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XR-NTX 380 mg, intramuscular injection
XR-NTX 380 mg, intramuscular injection is a Opioid receptor antagonist Small molecule drug developed by University of Pennsylvania. It is currently FDA-approved for Opioid use disorder (prevention of relapse and maintenance of abstinence). Also known as: Vivitrol naltrexone for extended-release injectable suspension.
XR-NTX 380 mg is an extended-release formulation of naltrexone that blocks opioid receptors to prevent opioid use and reduce cravings in opioid use disorder.
XR-NTX 380 mg is an extended-release formulation of naltrexone that blocks opioid receptors to prevent opioid use and reduce cravings in opioid use disorder. Used for Opioid use disorder (prevention of relapse and maintenance of abstinence).
At a glance
| Generic name | XR-NTX 380 mg, intramuscular injection |
|---|---|
| Also known as | Vivitrol naltrexone for extended-release injectable suspension |
| Sponsor | University of Pennsylvania |
| Drug class | Opioid receptor antagonist |
| Target | Mu opioid receptor (primary); delta and kappa opioid receptors |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Addiction Medicine |
| Phase | FDA-approved |
Mechanism of action
Naltrexone is a competitive opioid receptor antagonist that binds to mu, delta, and kappa opioid receptors with high affinity. The extended-release intramuscular formulation provides sustained drug delivery over approximately one month, maintaining therapeutic opioid receptor blockade and reducing the reinforcing effects of opioid use. This mechanism helps prevent relapse and supports abstinence in patients with opioid use disorder.
Approved indications
- Opioid use disorder (prevention of relapse and maintenance of abstinence)
Common side effects
- Injection site reactions (pain, erythema, induration)
- Nausea
- Headache
- Insomnia
- Anxiety
- Hepatotoxicity (elevated liver enzymes)
Key clinical trials
- Naltrexone in AUD Reward Drinkers (PHASE4)
- Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults (PHASE4)
- Alcohol Disorder hOsPital Treatment Trial (PHASE4)
- Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway (PHASE3)
- Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM) (PHASE2)
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:
- XR-NTX 380 mg, intramuscular injection CI brief — competitive landscape report
- XR-NTX 380 mg, intramuscular injection updates RSS · CI watch RSS
- University of Pennsylvania portfolio CI
Frequently asked questions about XR-NTX 380 mg, intramuscular injection
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Related
- Drug class: All Opioid receptor antagonist drugs
- Target: All drugs targeting Mu opioid receptor (primary); delta and kappa opioid receptors
- Manufacturer: University of Pennsylvania — full pipeline
- Therapeutic area: All drugs in Psychiatry / Addiction Medicine
- Indication: Drugs for Opioid use disorder (prevention of relapse and maintenance of abstinence)
- Also known as: Vivitrol naltrexone for extended-release injectable suspension
- Compare: XR-NTX 380 mg, intramuscular injection vs similar drugs
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