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Vanrafia (ATRASENTAN)
Vanrafia works by binding to and blocking the activity of a specific receptor involved in the progression of IgAN.
At a glance
| Generic name | ATRASENTAN |
|---|---|
| Sponsor | Novartis |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Atrasentan is an ET A receptor antagonist (Ki = 0.034 nM) with >1800-fold selectivity for the ET A receptor compared to the endothelin type B receptor (Ki = 63.3 nM). Endothelin (ET)-1 is thought to contribute to the pathogenesis of IgAN via the ET A R.
Approved indications
- primary immunoglobulin A nephropathy (IgAN)
- primary immunoglobulin A nephropathy (IgAN)
Boxed warnings
- WARNING: EMBRYO-FETAL TOXICITY VANRAFIA is contraindicated for use in pregnant patients; it may cause major birth defects based on animal data [see Contraindications (4.1), Warnings and Precautions (5.1), Use in Specific Populations (8.1)] . Exclude pregnancy prior to initiation of treatment with VANRAFIA. Advise use of effective contraception before the initiation of treatment, during treatment, and for two weeks after discontinuation of treatment with VANRAFIA. Stop VANRAFIA as soon as possible if the patient becomes pregnant [see Dosage and Administration (2.1), Contraindications (4.1), Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. VANRAFIA may cause major birth defects if used during pregnancy ( 4.1 , 5.1 , 8.1 ) Exclude pregnancy before start of treatment. ( 2.1 , 4.1 , 5.1 , 8.3 ) Use effective contraception before start of treatment, during treatment and two weeks after treatment. ( 4.1 , 5.1 , 8.3 ) Discontinue VANRAFIA if pregnancy occurs. ( 4.1 , 5.1 )
Common side effects
- Peripheral edema
- Anemia
- Hemoglobin Decrease
- Blood Pressure Decrease
- Hypotension
- Liver transaminase elevation
Drug interactions
- Strong or moderate CYP3A inducers
- OATP1B1/1B3 inhibitors
- Atrasentan
Key clinical trials
- Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN (PHASE3)
- IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and/or Atrasentan Using Primary Data Collection
- Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy (PHASE2)
- Managed Access Programs for EXV811, Atrasentan
- Atrasentan in Patients With Proteinuric Glomerular Diseases (PHASE2)
- A Mobile App-Based Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US
- Atrasentan in Patients With IgA Nephropathy (PHASE3)
- Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vanrafia CI brief — competitive landscape report
- Vanrafia updates RSS · CI watch RSS
- Novartis portfolio CI