VX-445 (Elexacaftor) Clinical Trials

Size	Price	Qty
2mg	USD 190
5mg	USD 357

Clinical Trials

Numerous clinical trials evaluate VX-445 (elexacaftor), primarily focusing on cystic fibrosis and related manifestations such as CFTR gene mutations, chronic rhinosinusitis, olfactory disorders, and bacterial respiratory infections. Spanning Phase 1 through Phase 4 as well as post-marketing evaluations, these protocols display varied recruitment statuses, ranging from active and completed trials to those not yet recruiting. The broader research landscape reflects diverse sponsorship across industrial entities like Vertex Pharmaceuticals and academic medical centers such as University Hospital Strasbourg and Sheffield Teaching Hospitals.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07148739	RECRUITING	Cystic Fibrosis (CF)	Arkansas Children's Hospital Research Institute	2025-06-10	PHASE4
NCT06457451	RECRUITING	Cystic Fibrosis	University Hospital, Tours	2024-11-25
NCT06460506	ACTIVE_NOT_RECRUITING	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2024-11-21	PHASE3
NCT05331183	ACTIVE_NOT_RECRUITING	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2022-11-23	PHASE3
NCT07314229	RECRUITING	Cystic Fibrosis (CF); Mucoviscidosis	University Hospital, Lille	2025-12-17
NCT05937815	RECRUITING	Cystic Fibrosis	University Hospital, Bordeaux	2021-09-13
NCT05153317	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2022-01-17	PHASE3
NCT05818319	RECRUITING	Cystic Fibrosis (CF); CFTR Gene Mutation	University of Aarhus	2023-06-01
NCT05882357	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2023-06-27	PHASE3
NCT04840862	COMPLETED	Drug Drug Interaction	University of Southern California	2022-05-09	PHASE4
NCT06331000	Not yet recruiting	Cystic Fibrosis	University Hospital Strasbourg France	2024-03	--
NCT04545515	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2021-01-11	PHASE3
NCT03525574	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2018-10-09	PHASE3
NCT04362761	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2020-05-04	PHASE3
NCT05111145	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2022-01-14	PHASE3
NCT04058366	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2019-12-05	PHASE3
NCT04043806	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2019-08-09	PHASE3
NCT04969224	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2021-10-12	PHASE3
NCT04599465	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2021-01-15	PHASE3
NCT05519020	Recruiting	Cystic Fibrosis	Sheffield Teaching Hospitals NHS Foundation Trust	2022-07-27	--
NCT04537793	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2020-11-19	PHASE3
NCT04684823	COMPLETED	Cystic Fibrosis; Adherence, Medication	The University of Texas Health Science Center at San Antonio	2021-01-15
NCT04353817	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2020-06-19	PHASE3
NCT03691779	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2018-10-02	PHASE3
NCT04105972	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2019-10-03	PHASE3
NCT04058353	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2019-08-28	PHASE3
NCT03525444	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2018-06-15	PHASE3
NCT03525548	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2018-08-03	PHASE3
NCT03525548	Completed	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2018-08-03	Phase 3
NCT03525444	Completed	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2018-06-15	Phase 3
NCT03227471	COMPLETED	Cystic Fibrosis	Vertex Pharmaceuticals Incorporated	2017-01-23	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-02)

Check the VX-445 (Elexacaftor) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Elexacaftor (VX-445) functions as a next-generation cystic fibrosis transmembrane conductance regulator (CFTR) corrector that binds to mutant CFTR proteins, facilitating their proper folding, cellular trafficking, and insertion into the plasma membrane to restore chloride ion transport. By increasing functional CFTR expression at the cell surface, this compound mitigates epithelial fluid imbalances, directly addressing the underlying pathophysiological defects in patients evaluated across clinical trials for cystic fibrosis and associated pulmonary complications.

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>).