Clinical Trials

Multiple completed Phase 1 clinical trials have evaluated revefenacin for the treatment of chronic obstructive pulmonary disease (COPD). Sponsored by major pharmaceutical companies, including GlaxoSmithKline, Theravance Biopharma, Mylan Inc., and Viatris Inc., these early-phase studies assessed the drug's safety, tolerability, pharmacodynamics, and comprehensive pharmacokinetic parameters. Ultimately, these clinical evaluations established essential pharmacological baselines for the development of revefenacin in managing obstructive airway disorders.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02772159 Completed
Chronic Obstructive Pulmonary Disease (COPD)
Mylan Inc.|Theravance Biopharma|Viatris Inc.
 2015-06 Phase 1
NCT00555022 Completed
Pulmonary Disease Chronic Obstructive
GlaxoSmithKline
 2007-12-12 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Revefenacin selectively binds to and antagonizes muscarinic acetylcholine receptors in respiratory tissues, blocking acetylcholine-stimulated G-protein signaling and intracellular calcium mobilization within airway smooth muscle cells. This inhibition prevents cholinergic bronchoconstriction and promotes prolonged airway relaxation, thereby alleviating bronchial obstruction and improving ventilatory function in clinical conditions such as chronic obstructive pulmonary disease.

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.