gabapentin enacarbil
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | HORIZANT | — | 2012-06-06 – 2013-03-27 | fda.gov ↗ |
| Approved | US (FDA) | HORIZANT | — | 2011-04-06 | fda.gov ↗ |
Trials 28 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT02633657 | Jan 2016 → Jul 2017 | restless legs syndrome | XenoPort, Inc. | Withdrawn | No outcome recorded |
| Phase 1 | NCT01516372 | Jan → Mar 2012 | restless legs syndrome | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01476124 | Aug → Oct 2011 | restless legs syndrome | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01411124 | Jun → Oct 2011 | restless legs syndrome | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02632331 | Jan → Feb 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00833391 | Jan → Mar 2009 | — | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02629224 | Feb → Oct 2008 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT00643760 | Mar 2008 → Feb 2009 | diabetic polyneuropathy | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00617461 | Mar 2008 → Jul 2009 | postherpetic neuralgia | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00619476 | Feb 2008 → Jul 2009 | postherpetic neuralgia | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00530530 | Sep 2007 → Jan 2009 | restless legs syndrome | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT00508430 | Jul 2007 → Nov 2008 | diabetic polyneuropathy | Astellas Pharma Inc | Terminated | No outcome recorded |
| Phase 2 | NCT01332318 | Apr → Nov 2007 | restless legs syndrome | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01332305 | Jan 2007 → Jan 2008 | restless legs syndrome | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT00748098 | Oct 2008 → Jul 2009 | restless legs syndrome | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02658188 | Dec 2007 → Apr 2009 | restless legs syndrome | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00365352 | Aug 2006 → Dec 2007 | restless legs syndrome | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00333359 | Jun 2006 → Dec 2008 | restless legs syndrome | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00298623 | Mar 2006 → Feb 2007 | restless legs syndrome | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT06097676 | Sep 2021 → Jun 2022 | substance abuse | Arbor Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT03082755 | Jul 2017 → Aug 2022 overdue | Alzheimer disease | University of Texas at Austin | Recruiting | No outcome recorded |
| Phase 4 | NCT03053427 | Mar 2017 → Jun 2018 | restless legs syndrome | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT02560766 | Feb 2016 → Oct 2023 | restless legs syndrome | XenoPort, Inc. | Unknown | No outcome recorded |
| Phase 4 | NCT02633683 | Jan 2016 → May 2024 | restless legs syndrome | XenoPort, Inc. | Unknown | No outcome recorded |
| Phase 4 | NCT02424695 | Jun 2015 → Jun 2016 | restless legs syndrome | Cleveland Sleep Research Center | Unknown | No outcome recorded |
| Phase 4 | NCT01981941 | Nov 2013 → May 2015 | restless legs syndrome | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02642315 | Jan 2016 → May 2019 | restless legs syndrome | University of Missouri-Columbia | Completed | No outcome recorded |
| — | NCT02840240 | Jan 2016 → Nov 2018 | — | The Cleveland Clinic | Completed | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT02252536 Comparator | Jun 2015 → Mar 2017 | alcohol-related disorders | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Completed | No outcome recorded |
| Phase 2 | NCT00742209 Comparator | Aug 2008 → Jun 2010 | migraine disorder | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02117076 Comparator | Apr 2014 → Jun 2016 | restless legs syndrome | Theresa Zesiewicz, MD | Terminated | No outcome recorded |
| Phase 4 | NCT01668667 Comparator | Jun 2012 → Nov 2013 | restless legs syndrome | XenoPort, Inc. | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gabapentin Enacarbil | “gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with diabetic peripheral neuropathy(DPN)” NCT00643760 ↗18“The objective of this article is to evaluate the efficacy and safety of gabapentin enacarbil (GEn) for migraine prophylaxis.” PMID 23165696 ↗ Nov 2012 “1,200 mg/day) oral gabapentin enacarbil (GEn) on pain intensity in adults with postherpetic neuralgia” PMID 24102928 ↗ Sep 2013 “We assessed the effects of gabapentin enacarbil (GEn) on individual IRLS items.” PMID 27288210 ↗ Jun 2016 “gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn” NCT00619476 ↗ “Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)” NCT00833391 ↗ “HORIZANT (Gabapentin Enacarbil) Extended-Release Tablets” NCT02633683 ↗ “Gabapentin enacarbil (GEn) is a prodrug of gabapentin” PMID 24290737 ↗ Nov 2013 “HORIZANT (Gabapentin Enacarbil)” NCT02633657 ↗ “Gabapentin enacarbil 600 mg” NCT01476124 ↗ |
| Known as | ASP8825 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02632331 ↗ |
| Known as | Gabapentin encarbil | ChEMBL registry synonym — accepted as the source's own label CHEMBL1628502 ↗ |
| Known as | Gabapentina enacarbilo | ChEMBL registry synonym — accepted as the source's own label CHEMBL1628502 ↗ |
| Known as | Gabapentine enacarbil | ChEMBL registry synonym — accepted as the source's own label CHEMBL1628502 ↗ |
| Known as | GE-IR | “Drug: Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg” NCT06097676 ↗ |
| Known as | GEn | “This study evaluated whether there was any interaction between gabapentin enacarbil (GEn), which is a prodrug of gabapentin, and morphine in terms of pharmacokinetics,...” PMID 25467190 ↗ Nov 20148“The objective of this article is to evaluate the efficacy and safety of gabapentin enacarbil (GEn) for migraine prophylaxis.” PMID 23165696 ↗ Nov 2012 “Gabapentin enacarbil (GEn), a transported prodrug of gabapentin, provides sustained, dose-proportional gabapentin exposure.” PMID 23186035 ↗ Nov 2012 “We assessed the effects of gabapentin enacarbil (GEn) on individual IRLS items.” PMID 27288210 ↗ Jun 2016 “gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn” NCT00619476 ↗ “determine the effect of gabapentin enacarbil (GEn) compared to placebo” PMID 32966585 ↗ Sep 2020 “Gabapentin enacarbil (GEn) is a prodrug of gabapentin” PMID 24290737 ↗ Nov 2013 “Gabapentin Enacarbil (GEn)” NCT02424695 ↗ “XP13512 (GEn)” NCT00333359 ↗ |
| Known as | GSK1838262 | “Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)” NCT00833391 ↗ |
| Known as | HORIZANT | “A PK and Safety Evaluation of HORIZANT (Gabapentin Enacarbil) in Adolescents With Moderate-to-Severe Primary RLS” NCT02633657 ↗ |
| Known as | XP13512 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00333359 ↗ |
| Modality | Small molecule | — CHEMBL1628502 ↗ |
| Route | Oral | “1200 mg XP13512, orally, once daily for 52 weeks” NCT00333359 ↗ |