Treats moderate-to-severe primary Restless Legs Syndrome (RLS). Sold as Horizant. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 15, 2026, FDA lists 2 applications for Gabapentin Enacarbil (sold as Horizant), first approved Apr 6, 2011, with 2 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Horizant | Part D | $32.6M | +2% | 5,494 |
| Physical Therapy for the Management of Postoperative Pain After Minimally Invasive Thoracic SurgeryPost Operative Pain · University of Miami | Phase 4 | Not yet recruiting | Nov 12, 2026 |
| Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPHPostdural Puncture Headache (PDPH) · Assiut University | Phase 2 / Phase 3 | Recruiting | Nov 4, 2026 |
| Suzetrigine for Analgesiain Arthroscopic Rotator Cuff RepairArtroscopic Surgery, Pain Management · University of Alabama at Birmingham | Phase 4 | Not yet recruiting | Oct 8, 2026 |
| Gabapentin vs. Benzonatate vs. Standard of Care for Cough in ILDInterstitial Lung Disease · Post Graduate Institute of Medical Education and Research, Chandigarh | Phase 4 | Not yet recruiting | Oct 6, 2026 |
| Mechanistic Evaluation of Polypharmacy Effects for PainChronic Lower Back Pain (CLBP) · University of Maryland, Baltimore | Phase 1 / Phase 2 | Not yet recruiting | Sep 29, 2026 |
| Epidural Analgesia Versus Opioid-sparing Analgesia for Open Ventral Hernia Repair With Transversus Abdominis ReleaseVentral Hernia, Ventral Hernia Repair · Northwestern University | Phase 4 | Recruiting | Sep 24, 2026 |
| Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug-Dependent, Recreational Opioid UsersHealthy · Viatris Inc. | Phase 4 | Recruiting | Sep 10, 2026 |
| Modality Choice Before and After Failure for the Treatment of Painful Diabetic NeuropathyPainful Diabetic Neuropathy (PDN), Diabetic Nephropathies · University of Michigan | Phase 4 | Not yet recruiting | Aug 31, 2026 |
| Apr 6, 2011 | HorizantNDA 22399 · New molecular entity | Azurity | 10 | Marketed |
| — | Gabapentin EnacarbilANDA 220420 | Annora Pharma Private Limited | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
