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Open Label Lofexidine HCL — Competitive Intelligence Brief

Open Label Lofexidine HCL (Open Label Lofexidine HCL) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Alpha-2 adrenergic agonist. Area: Addiction Medicine / Substance Use Disorder.

phase 3 Alpha-2 adrenergic agonist Alpha-2 adrenergic receptor Addiction Medicine / Substance Use Disorder Small molecule Live · refreshed every 30 min

Target snapshot

Open Label Lofexidine HCL (Open Label Lofexidine HCL) — USWM, LLC (dba US WorldMeds). Lofexidine is an alpha-2 adrenergic agonist that reduces noradrenergic hyperactivity associated with opioid withdrawal.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Open Label Lofexidine HCL TARGET Open Label Lofexidine HCL USWM, LLC (dba US WorldMeds) phase 3 Alpha-2 adrenergic agonist Alpha-2 adrenergic receptor
Catapresan TTS 2 Catapresan TTS 2 Heart Care Foundation marketed Central alpha-2 adrenergic agonist Alpha-2 adrenergic receptor
Brimonidine/Timolol mixed combination Brimonidine/Timolol mixed combination Seoul National University Hospital marketed Alpha-2 adrenergic agonist / Beta-blocker combination Alpha-2 adrenergic receptor; Beta-1 and Beta-2 adrenergic receptors
dexmedetomidine 1 µg/kg IV dexmedetomidine 1 µg/kg IV American University of Beirut Medical Center marketed Alpha-2 adrenergic agonist Alpha-2 adrenergic receptor
Pregabalin and dexmedetomidine Pregabalin and dexmedetomidine Wonkwang University Hospital marketed Combination analgesic/sedative (gabapentinoid + alpha-2 agonist) Alpha-2-delta calcium channel subunit (pregabalin); alpha-2 adrenergic receptor (dexmedetomidine)
oxymetazoline-fluticasone propionate oxymetazoline-fluticasone propionate Brian J Lipworth marketed Nasal decongestant/corticosteroid combination Alpha-2 adrenergic receptor; glucocorticoid receptor
Intravenous dexmedetomidine Intravenous dexmedetomidine University of Jordan marketed Alpha-2 adrenergic receptor agonist Alpha-2 adrenergic receptor

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Alpha-2 adrenergic agonist class)

  1. USWM, LLC (dba US WorldMeds) · 2 drugs in this class
  2. China International Neuroscience Institution · 1 drug in this class
  3. Icahn School of Medicine at Mount Sinai · 1 drug in this class
  4. Eye Therapies, LLC · 1 drug in this class
  5. Galderma R&D · 1 drug in this class
  6. Guangzhou Women and Children's Medical Center · 1 drug in this class
  7. Derm Research, PLLC · 1 drug in this class
  8. Irmandade da Santa Casa de Misericordia de Sao Paulo · 1 drug in this class
  9. KK Women's and Children's Hospital · 1 drug in this class
  10. American University of Beirut Medical Center · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Open Label Lofexidine HCL — Competitive Intelligence Brief. https://druglandscape.com/ci/open-label-lofexidine-hcl. Accessed 2026-05-18.

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