Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INDV-6001 · 1 trial · 1 indication
AUCtau for Cohorts 1-4
Cmax for Cohorts 1-4
Tmax for Cohorts 1-4
Cmin for Cohorts 1-4
Ctrough for Cohorts 1-4
Cavg for Cohorts 1-4
% fluctuation for Cohorts 1-4
AUCtau for Cohort 1a \[Day 260 injection in the back of the upper arm\] Vs Cohort 1 \[Day 176 Injection in the abdomen\]
Cmax for Cohort 1a \[Day 260 injection in the back of the upper arm\] Vs Cohort 1 \[Day 176 Injection in the abdomen\]
Tmax for Cohort 1a \[Day 260 injection in the back of the upper arm\] Vs Cohort 1 \[Day 176 Injection in the abdomen\]
Cmin for Cohort 1a \[Day 260 injection in the back of the upper arm\] Vs Cohort 1 \[Day 176 Injection in the abdomen\]
Ctrough for Cohort 1a \[Day 260 injection in the back of the upper arm\] Vs Cohort 1 \[Day 176 Injection in the abdomen\]
Cavg for Cohort 1a \[Day 260 injection in the back of the upper arm\] Vs Cohort 1 \[Day 176 Injection in the abdomen\]
% fluctuation for Cohort 1a \[Day 260 injection in the back of the upper arm\] Vs Cohort 1 \[Day 176 Injection in the abdomen\]
AUCtau for Cohort 2a \[Day 232 injection in the Thigh\] Vs Cohort 2 \[Day 176 injection in the abdomen\]
Cmax for Cohort 2a \[Day 232 injection in the Thigh\] Vs Cohort 2 \[Day 176 injection in the abdomen\]
Tmax for Cohort 2a \[Day 232 injection in the Thigh\] Vs Cohort 2 \[Day 176 injection in the abdomen\]
Cmin for Cohort 2a \[Day 232 injection in the Thigh\] Vs Cohort 2 \[Day 176 injection in the abdomen\]
Ctrough for Cohort 2a \[Day 232 injection in the Thigh\] Vs Cohort 2 \[Day 176 injection in the abdomen\]
Cavg for Cohort 2a \[Day 232 injection in the Thigh\] Vs Cohort 2 \[Day 176 injection in the abdomen\]
% fluctuation for Cohort 2a \[Day 232 injection in the Thigh\] Vs Cohort 2 \[Day 176 injection in the abdomen\]
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, followed by 600 mg on Day 8, Day 92, and Day 176) |
| Cohort 2 | EXPERIMENTAL | SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, followed by 600 mg on Day 8, Day 64, Day 120, and Day 176) |
| Cohort 3 | EXPERIMENTAL | SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, 600 mg Day 8, followed by 250 mg on Day 15, Day 43, Day 71, and Day 99) |
| Cohort 4 | EXPERIMENTAL | SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, followed by 100 mg on Day 8, Day 36, Day 64, and Day 92) |
| Cohort 1a | EXPERIMENTAL | In Cohort 1, up to 15 participants who reach Day 260 will be enrolled into Cohort 1a. Participants in Cohort 1a will receive an additional injection of INDV-6001 600 mg in the back of the upper arm on Day 260. |
| Cohort 2a | EXPERIMENTAL | In Cohort 2, up to 15 participants who reach Day 232 will be enrolled into Cohort 2a. Participants in Cohort 2a will receive an additional injection of INDV-6001 600 mg in the thigh on Day 232. |
| Cohort 3a | EXPERIMENTAL | In Cohort 3, up to 15 participants who reach Day 127 will be enrolled into Cohort 3a. Participants in Cohort 3a will receive an injection of SUBLOCADE 300 mg (abdomen) on Day 127. |
| Cohort 4a | EXPERIMENTAL | In Cohort 4, up to 15 participants who reach Day 120 will be enrolled in Cohort 4a. Participants in Cohort 4a will receive an injection of SUBLOCADE 100 mg (abdomen) on Day 120. |
| Cohort 7 | EXPERIMENTAL | Participants in Cohort 7 who are new to BUP treatment will undergo rapid induction with SUBLOCADE 300 mg (per product labelling) in the abdomen on Day 1 following an initial dose of SUBOXONE (eg, 4 mg). All participants in Cohort 7 will receive: SUBLOCADE 300 mg (abdomen) on Day 1 and Day 8, SUBLOCADE 100 mg (abdomen) on Day 36, and 600mg INDV-6001 on Day 64. |
| Name | Type | Description |
|---|---|---|
| INDV-6001 | DRUG | Extended-release subcutaneous injection |
| Suboxone | DRUG | Oral sublingual film |
| Sublocade | DRUG | Extended-release subcutaneous injection |
Inclusion Criteria Participants are eligible to be included in any cohort open to enrolment in the study only if all of the following criteria apply: 1. Has signed the ICF and have the ability to understand and comply with the requirements and restrictions listed therein 2. Is an adult (male or fe...
INDV-6001 is an investigational small molecule being developed for the treatment of moderate to severe opioid use disorder. It is currently in Phase 2 clinical development and has completed a multiple-dose pharmacokinetic study in the United States.
INDV-6001 is being developed by Indivior Pharmaceuticals, Inc., a company listed on the stock exchange under the ticker INDV. The drug is currently in Phase 2 clinical development for moderate to severe opioid use disorder.
INDV-6001 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 multiple-dose pharmacokinetic study has been completed in patients with moderate to severe opioid use disorder.
INDV-6001 has one completed clinical trial, NCT06576843, titled "INDV-6001 Multiple-Dose Pharmacokinetic Study." This Phase 2 study enrolled 123 participants with moderate to severe opioid use disorder in the United States, with a minimum age of 18 years.
No alternative names for INDV-6001 have been disclosed. The drug is identified solely by its development code INDV-6001 and is being studied for moderate to severe opioid use disorder.