Bardoxolone methyl

Unassigned

New Medicines

Familial hereditary nephritis (Alport syndrome)

Information

New molecular entity
Reata
Reata

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Yes

Category

Nrf2 gene activator
Alports syndrome (AS) is the most common hereditary nephritis, accounting for 3% of end stage kidney disease (ESKD) in childhood. Disease frequency is estimated at 1:5,000. Males are more severely affected than females [1].
Familial hereditary nephritis (Alport syndrome)
Oral

Pulmonary hypertension associated with connective tissue disease

Information

New molecular entity
Reata
Reata

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Nrf2 gene activator
Prevalence of PAH is estimated at 15-52 per million [2].
Pulmonary hypertension associated with connective tissue disease
Oral

Chronic kidney disease in autosomal dominant polycystic kidney disease (ADPKD), IgA nephropathy, type 1 diabetic CKD, and focal glomerulosclerosis (FSGS)

Information

New molecular entity
Reata
Reata

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes

Category

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
A large primary care study (practice population 162,113) suggests an age standardised prevalence of stage 3-5 CKD of 8.5% [1].
Chronic kidney disease in autosomal dominant polycystic kidney disease (ADPKD), IgA nephropathy, type 1 diabetic CKD, and focal glomerulosclerosis (FSGS)
Oral