Bardoxolone Methyl (RTA 402) Clinical Trials

Size	Price	Qty
25mg	USD 147
200mg	USD 570

Clinical Trials

Multiple clinical trials spanning Phase I, Phase II, and Phase III evaluate bardoxolone methyl across completed, withdrawn, and terminated statuses. Sponsored by industry partners like Biogen and Kyowa Kirin alongside academic institutions such as NYU Langone Health, this research targets renal, metabolic, cardiovascular, and respiratory conditions, in addition to pharmacokinetic assessments in healthy volunteers. Together, these trials reflect an extensive clinical evaluation of the compound's therapeutic potential.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03749447	TERMINATED	Chronic Kidney Diseases; Alport Syndrome; Autosomal Dominant Polycystic Kidney	Biogen	2019-03-08	PHASE3
NCT03918447	TERMINATED	Autosomal Dominant Polycystic Kidney; ADPKD	Biogen	2019-05-29	PHASE3
NCT03550443	TERMINATED	Diabetic Kidney Disease	Kyowa Kirin Co., Ltd.	2018-05-30	PHASE3
NCT04702997	COMPLETED	Chronic Kidney Diseases	Biogen	2021-02-09	PHASE2
NCT04494646	COMPLETED	Covid19	NYU Langone Health	2020-09-08	PHASE2
NCT03019185	COMPLETED	Alport Syndrome	Biogen	2017-03-02	PHASE2; PHASE3
NCT03068130	TERMINATED	Pulmonary Hypertension	Biogen	2017-04-18	PHASE3
NCT04018339	COMPLETED	Obese Adult Male	Kyowa Kirin Co., Ltd.	2019-08-20	PHASE1
NCT02657356	TERMINATED	Connective Tissue Disease-Associated Pulmonary Arterial Hypertension	Biogen	2016-10-04	PHASE3
NCT04023903	COMPLETED	Healthy Subject	Kyowa Kirin Co., Ltd.	2019-04-04	PHASE1
NCT03366337	COMPLETED	IgA Nephropathy; CKD Associated With Type 1 Diabetes; Focal Segmental Glomerulosclerosis; Autosomal Dominant Polycystic Kidney	Biogen	2017-12-26	PHASE2
NCT02036970	COMPLETED	Pulmonary Arterial Hypertension; Pulmonary Hypertension; Interstitial Lung Disease; Idiopathic Interstitial Pneumonia; Idiopathic Pulmonary Fibrosis; Sarcoidosis; Respiratory Bronchiolitis Associated Interstitial Lung Disease; Desquamative Interstitial Pneumonia; Cryptogenic Organizing Pneumonia; Acute Interstitial Pneumonitis; Idiopathic Lymphoid Interstitial Pneumonia; Idiopathic Pleuroparenchymal Fibroelastosis	Biogen	2014-05-31	PHASE2
NCT03264079	COMPLETED	Healthy Volunteers	Biogen	2017-10-16	PHASE1
NCT02316821	Completed	Chronic Kidney Disease\|Type 2 Diabetes	Kyowa Kirin Co. Ltd.	2014-12	Phase 2
NCT02036970	Completed	Pulmonary Arterial Hypertension\|Pulmonary Hypertension\|Interstitial Lung Disease\|Idiopathic Interstitial Pneumonia\|Idiopathic Pulmonary Fibrosis\|Sarcoidosis\|Respiratory Bronchiolitis Associated Interstitial Lung Disease\|Desquamative Interstitial Pneumonia\|Cryptogenic Organizing Pneumonia\|Acute Interstitial Pneumonitis\|Idiopathic Lymphoid Interstitial Pneumonia\|Idiopathic Pleuroparenchymal Fibroelastosis	Reata a wholly owned subsidiary of Biogen\|Biogen	2014-05-31	Phase 2
NCT01551446	WITHDRAWN	Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2	Biogen	2012-04-30	PHASE1
NCT01563562	COMPLETED	Hepatic Impairment; Healthy	Biogen	2012-04-30	PHASE1
NCT01549769	TERMINATED	Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2	Biogen	2012-04-30	PHASE1
NCT01689116	COMPLETED	Healthy Volunteers	Biogen	2012-08-31	PHASE1
NCT01500798	TERMINATED	Chronic Kidney Disease; Type 2 Diabetes	Biogen	2012-01-31	PHASE1
NCT01655186	WITHDRAWN	Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2	Biogen	2012-09-30	PHASE2
NCT01576887	WITHDRAWN	End-Stage Renal Disease; Type 2 Diabetes Mellitus	Biogen	2012-07-31	PHASE2
NCT01351675	TERMINATED	Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2	Biogen	2011-06-30	PHASE3
NCT01598363	COMPLETED	Healthy Volunteers	Biogen	2012-06-30	PHASE1
NCT01598363	Completed	Healthy Volunteers	Reata a wholly owned subsidiary of Biogen\|Biogen	2012-06-30	Phase 1
NCT01551446	Withdrawn	Renal Insufficiency Chronic\|Diabetes Mellitus Type 2	Reata a wholly owned subsidiary of Biogen\|Biogen	2012-04-30	Phase 1
NCT01461161	COMPLETED	Healthy Volunteers	Biogen	2011-10-31	PHASE1
NCT01503866	COMPLETED	Healthy	Biogen	2011-12-01	PHASE1
NCT01503866	Completed	Healthy	Reata a wholly owned subsidiary of Biogen\|Biogen	2011-12-01	Phase 1
NCT01053936	COMPLETED	Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2	Biogen	2010-01-31	PHASE2
NCT00811889	COMPLETED	Chronic Kidney Disease; Type 2 Diabetes; Diabetic Nephropathy	Biogen	2009-04-30	PHASE2
NCT00529113	TERMINATED	Pancreatic Neoplasms; Pancreatic Cancer	Biogen	2007-09-30	PHASE1
NCT00664027	COMPLETED	Diabetic Nephropathy	Biogen	2008-04-30	PHASE2
NCT00529438	COMPLETED	Advanced Solid Tumors; Lymphoid Malignancies	Biogen	2006-04-30	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-06-03)

Check the Bardoxolone Methyl (RTA 402) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bardoxolone methyl directly targets IκB kinase to inhibit downstream nuclear factor-κB signaling while simultaneously activating the Nrf2 pathway, thereby suppressing pro-inflammatory cytokine transcription and preventing ferroptosis and oxidative cellular damage. By blunting inflammatory cascades and enhancing cytoprotective responses in renal and pulmonary tissues, this molecular mechanism mitigates pathological damage in conditions such as chronic kidney disease, diabetic nephropathy, and pulmonary arterial hypertension evaluated in clinical trials.

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>).