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naltrexone

Generic: NALTREXONE·Brand: Contrave, NALTREXONE, NALTREXONE HYDROCHLORIDE, REVIA, ReVia, VIVITROL, Vivitrol

naltrexone: sourced relationships with 1 company · 1 clinical trial tracked · 1 FDA decision.

naltrexone evidence translation

What we can confirm

1 FDA record · 1 tracked trial

What it means

Source-backed records connect naltrexone to ALKS; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could naltrexone → ALKS affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 0 study sponsors

Related indications

Treatment of alcohol dependence in patients able to abstain from alcohol prior to initiation; Prevention of relapse to opioid dependence following opioid detoxificationMajor Depressive Disorder

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
Alkermes plc. (ALKS)
owner · Reported 2025-02-12 · Current development: unknownSource
Treatment of alcohol dependence in patients able to abstain …
Approved
Clinical Trial Registry Records (1)

Neurocomputational Mechanisms of Mood Improvement

NCT04276259Registry updated 2026-02-13·Phase 4
Completed

Primary endpoint: BOLD Responses in the vmPFC-VS circuit

InterventionalRandomizeddouble120 enrolledStarted 2020-10Completion 2026-011 site · United StatesMarta Peciña, MD PhD
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support. VIVITROL contains naltrexone, an opioid antagonist, and is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration ( 1.1 ). VIVITROL is indicated for the preve(ALKS)FDA ↗
NDA021897Type 3 - New Dosage FormPriority ReviewPrioritySubcutaneousFor Suspension, Extended Release

Frequently asked questions

Which companies have sourced relationships with naltrexone?

naltrexone has dated SEC/FDA relationship records for Alkermes plc..

How many clinical trials involve naltrexone?

BioSniper tracks 1 clinical trial involving naltrexone.

What is naltrexone's latest FDA decision?

The most recent tracked FDA decision for naltrexone is Approval for 1 INDICATIONS AND USAGE Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support. VIVITROL contains naltrexone, an opioid antagonist, and is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration ( 1.1 ). VIVITROL is indicated for the preve, dated April 13, 2006.