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Indivior PLC (INDV)
NASDAQ:INDV
SUBLOCADE, Indv-6001, Suboxone
Moderate To Severe Opioid Use Disorder
Phase II
Active Not Recruiting
INDV-6001 Multiple-Dose Pharmacokinetic Study
Aug 27, 2024
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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
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[14C]Idv184001an
Opioid Use Disorder
Phase I
Completed
Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants
Jun 06, 2023
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Buprenorphine Extended-Release Injection
Opioid Use Disorder
Phase IV
Completed
Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations
Jan 19, 2023
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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
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SUBLOCADE
Opioid Use Disorder, Severe, Opioid Use Disorder, Moderate
Phase IV
Completed
SUBLOCADE Rapid Initiation Extension Study
Aug 15, 2019
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SUBLOCADE, Tm Buprenorphine
Opioid-Use Disorder
Phase IV
Completed
SUBLOCADE Rapid Initiation Study
Jun 19, 2019
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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
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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
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
INDV is currently developing the following drugs: SUBLOCADE, Indv-6001, Suboxone, Indv-2000, [14C]Idv184001an. These drug candidates are in various stages of clinical development as the company works toward FDA approval.