LOFEXIDINE HYDROCHLORIDE
Lofexidine hydrochloride helps adults manage the physical symptoms that occur when they suddenly stop taking opioids. It is used to make the process of opioid discontinuation more manageable for patients. This medication provides support during the transition period to help individuals successfully stop their opioid use.
How LOFEXIDINE HYDROCHLORIDE Works
This drug works by binding to alpha-2 adrenergic receptors on neurons in the central nervous system. This interaction reduces the release of norepinephrine and lowers sympathetic tone. By decreasing these signals, the medication helps mitigate the physiological effects of opioid withdrawal.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-08-20
- Routes
- ORAL
- Dosage Forms
- TABLET
LOFEXIDINE HYDROCHLORIDE Approval History
What LOFEXIDINE HYDROCHLORIDE Treats
1 indicationsLOFEXIDINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Opioid Withdrawal
LOFEXIDINE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01629446 | USWM-LX1-1003-1 1R01DA030916-01 | Ph 1 | completed | Lofexidine Mass Balance in Volunteers |
| NCT01310296 | USWM-LX1-1003/ 02749MZ | Ph 1 | completed | Lofexidine ADME & Mass Balance in Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LOFEXIDINE HYDROCHLORIDE FDA Label Details
Indications & Usage
LOFEXIDINE HYDROCHLORIDE is indicated for the treatment of Opioid Withdrawal.
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LUCEMYRA
Full clinical data, patents, trials, and competitive landscape for lofexidine hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment