NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE is indicated for the treatment of Alcohol Dependence.
Details
- Status
- Prescription
- First Approved
- 1998-05-08
- Routes
- ORAL
- Dosage Forms
- TABLET
NALTREXONE HYDROCHLORIDE Approval History
What NALTREXONE HYDROCHLORIDE Treats
1 indicationsNALTREXONE HYDROCHLORIDE is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Alcohol Dependence
NALTREXONE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07398404 | 2000041823 1K23DA064898-01 | Ph 1, Ph 2 | not yet recruiting | A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients |
| NCT07224087 | 2000041069 | Ph 1 | recruiting | Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients |
| NCT03482479 LoDoNaVasc | VCRC5564 | Ph 2 | completed | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis |
| NCT04791969 results posted | 20-32912 R01DA053171 | Ph 2 | completed | Intermittent Oral Naltrexone Enhanced With an Ecological Momentary Intervention for Methamphetamine-using MSM |
| NCT05073679 ONPED results posted | STUDY00014382 150408 | Ph 2, Ph 3 | terminated | Oral Naltrexone In Pediatric Eating Disorders |
| NCT02454712 SAD | PF614-101 | Ph 1 | completed | Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101) |
| NCT05043766 | PF614-102 | Ph 1 | completed | Evaluation of Oral PF614 Relative to OxyContin (PF614-102) |
| NCT05090280 MPAR-101 | QSC203698 5UH3DA047682-04 | Ph 1 | completed | Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101) |
| NCT05955313 | VN21 | Ph 2 | recruiting | Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia |
| NCT03879460 TEST CANADA | 2018-044 | Ph 1 | completed | The Evaluation of Safety and Tolerance of Commercially Available Naltrexone Administered Daily - Assessment for CBRN Operations |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NALTREXONE HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)NALTREXONE HYDROCHLORIDE is indicated for the treatment of Alcohol Dependence.
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Full clinical data, patents, trials, and competitive landscape for naltrexone hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.