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Indivior (INDV) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| SUBLOCADE, Indv-6001, Suboxone | Moderate To Severe Opioid Use Disorder | Phase II | Active Not Recruiting | INDV-6001 Multiple-Dose Pharmacokinetic Study | Aug 27, 2024 | ― |
| Indv-2000 | Opioid Use Disorder | Phase II | Active Not Recruiting | Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder | Apr 22, 2024 | ― |
| [14C]Idv184001an | Opioid Use Disorder | Phase I | Completed | Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants | Jun 06, 2023 | ― |
| Buprenorphine Extended-Release Injection | Opioid Use Disorder | Phase IV | Completed | Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations | Jan 19, 2023 | ― |
| Transmucosal Buprenorphine, Extended-Release Buprenorphine | Moderate To Severe Opioid-Use Disorder | Phase IV | Completed | Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users | Jul 29, 2021 | ― |
| SUBLOCADE | Opioid Use Disorder, Severe, Opioid Use Disorder, Moderate | Phase IV | Completed | SUBLOCADE Rapid Initiation Extension Study | Aug 15, 2019 | ― |
| SUBLOCADE, Tm Buprenorphine | Opioid-Use Disorder | Phase IV | Completed | SUBLOCADE Rapid Initiation Study | Jun 19, 2019 | ― |
| Buprenorphine Injectable Solution - Part A, Fentanyl - Part A, Ondansetron - Parts A + B, Buprenorphine Injectable Solution - Part B, Fentanyl - Part B, Oxycodone - Part B | Healthy, Opioid Use | Phase I | Completed | Buprenorphine-Fentanyl Interaction Study | Nov 16, 2018 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| SUBLOCADE, Indv-6001, Suboxone | Phase II | Moderate To Severe Opioid Use Disorder | Active Not Recruiting | INDV-6001 Multiple-Dose Pharmacokinetic Study | Aug 27, 2024 | ― |
| Indv-2000 | Phase II | Opioid Use Disorder | Active Not Recruiting | Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder | Apr 22, 2024 | ― |
| [14C]Idv184001an | Phase I | Opioid Use Disorder | Completed | Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants | Jun 06, 2023 | ― |
| Buprenorphine Extended-Release Injection | Phase IV | Opioid Use Disorder | Completed | Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations | Jan 19, 2023 | ― |
| Transmucosal Buprenorphine, Extended-Release Buprenorphine | Phase IV | Moderate To Severe Opioid-Use Disorder | Completed | Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users | Jul 29, 2021 | ― |
| SUBLOCADE | Phase IV | Opioid Use Disorder, Severe, Opioid Use Disorder, Moderate | Completed | SUBLOCADE Rapid Initiation Extension Study | Aug 15, 2019 | ― |
| SUBLOCADE, Tm Buprenorphine | Phase IV | Opioid-Use Disorder | Completed | SUBLOCADE Rapid Initiation Study | Jun 19, 2019 | ― |
| Buprenorphine Injectable Solution - Part A, Fentanyl - Part A, Ondansetron - Parts A + B, Buprenorphine Injectable Solution - Part B, Fentanyl - Part B, Oxycodone - Part B | Phase I | Healthy, Opioid Use | Completed | Buprenorphine-Fentanyl Interaction Study | Nov 16, 2018 | ― |
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Indivior PLC (INDV) have in its pipeline
Indivior INDV is currently developing the following drugs: SUBLOCADE, Indv-6001, Suboxone, Indv-2000, [14C]Idv184001an, Buprenorphine Extended-Release Injection, Transmucosal Buprenorphine, Extended-Release Buprenorphine, SUBLOCADE, SUBLOCADE, Tm Buprenorphine, Buprenorphine Injectable Solution - Part A, Fentanyl - Part A, Ondansetron - Parts A + B, Buprenorphine Injectable Solution - Part B, Fentanyl - Part B, Oxycodone - Part B. These drug candidates are in various stages of clinical development as the company works toward FDA approval.