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Naltrexone Oral Product
Naltrexone is an opioid receptor antagonist that blocks the effects of opioids and endogenous opioid peptides in the central nervous system.
Naltrexone is an opioid receptor antagonist that blocks the effects of opioids and endogenous opioid peptides in the central nervous system. Used for Opioid use disorder, Alcohol use disorder.
At a glance
| Generic name | Naltrexone Oral Product |
|---|---|
| Sponsor | Texas Tech University |
| Drug class | Opioid receptor antagonist |
| Target | Opioid receptors (mu, delta, kappa) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Addiction Medicine |
| Phase | FDA-approved |
Mechanism of action
Naltrexone competitively binds to opioid receptors (mu, delta, and kappa) with highest affinity for mu receptors, preventing opioid agonists from activating these receptors. This mechanism is used to treat opioid use disorder by reducing cravings and blocking the rewarding effects of opioids, and also to treat alcohol use disorder through modulation of endogenous opioid signaling involved in reward pathways.
Approved indications
- Opioid use disorder
- Alcohol use disorder
Common side effects
- Nausea
- Headache
- Anxiety
- Insomnia
- Abdominal pain
- Joint and muscle pain
Key clinical trials
- Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT) (PHASE2)
- Rapid Antidepressant Improvement Secondary to Excitatory Brain Responses (PHASE4)
- Low-Dose Naltrexone For ME/CFS: Dose-Finding (PHASE2)
- A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence (PHASE2)
- Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis (PHASE2)
- A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America (PHASE4)
- Intermittent Oral Naltrexone Enhanced With an Ecological Momentary Intervention for Methamphetamine-using MSM (PHASE2)
- Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Naltrexone Oral Product CI brief — competitive landscape report
- Naltrexone Oral Product updates RSS · CI watch RSS
- Texas Tech University portfolio CI