Feb 13, 2026
  • In ALIGN study, Vanrafia (atrasentan) showed positive difference in eGFR change from baseline vs. placebo at Week 136, 4 weeks after study treatment ended1
  • Results favored Vanrafia across multiple timepoints, measures of kidney function and in patients additionally receiving SGLT2 inhibitors1  
  • Vanrafia received accelerated approval in U.S. and China for reduction of proteinuria in adults with IgAN in 2025; Novartis plans to submit for traditional approval in 20262

East Hanover, February 13, 2026 – Novartis today announced final results from the Phase III ALIGN study supporting a slowing decline in kidney function in adults with IgA nephropathy (IgAN) who were treated with Vanrafia® (atrasentan). Vanrafia showed a difference of 2.39 ml/min/1.73m2 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 treatment1.

Clinically meaningful results were observed with Vanrafia compared to placebo in eGFR change from baseline at the end of study treatment at Week 132, and in the prespecified exploratory group of patients additionally receiving sodium-glucose co-transporter-2 (SGLT2) inhibitors1. At the end of treatment at Week 132, the eGFR change from baseline compared to placebo was 2.59 ml/min/1.73 m2 (nominal 2- sided p = 0.039)1.

“Progressive and complex diseases such as IgAN present an urgent need for medicines that can target the different drivers of the disease. Vanrafia can be seamlessly integrated into patients’ existing treatment plans, with a consistent safety profile,” said Ruchira Glaser, M.D., Global Head, Cardiovascular, Renal & Metabolic Development Unit, Novartis. “We are pleased with today’s Phase III ALIGN results, which add to the growing evidence of Vanrafia as a potential foundational therapy to slow kidney function decline.”

ALIGN provides the longest follow-up period in pivotal Phase III studies for IgAN3. Safety was consistent with previous findings1.

Alongside Vanrafia, Novartis continues to advance its multi-asset IgAN portfolio, which also includes Fabhalta® (iptacopan) and investigational compound zigakibart.

About IgAN
IgAN is a progressive autoimmune kidney disease with approximately 25 per million people newly diagnosed worldwide each year4. IgAN is highly debilitating as it leads to glomerular inflammation (when the small filters in the kidneys are inflamed), proteinuria (excess protein in urine), and a gradual decline in eGFR5. Up to 50% of patients with persistent proteinuria progress to kidney failure within 10 to 20 years of diagnosis, often requiring dialysis or kidney transplantation as part of long-term disease management5-7.

Furthermore, people living with IgAN often face mental, social, and economic challenges5-8. Supportive care has not addressed the underlying causes of the disease and often fails to slow disease progression, reinforcing the need for more targeted therapies for IgAN4-9.

About Vanrafia® (atrasentan)
Vanrafia (atrasentan) is a potent and highly selective endothelin A (ETA) receptor antagonist, which is part of the endothelin system, a key system involved in the progression of IgAN10-13.

Vanrafia is the first and only selective ETA receptor antagonist approved for primary IgAN, a once-daily, oral treatment and can be seamlessly added to, or used alongside, existing supportive care (e.g. renin-angiotensin system (RAS) inhibitor with or without SGLT2 inhibitor) without the need for titration2. Vanrafia does not require a Risk Evaluation and Mitigation Strategy (REMS) program. Because some endothelin receptor antagonists have caused elevations of aminotransferases, hepatotoxicity, and liver failure, clinicians should obtain liver enzyme testing before initiating Vanrafia and during treatment when clinically indicated. Vanrafia may cause serious birth defects2.

About ALIGN
The ALIGN study (NCT04573478) is a global, randomized, multicenter, double-blind, placebo-controlled Phase III clinical trial comparing the efficacy and safety of Vanrafia versus placebo in patients with IgAN at risk of progressive loss of kidney function1-3. In total, 340 patients with biopsy-proven IgAN with baseline total proteinuria ≥1 g/day despite optimized RAS inhibitor treatment were randomized to receive once-daily, oral Vanrafia (0.75 mg) or placebo for approximately 132 weeks1,11. Patients continue receiving a maximally tolerated and stable dose of a RAS inhibitor as supportive care1,11. An additional cohort of 64 patients receiving an SGLT2 inhibitor in addition to RAS inhibitor for at least 12 weeks was also enrolled1,11. The primary efficacy endpoint for the interim analysis (in 270 patients) was change in proteinuria, as measured by 24-hour urine protein-to-creatinine ratio (UPCR) from baseline to 36 weeks1,3,11. The key secondary endpoint for the final analysis is the change from baseline to 136 weeks in kidney function as measured by eGFR. Other secondary efficacy endpoints as well as safety and tolerability are also assessed1-3.

Novartis commitment to kidney diseases
Building on a legacy of more than 40 years that began in transplant, Novartis is on a mission to empower breakthroughs and transform care in kidney health, starting with kidney conditions that have significant unmet need.

Historically, these conditions have had considerably less funding and research, leading to a treatment landscape largely focused on reactive or end-stage disease management, often with significant physical, emotional, and financial burdens. Our portfolio targets the underlying causes of disease, with an aim to protect kidney health and delay or prevent dialysis and/or transplantation. Our goal is to help patients get back to living life on their terms - whether at work, in school, or with loved ones, and by partnering with patients, advocates, clinicians and policymakers, we aim to raise awareness, accelerate diagnosis, and get patients the right care, sooner.

VANRAFIA Indications 
VANRAFIA is a prescription medicine used to reduce protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at risk of their disease getting worse quickly. It is not known if VANRAFIA is safe and effective in children.

VANRAFIA is approved based on a reduction of proteinuria. Continued approval may require results from an ongoing study to determine whether VANRAFIA slows decline in kidney function.

VANRAFIA Important Safety Information
VANRAFIA can cause serious birth defects if taken during pregnancy. Females should not be pregnant when they start taking VANRAFIA, become pregnant during treatment, or for 2 weeks after stopping treatment. Females who can become pregnant should have a negative pregnancy test before starting VANRAFIA.

Patients who can become pregnant are those who have entered puberty, even if they have not started their menstrual period, and have a uterus, and have not gone through menopause. Menopause means that patients have not had a menstrual period for at least 12 months for natural reasons, or that patients have had their ovaries removed. Patients who cannot become pregnant are those who have not yet entered puberty, or do not have a uterus, or have gone through menopause. Females who can become pregnant should use effective birth control before starting treatment with VANRAFIA, during treatment with VANRAFIA and for 2 weeks after stopping VANRAFIA because the medicine may still be in their body. Patients should talk to their health care provider or gynecologist (a health care provider who specializes in reproduction) to find out about options for effective forms of birth control that they may use to prevent pregnancy during treatment with VANRAFIA. If the patient decides that they want to change the form of birth control that they use, they should talk to their health care provider or gynecologist to be sure that they choose another effective form of birth control. Patients should not have unprotected sex. Patients should talk to their health care provider or pharmacist right away if they have unprotected sex or if patients think their birth control has failed. Their health care provider may talk to them about using emergency birth control.

Patients should tell their health care provider right away if they miss a menstrual period or think that they may be pregnant. Patients should not take VANRAFIA if they are pregnant, plan to become pregnant, or become pregnant during treatment with VANRAFIA. VANRAFIA can cause serious birth defects. Patients should not take VANRAFIA if they are allergic to atrasentan or any of the ingredients in VANRAFIA.

Before taking VANRAFIA, patients should tell their health care provider about all their medical conditions, including if they have liver problems, are pregnant or plan to become pregnant during VANRAFIA treatment (VANRAFIA can cause serious birth defects) or if they are breastfeeding or plan to breastfeed. It is not known if VANRAFIA passes into their breast milk. Patients should not breastfeed during treatment with VANRAFIA. Patients should talk to their health care provider about the best way to feed their baby if they take VANRAFIA. 

Patients should tell their health care provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking VANRAFIA with certain medications may affect the way VANRAFIA, and the other medicine works and may increase their risk for side effects. Patients should not start any new medicine until they check with their health care provider.

VANRAFIA may cause serious side effects, including those mentioned above as well as liver problems, fluid retention and decreased sperm counts. Medicines like VANRAFIA can cause liver problems, including liver failure. VANRAFIA can increase liver enzymes in the patients’ blood. The patients’ healthcare provider will do blood tests to check their liver enzymes before starting treatment and if needed during treatment. The patients’ healthcare provider may temporarily stop or permanently stop treatment with VANRAFIA if their liver enzymes increase or if they develop symptoms of liver problems. Patients should tell their health care provider if they have any of the following symptoms of liver problems while taking VANRAFIA; nausea or vomiting, pain in the upper right stomach, tiredness, loss of appetite, yellowing of their skin or whites of their eyes, dark urine, fever, itching. VANRAFIA can cause their body to hold too much water (fluid retention). Patients should tell their healthcare provider if they develop any unusual weight gain, trouble breathing, or swelling of their ankles or legs during treatment. Their healthcare provider may prescribe other medicines (diuretics) and may temporarily stop VANRAFIA if they develop fluid retention. VANRAFIA may cause decreased sperm counts in males and may affect the ability to father a child. Patients should tell their doctor if being able to have children is important to them.

The most common side effects of VANRAFIA include swelling of the hands, legs, ankles, and feet (peripheral edema) and low red blood cell count (anemia).

Please see full Prescribing Information, including Boxed WARNING and Medication Guide.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.us and connect with us on LinkedIn US, X/Twitter US and Instagram US.

References

  1. Novartis. Data on file.
  2. Novartis Pharmaceuticals Corporation. 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). Available at: https://www.novartis.com/news/media-releases/novartis-receives-fda-accelerated-approval-vanrafia-atrasentan-first-and-only-selective-endothelin-receptor-antagonist-proteinuria-reduction-primary-iga-nephropathy-igan. Accessed February 2026.
  3. ClinicalTrials.gov. NCT04573478. A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function. Available at https://clinicaltrials.gov/study/NCT04573478. Accessed February 2026.
  4. Cheung C, Barratt J. The rapidly changing treatment landscape of IgA nephropathy. Semin Nephrol. 2025;44:151573.
  5. Kwon CS, Daniele P, Forsythe A et al. A systematic literature review of the epidemiology, health-related quality of life impact, and economic burden of immunoglobulin a nephropathy. J Health Econ Outcomes Res. 2021;8:36–45.
  6. Pitcher D, Braddon F, Hendry B et al. Long-term outcomes in IgAN. Clin J Am Soc Nephrol. 2023;18:727–8.
  7. Mohd R, Mohammad Kazmin NE, Abdul Cader R, et al. Long-term outcome of immunoglobulin A (IgA) nephropathy: a single center experience. PLoS One. 2021;16:e0249592.
  8. National Kidney Foundation. The voice of the patient (2020). Available at: https://igan.org/wp-content/uploads/2021/01/VOP_IgAN_12-7-20__FNL.pdf. Accessed February 2026.
  9. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021;100:S1–276.
  10. Barratt J, Kim SG, Inker LA et al. AFFINITY study: 1-year results of atrasentan in IgAN. J Am Soc Nephrol. 2024;35(Suppl):720. Abstract FR-P0855.
  11. Heerspink HJL, Jardine M, Kohan DE et al. Atrasentan in patients with IgAN. N Engl J Med. 2025;392:544–54.
  12. Heerspink HJL, Jardine M, Kohan DE et al. Study design and baseline characteristics of ALIGN, a randomized controlled study of atrasentan in patients with IgAN. Kidney Int Rep. 2024;10:217–26.
  13. Kohan DE, Barratt J, Heerspink HJL et al. Targeting the endothelin A receptor in IgAN. Kidney Int Rep. 2023;8:2198–210.

 

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