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Data updated: May 26, 2026

RELGAABI (gabapentin)

Neurology Approved 2016-02-18

RELGAABI is indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy RELGAABI is indicated for: Postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy

Source: FDA Label • SCIEGEN PHARMS
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
10
Years on Market

Details

Status
Prescription
First Approved
2016-02-18
Routes
ORAL
Dosage Forms
CAPSULE

Companies

SCIEGEN PHARMS
Active Ingredient: GABAPENTIN

RELGAABI Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
40 FDA actions from 2016 to 2026
Feb 2026 SUPPL
Label · Labeling
Dec 2024 SUPPL
Label · Labeling
Sep 2020 SUPPL
Label · Labeling

What RELGAABI Treats

1 FDA approvals

Originally approved for its first indication in 2016 .

  • Other (1)
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Clinical Trial Registry

144 trials
Trial Sponsor ID Phase Status Title
NCT06992427 HOPE A222301 NCI-2025-00501 Ph 3 recruiting High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
NCT03574792 results posted I 61117 NCI-2018-01055, I 61117 Ph 2 completed Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy
NCT03818932 results posted 123192 Ph 2, Ph 3 completed Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction
NCT02219373 P00008001 Ph 3 not yet recruiting Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Clinical Effectiveness Study
NCT05063656 STUDY00000151 Ph 4 completed Biomarker-Driven Pharmacological Treatment of Adolescents With Autism Spectrum Disorder With Gabapentin
NCT06997016 Baylor IRB #025-220 Ph 4 enrolling by invitation Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients
NCT04025203 CE0072015-02-01 Ph 4 completed Pain Reduction and Changes in Upper Limb Function Produced by Different Treatments in Carpal Tunnel Syndrome
NCT05302999 IRB21-00609 Ph 4 recruiting Feasibility of Early Gabapentin as an Intervention for Neurorecovery
NCT05443555 GRAIL H-42904 R01AA030460 Ph 2 recruiting Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
NCT04724252 1571754 Ph 2, Ph 3 recruiting Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
NCT01744444 2012.737 Ph 2 completed Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Multiple Sclerosis
NCT02466191 69HCL14_0438 2014-005548-17 Ph 4 completed Treatment of Pendular Nystagmus in OPT
NCT02685735 results posted IRB00032506 5P01GM113852 Ph 4 terminated Predicting, Understanding and Speeding Recovery After TKA
NCT05658887 results posted 202207210 Ph 4 completed Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery
NCT03498261 2017H0466 Ph 1 active not recruiting A Prospective Randomized Double Blind Trial to Assess the Effect of a Single Preoperative Dose of Gabapentin on Postoperative Opioid Consumption in Patients Undergoing Rhinoplasty
NCT07047040 pre-operative analgesia Ph 2, Ph 3 not yet recruiting Analgesic Efficacy of Pre-operative Dose of Ketorolac and Gabapentin
NCT05064319 00112593 R01DA054275 Ph 2 recruiting Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders
NCT05076110 21-003441 Ph 4 recruiting Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures
NCT05965492 20230423 Ph 3 withdrawn Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery
NCT06379425 23-0050 Ph 4 recruiting Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries
NCT06466421 Fexof vs Gaba for UP in RHD Ph 4 completed Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis
NCT05921604 35648 Ph 3 active not recruiting Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve Gastrectomy
NCT05620641 35647 Ph 3 completed Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy
NCT04429347 191167 UL1TR000100 Ph 2 completed Gabapentin and Tizanidine for Insomnia in Chronic Pain
NCT04802967 results posted KLG0120 2020-004212-10 Ph 1 completed A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males
NCT03084536 results posted 201703053 Ph 2 completed PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery
NCT04176419 CASE6319 Ph 3 terminated Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery
NCT05156060 VICC HNP 2173 Ph 1, Ph 2 recruiting Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
NCT03205423 results posted 7476 Ph 2 completed Medication Development for Opioid and Alcohol Abuse
NCT03747562 stREnGTH BC-2657 Ph 3 withdrawn Study of Efficacy and Safety of Gabapentin to Reduce the Need for Strong Opioid Use in Head and Neck Cancer Patients.
NCT03859024 results posted IRB-300002992 Ph 4 completed Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty
NCT05494437 CAN-002 Ph 2 completed Effect of PP-01 on Cannabis Withdrawal Syndrome
NCT03423264 IRB17-1550 Ph 2 withdrawn PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing
NCT05664464 GLUGLIO 2022-01877 Ph 1, Ph 2 recruiting Glutamate Inhibitors in Glioblastoma
NCT04619862 H20-02023 Ph 2 recruiting Efficacy of Gabapentin in Treating Pain in Children With SNI (Gabapentin Trial)
NCT03818919 results posted 123191 Ph 2 completed Nonopioid Analgesia After Rotator Cuff Repair
NCT05172570 results posted 10069 Ph 3 terminated Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy
NCT01680549 L12-078 results posted L12-078 Ph 4 completed Pain Control With Total Knee Replacement
NCT03220776 results posted 64964 R01AA025365 Ph 2 completed Imaging GABAergic/Glutamatergic Drugs in Bipolar Alcoholics Alcoholics
NCT04230980 results posted 19-08020686 Ph 3 completed Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery
NCT05626998 FMASU R 164/ 2022 Ph 4 completed Dexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty
NCT04246697 00025711 Ph 4 completed Multimodal Pain Study in Free Flap Patients
NCT04429022 RA-TLH results posted STUDY00004549 Ph 3 completed Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
NCT05100160 2021-0653 NCI-2021-10727 Ph 3 withdrawn Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)
NCT05750875 9669/REG/KEMU/2021 Ph 4 completed Gabapentin Versus Loratadine in Uremic Pruritus
NCT02163434 results posted 496486-3 1R01HD076313-01A1 Ph 2 completed Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
NCT01421264 NEU3280611A Ph 1 completed Gabapentin's Effects on Insomnia in Patients With Recent Concussion
NCT02056899 423140-2 Ph 1 completed Maintenance Gabapentin to Prolong Pregnancy.
NCT02693821 PPP 2575 Ph 4 completed Persistent Postoperative Pain Incidence With Gabapentin Used
NCT02957097 2016p001548 Ph 4 withdrawn Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures

Showing 50 of 144 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

RELGAABI FDA Label Details

Indications & Usage

RELGAABI is indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy RELGAABI is indicated for: Postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy

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Data Sources

FDA Approval: ANDA204989 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.