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XP13512 (GEn)
XP13512 (GEn) is a Small molecule drug developed by XenoPort, Inc.. It is currently in Phase 3 development. Also known as: GSK1838262, Gabapentin Enacarbil.
XP13512, also known as Gabapentin Enacarbil (GEn), is a medication studied for the treatment of Restless Legs Syndrome. It is a synthetic compound with a mechanism that is not clearly described in the provided facts, but it is classified as an antibody modality according to ChEMBL.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | XP13512 (GEn) |
|---|---|
| Also known as | GSK1838262, Gabapentin Enacarbil |
| Sponsor | XenoPort, Inc. |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
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:
- XP13512 (GEn) CI brief — competitive landscape report
- XP13512 (GEn) updates RSS · CI watch RSS
- XenoPort, Inc. portfolio CI
Frequently asked questions about XP13512 (GEn)
What is XP13512 (GEn)?
Who makes XP13512 (GEn)?
Is XP13512 (GEn) also known as anything else?
What development phase is XP13512 (GEn) in?
Related
- Manufacturer: XenoPort, Inc. — full pipeline
- Also known as: GSK1838262, Gabapentin Enacarbil
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing