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 drug being developed by Supernus Pharmaceuticals for moderate to severe opioid use disorder. It is in Phase 2 clinical development and has been studied in a completed multiple-dose pharmacokinetic trial conducted in the United States.
INDV-6001 is being developed for the treatment of moderate to severe opioid use disorder. The completed Phase 2 study enrolled adults 18 years and older with that condition. INDV-6001 remains investigational and is not established as a marketed treatment.
INDV-6001 is being developed by Supernus Pharmaceuticals, Inc., which trades on Nasdaq under the ticker SUPN. Supernus is the sponsor of the clinical program for the drug in opioid use disorder.
INDV-6001 is in Phase 2 clinical development. Its single listed trial, a multiple-dose pharmacokinetic study, is recorded as completed. The drug is investigational, and the available program information does not indicate that it has been approved by the FDA for any use.
INDV-6001 has been studied in one clinical trial, NCT06576843, a Phase 2 multiple-dose pharmacokinetic study in moderate to severe opioid use disorder. The trial was controlled, enrolled 123 participants, included all sexes, and was conducted in the United States. It is listed as completed.