Irbesartan is an oral angiotensin II receptor blocker used for hypertension and diabetic nephropathy in hypertensive patients with type 2 diabetes and proteinuric kidney disease. It is dosed once daily and carries class warnings for fetal toxicity. Initial U.S. approval was in 1997.
The FDA granted full approval to Filspari to reduce proteinuria in patients aged eight and older with FSGS without nephrotic syndrome. The decision was based on Phase III DUPLEX data versus irbesartan.
The FDA is set to make decisions on four drug applications in April 2026, including Orca-T for hematological malignancies, orforglipron for obesity, sparsentan for kidney disease, and a doravirine/islatravir combination for HIV-1.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07555054 |
A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease |
NOT_YET_RECRUITING | PHASE2 |
