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Restless legs — Treatment Landscape & Competitive Intelligence

Restless legs (disease) competitive landscape: 7 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

7 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Restless legs, deduplicated by molecule. See the full disease page for line-of-therapy detail.

DrugGenericSponsorClassTargetLine of therapyFirst approval
Horizant GABAPENTIN ENACARBIL Azurity Anti-epileptic Agent Voltage-dependent calcium channel subunit alpha-2/delta-1 2011-01-01
Neupro ROTIGOTINE UCB Nonergot Dopamine Agonist [EPC] dopamine receptors 2007-01-01
Neurontin gabapentin Generic (originally Parke-Davis/Pfizer) Gabapentinoid (anticonvulsant/neuropathic pain agent) Large neutral amino acids transporter small subunit 1, Adenosine receptor A1, Alpha-2A adrenergic receptor 1993-12-30
Requip Requip Boehringer Ingelheim D(1B) dopamine receptor, D(4) dopamine receptor, 5-hydroxytryptamine receptor 1A
Requip ropinirole GSK D(1B) dopamine receptor, D(4) dopamine receptor, 5-hydroxytryptamine receptor 1A
gabapentine gabapentine Dominik Irnich Large neutral amino acids transporter small subunit 1, Adenosine receptor A1, Alpha-2A adrenergic receptor
Horizant Horizant University of Missouri-Columbia Voltage-dependent calcium channel subunit alpha-2/delta-1, Voltage-dependent calcium channel subunit alpha-2/delta-2

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

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

Upcoming PDUFA dates (next 180 days)

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

Sponsor landscape

  1. Azurity · 1 drug in Restless legs
  2. Boehringer Ingelheim · 1 drug in Restless legs
  3. Dominik Irnich · 1 drug in Restless legs
  4. GSK · 1 drug in Restless legs
  5. Generic (originally Parke-Davis/Pfizer) · 1 drug in Restless legs
  6. UCB · 1 drug in Restless legs
  7. University of Missouri-Columbia · 1 drug in Restless legs

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Every new regulatory action, PDUFA date, or trial completion in Restless legs:

Cite this brief

Drug Landscape (2026). Restless legs — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/restless-legs. Accessed 2026-06-10.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing