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GEn (XP13512)
XP13512 is a prodrug of gabapentin that uses a novel amino acid transporter-mediated delivery system to enhance absorption and bioavailability in the gastrointestinal tract.
XP13512 is a prodrug of gabapentin that uses a novel amino acid transporter-mediated delivery system to enhance absorption and bioavailability in the gastrointestinal tract. Used for Postherpetic neuralgia, Diabetic peripheral neuropathy.
At a glance
| Generic name | GEn (XP13512) |
|---|---|
| Also known as | Gabapentin Enacabil, XP13512, Gabapentin Enacarbil |
| Sponsor | XenoPort, Inc. |
| Drug class | Gabapentin prodrug / Anticonvulsant |
| Target | LAT1 (Large Neutral Amino Acid Transporter 1) |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
XP13512 is designed to overcome the saturable absorption of gabapentin by leveraging the large neutral amino acid transporter type 1 (LAT1) for active transport across the intestinal epithelium. This transporter-mediated mechanism allows for improved oral bioavailability and more consistent plasma levels compared to gabapentin alone, potentially enabling lower doses or improved efficacy in neuropathic pain conditions.
Approved indications
- Postherpetic neuralgia
- Diabetic peripheral neuropathy
Common side effects
- Dizziness
- Somnolence
- Peripheral edema
- Headache
Key clinical trials
- Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study (PHASE4)
- Simulated Driving Study in Restless Legs Syndrome (PHASE2)
- A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment (PHASE2)
- XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome. (PHASE3)
- Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome (PHASE2)
- A Study In Patients With Neuropathic Pain From Post-Herpetic Neuralgia (PHN) (PHASE2)
- A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN) (PHASE2)
- Long-Term Study of Gabapentin Enacarbil (GEn, XP13512) vs. Placebo in Patients With Restless Legs Syndrome. (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- GEn (XP13512) CI brief — competitive landscape report
- GEn (XP13512) updates RSS · CI watch RSS
- XenoPort, Inc. portfolio CI