GLPG1837 Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 217

Clinical Trials

Galapagos NV has sponsored several completed Phase I and Phase II clinical trials to evaluate the therapeutic potential, safety, and pharmacokinetic profile of GLPG1837. These clinical trials investigated drug-drug interactions with midazolam in healthy male volunteers as well as the efficacy and safety of dosing regimens in cystic fibrosis patients carrying the S1251N mutation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02690519	Completed	Cystic Fibrosis	Galapagos NV	2016-01	Phase 2
NCT02562950	Completed	Healthy	Galapagos NV	2015-09	Phase 1

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

Check the GLPG1837 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GLPG1837 functions as a potent CFTR potentiator that binds to mutant CFTR ion channels, facilitating increased channel gating open probability and restoring transepithelial chloride ion secretion across cell membranes. By enhancing the functional ion gating of mutant CFTR channels such as the F508del and class III variants, this compound directly addresses the physiological chloride transport defects characteristic of cystic fibrosis.

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>).