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1. 2-cyano-3,12-dioxoolean-1,9-dien-28-oic Acid Methyl Ester
2. Cddo Methyl Ester
3. Cddo-me
4. Methyl 2-cyano-3,12-dioxoolean-1,9-dien-28-oate
5. Rta-402
1. 218600-53-4
2. Cddo-me
3. Cddo Methyl Ester
4. Rta 402
5. Nsc 713200
6. Cddo-methyl Ester
7. Rta-402
8. Nsc713200
9. Rta402
10. Methyl (4as,6ar,6bs,8ar,12as,14ar,14bs)-11-cyano-2,2,6a,6b,9,9,12a-heptamethyl-10,14-dioxo-1,3,4,5,6,7,8,8a,14a,14b-decahydropicene-4a-carboxylate
11. Tp-155
12. Ceg1q6ogu1
13. Bardoxolone Methyl [usan]
14. Nsc-713200
15. Methyl 2-cyano-3,12-dioxooleana-1,9(11)-dien-28-oate
16. 2-cyano-3,12-dioxooleana-1,9(11)-dien-28-oic Acid Methyl Ester
17. Methyl (4as,6ar,6bs,12as,14ar,14br)-11-cyano-2,2,6a,6b,9,9,12a-heptamethyl-10,14-dioxo-1,3,4,5,6,7,8,8a,14a,14b-decahydropicene-4a-carboxylate
18. Bardoxolone-methyl
19. (4as,6ar,6bs,8ar,12as,14ar,14bs)-methyl 11-cyano-2,2,6a,6b,9,9,12a-heptamethyl-10,14-dioxo-1,2,3,4,4a,5,6,6a,6b,7,8,8a,9,10,12a,14,14a,14b-octadecahydropicene-4a-carboxylate
20. Mfcd11983137
21. Ncgc00186460-01
22. Bardoxolone (methyl)
23. Bardoxolone Methyl Ester
24. Unii-ceg1q6ogu1
25. Cddo-me, 2
26. Dsstox_cid_28690
27. Dsstox_rid_82960
28. Dsstox_gsid_48764
29. Methyl 2-cyano-3,12-dioxoolean-1,9-dien-28-oate
30. Gtpl3443
31. Bardoxolone Methyl (jan/usan)
32. Bardoxolone Methyl [jan]
33. Chembl1762621
34. Dtxsid5048764
35. Schembl12521530
36. Chebi:177406
37. 2-cyano-3,12-dioxoolean-1,9-dien-28-oic Acid Methyl Ester
38. 2-cyano-3,12-dioxooleana-1,9-dien-28-oic Acid Methyl Ester
39. Bdbm217379
40. Bardoxolone Methyl [who-dd]
41. Bcp04660
42. Zinc3982151
43. Tox21_113229
44. S8078
45. Bardoxolone Methyl Ester [mi]
46. Akos025401880
47. Ccg-269743
48. Cs-0598
49. Db05983
50. Cddo Methyl Ester, >=98% (hplc)
51. Ac-26830
52. Csa:218600-53-4;bardoxolone Methyl
53. Hy-13324
54. Cas-218600-53-4
55. D09585
56. Nsc 713200; Rta 402; Cddo Methyl Ester
57. A847580
58. Q4860208
59. (+)-methyl 2-cyano-3,12-dioxooleana-1,9(11)-dien-28-oate
60. (4as,6ar,6bs,8ar,12as,14bs)-methyl 11-cyano-2,2,6a,6b,9,9,12a-he
61. Oleana-1,9(11)-dien-28-oic Acid, 2-cyano-3,12-dioxo-, Methyl Ester
Molecular Weight | 505.7 g/mol |
---|---|
Molecular Formula | C32H43NO4 |
XLogP3 | 6.7 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 5 |
Rotatable Bond Count | 2 |
Exact Mass | 505.31920885 g/mol |
Monoisotopic Mass | 505.31920885 g/mol |
Topological Polar Surface Area | 84.2 Ų |
Heavy Atom Count | 37 |
Formal Charge | 0 |
Complexity | 1210 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 7 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Investigated for use/treatment in lymphoma (unspecified), multiple myeloma, and solid tumors.
Treatment of Alport syndrome
RTA 402 inhibits the activity of nuclear factor kappa-B (NF-kB) activated by tumor necrosis factor (TNF) and other inflammatory agents in a variety of cancer cells. It is a novel targeted cancer therapy with a unique mechanism of action. It exploits fundamental physiological differences between cancerous and noncancerous cells by modulating oxidative stress response pathways. As a result, the drug is toxic to cancer cells but induces protective antioxidant and anti-inflammatory responses in normal cells.
Details:
RTA 402 (bardoxolone methyl) is a small-molecule compound licensed from Reata Pharmaceuticals has been designated as a "SAKIGAKE Designation" program for the treatment of diabetic kidney disease, a Phase III clinical study for the indication in Japan.
Lead Product(s): Bardoxolone Methyl
Therapeutic Area: Nephrology Brand Name: RTA 402
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Reata Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2023
Lead Product(s) : Bardoxolone Methyl
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Reata Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : RTA 402 (bardoxolone methyl) is a small-molecule compound licensed from Reata Pharmaceuticals has been designated as a "SAKIGAKE Designation" program for the treatment of diabetic kidney disease, a Phase III clinical study for the indication in Japan.
Brand Name : RTA 402
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 10, 2023
Details:
Bardoxolone is orally administered activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.
Lead Product(s): Bardoxolone Methyl
Therapeutic Area: Nephrology Brand Name: RTA 402
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2022
Lead Product(s) : Bardoxolone Methyl
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Bardoxolone is orally administered activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signa...
Brand Name : RTA 402
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 25, 2022
Details:
USFDA revealed an unflattering opinion of the company’s experimental drug RTA 402 (Bardoxolone methyl) for the treatment of patients with chronic kidney disease (“CKD”) caused by Alport syndrome.
Lead Product(s): Bardoxolone Methyl
Therapeutic Area: Genetic Disease Brand Name: RTA 402
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2021
Lead Product(s) : Bardoxolone Methyl
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : USFDA revealed an unflattering opinion of the company’s experimental drug RTA 402 (Bardoxolone methyl) for the treatment of patients with chronic kidney disease (“CKD”) caused by Alport syndrome.
Brand Name : RTA 402
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 08, 2021
Details:
If approved, bardoxolone would become the first therapy specifically indicated for the treatment of CKD caused by Alport syndrome.
Lead Product(s): Bardoxolone Methyl
Therapeutic Area: Genetic Disease Brand Name: RTA 402
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2021
Lead Product(s) : Bardoxolone Methyl
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Reata Pharmaceuticals, Inc. Submits NDA for Company’s Lead Program: Bardoxolone in Alport Syndro...
Details : If approved, bardoxolone would become the first therapy specifically indicated for the treatment of CKD caused by Alport syndrome.
Brand Name : RTA 402
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 01, 2021
Details:
Company Plans to submit NDA for bardoxolone in Alport syndrome during fourth quarter of 2020 for accelerated approval based on the one-year data from the Phase 3 portion of CARDINAL.
Lead Product(s): Bardoxolone Methyl
Therapeutic Area: Genetic Disease Brand Name: RTA 402
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Lead Product(s) : Bardoxolone Methyl
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Company Plans to submit NDA for bardoxolone in Alport syndrome during fourth quarter of 2020 for accelerated approval based on the one-year data from the Phase 3 portion of CARDINAL.
Brand Name : RTA 402
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 09, 2020
Details:
Bardoxolone achieved the year 2 primary and key secondary endpoints with statistically significant improvements in EGFR as compared to placebo at week 100 and week 104.
Lead Product(s): Bardoxolone Methyl
Therapeutic Area: Genetic Disease Brand Name: RTA 402
Study Phase: Phase II/ Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Lead Product(s) : Bardoxolone Methyl
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Bardoxolone achieved the year 2 primary and key secondary endpoints with statistically significant improvements in EGFR as compared to placebo at week 100 and week 104.
Brand Name : RTA 402
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 09, 2020
Details:
Researchers at NYU Grossman School of Medicine led by Sripal Bangalore, MD, interventional cardiologist and professor of Medicine, are initiating an Investigator-Sponsored Trial known as BARCONA, to study the effect of bardoxolone methyl in patients suffering from COVID-19.
Lead Product(s): Bardoxolone Methyl
Therapeutic Area: Infections and Infectious Diseases Brand Name: RTA 402
Study Phase: PreclinicalProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2020
Lead Product(s) : Bardoxolone Methyl
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Researchers at NYU Grossman School of Medicine led by Sripal Bangalore, MD, interventional cardiologist and professor of Medicine, are initiating an Investigator-Sponsored Trial known as BARCONA, to study the effect of bardoxolone methyl in patients suff...
Brand Name : RTA 402
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 28, 2020
Details:
Financing from Blackstone will Advance Reata's Bardoxolone as the First Potential Therapy for Alport Syndrome, as well as Continue Development for Other Rare and Serious Forms of Chronic Kidney Disease
Lead Product(s): Bardoxolone Methyl
Therapeutic Area: Genetic Disease Brand Name: RTA 402
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Blackstone Life Sciences
Deal Size: $350.0 million Upfront Cash: Undisclosed
Deal Type: Financing June 11, 2020
Lead Product(s) : Bardoxolone Methyl
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Blackstone Life Sciences
Deal Size : $350.0 million
Deal Type : Financing
Details : Financing from Blackstone will Advance Reata's Bardoxolone as the First Potential Therapy for Alport Syndrome, as well as Continue Development for Other Rare and Serious Forms of Chronic Kidney Disease
Brand Name : RTA 402
Molecule Type : Small molecule
Upfront Cash : Undisclosed
June 11, 2020
Details:
Company has decided to stop the Phase 3 CATALYST study of bardoxolone methyl (bardoxolone) in patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH).
Lead Product(s): Bardoxolone Methyl
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2020
Lead Product(s) : Bardoxolone Methyl
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Company has decided to stop the Phase 3 CATALYST study of bardoxolone methyl (bardoxolone) in patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH).
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 30, 2020
11 May 2023
// Kyle LaHucik ENDPTS
https://endpts.com/reata-culls-bardoxolone-ending-decade-of-rd-on-troubled-kidney-disease-drug/
10 May 2023
// Max Bayer FIERCE BIOTECH
https://www.fiercebiotech.com/biotech/reata-kyowa-kirin-partnered-med-bardoxolone-faces-music-after-ph-3-flop-ending-13-year-saga
01 Aug 2022
// BUSINESSWIRE
26 Feb 2022
// D. Lokuwithana SEEKING ALPHA
https://seekingalpha.com/news/3806235-reta-stock-slips-as-fda-rejects-kidney-disease-drug
06 Dec 2021
// Zachary Brennan ENDPTS
https://endpts.com/fda-slams-reatas-kidney-drug-as-ineffective-ahead-of-adcomm-meeting-wednesday/
01 Mar 2021
// GLOBENEWSWIRE
https://www.globenewswire.com/fr/news-release/2021/03/01/2184047/0/en/Reata-Pharmaceuticals-Inc-Submits-NDA-for-Company-s-Lead-Program-Bardoxolone-in-Alport-Syndrome.html#:~:text=(Nasdaq%3A%20RETA)%20(%E2%80%9C,U.S.%20Food%20and%20Drug%20Administration
ABOUT THIS PAGE
A Bardoxolone (methyl) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bardoxolone (methyl), including repackagers and relabelers. The FDA regulates Bardoxolone (methyl) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bardoxolone (methyl) API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Bardoxolone (methyl) supplier is an individual or a company that provides Bardoxolone (methyl) active pharmaceutical ingredient (API) or Bardoxolone (methyl) finished formulations upon request. The Bardoxolone (methyl) suppliers may include Bardoxolone (methyl) API manufacturers, exporters, distributors and traders.
Bardoxolone (methyl) Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Bardoxolone (methyl) GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Bardoxolone (methyl) GMP manufacturer or Bardoxolone (methyl) GMP API supplier for your needs.
A Bardoxolone (methyl) CoA (Certificate of Analysis) is a formal document that attests to Bardoxolone (methyl)'s compliance with Bardoxolone (methyl) specifications and serves as a tool for batch-level quality control.
Bardoxolone (methyl) CoA mostly includes findings from lab analyses of a specific batch. For each Bardoxolone (methyl) CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Bardoxolone (methyl) may be tested according to a variety of international standards, such as European Pharmacopoeia (Bardoxolone (methyl) EP), Bardoxolone (methyl) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bardoxolone (methyl) USP).
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