Treats alcohol dependence. Sold as Vivitrol. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 14, 2026, FDA lists 2 applications for Naltrexone (sold as Vivitrol), first approved Apr 13, 2006, with 1 new use approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Naltrexone HCl | Part D | $34.0M | +48% | 174,607 |
| The Study of Brave-LC LDN Treatment TrialPost-acute COVID-19 Syndrome · National Institute of Allergy and Infectious Diseases (NIAID) | Phase 3 | Not yet recruiting | Nov 4, 2026 |
| Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use DisorderOpioid Use Disorder, Opioid Withdrawal · Clive Michelsen | Phase 1 / Phase 2 | Not yet recruiting | Oct 13, 2026 |
| A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for VulvodyniaVulvodynia · University of Florida | Phase 2 | Not yet recruiting | Oct 7, 2026 |
| Comparing Different Medication Regimens to Maintaining Weight Loss Among Adults With Obesity Using GLP-1sObesity & Overweight, Cardiometabolic Health Indicators · Jing Luo | Phase 4 | Not yet recruiting | Sep 21, 2026 |
| Pragmatic Trial to Study the Cost-Effectiveness of MyPhenome-RX Test to Guide Anti-Obesity PharmacotherapyObesity & Overweight · Phenomix Sciences | Not applicable | Not yet recruiting | Jul 27, 2026 |
| Naltrexone for Nonsuicidal Self-InjuryNonsuicidal Self-Injury, Self-Injurious Behavior · Seoul National University Hospital | Not applicable | Not yet recruiting | Jun 11, 2026 |
| Evaluate the Efficacy and Safety of Naltrexone Hydrochloride Implant in Patients With Alcohol Use DisorderAlcohol Use Disorder (AUD) · Shenzhen Sciencare Medical Industries Co., Ltd. | Phase 3 | Not yet recruiting | Feb 25, 2026 |
| A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery PatientsObesity, Smoking Cessation · Medical University of South Carolina | Phase 1 / Phase 2 | Not yet recruiting | Feb 9, 2026 |
| Apr 13, 2006 | VivitrolNDA 21897 · New dosage form | Alkermes | 27 | Marketed |
| Jul 6, 2023 | NaltrexoneANDA 213195 | Teva Pharms USA Inc | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
