Apabetalone (RVX-208) Clinical Trials

Size	Price	Qty
5mg	USD 147
20mg	USD 270

Clinical Trials

Apabetalone (RVX-208) has been evaluated in several clinical trials spanning Early Phase 1 through Phase 3, with recruitment statuses encompassing completed, terminated, withdrawn, and not yet recruiting stages. Primarily sponsored by Resverlogix Corp alongside academic and clinical partners such as Laval University and The Cleveland Clinic, these investigations targeted cardiovascular and metabolic conditions—including coronary artery disease, dyslipidemia, and type 2 diabetes mellitus—as well as secondary indications like chronic kidney failure, Fabry disease, pulmonary arterial hypertension, and COVID-19 infection.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03160430	NOT_YET_RECRUITING	Kidney Failure, Chronic	Resverlogix Corp	2024-11-22	PHASE1; PHASE2
NCT06590324	RECRUITING	Post-Acute COVID-19 Syndrome	Resverlogix Corp	2025-04-15	PHASE2; PHASE3
NCT04915300	UNKNOWN	Pulmonary Arterial Hypertension	Laval University	2023-10	PHASE2
NCT03160430	Not yet recruiting	Kidney Failure Chronic	Resverlogix Corp	2024-11-22	Phase 1\|Phase 2
NCT03228940	Withdrawn	Fabry Disease	Resverlogix Corp	2022-11-22	Phase 1\|Phase 2
NCT04894266	TERMINATED	COVID-19 Infection	Resverlogix Corp	2022-01-14	PHASE2; PHASE3
NCT03655704	COMPLETED	Pulmonary Arterial Hypertension	Steeve Provencher	2019-08-22	EARLY_PHASE1
NCT02586155	COMPLETED	Diabetes Mellitus, Type 2; Coronary Artery Disease	Resverlogix Corp	2015-11	PHASE3
NCT01863225	Terminated	Dyslipidemia\|Coronary Artery Disease	Resverlogix Corp\|South Australian Health and Medical Research Institute	2013-05	Phase 2
NCT01728467	Completed	Diabetes	Resverlogix Corp\|Baker Heart and Diabetes Institute\|Nucleus Network Ltd	2012-11	Phase 2
NCT01067820	Completed	Coronary Artery Disease	Resverlogix Corp\|The Cleveland Clinic	2011-09	Phase 2
NCT01423188	Completed	Coronary Artery Disease\|Dyslipidemia	Resverlogix Corp\|The Cleveland Clinic	2011-08	Phase 2

(data from https://clinicaltrials.gov, updated on 2023-11-15)

Check the Apabetalone (RVX-208) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Apabetalone acts as a selective inhibitor of bromodomain and extra-terminal (BET) family proteins, binding preferentially to the second bromodomain (BD2) to suppress epigenetic transcriptional activation of pro-inflammatory and pro-atherogenic genes. This selective transcriptional modulation attenuates vascular inflammation and systemic endothelial dysfunction, offering therapeutic utility for conditions evaluated in clinical trials such as coronary artery disease, dyslipidemia, and chronic kidney failure.

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>).