NDAORALTABLET
Approved
Apr 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
18
Data completeness
3/8 — Basic
Drug data last refreshed 2h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VANRAFIA (atrasentan) is an oral small-molecule endothelin receptor antagonist approved by the FDA on April 2, 2025. The specific indication and mechanism of action are not disclosed in available data, but atrasentan is established in clinical development for renal and cardiovascular indications. This Novartis product represents a new chemical entity entering the market in the growth phase.
Growth16.8 years to LOE
Recent approval positions VANRAFIA in early commercial expansion; Novartis will be scaling commercial teams to build market share in a newly defined market segment.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Started Aug 2026
28 enrolled
Berger DiseaseBergers DiseaseIgA Nephropathy+3 more
IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and/or Atrasentan Using Primary Data Collection
Started May 2026
80 enrolled
IgA Nephropathy
Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy
Started Jul 2023
54 enrolled
IgA NephropathyImmunoglobulin A Nephropathy
Atrasentan in Patients With Proteinuric Glomerular Diseases
Started Mar 2021
103 enrolled
IgA NephropathyFocal Segmental GlomerulosclerosisAlport Syndrome+3 more
Atrasentan in Patients With IgA Nephropathy
Started Dec 2020
404 enrolled
IgA NephropathyImmunoglobulin A Nephropathy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.