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lofexidine HCl
Lofexidine is an alpha-2 adrenergic agonist that reduces noradrenergic hyperactivity in the central nervous system to alleviate opioid withdrawal symptoms.
Lofexidine is an alpha-2 adrenergic agonist that reduces noradrenergic hyperactivity in the central nervous system to alleviate opioid withdrawal symptoms. Used for Opioid withdrawal.
At a glance
| Generic name | lofexidine HCl |
|---|---|
| Sponsor | USWM, LLC (dba US WorldMeds) |
| Drug class | Alpha-2 adrenergic agonist |
| Target | Alpha-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Addiction Medicine / Substance Use Disorder |
| Phase | FDA-approved |
Mechanism of action
Lofexidine binds to alpha-2 adrenergic receptors in the brain, suppressing the release of norepinephrine and reducing the hyperadrenergic state characteristic of opioid withdrawal. This mechanism dampens withdrawal-related symptoms such as anxiety, agitation, muscle aches, and autonomic hyperactivity without producing opioid-like euphoria or dependence.
Approved indications
- Opioid withdrawal
Common side effects
- Hypotension
- Dizziness
- Sedation
- Dry mouth
- Bradycardia
Key clinical trials
- Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal (PHASE2)
- An Innovative Intervention for OUD Treatment (PHASE2, PHASE3)
- Sublingual Dexmedetomidine for Treating Opioid Withdrawal (PHASE1, PHASE2)
- Evaluating Buspirone to Treat Opioid Withdrawal (PHASE2)
- Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids (PHASE2)
- Assessing a Clinically-meaningful Opioid Withdrawal Phenotype (PHASE2)
- A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects (PHASE1)
- Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder (NA)
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:
- lofexidine HCl CI brief — competitive landscape report
- lofexidine HCl updates RSS · CI watch RSS
- USWM, LLC (dba US WorldMeds) portfolio CI