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 DisorderChoreoathetosisDiabetic peripheral neuropathic pain+ [2]

Originator Organization

XenoPort, Inc.

Active Organization

Azurity Pharmaceuticals, Inc.

Astellas Pharma, 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

/ Unknown statusPhase 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

130

Literatures (Medical) associated with Gabapentin Enacarbil

01 Oct 2025·SLEEP MEDICINE

Partial endorsement of “Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline” by the World Sleep Society

Article

Author: Ferri, Raffaele ; Manconi, Mauro ; Silber, Michael H ; Trenkwalder, Claudia ; Kushida, Clete A ; Inoue, Yuichi

BACKGROUND:

The 2025 American Academy of Sleep Medicine (AASM) clinical practice guideline for the treatment of Restless Legs Syndrome (RLS) and Periodic Limb Movement Disorder (PLMD) provides updated, evidence-based recommendations. The World Sleep Society (WSS) conducted an international review to assess the guideline's global applicability and implementation feasibility.

METHODS:

A structured questionnaire was distributed to representatives of 53 national sleep societies affiliated with the WSS. The survey addressed guideline familiarity, perceived applicability, agreement with 20 treatment recommendations, and availability of key therapies. Responses were analyzed using descriptive statistics and the within-group interrater agreement coefficient (rWG) to assess consensus levels.

RESULTS:

Twenty-three national societies (43.9 %) from all inhabited continents responded. The AASM guideline was perceived as fully or partially applicable in most countries. Twelve recommendations were fully supported by the WSS, five partially supported, two (regarding dopamine agonists) endorsed with caveats, and one (dipyridamole) not supported. Key barriers included limited access to certain medications (e.g., IV iron, gabapentin enacarbil), regulatory restrictions, and divergent treatment traditions. There was strong global consensus on discouraging ineffective or harmful treatments (e.g., cabergoline, valproic acid), while the avoidance of dopaminergic agents generated regional disagreement.

CONCLUSIONS:

The AASM guidelines received broad international support but require region-specific adaptation for optimal implementation. The WSS endorses the guideline's structure and scientific foundation while recommending flexible dissemination strategies and greater clarity in therapeutic algorithms. These findings support the development of globally relevant, context-sensitive guidance in sleep medicine.

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

OBJECTIVES:

Restless 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.

DESIGN:

This 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 PARTICIPANTS:

Older adults (N = 147) with dementia due to Alzheimer's disease, nighttime agitation, and RLS, residing in long-term care or at home, participated.

METHODS:

The 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.

RESULTS:

Mean 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 IMPLICATIONS:

Our 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

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

Article

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

BACKGROUND:

Gabapentin, 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.

METHODS:

Baseline 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.

RESULTS:

Analyses 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.

CONCLUSION:

Baseline 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.

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.

to view more data

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
Alcohol Use Disorder	Phase 2	United States	Arbor Pharmaceuticals, Inc.	01 Jun 2015
Migraine Disorders	Phase 2	United States	XenoPort, Inc.	01 Aug 2008
Migraine Disorders	Phase 2	Canada	XenoPort, Inc.	01 Aug 2008
Diabetic peripheral neuropathy	Phase 2	United States	XenoPort, Inc.	01 Mar 2008
Neuralgia	Phase 2	United States	XenoPort, Inc.	01 Mar 2008
Diabetic peripheral neuropathic pain	Phase 2	Japan	Astellas Pharma, Inc.	01 Jul 2007
Choreoathetosis	Phase 1	United States	XenoPort, Inc.	01 Jan 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06247488 (CTgov)	Phase 4	-	110	Placebo (Placebo)	gewmlslxzn(kbzlwmqqzu) = tuklumlsej tbaawhfiqp (myiuqwqxoj, 1.75) View more	-	30 Jul 2024
				Oxycodone 20 mg (Oxycodone 20 mg)	gewmlslxzn(kbzlwmqqzu) = dzdvsbltjs tbaawhfiqp (myiuqwqxoj, 2.08) View more
NCT02840240 (CTgov)	Not Applicable	Pain \| Anesthesia	107	Gabapentin enacarbil (Gabapentin Enacarbil)	hnsjlnkbne(dijirsblgc) = ciyftrycbu nawuueuhgp (wzfopcgklk, 1.6) View more	-	09 Jan 2024
				Placebo (Placebo)	hnsjlnkbne(dijirsblgc) = hlcrftbehu nawuueuhgp (wzfopcgklk, 1.7) View more
NCT06097676 (CTgov)	Phase 4	-	86	Placebo (Placebo)	rirwvenfnp(bsfcegfund) = wojcoopbds jmwibvimtk (hgqovblrul, 1.47) View more	-	03 Jan 2024
				Alprazolam 2 mg (Alprazolam 2 mg)	rirwvenfnp(bsfcegfund) = tuwioxdrim jmwibvimtk (hgqovblrul, 1.93) View more
NCT02642315 (XP-IIT-0034, CTgov)	Not Applicable	Restless Legs Syndrome	10	Horizant	thtvytxmnb(tquuhpkctl) = dvqiikywvx kpfnmwswsh (ggzmxnrhcy, ztdfvibjpe - ncfuqoiczv) View more	-	24 Feb 2022
NCT03053427 (CTgov)	Phase 4	Restless Legs Syndrome	375	Placebo (Placebo)	vbkzvdjcni(ihbscialxh) = ecbtctlaju osuqnrpukx (xflizidjmn, wkqrajxuoi - qqolnxvkyx) View more	-	10 Jul 2019
				Gabapentin enacarbil (Gabapentin Enacarbil)	vbkzvdjcni(ihbscialxh) = qyyepoangy osuqnrpukx (xflizidjmn, jultgahcht - tufkqwulmn) View more
NCT02252536 (Pubmed) Manual	Phase 2	Alcohol Use Disorder	346	gabapentin enacarbil	rgtywvixzm(qseftdaviq) = twjudaeeyp vglzzclizq (spvheplsod )	Negative	01 Jan 2019
				Placebo	rgtywvixzm(qseftdaviq) = nuogqkvyzf vglzzclizq (spvheplsod )
NCT02252536 (CTgov)	Phase 2	Alcohol Use Disorder	346	Placebo (Sugar Pill)	umpcauzexr = ginovbhuzh galiamyqgs (kbilgqupac, bcudzbqvgp - mpjpjiqbuq) View more	-	21 Sep 2018
				gabapentin enacarbil (Gabapentin Enacarbil)	umpcauzexr = ybmbscjpzs galiamyqgs (kbilgqupac, ghfsvnhclw - aagruiaswd) View more
AAN2015	Not Applicable	Restless Legs Syndrome	541	Gabapentin Enacarbil 600 mg	ruavdnjarg(bokgclazpp) = hjtlidtxvx axmmwpvble (kuaschxedd )	-	06 Apr 2015
				Gabapentin Enacarbil 1200 mg	ruavdnjarg(bokgclazpp) = sazsfkjtks axmmwpvble (kuaschxedd )
NCT01668667 (CONCORD, CTgov)	Phase 4	Restless Legs Syndrome	501	GSK1838262 600 mg (GSK1838262 600 mg)	lozwsvydwf(zlxxjddxgm) = uifosyfnhq mxenncxmga (ttydzlwvjy, 0.745) View more	-	17 Nov 2014
				GSK1838262 450 mg (GSK1838262 450 mg)	lozwsvydwf(zlxxjddxgm) = appwizilaf mxenncxmga (ttydzlwvjy, 0.764) View more
NCT01332305 (Pubmed \| Clin Neuropharmacol) Manual	Phase 2	Restless Legs Syndrome	217	gabapentin enacarbil	dfoejfibhh(xcgmkqkfmt) = pcanfvvczy ccgvduuknl (irksvilgri )	Positive	01 Jul 2012
				Placebo	dfoejfibhh(xcgmkqkfmt) = yhdswfxycn ccgvduuknl (irksvilgri )

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