Clinical Trials

Several clinical trials are currently evaluating interventions for conditions including anemia, post-essential thrombocythemia myelofibrosis, post-polycythemia vera myelofibrosis, obesity, hypertension, circadian dysregulation, excess salt intake, and alcoholism. Spanning Phase 1, Phase 1/2, and phase-not-applicable designs, these studies reflect both recruiting and completed recruitment statuses. The trial landscape is supported by a mix of commercial entities, such as Incyte Corporation, and academic institutions, including the University of Alabama at Birmingham and the University of Pittsburgh.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04455841 Recruiting
Anemia|Post-essential Thrombocythemia Myelofibrosis|Post-polycythemia Vera Myelofibrosis
Incyte Corporation
 2021-03-19 Phase 1|Phase 2
NCT04021355 Recruiting
Obesity|Hypertension|Circadian Dysregulation|Salt; Excess
University of Alabama at Birmingham
 2020-07-14 Not Applicable
NCT01904487 Completed
Alcoholism
Rajesh Narendran|University of Pittsburgh
 2011-04-19 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tiagabine selectively binds to presynaptic gamma-aminobutyric acid transporters and blocks GABA reuptake, thereby increasing synaptic neurotransmitter concentrations and enhancing inhibitory GABAergic signaling. This sustained cellular inhibition suppresses neuronal hyperexcitability, providing therapeutic relevance for modulating altered central nervous system neurotransmission in clinical conditions such as alcoholism.

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.