Also known as: Vanrafia, Vanrafia®
Atrasentan is a selective endothelin A receptor antagonist marketed as Vanrafia for kidney disease. In April 2025, the U.S. FDA granted accelerated approval for reduction of proteinuria in adults with primary IgA nephropathy at risk of rapid progression. The approval was based on interim Phase III data and continued approval depends on confirmatory clinical benefit data.
Final phase 3 trial results show atrasentan (Vanrafia®) provides significant long-term kidney function benefits in IgA nephropathy patients, with a 2.59 mL/min/1.73m² eGFR improvement versus placebo. Earlier phase 2 data demonstrated the drug reduces proteinuria by 30.7% when added to standard background therapy. The drug's manufacturer plans to seek traditional FDA approval in 2026 based on these findings.
Morgan Stanley raised its Novartis price target to $170 from $143 with an Overweight rating, while TD Cowen increased its target to $180 from $160 with a Hold rating. Morgan Stanley sees $23 billion in risk-adjusted potential from nine pipeline assets, with additional upside in success scenarios.
Novartis announced positive Phase III ALIGN results for Vanrafia in IgA nephropathy and plans to build a new radioligand therapy manufacturing site in Denton, Texas, operational by 2028.
Phase 3 trials demonstrate atrasentan slows kidney function decline in IgA nephropathy patients, while obinutuzumab achieves superior remission rates in primary membranous nephropathy compared to standard treatment.
Novartis commits $23 billion to U.S. manufacturing expansion with new facilities in North Carolina, California, and Florida, while advancing its immunoglobulin A nephropathy drug portfolio with positive Phase III results for Vanrafia.
Novartis announced final Phase III ALIGN trial results showing Vanrafia (atrasentan) slowed kidney function decline in adults with IgA nephropathy, with a 2.39ml/min/1.73m² eGFR difference versus placebo at week 136.
Novartis US shares traded at all-time highs in early February 2026 despite expected generic competition, driven by sales above expectations and positive Phase 3 kidney drug data. The company's market capitalization reached $265.2 billion.
Novartis announced final Phase III ALIGN results showing Vanrafia slowed kidney function decline in adults with IgA nephropathy, supporting planned submissions for traditional approval in 2026 following accelerated approvals in the U.S. and China in 2025.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07319585 |
Managed Access Programs for EXV811, Atrasentan |
AVAILABLE | |
| NCT05834738 |
Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy |
COMPLETED | PHASE2 |
| NCT04573920 |
Atrasentan in Patients With Proteinuric Glomerular Diseases |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT04573478 |
Atrasentan in Patients With IgA Nephropathy |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT02118714 |
Atrasentan Spermatogenesis and Testicular Function |
COMPLETED | PHASE2 |
| NCT01858532 |
Study Of Diabetic Nephropathy With Atrasentan |
TERMINATED | PHASE3 |
| NCT01399580 |
A Prospective, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of Atrasentan, Including Thoracic Bioimpedance, in Type 2 Diabetic Subjects With Nephropathy |
COMPLETED | PHASE2 |
| NCT01356849 |
Evaluate the Efficacy and Safety of Once Daily Administration of Atrasentan Tablets (Low and High) Compared to Placebo in Reducing Residual Albuminuria in Type 2 Diabetic Patients With Nephropathy Who Are Treated With the Maximum Tolerated Labeled Dose of a Renin Angiotensin System (RAS) Inhibitor |
COMPLETED | PHASE2 |
| NCT00271492 |
Correlation of Endothelial Function and Early Coronary Artery Disease in Humans |
COMPLETED | PHASE3 |
| NCT00181558 |
Atrasentan and Zometa for Men With Prostate Cancer Metastatic to Bone |
COMPLETED | PHASE2 |
