volunteers will receive INDV-2000 100 mg once daily for 7 days. |
| Part I Cohort 1 Placebo | PLACEBO_COMPARATOR | Healthy volunteers will receive placebo once daily for 7 days. |
| Part I Cohort 2 INDV-2000 100 mg BID | EXPERIMENTAL | Healthy volunteers will receive INDV-2000 100 mg twice daily for 7 days. |
| Part I Cohort 2 Placebo | PLACEBO_COMPARATOR | Healthy volunteers will receive placebo twice daily for 7 days. |
| Part II Cohort 1 INDV-2000 200 mg BID | EXPERIMENTAL | Healthy volunteers will receive INDV-2000 200 mg twice daily for 28 days. |
| Part II Cohort 1 Placebo | PLACEBO_COMPARATOR | Healthy volunteers will receive placebo twice daily for 28 days. |
| Part II Cohort 2 INDV-2000 400 mg BID | EXPERIMENTAL | Healthy volunteers will receive INDV-2000 400 mg twice daily for 28 days. |
| Part II Cohort 2 Placebo | PLACEBO_COMPARATOR | Healthy volunteers will receive placebo twice daily for 28 days. |
| Part III INDV-2000 400 mg BID + SUBOXONE SL Film | EXPERIMENTAL | Participants with opioid use disorder will receive SUBOXONE sublingual (SL) film for 6 days during the run-in period. Participants will then receive SUBOXONE SL film alone for 2 days, then SUBOXONE SL film and INDV-2000 for 7 days followed by INDV-2000 dosing alone for 4 days. |
| Part I: INDV-2000 | EXPERIMENTAL | Participants will receive a single dose of INDV-2000. The starting dose is 1 mg with dose escalation dependent upon observed clinical safety, tolerability and pharmacokinetics. |
| Part I: Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of matching placebo. |
| Part II: INDV-2000 Fasted/Fed | EXPERIMENTAL | Participants will receive a single dose of INDV-2000 orally on Day 1 under fasted conditions and a single dose of INDV-2000 after a high-fat breakfast on Day 8. Dose to be determined based on a well-tolerated dose studied in Part I. |
| 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. |
| Midazolam | DRUG | Midazolam syrup administered orally on Days 1 and 15 |
| SUBOXONE® sublingual film | DRUG | Administered either under the tongue (sublingual) or between the gum and cheek (buccal) |
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 ...
INDV-2000 is an investigational small molecule being developed for opioid use disorder and opioid dependence. It has been studied in healthy volunteers and in treatment-seeking individuals with opioid use disorder, including a proof-of-concept trial in people with moderate to severe opioid use disorder.
INDV-2000 is being developed by Indivior Pharmaceuticals, Inc., a company listed on the stock exchange under the ticker INDV. The developer is a pharmaceutical company focused on treatments for addiction and related disorders.
INDV-2000 is in Phase 2 clinical development. It has completed Phase 1 trials in healthy volunteers and individuals with opioid dependence, and a Phase 2 proof-of-concept and dose-ranging study in opioid use disorder has also been completed.
INDV-2000 has been studied in several clinical trials, including NCT04413552 (first in human), NCT04976855 (repeated doses in healthy volunteers and opioid use disorder), NCT05694533 (CYP3A4 induction in healthy adults), and NCT06384157 (proof of concept in moderate to severe opioid use disorder). All trials are completed.
INDV-2000 is not FDA approved. It is an investigational drug that has completed Phase 1 and Phase 2 clinical trials, but it remains in clinical development and has not been approved for any use.