Drugs / gabapentin enacarbil
gabapentin enacarbil
also known as
GEn · ASP8825 · HORIZANT · GSK1838262 · XP13512 · Gabapentin encarbil · Gabapentina enacarbilo · Gabapentine enacarbil · +1 more
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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials · 2 met primary | ||||||
| Phase 1 | NCT02633657 | Jan 2016 → Jul 2017 | restless legs syndrome | XenoPort, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01516372 | Jan → Mar 2012 | restless legs syndrome | XenoPort, Inc. | Completed | Met primary |
| Phase 1 | NCT01476124 | Aug → Oct 2011 | restless legs syndrome | XenoPort, Inc. | Completed | Met primary |
| Phase 1 | NCT01411124 | Jun → Oct 2011 | restless legs syndrome | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00833391 | Jan → Mar 2009 | — | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02632331 | Jan → Feb 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT02629224 | Feb → Oct 2008 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 27 trials · 3 met primary · 2 missed | ||||||
| Phase 2 | NCT00643760 | Mar 2008 → Feb 2009 | diabetic polyneuropathy | XenoPort, Inc. | Completed | Missed primary |
| Phase 2 | NCT00617461 | Mar 2008 → Jul 2009 | postherpetic neuralgia | XenoPort, Inc. | Completed | Met primary |
| Phase 2 | NCT00619476 | Feb 2008 → Jul 2009 | postherpetic neuralgia | XenoPort, Inc. | Completed | Met primary |
| Phase 2 | NCT00530530 | Sep 2007 → Jan 2009 | restless legs syndrome | Astellas Pharma Inc | Completed | Met primary |
| 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 | Missed primary |
| Phase 2 | NCT01332305 | Jan 2007 → Jan 2008 | restless legs syndrome | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 35 trials · 2 met primary | ||||||
| Phase 3 | NCT00748098 | Oct 2008 → Jul 2009 | restless legs syndrome | XenoPort, Inc. | Completed | Met primary |
| 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 | Met primary |
| 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 · 1 missed | ||||||
| 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 | Missed primary |
| 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 |
| Comparator or background therapy4 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 4 | NCT02117076 Comparator | Apr 2014 → Jun 2016 | restless legs syndrome | Theresa Zesiewicz, MD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01668667 Comparator | Jun 2012 → Nov 2013 | restless legs syndrome | XenoPort, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2020-12-31 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA final approval for Tadalafil Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg; and receives ANDA tentative approvals for Gabapentin Enacarbil Extended-Release Tablets, 300 mg and 600 mg and Apremilast Tablets, 10 mg, 20 mg and 30 mg glenmarkpharma.com ↗ |
| 2012-06-07 | GlaxoSmithKline | Regulatory GSK and XenoPort receive FDA approval for Horizant® for postherpetic neuralgia gsk.com ↗
GlaxoSmithKline plc (GSK) and XenoPort, Inc. (Nasdaq: XNPT) announced today that the United States (US) Food and Drug Administration (FDA) has approvedHorizant® (gabapentin enacarbil) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults. |
| 2012-01-18 | Astellas Pharma Inc | Regulatory Astellas and XenoPort Announce Approval of Regnite® Tablets for Restless Legs Syndrome in Japan astellas.com ↗
Astellas Pharma Inc. (Tokyo: 4503) and XenoPort, Inc. (NASDAQ: XNPT) announced today that Regnite® (gabapentin enacarbil) has received marketing approval in Japan for the treatment of moderate-to-severe primary restless legs syndrome (RLS). |
| 2011-08-09 | GlaxoSmithKline | Regulatory Regulatory Update: GSK and XenoPort submit supplemental New Drug Application to FDA for Horizant™ in postherpetic neuralgia gsk.com ↗ |
| 2011-04-06 | GlaxoSmithKline | Regulatory GlaxoSmithKline and XenoPort receive FDA approval for Horizant™ gsk.com ↗
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved Horizant™ (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome in adults. |
| 2010-02-16 | GlaxoSmithKline | Regulatory GlaxoSmithKline and XenoPort receive FDA Complete Response letter for Horizant™ (GSK1838262/XP13512) for RLS gsk.com ↗
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) Wednesday received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Horizant™(gabapentin enacarbil) Extended-Release Tablets, an investigational non-dopaminergic treatment for moderate-to-severe primary Restless Legs Syndrome (RLS). |
| 2009-11-05 | GlaxoSmithKline | Regulatory GlaxoSmithKline and XenoPort announce extension of GSK1838262 (XP13512) FDA review date to 9 February 2010 gsk.com ↗
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) today announced that the U.S. Food and Drug Administration (FDA) has extended the original Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for GSK1838262/XP13512 (gabapentin enacarbil) to February 9, 2010. |
| 2009-10-05 | GlaxoSmithKline | Results Positive phase II results for GSK1838262 (XP13512) reported for subjects with post-herpetic neuralgia and a history of inadequate response to gabapentin gsk.com ↗
A greater reduction in the 24-hour average pain score was observed for the 3600 mg/day than for the 1200 mg/day (adjusted difference of -0.29; p= 0.013.) |
| 2009-03-03 | Astellas Pharma Inc | Results Astellas and XenoPort Announce Positive Results from Phase 2 Trial of ASP8825/XP13512 in Japan for Restless Legs Syndrome astellas.com ↗
Astellas Pharma Inc. (Astellas) and XenoPort, Inc. (NASDAQ: XNPT) today announced preliminary top-line results from a Phase 2 clinical trial of ASP8825/XP13512 for the treatment of symptoms in moderate-to-severe primary restless legs syndrome (RLS) patients. |
All press releases naming this drug 9 releases
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 NCT02629224 ↗ |
| 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 ↗ |