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Open Label Lofexidine HCL
Open Label Lofexidine HCL is a Alpha-2 adrenergic agonist Small molecule drug developed by USWM, LLC (dba US WorldMeds). It is currently in Phase 3 development for Opioid withdrawal syndrome.
Lofexidine is an alpha-2 adrenergic agonist that reduces noradrenergic hyperactivity associated with opioid withdrawal.
Lofexidine is an alpha-2 adrenergic agonist that reduces noradrenergic hyperactivity associated with opioid withdrawal. Used for Opioid withdrawal syndrome.
At a glance
| Generic name | Open Label 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 | Phase 3 |
Mechanism of action
Lofexidine binds to alpha-2 adrenergic receptors in the central nervous system, suppressing the release of norepinephrine and reducing the sympathomimetic symptoms of opioid withdrawal such as anxiety, irritability, and physical discomfort. By dampening the hyperactive noradrenergic state that occurs when opioids are discontinued, it alleviates withdrawal symptoms without producing euphoria or abuse potential.
Approved indications
- Opioid withdrawal syndrome
Common side effects
- Dry mouth
- Dizziness
- Sedation
- Hypotension
- Bradycardia
Key clinical trials
- Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids (PHASE2)
- Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal (PHASE3)
- Open-Label, Safety Study of Lofexidine (PHASE3)
- Lofexidine Food Effect Study in Healthy Volunteers (PHASE1)
- Lofexidine Mass Balance in Volunteers (PHASE1)
- Lofexidine ADME & Mass Balance in Volunteers (PHASE1)
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:
- Open Label Lofexidine HCL CI brief — competitive landscape report
- Open Label Lofexidine HCL updates RSS · CI watch RSS
- USWM, LLC (dba US WorldMeds) portfolio CI
Frequently asked questions about Open Label Lofexidine HCL
What is Open Label Lofexidine HCL?
How does Open Label Lofexidine HCL work?
What is Open Label Lofexidine HCL used for?
Who makes Open Label Lofexidine HCL?
What drug class is Open Label Lofexidine HCL in?
What development phase is Open Label Lofexidine HCL in?
What are the side effects of Open Label Lofexidine HCL?
What does Open Label Lofexidine HCL target?
Related
- Drug class: All Alpha-2 adrenergic agonist drugs
- Target: All drugs targeting Alpha-2 adrenergic receptor
- Manufacturer: USWM, LLC (dba US WorldMeds) — full pipeline
- Therapeutic area: All drugs in Addiction Medicine / Substance Use Disorder
- Indication: Drugs for Opioid withdrawal syndrome
- Compare: Open Label Lofexidine HCL vs similar drugs
- Pricing: Open Label Lofexidine HCL cost, discount & access