Horizant

(gabapentin enacarbil)

ApprovedSmall molecule

AAzurity Pharmaceuticals

Horizant is one of 22 small molecule programs targeting Restless Legs Syndrome. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Restless Legs SyndromeUnknown status

Opioid ConsumptionCompleted

Restless Legs SyndromeApproved

Unknown status

Opioid ConsumptionPreclinical

Completed

Competition

Competitive Landscape

22 competitors in Restless Legs Syndrome

#DrugCompanyPhaseTrials

Neupro

UCB

Approved

13 2

Mirapex

Boehringer Ingelheim

Approved

12 3

Requip Xl

GGlaxo Dba Glaxosmithkline

Approved

12 4

Lyrica

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

6 5

Avelox

Dostinex

Calciferol

Injectafer

AAmerican Regent, Inc.

Approved

3 9

Belsomra

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

2 10

Wakix

HHarmony Biosciences Management, Inc.

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Restless Legs Syndrome3 trials

Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease

Recruiting·UUniversity of Texas at Austin·Phase 4·NCT03082755·156 enrolled

Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome

Unknown status·—·Phase 4·NCT02424695·20 enrolled

A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

Completed· Astellas logo

Astellas·Phase 4·NCT03053427·375 enrolled

Restless Leg Syndrome2 trials

Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome

Terminated·TTheresa Zesiewicz, MD·Phase 4·NCT02117076·5 enrolled

Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment

Completed· Astellas logo

Astellas·Phase 4·NCT01981941·19 enrolled

Abuse Potential1 trial

An Abuse Potential Study of Orally Administered HORIZANT in Healthy, Non-dependent, Recreational Drug Users

Completed·AArbor Pharmaceuticals, Inc.·Phase 4·NCT06097676·86 enrolled

Alcohol Use Disorder1 trial

HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT02252536·346 enrolled

Opioid Consumption1 trial

Effect of Gabapentin Enacarbil on Opioid Consumption and Pain Scores

Completed·TThe Cleveland Clinic·N/A·NCT02840240·107 enrolled

1 more indication

Driving1 trial

Study to Assess the Effect of Gabapentin Enacarbil on Simulated Driving in Healthy Subjects

Completed·XXenoPort, Inc.·Phase 1·NCT01411124·36 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 13, 2011

HORIZANT

NDA NDA022399

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for gabapentin enacarbil. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — gabapentin enacarbil compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for gabapentin enacarbil. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022399). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Horizant. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Azurity Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAzurity Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Nov 10, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8114909Apr 11, 2026

8026279Nov 10, 2026

8795725Jun 10, 2029

Horizant

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Restless Legs Syndrome3 trials

Restless Leg Syndrome2 trials

Abuse Potential1 trial

Alcohol Use Disorder1 trial

Opioid Consumption1 trial

Driving1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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