Drugs / Bardoxolone methyl
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | Alport syndrome 3b, autosomal recessive | 2021-07-27 | “Kyowa Kirin has submitted an NDA of bardoxolone methyl (RTA 402) for the treatment of Alport Syndrome on July 27th.” kyowakirin.com ↗ |
Trials 34
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 113 trials | ||||||
| Phase 1 | NCT04018339 | Aug 2019 → May 2020 | morbid obesity | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04023903 | Apr → Jun 2019 | — | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03264079 | Oct → Nov 2017 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01689116 | Aug → Nov 2012 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01549769 | Apr → Nov 2012 | chronic kidney disease, type 2 diabetes mellitus | Biogen | Terminated | No outcome recorded |
| Phase 1 | NCT01551446 | Apr → Nov 2012 | chronic kidney disease, type 2 diabetes mellitus | Biogen | Withdrawn | No outcome recorded |
| Phase 1 | NCT01563562 | Apr → Nov 2012 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01500798 | Jan → Nov 2012 | chronic kidney disease, type 2 diabetes mellitus | Biogen | Terminated | No outcome recorded |
| Phase 1 | NCT01503866 | Dec 2011 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01461161 | Oct → Dec 2011 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT00529113 | Sep 2007 → Nov 2009 | malignant pancreatic neoplasm | Biogen | Terminated | No outcome recorded |
| Phase 1 | NCT00529438 | Apr 2006 → Dec 2008 | cancer, lymphoid neoplasm | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT00508807 | Apr 2006 → Dec 2009 | cancer, lymphoid neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00550849 | Apr → Nov 2007 | liver disorder | Biogen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 213 trials · 3 met primary · 2 missed | ||||||
| Phase 2 | NCT04702997 | Feb → Oct 2021 | chronic kidney disease | Biogen | Completed | Met primary |
| Phase 2 | NCT04494646 | Sep 2020 → Jan 2021 | COVID-19 | NYU Langone Health | Completed | No outcome recorded |
| Phase 2 | NCT03366337 | Dec 2017 → Jan 2019 | IgA glomerulonephritis, autosomal dominant polycystic kidney disease, diabetic kidney disease, focal segmental glomerulosclerosis | Biogen | Completed | Met primary |
| Phase 2 | NCT02316821 | Dec 2014 → May 2016 | chronic kidney disease, type 2 diabetes mellitus | Kyowa Kirin, Inc. | Completed | Missed primary |
| Phase 2 | NCT02036970 | May 2014 → Jan 2018 | acute interstitial pneumonia, cryptogenic organizing pneumonia, desquamative interstitial pneumonia, idiopathic pleuroparenchymal fibroelastosis +5 | Biogen | Completed | Missed primary |
| Phase 2 | NCT01655186 | Sep → Oct 2012 | chronic kidney disease, type 2 diabetes mellitus | Biogen | Withdrawn | No outcome recorded |
| Phase 2 | NCT01576887 | Jul → Oct 2012 | end stage renal failure, type 2 diabetes mellitus | Biogen | Withdrawn | No outcome recorded |
| Phase 2 | NCT01574365 | Feb 2012 → Nov 2013 | chronic kidney disease, type 2 diabetes mellitus | Kyowa Kirin, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01572610 | Feb 2012 → Nov 2013 | chronic kidney disease, type 2 diabetes mellitus | Kyowa Kirin, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01053936 | Jan → Dec 2010 | chronic kidney disease, type 2 diabetes mellitus | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00811889 | Apr 2009 → May 2010 | diabetic kidney disease, type 2 diabetes mellitus | Biogen | Completed | Met primary |
| Phase 2 | NCT00664027 | Apr 2008 → May 2009 | diabetic kidney disease | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00535314 | — | melanoma | Biogen | Withdrawn | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT03019185 | Mar 2017 → Oct 2020 | Alport syndrome | Biogen | Completed | Met primary |
| Phase 36 trials · 3 missed | ||||||
| Phase 3 | NCT03918447 | May 2019 → Aug 2023 | autosomal dominant polycystic kidney disease | Biogen | Terminated | Missed primary |
| Phase 3 | NCT03749447 | Mar 2019 → Aug 2023 | Alport syndrome, autosomal dominant polycystic kidney disease, chronic kidney disease | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT03550443 | May 2018 → Nov 2022 | diabetic kidney disease | Kyowa Kirin, Inc. | Terminated | Mixed |
| Phase 3 | NCT03068130 | Apr 2017 → Sep 2020 | pulmonary hypertension | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT02657356 | Oct 2016 → May 2020 | pulmonary arterial hypertension | Biogen | Terminated | Missed primary |
| Phase 3 | NCT01351675 | Jun 2011 → Oct 2012 | chronic kidney disease, type 2 diabetes mellitus | Biogen | Terminated | Missed primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2023-05-10 | Kyowa Kirin, Inc. | Results Kyowa Kirin Announces Phase III Study Results of bardoxolone methyl (RTA 402) in Japan and Discontinuation of Development kyowakirin.com ↗
Patients administered RTA 402 showed statistically significant improvement for “Time to onset a ≥ 30% decrease in eGFR from baseline or ESRD” and “Time to onset a ≥ 40% decrease in eGFR from baseline or ESRD”, thereby meeting the primary and key secondary endpoints. |
| 2021-07-28 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces NDA Submission of Bardoxolone Methyl (RTA 402) for Alport Syndrome in Japan kyowakirin.com ↗
Kyowa Kirin Co., Ltd. (President and CEO: Masashi Miyamoto, Kyowa Kirin, TSE: 4151) announced that Kyowa Kirin has submitted an NDA of bardoxolone methyl (RTA 402) for the treatment of Alport Syndrome on July 27th. |
| 2018-03-28 | Kyowa Kirin, Inc. | Regulatory Bardoxolone Methyl (RTA 402) Designated for the Treatment of Diabetic Kidney Disease under the Priority Review and Designation System by the Ministry of Health, Labour and Welfare kyowakirin.com ↗ |
| 2017-11-06 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Presented Results of Phase II Study of Bardoxolone Methyl in Japan at the ASN Kidney Week 2017 kyowakirin.com ↗
the results were presented as a Late-Breaking Clinical Trial oral presentation at the American Society of Nephrology Kidney Week 2017. |
| 2016-05-23 | Kyowa Kirin, Inc. | Results Bardoxolone Methyl (RTA 402) Data Show Improvement in Renal Function by Inulin Clearance in a Phase II Clinical Study in Japan kyowakirin.com ↗
Data from interim analysis were assessed by an Independent Data Monitoring Committee*5 and demonstrated that a significant improvement in GFR was seen in the RTA 402 compared with the placebo group. |
| 2013-11-11 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Announces the Development Status of Bardoxolone Methyl (RTA 402) in Patients with Chronic Kidney Disease and Type 2 Diabetes in Japan kyowakirin.com ↗ |
All press releases naming this drug 11 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bardoxolone methyl | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01461161 ↗ |
| Known as | Bardoxolone methyl ester | ChEMBL registry synonym — accepted as the source's own label CHEMBL1762621 ↗ |
| Known as | CDDO-Me | “Randomized, Double-blind, Placebo-controlled, Multiple-dose, Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacodynamics of RTA 402 (CDDO-Me) Administered...” NCT00550849 ↗1“Clinical Study Protocol RTA 402-C-0501: A Phase I Dose-finding and Pharmacokinetic Study of RTA 402 (CDDO-Me) Administered Orally for 21 Days of a 28-day Cycle in Patients With...” NCT00508807 ↗ |
| Known as | CDDO-METHYL ESTER | ChEMBL registry synonym — accepted as the source's own label CHEMBL1762621 ↗ |
| Known as | NSC 713200 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1762621 ↗ |
| Known as | RTA 402 | “Bardoxolone methyl (RTA 402) is an Antioxidant Inflammation Modulator (AIM) that is undergoing clinical testing in chronic kidney disease (CKD) and cancer.” NCT00811889 ↗8“Bardoxolone methyl (RTA 402) is an Antioxidant Inflammation Modulator (AIM) that is undergoing clinical testing in chronic kidney disease (CKD).” NCT01053936 ↗ “RTA 402 (Bardoxolone Methyl)” NCT00664027 ↗ |
| Action | Inhibit | “Inhibitor of nuclear factor kappa B kinase beta subunit inhibitor” CHEMBL1762621 ↗2“Peroxisome proliferator-activated receptor gamma antagonist” CHEMBL1762621 ↗ “inhibits immune-mediated inflammation” NCT00664027 ↗ |
| Modality | Small molecule | “synthetic triterpenoid” NCT00529438 ↗ |
| Route | Oral | “RTA 402 capsules administered orally for 21 days” NCT00508807 ↗ |
| Target | IKBKB | “Inhibitor of nuclear factor kappa B kinase beta subunit inhibitor” CHEMBL1762621 ↗ |
| Target | NFE2L2 | “by inducing the cytoprotective transcription factor Nrf2” NCT00811889 ↗ |
| Target | PPARG | “Peroxisome proliferator-activated receptor gamma antagonist” CHEMBL1762621 ↗ |