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Naltrexon
At a glance
| Generic name | Naltrexon |
|---|---|
| Sponsor | Institute of Liver and Biliary Sciences, India |
| Target | Neuronal acetylcholine receptor subunit alpha-7, Cytochrome P450 2D6, Delta-type opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
Approved indications
- Alcoholism
- Chronic Pain with Opioid Tolerance
- Chronic pain
- Obesity
- Prevention of opioid abuse
- Severe Pain with Opioid Tolerance
- Severe pain
- Therapeutic opioid induced constipation
Common side effects
- Nausea
- Headache
- Dizziness
- Nervousness
- Fatigue
- Insomnia
- Vomiting
- Anxiety
- Somnolence
- Abdominal cramps
- Restlessness
- Bone or joint pain
Serious adverse events
- Hepatocellular injury
- Precipitated opioid withdrawal
- Depression
- Suicidal ideation
- Suicidal attempts
Key clinical trials
- Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1) (PHASE2, PHASE3)
- Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep (PHASE3)
- Preoperative Weight Loss for Open Abdominal Wall Reconstruction (NA)
- A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients (PHASE1, PHASE2)
- Low-dose Naltrexone for Post-COVID Fatigue Syndrome (PHASE2)
- Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients (PHASE1)
- Combination Gerotherapeutic Interventions for Healthspan Improvement (PHASE3)
- Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Naltrexon CI brief — competitive landscape report
- Naltrexon updates RSS · CI watch RSS
- Institute of Liver and Biliary Sciences, India portfolio CI