Drugs / Atrasentan
Atrasentan
also known as
A-127722 · A-147627.1 · ABBOT-147627 · ABT-627 · Atrasentan hcl · ATRASENTAN HYDROCHLORIDE
Other / unclassified targets EDNRA via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed IgA glomerulonephritis 1 milestone | |||||
| Filed | US (FDA) | — | IgA glomerulonephritis | — | “atrasentan, an investigational oral endothelin A receptor antagonist that received FDA filing acceptance in Q2 2024” novartis.com ↗ “Atrasentan FDA filing accepted for the treatment of adult patients with IgAN” novartis.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | VANRAFIA | — | 2025-04-02 | fda.gov ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00017264 | Jun 2002 → ? | central nervous system neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 28 trials · 2 met primary | ||||||
| Phase 2 | NCT05834738 | Jul 2023 → Jun 2025 | IgA glomerulonephritis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT04573920 | Mar 2021 → Jul 2024 overdue | Alport syndrome, IgA glomerulonephritis, diabetic kidney disease, focal segmental glomerulosclerosis | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02118714 | Apr 2015 → Apr 2018 | diabetes mellitus, diabetic kidney disease | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01424319 | Aug 2011 → Jul 2012 | diabetic kidney disease | AbbVie | Completed | Met primary |
| Phase 2 | NCT00039429 | Jul 2003 → Apr 2006 | kidney cancer | Eastern Cooperative Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00653328 | May 2003 → Mar 2009 | fallopian tube cancer, ovarian cancer, peritoneum cancer | Vanderbilt-Ingram Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT00038662 | May 2002 → ? | prostate cancer | Abbott | Completed | No outcome recorded |
| Phase 2 | NCT00181558 | Dec 2001 → Dec 2006 | prostate adenocarcinoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00127478 | Jul 2001 → Jun 2007 | adenocarcinoma, prostate cancer | Abbott | Completed | No outcome recorded |
| Phase 37 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT07850752 | Dec 2026 → Sep 2028 expected | IgA glomerulonephritis | Novartis Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07498335 | Aug 2026 → Sep 2031 expected | IgA glomerulonephritis | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT04573478 | Dec 2020 → Apr 2028 expected | IgA glomerulonephritis | Novartis Pharmaceuticals | Active not recruiting | Met primary |
| Phase 3 | NCT00134056 | Aug 2006 → Feb 2016 | metastatic malignant neoplasm, prostate cancer | SWOG Cancer Research Network | Completed | Missed primary |
| Phase 3 | NCT00046943 | Sep 2002 → Jun 2007 | prostate cancer | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00036556 | Jun 2001 → ? | prostate neoplasm | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00036543 | May 2001 → ? | prostate cancer | Abbott | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07820995 | Sep 2026 → Dec 2027 expected | IgA glomerulonephritis | University of Illinois at Chicago | Not yet recruiting | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 2 | NCT01399580 Comparator | Aug 2011 → Sep 2012 | diabetic kidney disease | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01356849 Comparator | Apr 2011 → Aug 2012 | diabetic kidney disease | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT00920764 Comparator | Jun 2009 → Apr 2010 | diabetic kidney disease | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01858532 Comparator | May 2013 → Mar 2018 | diabetic kidney disease | AbbVie | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00271492 Comparator | Jul 2001 → Jun 2006 | — | Mayo Clinic | Completed | No outcome recorded |
| — | NCT07319585 Background | — | IgA glomerulonephritis | Novartis Pharmaceuticals | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-06-04 | Novartis Pharmaceuticals | Results Novartis IgAN data in The Lancet show clinically meaningful slowing of kidney function decline with Vanrafia® over 2.5 years novartis.com ↗
Novartis reported final 2.5-year Phase III ALIGN results showing slower kidney function decline with Vanrafia ® (atrasentan) versus placebo in adults with IgA nephropathy (IgAN) 1 ,2 . |
| 2026-02-13 | Novartis Pharmaceuticals | Results Novartis Vanrafia® Phase III data support slowing of kidney function decline in patients with IgA nephropathy novartis.com ↗
Vanrafia showed a difference of 2.39 ml/min/1.73m 2 in estimated glomerular filtration rate (eGFR) change from baseline vs. placebo (2-sided p = 0.057) at Week 136, 4 weeks after the end of study treatment 1 . |
| 2025-04-03 | Novartis Pharmaceuticals | Regulatory 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.com ↗
Vanrafia was granted accelerated approval based on a prespecified interim analysis of the Phase III ALIGN study measuring the reduction of proteinuria at 36 weeks compared to placebo 1 . |
| 2024-05-25 | Novartis Pharmaceuticals | Results Novartis atrasentan Phase III data show clinically meaningful proteinuria reduction further advancing company's IgA nephropathy (IgAN) portfolio novartis.com ↗
In the ALIGN study, atrasentan, in addition to supportive care with a renin-angiotensin system (RAS) inhibitor, demonstrated a statistically significant 36.1% proteinuria (protein in urine) reduction vs. placebo + supportive care at 36 weeks 1 |
| 2023-10-30 | Novartis Pharmaceuticals | Results Novartis investigational atrasentan Phase III study demonstrates clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy (IgAN) novartis.com ↗ |
| 2017-12-01 | AbbVie | Results AbbVie Closes SONAR Study Evaluating Investigational Compound Atrasentan on Renal Outcomes in Patients with Diabetic Nephropathy abbvie.com ↗
The ongoing monitoring of renal events observed in the study has revealed considerably fewer end-points than expected by this time, which will likely affect the ability to test the SONAR study hypothesis. |
All press releases naming this drug 7 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Atrasentan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01858532 ↗ |
| Known as | A-127722 | ChEMBL registry synonym — accepted as the source's own label CHEMBL9194 ↗ |
| Known as | A-147627.1 | ChEMBL registry synonym — accepted as the source's own label CHEMBL9194 ↗ |
| Known as | ABBOT-147627 | ChEMBL registry synonym — accepted as the source's own label CHEMBL9194 ↗ |
| Known as | ABT-627 | “A Phase 2 Study Evaluating the Safety and Efficacy of Atrasentan (ABT-627) in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure” NCT00038662 ↗ |
| Known as | Atrasentan hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL9194 ↗ |
| Known as | ATRASENTAN HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL9194 ↗ |
| Action | Inhibit | “Atrasentan is an oral selective endothelin-A receptor antagonist that may inhibit cell proliferation and interfere with angiogenesis during glioma growth.” PMID 18477765 ↗ May 20081“Endothelin receptor ET-A antagonist” CHEMBL9194 ↗ |
| Modality | Other / unclassified | “the selective endothelin receptor antagonist atrasentan” PMID 37716952 ↗ Sep 2023 |
| Route | Oral | “Patients receive oral atrasentan once daily.” NCT00017264 ↗ |
| Target | EDNRA | “Endothelin receptor ET-A antagonist” CHEMBL9194 ↗ |