GRALISE (gabapentin)
Gralise is indicated for the management of postherpetic neuralgia (PHN). It is not interchangeable with other gabapentin products due to its unique pharmacokinetic profile, which dictates a specific dosing frequency. This medication is specifically used to manage neuropathic pain associated with the aftermath of herpes zoster infections.
How GRALISE Works
The exact mechanism by which gabapentin exerts its analgesic effect is unknown. In animal models of neuropathic pain, it prevents allodynia (pain from non-painful stimuli) and hyperalgesia (exaggerated pain response). While gabapentin is a structural derivative of the neurotransmitter GABA, it does not bind to GABA receptors, is not converted into GABA, and does not inhibit GABA uptake or degradation. It also shows no affinity for other common receptor systems, including benzodiazepine, glutamate, NMDA, dopamine, or serotonin receptors. Research indicates it binds with high affinity to the alpha-2-delta subunit of voltage-gated calcium channels.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-01-28
- Routes
- ORAL
- Dosage Forms
- TABLET
GRALISE Approval History
What GRALISE Treats
1 indicationsGRALISE is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Postherpetic Neuralgia
GRALISE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to GRALISE
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
145 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 145 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
GRALISE FDA Label Details
Indications & Usage
FDA Label (PDF)GRALISE is indicated for the treatment of Postherpetic Neuralgia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment