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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 Product Name: RTA 402
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Reata Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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 Product Name: RTA 402
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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 Product Name: RTA 402
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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 Product Name: RTA 402
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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 Product Name: RTA 402
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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 Product Name: RTA 402
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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 Product Name: RTA 402
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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 Product Name: RTA 402
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Blackstone Life Sciences
Deal Size: $350.0 million Upfront Cash: Undisclosed
Deal Type: Financing 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 Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2020
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