Chemistry:Atrasentan

From HandWiki

Atrasentan, sold under the brand name Vanrafia, is a medication used to reduce proteinuria.[1] It is an endothelin receptor antagonist.[1] It is taken by mouth.[1]

Atrasentan was approved for medical use in the United States in April 2025.[1][2]

Medical uses

Atrasentan is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression, generally a urine protein-to-creatinine ratio >= 1.5 g/g.[1]

Society and culture

Atrasentan was approved for medical use in the United States in April 2025.[1][2]

Names

Atrasentan is the international nonproprietary name.[3]

Atrasentan is sold under the brand name Vanrafia.[1][2]

Research

Clinical trials

Atrasentan failed a phase III trial for prostate cancer in patients unresponsive to hormone therapy.[4] A second trial confirmed this finding.[5]

A study published in 2014 showed that 0.75 mg and 1.25 mg of atrasentan reduced urinary albumin by 35 and 38% respectively with modest side effects. Patients also had decreased home blood pressures (but no change in office readings) decrease total cholesterol and LDL. Patients in the 1.25 mg dose group had increased weight gain which was presumably due to increased edema and had to withdraw from the study more than the placebo or 0.75 mg dose group.[6]

In 2013, the SONAR trial[7] was initiated to determine if atrasentan reduces kidney failure in diabetic kidney disease.[8]

In 2024, the phase III ALIGN trial found atrasentan to be effective in reducing proteinuria in participants with IgA nephropathy.[9][10]

Atrasentan is being studied for the treatment of various types of cancer,[11] including non-small-cell lung cancer.[12] It is also being investigated as a therapy for diabetic kidney disease.[13]

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 Cite error: Invalid <ref> tag; no text was provided for refs named Vanrafia FDA label
  2. 2.0 2.1 2.2 "Novartis receives FDA accelerated approval for Vanrafia (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy (IgAN)". Novartis (Press release). 3 April 2025. Retrieved 4 April 2025.
  3. "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 46". WHO Drug Information 15 (3–4): 187–218. 2001. 
  4. "Addition of experimental drug to standard chemotherapy for advanced prostate cancer shows no benefit in phase 3 clinical trial" (Press release). National Cancer Institute. 21 April 2011. Retrieved 18 October 2014.
  5. "Docetaxel and atrasentan versus docetaxel and placebo for men with advanced castration-resistant prostate cancer (SWOG S0421): a randomised phase 3 trial". The Lancet. Oncology 14 (9): 893–900. August 2013. doi:10.1016/S1470-2045(13)70294-8. PMID 23871417. 
  6. "The endothelin antagonist atrasentan lowers residual albuminuria in patients with type 2 diabetic nephropathy". Journal of the American Society of Nephrology 25 (5): 1083–93. May 2014. doi:10.1681/ASN.2013080830. PMID 24722445. 
  7. Clinical trial number NCT01858532 for "Study Of Diabetic Nephropathy With Atrasentan (SONAR)" at ClinicalTrials.gov
  8. "Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial". Lancet 393 (10184): 1937–1947. May 2019. doi:10.1016/S0140-6736(19)30772-X. PMID 30995972. https://pure.rug.nl/ws/files/93428784/1_s2.0_S014067361930772X_main.pdf. 
  9. "Atrasentan in Patients with IgA Nephropathy". The New England Journal of Medicine. October 2024. doi:10.1056/NEJMoa2409415. PMID 39460694. 
  10. "Novartis investigational atrasentan Phase III study demonstrates clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy (IgAN)". Novartis (Press release). 30 October 2023. Retrieved 4 April 2025.
  11. "NCI Drug Dictionary". 2 February 2011. https://www.cancer.gov/publications/dictionaries/cancer-drug/def/atrasentan-hydrochloride. 
  12. "Phase I/II study of atrasentan, an endothelin A receptor antagonist, in combination with paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer". Clinical Cancer Research 14 (5): 1464–9. March 2008. doi:10.1158/1078-0432.CCR-07-1508. PMID 18316570. 
  13. "Atrasentan - Chinook Therapeutics". AdisInsight. Springer Nature Switzerland AG. https://adisinsight.springer.com/drugs/800008541.