Clinical Trials

Several clinical trials evaluate gabapentin across diverse indications, including post-operative pain management, opioid use reduction, and uremic pruritus in patients with chronic kidney disease. Sponsored primarily by academic institutions such as Stanford University, the University of Oklahoma, and King Edward Medical University, these studies span Early Phase 1, Phase 4, and observational designs. Their recruitment statuses vary from not yet recruiting to actively recruiting and completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04613024 Not yet recruiting
Weight Loss|Pain Postoperative
Stanford University
 2023-07-01 Early Phase 1
NCT05276089 Not yet recruiting
Opioid Use
Dr Yu Fu|Teesside University|NIHR Applied Research Collaboration for North East and North Cumbria|North East Academic Health Science Network|Newcastle University
 2023-02-01 Not Applicable
NCT05609682 Recruiting
Post Operative Pain
University of Oklahoma
 2022-11-29 Early Phase 1
NCT05750875 Completed
Pruritus|Uremia|Chronic Kidney Diseases
King Edward Medical University
 2022-05-01 Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Gabapentin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gabapentin selectively binds to the alpha-2-delta auxiliary subunit of voltage-gated calcium channels in the central nervous system, thereby inhibiting presynaptic calcium influx and reducing the release of excitatory neurotransmitters. This attenuation of neuronal hyperexcitability suppresses central sensitization and nociceptive signaling, providing therapeutic efficacy in managing post-operative pain, neuropathic discomfort, and uremic pruritus.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.