CACNA2D1 blockers(Voltage-gated calcium channel alpha2/delta subunit 1 blockers), CACNA2D2 blockers(Voltage-gated calcium channel alpha2/delta subunit 2 blockers)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Neuralgia, PostherpeticRestless Legs Syndrome

Inactive Indication

Alcohol Use DisorderDiabetic NeuropathiesDiabetic peripheral neuropathy+ [2]

Originator Organization

XenoPort, Inc.

Active Organization

Astellas Pharma, Inc.

Azurity Pharmaceuticals, Inc.

Inactive Organization

XenoPort, Inc.Arbor Pharmaceuticals, Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (06 Apr 2011),

Restless Legs Syndrome

RegulationOrphan Drug (United States)

Structure/Sequence

Molecular FormulaC16H27NO6

InChIKeyTZDUHAJSIBHXDL-UHFFFAOYSA-N

CAS Registry478296-72-9

Clinical Trials associated with Gabapentin Enacarbil

NCT06247488

/ CompletedPhase 4

Randomized, Double-blind, Active & Placebo-controlled, 6-way Crossover Study of Abuse Potential of Oral Gabapentin Enacarbil IR Capsules With and Without Oxycodone in Healthy, Nondependent, Recreational Opioid Users

The purpose of this study is to assess the abuse potential of gabapentin enacarbil immediate release capsules taken alone and in combination with oxycodone in healthy adult, non-dependent, recreational opioid users.

Start Date31 Jan 2022

Sponsor / Collaborator

Arbor Pharmaceuticals, Inc.

NCT06097676

/ CompletedPhase 4

A Randomized, Double Blind, Active and Placebo Controlled, 5 Way Crossover Study to Determine the Abuse Potential of Orally Administered Gabapentin Enacarbil Immediate Release Capsules in Healthy, Nondependent Recreational Drug Users With Sedative Experience

The purpose of this study is to assess the abuse potential of gabapentin enacarbil in healthy adult, non-dependent, recreational drug users.

Start Date28 Sep 2021

Sponsor / Collaborator

Arbor Pharmaceuticals, Inc.

NCT03082755

/ RecruitingPhase 4IIT

Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease

Nighttime agitation in persons with Alzheimer's disease causes patient suffering, distresses caregivers, and often results in prescriptions for harmful antipsychotics. Effective treatments are lacking because of limited knowledge of the etiology of nighttime agitation. The investigators propose a clinical trial to better elucidate whether a sleep disorder, restless legs syndrome, may be a mechanism for nighttime agitation, and if treatment with gabapentin enacarbil (Horizant®) reduces nighttime agitation, improves sleep, reduces restless legs syndrome behaviors, and reduces antipsychotic medications.

Start Date01 Jul 2017

Sponsor / Collaborator

The University of Texas at Austin

[+1]

100 Clinical Results associated with Gabapentin Enacarbil

100 Translational Medicine associated with Gabapentin Enacarbil

100 Patents (Medical) associated with Gabapentin Enacarbil

148

Literatures (Medical) associated with Gabapentin Enacarbil

01 May 2025·Journal of the American Medical Directors Association

Treatment of Restless Legs Syndrome Improves Agitation and Sleep in Persons with Dementia: A Randomized Trial

Article

Author: Bliwise, Donald L ; Lozano, Alicia J ; Gooneratne, Nalaka S ; Ji, Wenyan ; Morrison, Janet D ; Britt, Katherine C ; Hanlon, Alexandra L ; Richards, Kathy C ; Fry, Liam M

OBJECTIVESRestless legs syndrome (RLS), a common, treatable, sensorimotor disorder of nighttime uncomfortable leg sensations that interfere with sleep, may prompt nighttime agitation in persons with dementia.DESIGNThis randomized trial was double-blind and placebo-controlled. Participants received a Food and Drug Administration-approved drug for RLS, gabapentin enacarbil (GEn) (Horizant) or placebo.SETTING AND PARTICIPANTSOlder adults (N = 147) with dementia due to Alzheimer's disease, nighttime agitation, and RLS, residing in long-term care or at home, participated.METHODSThe primary outcome was change from baseline to 8 weeks in nighttime agitation between 5 pm and 7 am on the Cohen-Mansfield Agitation Inventory Index, Direct Observation. Multivariable linear mixed effects regression models based on multiply imputed data were estimated on nighttime agitation and sleep, with treatment group, week, the 2-way interaction of group and week as predictors, and mean arterial pressure as a covariate based on baseline group imbalances.RESULTSMean age ± SD was 83.4 ± 9.1 years. Most were female (72.0%), white (92.3%), non-Hispanic (84.6%), and lived in nursing homes (76.9%). Nighttime agitation, by group over time, was significant at 8 weeks (estimate, -1.67; P = .003) and 2 weeks. Total sleep time (actigraphy) by group over time was significant at 8 weeks (estimate, 48.45; P = .026). Observed nighttime wake by group over time was significant at 2 (estimate, -12.54; P = .006) and 8 weeks (estimate, -11.12; P = .015). The number having ≥1 adverse events was 60 in the GEn group (81.1%) and 50 in the placebo group (68.5%); with 12 serious adverse events in placebo and 10 in the GEn group. The GEn group had a trend toward more falls (P = .066).CONCLUSIONS AND IMPLICATIONSOur findings suggest a novel approach for nighttime agitation in persons with dementia: assessing for RLS and initiating interventions. Larger and longer trials are needed.

25 Mar 2025·Alcohol and alcoholism (Oxford, Oxfordshire)

Identifying responders to gabapentin for the treatment of alcohol use disorder: an exploratory machine learning approach.

Article

Author: Cruz, Alondra ; Ray, Lara A ; Montoya, Amanda K ; Donato, Suzanna ; Baskerville, Wave-Ananda ; Grodin, Erica N

BACKGROUNDGabapentin, an anticonvulsant medication, has been proposed as a treatment for alcohol use disorder (AUD). A multisite study tested gabapentin enacarbil extended-release (GE-XR; 600 mg/twice a day), a prodrug formulation, combined with a computerized behavioral intervention, for AUD. In this multisite trial, the gabapentin GE-XR group did not differ significantly from placebo on the primary outcome of percent of subjects with no heavy drinking days. Despite the null findings, there is considerable interest in using machine learning methods to identify responders to GE-XR. The present study applies interaction tree machine learning methods to identify positive and iatrogenic (i.e. individuals who responded better to placebo than to GE-XR) treatment responders in the trial.METHODSBaseline characteristics taken from the multisite trial were examined as potential moderators of treatment response using qualitative interaction trees (QUINT; N = 338; 223 M/115F). QUINT models are an exploratory decision tree approach that iteratively splits the data into leaves based on predictor variables to maximize a specific criterion.RESULTSAnalyses identified key factors that are associated with the efficacy (or iatrogenic effects) of GE-XR for AUD. Such factors are baseline drinking levels, motivation for change, confidence in their ability to reach drinking goals (i.e. self-efficacy), cognitive impulsivity, and baseline anxiety levels.CONCLUSIONBaseline drinking levels and anxiety levels may be associated with the protracted withdrawal syndrome, previously implicated in the clinical response to gabapentin. However, these analyses underscore motivation for change and self-efficacy as predictors of clinical response to GE-XR, suggesting these established constructs should receive further attention in gabapentin research and clinical practice. Multiple studies using different machine learning methods are valuable as these novel analytic tools are applied to medication development for AUD.

01 Jan 2025·Journal of Clinical Sleep Medicine

Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline

Review

Author: Shelgikar, Anita V. ; Kazmi, Uzma ; Sharon, Denise ; Falck-Ytter, Yngve ; Koo, Brian B. ; DelRosso, Lourdes M. ; Trotti, Lynn Marie ; Berkowski, J. Andrew ; Walters, Arthur S. ; Zak, Rochelle S. ; Winkelman, John W. ; Scharf, Matthew T.

INTRODUCTIONThis guideline establishes clinical practice recommendations for treatment of restless legs syndrome (RLS) and periodic limb movement disorder (PLMD) in adults and pediatric patients.METHODSThe American Academy of Sleep Medicine (AASM) commissioned a task force of experts in sleep medicine to develop recommendations and assign strengths based on a systematic review of the literature and an assessment of the evidence using the grading of recommendations assessment, development, and evaluation methodology. The task force provided a summary of the relevant literature and the certainty of evidence, the balance of benefits and harms, patient values and preferences, and resource use considerations that support the recommendations. The AASM Board of Directors approved the final recommendations.GOOD PRACTICE STATEMENTThe following good practice statement is based on expert consensus, and its implementation is necessary for the appropriate and effective management of patients with RLS.1. In all patients with clinically significant RLS, clinicians should regularly test serum iron studies including ferritin and transferrin saturation (calculated from iron and total iron binding capacity). Testing should ideally be administered in the morning avoiding all iron-containing supplements and foods at least 24 hours prior to blood draw. Analysis of iron studies greatly influences the decision to use oral or intravenous (IV) iron treatment. Consensus guidelines, which have not been empirically tested, suggest that supplementation of iron in adults with RLS should be instituted with oral or IV iron if serum ferritin ≤ 75 ng/mL or transferrin saturation < 20%, and only with IV iron if serum ferritin is between 75 and 100 ng/mL. In children, supplementation of iron should be instituted for serum ferritin < 50 ng/mL with oral or IV formulations. These iron supplementation guidelines are different than for the general population.2. The first step in the management of RLS should be addressing exacerbating factors, such as alcohol, caffeine, antihistaminergic, serotonergic, antidopaminergic medications, and untreated obstructive sleep apnea.3. RLS is common in pregnancy; prescribers should consider the pregnancy-specific safety profile of each treatment being considered.RECOMMENDATIONSThe following recommendations are intended as a guide for clinicians in choosing a specific treatment for RLS and PLMD in adults and children. Each recommendation statement is assigned a strength ("strong" or "conditional"). A "strong" recommendation (ie, "We recommend…") is one that clinicians should follow under most circumstances. The recommendations listed below are ranked in the order of strength of recommendations and grouped by class of treatments within each PICO (Patient, Intervention, Comparator, Outcome) question. Some recommendations include remarks that provide additional context to guide clinicians with implementation of this recommendation.ADULTS WITH RLS1. In adults with RLS, the AASM recommends the use of gabapentin enacarbil over no gabapentin enacarbil (strong recommendation, moderate certainty of evidence).2. In adults with RLS, the AASM recommends the use of gabapentin over no gabapentin (strong recommendation, moderate certainty of evidence).3. In adults with RLS, the AASM recommends the use of pregabalin over no pregabalin (strong recommendation, moderate certainty of evidence).4. In adults with RLS, the AASM recommends the use of IV ferric carboxymaltose over no IV ferric carboxymaltose in patients with appropriate iron status (see good practice statement for iron parameters) (strong recommendation, moderate certainty of evidence).5. In adults with RLS, the AASM suggests the use of IV low molecular weight iron dextran over no IV low molecular weight iron dextran in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, very low certainty of evidence).6. In adults with RLS, the AASM suggests the use of IV ferumoxytol over no IV ferumoxytol in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, very low certainty of evidence).7. In adults with RLS, the AASM suggests the use of ferrous sulfate over no ferrous sulfate in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, moderate certainty of evidence).8. In adults with RLS, the AASM suggests the use of dipyridamole over no dipyridamole (conditional recommendation, low certainty of evidence).9. In adults with RLS, the AASM suggests the use of extended-release oxycodone and other opioids over no opioids (conditional recommendation, moderate certainty of evidence).10. In adults with RLS, the AASM suggests the use of bilateral high-frequency peroneal nerve stimulation over no peroneal nerve stimulation (conditional recommendation, moderate certainty of evidence).11. In adults with RLS, the AASM suggests against the standard use of levodopa (conditional recommendation, very low certainty of evidence).Remarks: levodopa may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).12. In adults with RLS, the AASM suggests against the standard use of pramipexole (conditional recommendation, moderate certainty of evidence).Remarks: pramipexole may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).13. In adults with RLS, the AASM suggests against the standard use of transdermal rotigotine (conditional recommendation, low certainty of evidence).Remarks: transdermal rotigotine may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).14. In adults with RLS, the AASM suggests against the standard use of ropinirole (conditional recommendation, moderate certainty of evidence).Remarks: ropinirole may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).15. In adults with RLS, the AASM suggests against the use of bupropion for the treatment of RLS (conditional recommendation, moderate certainty of evidence).16. In adults with RLS, the AASM suggests against the use of carbamazepine (conditional recommendation, low certainty of evidence).17. In adults with RLS, the AASM suggests against the use of clonazepam (conditional recommendation, very low certainty of evidence).18. In adults with RLS, the AASM suggests against the use of valerian (conditional recommendation, very low certainty of evidence).19. In adults with RLS, the AASM suggests against the use of valproic acid (conditional recommendation, low certainty of evidence).20. In adults with RLS, the AASM recommends against the use of cabergoline (strong recommendation, moderate certainty of evidence).SPECIAL ADULT POPULATIONS WITH RLS21. In adults with RLS and end-stage renal disease (ESRD), the AASM suggests the use of gabapentin over no gabapentin (conditional recommendation, very low certainty of evidence).22. In adults with RLS and ESRD, the AASM suggests the use of IV iron sucrose over no IV iron sucrose in patients with ferritin < 200 ng/mL and transferrin saturation < 20% (conditional recommendation, moderate certainty of evidence).23. In adults with RLS and ESRD, the AASM suggests the use of vitamin C over no vitamin C (conditional recommendation, low certainty of evidence).24. In adults with RLS and ESRD, the AASM suggests against the standard use of levodopa (conditional recommendation, low certainty of evidence).Remarks: levodopa may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).25. In adults with RLS and ESRD, the AASM suggests against the standard use of rotigotine (conditional recommendation, very low certainty of evidence).Remarks: rotigotine may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).ADULTS WITH PLMD26. In adults with PLMD, the AASM suggests against the use of triazolam (conditional recommendation, very low certainty of evidence).27. In adults with PLMD, the AASM suggests against the use of valproic acid (conditional recommendation, very low certainty of evidence).CHILDREN WITH RLS28. In children with RLS, the AASM suggests the use of ferrous sulfate over no ferrous sulfate in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, very low certainty of evidence).CITATIONWinkelman JW, Berkowski JA, DelRosso LM, et al. Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2025;21(1):137-152.

News (Medical) associated with Gabapentin Enacarbil

02 Dec 2024

·www.drugs.com

Guidelines Developed for Treatment of Restless Legs Syndrome

MONDAY, Dec. 2, 2024 -- In a clinical practice guideline issued by the American Academy of Sleep Medicine and published online Sept. 26 in the Journal of Clinical Sleep Medicine , recommendations are presented for the treatment of restless legs syndrome (RLS). John W. Winkelman, M.D., Ph.D., from Massachusetts General Hospital in Boston, and colleagues developed recommendations for treatment of RLS and periodic limb movement disorder in adults and pediatric patients. The researchers developed three good practice statements that were based on expert consensus. They recommend all clinicians should regularly test serum iron studies, including ferritin and transferrin saturation, in all patients with clinically significant RLS, ideally in the morning; analysis of these studies influences the decision to use oral or intravenous (IV) iron treatment. The authors also state that addressing exacerbating factors, including alcohol, caffeine, antihistaminergic, serotonergic, and anti-dopaminergic medications, should be the first step in RLS management. They note RLS is common in pregnancy and the pregnancy-specific safety profile of each treatment should be considered. Recommendations for adults with RLS include use of gabapentin enacarbil over no gabapentin enacarbil; use of gabapentin over no gabapentin; use of pregabalin over no pregabalin; and use of IV ferric carboxymaltose over no IV ferric carboxymaltose for those with appropriate iron status (strong recommendations; moderate certainty of evidence). In addition, there is a strong recommendation against use of cabergoline. "Guided by the best evidence in the scientific literature, we've provided recommendations that will improve the ability of clinicians to provide patient-centered care for people who have RLS," Winkelman said in a statement. One author disclosed ties to the pharmaceutical and medical device industries. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

10 Sep 2018

·www.biospace.com

Inoviem Scientific enters into service-based partnership with XoNovo

Inoviem Scientific today announces a service-based partnership with XoNovo, a preclinical-stage biopharmaceutical company developing a proprietary small molecule for the treatment of neurodegenerative diseases. Financial terms of the partnership were not disclosed. Strasbourg, France, and Ness Ziona, Israel, September 5, 2018 – Inoviem Scientific , a Contract Research Biotech (CRB), today announces a service-based partnership with XoNovo , a preclinical-stage biopharmaceutical company developing a proprietary small molecule for the treatment of neurodegenerative diseases. Financial terms of the partnership were not disclosed. The partnership aims to generate crucial information concerning XoNovo’s lead compound, XN001, a patented new chemical entity (NCE); an autophagy modulator for the treatment of neurodegenerative diseases. According to the agreement, Inoviem will apply its expertise and cutting-edge technological solutions to isolate and identify XN001’s therapeutic targets and elucidate its mode of action. This partnership is in line with Inoviem’s long-term strategy, focused on broadening international connections, lowering risks in drug discovery and development projects, and supporting its partners in bringing promising therapeutics to the clinic with the ultimate goal of improving patients’ lives. The synergy between the two companies will enable XoNovo to strengthen its pipeline/portfolio by validating XN001’s mode of action. For Inoviem, this agreement is a service-based partnership. The company plans to continue such collaborations in the future. This ‘win-win’ agreement paves the way for the collaborative strategy that Inoviem Scientific is keen to develop. “There is uncertainty in all drug development processes. We must think anew. The goal of our collaboration with XoNovo is to provide a therapeutic solution for patients with neurodegenerative diseases,” said Dr. Pierre Eftekhari, founder and president of Inoviem Scientific. “We are excited to collaborate with Inoviem, and, through this partnership, accelerate our technology with the aim of curing neurodegenerative diseases using the exciting novel mechanism of autophagy enhancement,” said Dr. Ido Nevo, XoNovo’s CEO. About XN001 XN001 is a first-in-class drug candidate, a synthetic small molecule derivative of a natural brain metabolite, Lanthionine Ketimine (LK). It augments the autophagy mechanism with therapeutic effects on the structure and function of neurons. XN001 is an orally-available brain-penetrating molecule that has shown initial efficacy in multiple animal model systems for neurodegenerative diseases, with a solid safety profile. About XoNovo XoNovo is a preclinical-stage biopharmaceutical company developing a proprietary small molecule for the treatment of neurodegenerative diseases through autophagy modulation. XoNovo is financed by an international syndicate composed of the J&J Investment Corporation, Takeda Ventures Inc., OrbiMed Israel and the Israel Innovation Authority. XoNovo’s objective is to provide a first-in-class therapy for preventing the progressive loss of neuronal function across multiple neurodegenerative diseases. About Inoviem Scientific Inoviem Scientific is a Contract Research Biotech (CRB) that provides state-of-the-art expertise in drug-target interaction analysis, based on its cutting-edge label-free technologies PIMS® and NPOT®. Inoviem is the partner of choice in the pharmaceutical industry due to its expertise in target deconvolution, clinical mechanism of action elucidation, GPCRs and membranous protein identification, biomarker identification and patient stratification. The company has developed a strong proficiency in supporting its partners in identifying the therapeutic effect of their pharmacological agents by deciphering the native clinical agent’s interactome, in the physiological environment, directly from human samples. Inoviem has collaborators worldwide, including leading pharmaceutical companies. With its unique technological solutions and know-how, the company is proud to have helped young pharmaceutical companies identify their clinical molecule’s mode of action to support fundraising activities and move their promising therapeutics towards clinical trials.

28 Mar 2016

·www.biospace.com

Bay Area’s XenoPort Snags Psoriasis and MS Deal Worth $490 Million+ from Dr. Reddy’s Laboratories Ltd.

March 28, 2016 (Last Updated: 5:50pm PT) By Mark Terry , BioSpace.com Breaking News Staff Hyberabad, India-based Dr. Reddy’s Laboratories , announced today that it had inked a licensing deal with Santa Clara, Calif.-based XenoPort worth more than $490 million. Dr. Reddy’s Laboratories will gain exclusive U.S. rights to develop and market XP23829 for all indications, including moderate-to-severe chronic plaque psoriasis and potentially for relapsing forms of multiple sclerosis (MS). Dr. Reddy’s will pay an upfront payment of $47.5 million to XenoPort and an extra $2.5 million for specific clinical trial materials. XenoPort is also eligible for up to $190 million in various regulatory milestones, and $250 million in possible commercial milestones. Royalties up to the mid-teens have also been negotiated. “XP23820 complements our internal development efforts, which have primarily focused on the mild-to-moderate psoriasis segment to date,” said Raghav Chari , executive vice president, Proprietary Products Group , for Dr. Reddy’s Laboratories, in a statement. “In other markets, fumarates have been used as first line choices of treatment prior to initiation of biologic therapies in patients with moderate-to-severe psoriasis. We intend to initiate the registration program for XP23820 as soon as feasible so that we can accelerate the availability of this important treatment choice for moderate-to-severe psoriasis patients in the U.S. market.” XP23820 is an oral fumaric acid ester that acts as a prodrug for monomethyl fumarate (MMF). Biogen ’s blockbuster drug, Tecfidera, for MS, and Fumaderm, for psoriasis, are based on another MMF prodrug, dimethyl fumarate (DMF). Cambridge, Mass.-based Biogen (BIIB) has dominated the MS market, but has made some shifts toward the even higher-risk areas of Alzheimer’s drugs. It has initiated enrollment in two identical Phase III clinical trials for its drug aducanumab, with a total combined 2,700 patients. Analysts project the trial costs to exceed $1 billion. Data is expected through 2020, with completion in 2022. Its MS franchise has been facing stiff competition, pricing pressures, and a decreasing number of untreated patients. The company’s 2015 second quarter financials showed softer sales of Tecfidera than as expected, although they improved in the third quarter. In January, there were reports that XenoPort might be up for sale. The company’s main focus has been drugs for restless leg syndrome, but was rumored to be working with investment banks and contacting potential buyers. In October 2015, XenoPort announced it was restructuring to maximize its HORIZANT (gabapentin encarbil) drug for restless leg syndrome. It was cutting 25 jobs and its chief executive officer and director, Ronald Barrett , was retiring immediately. He was replaced by Vincent Angotti , who was previously executive vice president and chief operating officer. But on Sept. 15, the company announced positive results in its Phase II clinical trial of XP23820 for psoriasis. It met its primary endpoint in both the 800 mg daily dosage and 400 mg twice daily dosage, demonstrating statistically significant improvement. It had also terminated its XP23820 program for plaque psoriasis. The drug showed significant gastrointestinal-related side effects that caused almost a third of its 200 subjects to drop out of its psoriasis study. Side effects included nausea, vomiting and stomach ache. Eric Schmidt , an analyst with Cowen & Co. , told Reuters at the time, “XenoPort should stop spending limited resources on a drug that, while active, appears to be inferior to the standard of care in psoriasis.” Which apparently they did, selling it to Dr. Reddy’s Laboratories. Dr. Reddy’s has a big interest in generics and biosimilars. In the U.S. market, its focus is on dermatology and neurology.

Phase 3License out/inPhase 2Clinical ResultFinancial Statement

100 Deals associated with Gabapentin Enacarbil

External Link

KEGG	Wiki	ATC	Drug Bank
D09539	Gabapentin Enacarbil	N03AX12	DB08872

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Neuralgia, Postherpetic	United States	Azurity Pharmaceuticals, Inc.	06 Jun 2012
Restless Legs Syndrome	United States	Azurity Pharmaceuticals, Inc.	06 Apr 2011

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Restless Legs Syndrome 1	Phase 1	United States	XenoPort, Inc.	01 Jan 2016
Diabetic Neuropathies	Phase 1	Japan	Astellas Pharma, Inc.	01 Jul 2007
Alcohol Use Disorder	Discovery	United States	Arbor Pharmaceuticals, Inc.	01 Jun 2015
Migraine Disorders	Discovery	United States	XenoPort, Inc.	01 Aug 2008
Migraine Disorders	Discovery	Canada	XenoPort, Inc.	01 Aug 2008
Diabetic peripheral neuropathy	Discovery	United States	XenoPort, Inc.	01 Mar 2008
Neuralgia	Discovery	United States	XenoPort, Inc.	01 Mar 2008
Neuralgia, Postherpetic	Discovery	Canada	XenoPort, Inc.	01 Feb 2008
Restless Legs Syndrome	Discovery	-	XenoPort, Inc.	01 Mar 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02840240 (CTgov)	Not Applicable	Pain \| Anesthesia	107	Gabapentin enacarbil (Gabapentin Enacarbil)	hsysuejjrh(uxkyjcbppw) = jwbyjwdjdn jbtmkvzpqy (loiauaaxrk, bzddcivioz - lgjvswowis) View more	-	09 Jan 2024
				Placebo (Placebo)	hsysuejjrh(uxkyjcbppw) = ozpgmyycwl jbtmkvzpqy (loiauaaxrk, sfcshrqqoy - cxgswtvgdl) View more
NCT03053427 (CTgov)	Phase 4	Restless Legs Syndrome	375	Placebo (Placebo)	wltnwwfkum(sbharaankc) = idvfwdlgsg bdnivigbap (errvhqxyqc, jncslmvgna - tnociqcvsx) View more	-	10 Jul 2019
				Gabapentin enacarbil (Gabapentin Enacarbil)	wltnwwfkum(sbharaankc) = plzwyhywaa bdnivigbap (errvhqxyqc, nckktnnaiq - tfbnhvrsjd) View more
NCT02252536 (Pubmed) Manual	Phase 2	Alcohol Use Disorder	346	gabapentin enacarbil	zaejsrudvt(elvikbwwis) = jsorlzmwhl laptfdivnt (ywhfilbnkc )	Negative	01 Jan 2019
				Placebo	zaejsrudvt(elvikbwwis) = grrcljfhxa laptfdivnt (ywhfilbnkc )
NCT02252536 (CTgov)	Phase 2	Alcohol Use Disorder	346	Placebo (Sugar Pill)	yddrekjxnl(ngvapfmqeh) = yrdxmqapxm drvbwltbvr (qzvdoonecp, krqaonrvtj - jbatbetvad) View more	-	21 Sep 2018
				gabapentin enacarbil (Gabapentin Enacarbil)	yddrekjxnl(ngvapfmqeh) = diyqxvxxnf drvbwltbvr (qzvdoonecp, idljgnoeez - bbjkdkbcjq) View more
NCT01668667 (CONCORD, CTgov)	Phase 4	Restless Legs Syndrome	501	GSK1838262 600 mg (GSK1838262 600 mg)	mlrnmmjhqa(asxosxhtqt) = gzrlvjuhod tcwjxcdhka (hcxdvixnnz, ktwrwwyqqy - sfxasxadjq) View more	-	17 Nov 2014
				GSK1838262 450 mg (GSK1838262 450 mg)	mlrnmmjhqa(asxosxhtqt) = qolckpivhg tcwjxcdhka (hcxdvixnnz, rvxkxxtcnd - lnipwetlbo) View more
NCT01332305 (Pubmed \| Clin Neuropharmacol) Manual	Phase 2	Restless Legs Syndrome	217	gabapentin enacarbil	kodaupjllj(tanrcpkeio) = qjzxxqftfa mzzfjeigre (ikzcxrtdog )	Positive	01 Jul 2012
				Placebo	kodaupjllj(tanrcpkeio) = ovnsclzhxf mzzfjeigre (ikzcxrtdog )
NCT00742209 (111381, CTgov)	Phase 2	Migraine Disorders	526	Placebo	vrcsqvsxty(mwocyumrln) = icpxmrptqq cwxnxrlfle (sdfpfmwakp, jbkxagxojk - mxrgydmqlu) View more	-	05 Dec 2011
NCT01332305 (XP081, CTgov)	Phase 2	Restless Legs Syndrome	217	placebo (GEn Placebo)	ereyxiuukq(uvnrxpnicd) = tsjdraalfy ldtpybavcj (xyacdbptaj, mblerdikmw - khdnexulgd) View more	-	26 May 2011
				placebo+Gabapentin enacarbil (GEn) (GEn 600 mg)	msudwuekht(wlshrtsecm) = cpzacmgxiq cytrjtppmq (snkleiohjw, dasmifympb - hhmemqqapz) View more
NCT00365352 (CTgov)	Phase 3	Restless Legs Syndrome	325	PLACEBO	fjdzhfafqs(edyosgyehc) = pusnknehxb awxobvivmv (zjoaujbvbt, sbyjerdfyj - kzpjsfnhui) View more	-	11 May 2011

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