A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of the NOX1/4 Inhibitor Setanaxib in Patients With Alport Syndrome

The purpose of the study is to learn about the safety and tolerability of setanaxib in subjects with Alport syndrome, when added to their standard of care treatment. The study will assess how safe setanaxib is when compared to placebo. Study participants will be asked if they are experiencing any side effects at each study visit. In addition, tests in blood, urine and other examinations will be used to look at the safety of setanaxib. The study will also measure how well setanaxib works in comparison to a placebo, by measuring urine protein and certain markers in the blood and urine. The concentration of setanaxib in the blood will also be measured throughout the course of the study.
Setanaxib is planned for use together with the current standard of care to hopefully provide additional therapeutic benefits by preserving kidney function.
The study will be conducted at multiple research sites in the UK, Spain, and Czech Republic. Eligible participants will be randomly assigned to receive either setanaxib or placebo. Setanaxib dose level will depend on age and all participants will receive their standard of care in addition to setanaxib or placebo. The study consists of a Screening period of up to 4 weeks, a 24-week Treatment period and a 4- week Follow-up period.

Start Date27 Nov 2023

Sponsor / Collaborator

Calliditas Therapeutics AB

NCT05323656

/ CompletedPhase 2

A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Setanaxib, When Administered With Pembrolizumab, in Patients With Recurrent or Metastatic SCCHN

The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab.

Start Date06 Apr 2022

Sponsor / Collaborator-

NCT05014672

/ CompletedPhase 2

TRANSFORM: A 24-week, Randomized, Placebo-controlled, Double-blind, Phase 2b Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness

The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA).

Start Date14 Feb 2022

Sponsor / Collaborator-

100 Clinical Results associated with Setanaxib

100 Translational Medicine associated with Setanaxib

100 Patents (Medical) associated with Setanaxib

146

Literatures (Medical) associated with Setanaxib

01 Mar 2026·PEDIATRIC NEPHROLOGY

From RAAS blockade to regenerative medicine: evolving treatment strategies in Alport syndrome

Review

Author: Kim, Jin-Ju ; Lo Re, Claudia ; Fornoni, Alessia

Abstract:

Alport syndrome (AS) is a hereditary glomerulopathy caused by mutations in the COL4A3 , COL4A4 , or COL4A5 genes, leading to progressive kidney decline and extrarenal manifestations. Advances in genetic testing have enabled the reclassification of AS into X-linked, autosomal recessive, and autosomal dominant forms, facilitating more accurate diagnosis and risk stratification. While renin-angiotensin-aldosterone system (RAAS) blockade remains the foundation of treatment to delay kidney failure, it does not directly target the underlying molecular pathology. Adjunctive commercially available metabolic modulators, including SGLT2i, mineralocorticoid receptor antagonists, ezetimibe and GLP-1 receptor agonists, may offer additional kidney protection. Ameliorating therapies being tested in Phase II trials include endothelin receptor antagonists (e.g., atrasentan), dual endothelin receptor antagonist and angiotensin II receptor inhibition (e.g., sparsentan) FXR agonists (e.g., vonafexor), inducers of cholesterol efflux (e.g., VAR200 and R3R01), and NOX1/4 inhibitors (e.g., setanaxib), several of which are currently being evaluated in clinical trials. Novel strategies such as exon skipping, gene editing, and nonsense mutation readthrough (e.g., ELX-02) are advancing toward precision medicine approaches as disease modifying agents targeting the genetic cause of AS. Moreover, therapies targeting mitochondrial function, such as mitophagy enhancers, have demonstrated preclinical promise. Stem cell-based approaches are also being explored for their regenerative and anti-fibrotic effects. This review summarizes the current landscape of AS classification and treatment, highlighting both standard interventions and experimental therapies. Emphasis is placed on the molecular mechanisms underlying podocyte injury and fibrosis, recent preclinical findings, and ongoing clinical trials that may shift future therapeutic paradigms. Graphical abstract

01 Jan 2026·EUROPEAN JOURNAL OF PHARMACOLOGY

Basal release of 6-cyanodopamine in human vas deferens, a new endogenous catecholamine that enhances smooth muscle contractility

Article

Author: Miller, Alex Henrique ; Jabbour, Sami ; De Nucci, Gilberto ; Fregonesi, Adriano ; Antunes, Edson ; Britto-Júnior, José ; Moraes, Maria Elisabete A ; Lima, Antonio Tiago ; Peterson, Larryn W ; Luvizotto, Rodrigo

6-Cyanodopamine (6-CYD) is a novel endogenous catecholamine that is released from rat isolated vas deferens epithelium and regulates smooth muscle contractility. Here it was investigated whether 6-CYD is released from human epididymal vas deferens (HEVD) and its interaction with the classical catecholamines dopamine, noradrenaline, and adrenaline. Basal release of 6-CYD was quantified by liquid chromatography coupled to tandem mass spectrometry in the absence and presence of either the voltage-gated sodium channel blocker tetrodotoxin or the dual NADPH oxidase NOX_1,4 inhibitor GKT137831. Concentration-response curves to dopamine, noradrenaline, and adrenaline were performed in the presence and absence of 6-CYD. Frequency-dependent electric-field stimulation (EFS) was conducted with and without pre-incubation with 6-CYD. The basal release of 6-CYD was decreased with pre-incubation with GKT137831 and unaffected by tetrodotoxin. Although 6-CYD itself (up to 100 μM) did not induce HEVD contractions, at 10 nM it remarkably potentiated the contractions induced by dopamine, noradrenaline, and EFS. At 100 nM, 6-CYD also potentiated the adrenaline-induced HEVD contractions. The potentiation of noradrenaline-induced contractions by 6-CYD was not observed in HEVD pre-treated with tetrodotoxin (1 μM). In separate experiments, HEVD strips also released 6-nitrodopamine (6-ND) that was significantly reduced by GKT137831 (1 μM). Co-incubation (30 min) with 6-CYD (100 pM) and 6-ND (100 pM) caused a significant leftward shift in the concentration-response curve to noradrenaline. The results indicate that epithelium 6-CYD is an endogenous mediator of HEVD contractility. Whether NADPH oxidases are involved in 6-CYD biosynthesis remains to be further investigated.

01 Jan 2026·PESTICIDE BIOCHEMISTRY AND PHYSIOLOGY

Pyraclostrobin induces brain oxidative stress, apoptosis and inflammation through mitochondrial phosphorylation-induced ROS activation of the p38 MAPK pathway

Article

Author: Chen, Yaru ; Chen, Jingjing ; Dong, Zibo ; Zhao, Panpan ; Li, Yuanyuan ; Dong, Qian ; Jin, Xiaomin

Pyraclostrobin (PY), a widely used fungicide, poses potential neurotoxic risks to mammals.This study investigates the effects of PY on brain damage in mice, while also exploring the underlying mechanisms. This study demonstrates that PY induces neuronal damage in mouse brains. ELISA analysis revealed elevated levels of S100β and NSE in serum, as well as the expression levels of inflammatory cytokines IL-1β, IL-6 and TNF-α were increased, suggesting that PY can cause brain damage in mice. Biochemical assays further indicated a significant rise in MDA levels in brain tissue and BV-2 cell line treated with PY, accompanied by a marked decrease in antioxidant indicators such as CAT, T-AOC, and GSH, which implies that PY triggers oxidative stress. TUNEL fluorescence staining experiments, combined with the expression profiles of Cleaved-caspase-3, Bcl-2, Cleaved-caspase-8, Cleaved-caspase-9, Cytochrome c, and Bax, confirm that PY induces apoptosis in both mouse brains and BV-2 cells. QPCR results show that the anti-inflammatory factor il-10 is downregulated in brain tissue and BV-2 cell line treated with PY, indicating that PY promotes inflammation in these tissues. Moreover, Adezmapimod blocking experiments reveal that PY activates the MAPK signaling pathway, thereby promoting apoptosis, inflammation, and oxidative stress. NAC and GKT137831 blocked ROS-mediated MAPK signaling. JC-1 and DHE staining experiments further demonstrate that PY causes mitochondrial dysfunction in the mouse brain and significantly increases ROS production. Collectively, these findings enhance our understanding of the neurotoxic effects of PY pesticide residues and provide a scientific foundation management.

News (Medical) associated with Setanaxib

18 Nov 2025

·www.drugs.com

American Society of Nephrology, Nov. 5-9

The annual meeting of the American Society of Nephrology (Kidney Week) was held this year from Nov. 5 to 9 in Houston, attracting attendees from around the world, including nephrology specialists, researchers, scientists, and other health care professionals. The conference featured presentations focusing on the latest advances in the management of patients with kidney diseases and related disorders. In one study, Daniel Gale, Ph.D., of University College London, and colleagues showed that an NADPH oxidase synthase (NOX) 1/4 inhibitor, setanaxib, has an acceptable safety profile, with some evidence of reduced proteinuria among patients with Alport syndrome. The researchers analyzed the safety and efficacy of setanaxib in Alport syndrome. In a 2:1 randomized controlled trial of 20 patients, 24 weeks of treatment was well tolerated, and there was some evidence of reduced proteinuria in the treatment group compared with placebo. The study was a small phase 2a exploratory study and none of the differences observed were statistically significant. "We conclude that these results justify a further (larger and longer) randomized controlled study to quantify the safety and efficacy of this drug to treat people with Alport syndrome," Gale said. The study was funded by Calliditas Therapeutics, which is developing setanaxib. Abstract No. SA-OR082 In another study, Charmaine E. Lok, M.D., of the University Health Network in Toronto, and colleagues found that daily oral supplementation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in the form of fish oil is safe and reduces the rate of serious cardiovascular events in patients with kidney failure on maintenance hemodialysis. As part of the PISCES study, 1,228 patients who were treated with chronic hemodialysis were randomly assigned to oral daily fish oil or placebo capsules. The investigators found that the rate of serious cardiovascular events (heart attack, stroke, peripheral vascular disease leading to amputation, and cardiac death) was reduced by approximately 40 percent in patients treated with maintenance hemodialysis who received daily oral supplementation of 4 g of fish oil (total EPA, 1.6 g; total DHA, 0.8 g) compared with placebo. The rate of serious cardiovascular events was 0.31/1,000 days in the fish oil group versus 0.61/1,000 days in the placebo group. Adverse events, including bleeding, did not differ between the groups. "Given the underlying high risk of cardiovascular events, lack of other preventative measures, and safety of fish oil, I would not be surprised if there is quick uptake of fish oil supplementation in patients receiving hemodialysis," Lok said. "It should be emphasized that the dose and formulation of fish oil, and how it is taken, is important." Abstract No. FR-OR082 Natalie Staplin, Ph.D., of the University of Oxford Medical Sciences Division in the United Kingdom, and colleagues demonstrated clear absolute benefits of sodium-glucose cotransporter 2 (SGLT2) inhibitors on kidney, hospitalization, and mortality outcomes irrespective of diabetes status and level of urine albumin-to-creatinine ratio. The authors conducted a meta-analysis of 58,816 participants enrolled in eight large randomized trials of SGLT2 inhibitors, including empagliflozin, dapagliflozin, and canagliflozin, compared with placebo. The investigators found that SGLT2 inhibitors substantially reduced the risks for kidney disease progression, acute kidney injury, hospitalization, and death among individuals with and without diabetes and across all levels of albuminuria. Compared with placebo, allocation to SGLT2 inhibition reduced the hazard of kidney disease progression by 35 percent among participants with diabetes and 26 percent among participants without diabetes. Allocation to SGLT2 inhibition reduced the risk for acute kidney injury to a similar extent in participants with and without diabetes by 23 and 28 percent, respectively. The risk for hospitalization for heart failure was 32 and 25 percent lower in people with and without diabetes, respectively, who were allocated to an SGLT2 inhibitor, and the risk for any hospitalization was reduced by 10 and 11 percent, respectively. People with lower albumin levels, who are often at lower risk for kidney failure, experienced benefit as a result of taking an SGLT2 inhibitor, particularly through reduced hospital admissions for heart failure and any other cause. Participants with higher albuminuria (≥200 mg/g) had larger absolute reductions in kidney disease progression. "The findings suggest that guideline recommendations distinguishing between patients based on diabetes status or albuminuria level may no longer be necessary," Staplin said. "Current international kidney disease guidelines give stronger recommendations for using SGLT2 inhibitors in patients with high albumin levels, but the new results indicate that all patients with chronic kidney disease can benefit." Abstract No. FR-OR086 In the multicenter, randomized OPTIMIZE trial, Stefan P. Berger, Ph.D., of the Universitair Medisch Centrum Groningen in the Netherlands, and colleagues found that a reduced-dose immunosuppressive regimen combining low-dose tacrolimus plus everolimus is safe among older kidney transplant recipients (age 65 years and older), but the regimen does not lead to improved outcomes compared with the current standard regimen. The authors investigated whether older kidney transplant recipients could benefit from a reduced and less nephrotoxic immunosuppressive regimen. Three hundred seventy-nine kidney transplant recipients aged 65 years or older, across six Dutch university medical centers and the University Hospitals Leuven, were included in the study. The study compared a "standard" immunosuppressive regimen (prednisolone + standard-dose tacrolimus + mycophenolate mofetil) versus an "adapted" regimen (prednisolone + low-dose tacrolimus + everolimus). The primary outcome was defined as a "successful transplantation" at two years: patient alive with functioning graft and minimum estimated glomerular filtration rate thresholds (≥30 mL/min/1.73m 2 for older deceased-donor kidneys; ≥45 mL/min/1.73m 2 for younger deceased donor or living donor kidneys). At two years, the authors observed no statistically significant difference between arms -- 50 percent success in the low-dose arm versus 57 percent in the standard-dose arm. "Importantly, the adapted regimen was safe, but it did not demonstrate superiority over the standard regimen in this older population," Berger said. "Clinicians should be reassured that older transplant recipients achieve very good outcomes under current standard regimens (89 percent patient survival; only 5 to 6 percent graft loss at two years) and that a reduced regimen is safe. We should move toward stratified immunosuppression in older patients with an awareness that immunosuppression can be reduced safely in most cases. Clearly the OPTIMIZE trial had not hit the threshold for reduction of immunosuppression. The study highlights the need for further research to tailor the immunosuppressive regimen to the individual older patient (taking into account donor age, immunosenescence, comorbidities, frailty, etc.)." The study was funded by Chiesi Pharmaceuticals. Abstract No. FR-OR085 ASN: Nearly All Adults With CKD Would Benefit from Systolic BP Target <120 mm Hg WEDNESDAY, Nov. 12, 2025 -- Nearly all adults with chronic kidney disease would benefit from a systolic blood pressure target <120 versus <140 mm Hg, according to a study presented at Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text ASN: Similar Risks Seen for Young, Older Patients With Primary Glomerular Diseases WEDNESDAY, Nov. 12, 2025 -- For patients with primary glomerular diseases, young patients face similar risks of kidney function decline as older patients, according to a study presented at Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text ASN: Expanding Kidney Transplant Wait-List Criteria to Include Risk for Kidney Failure Could Improve Outcomes WEDNESDAY, Nov. 12, 2025 -- Expanding the wait-listing criteria for kidney transplantation to include risk for kidney failure -- rather than taking a single measurement of kidney function -- could improve outcomes, according to a study presented at Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text ASN: New Tool Predicts CKD Survival With Conservative Management Versus Dialysis WEDNESDAY, Nov. 12, 2025 -- A new tool can predict individualized probability of survival with conservative management versus dialysis transition among individuals with advanced chronic kidney disease, according to a study presented at Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text ASN: Large Gap Between Creatinine-Based eGFR and Cystatin C-Based eGFR Tied to Worse Outcomes MONDAY, Nov. 10, 2025 -- In the outpatient setting, the presence of a cystatin C-based estimated glomerular filtration rate that is at least 30 percent lower than creatinine-based eGFR is associated with significantly higher rates of all-cause mortality, cardiovascular events, and kidney failure, according to a study published online Nov. 7 in the Journal of the American Medical Association to coincide with Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text ASN: Prevalence of Chronic Kidney Disease Increasing Globally MONDAY, Nov. 10, 2025 -- The prevalence of chronic kidney disease is increasing globally, according to a study published online Nov. 7 in The Lancet to coincide with Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text

Clinical ResultPhase 2

10 Nov 2025

·www.prnewswire.com

Calliditas Therapeutics Reports Safety Data for Setanaxib in Patients with Alport Syndrome at the American Society of Nephrology Kidney Week

STOCKHOLM, Nov. 10, 2025 /PRNewswire/ -- Calliditas Therapeutics (Calliditas), an Asahi Kasei company, announced today that primary safety endpoints of a Phase 2a, randomized, double-blind, placebo-controlled trial of setanaxib in patients with Alport syndrome were presented in a High-Impact Clinical Trials session at the American Society of Nephrology Kidney Week in Houston, Texas, on Saturday, November 8. Alport syndrome is a rare genetic kidney disease resulting from mutations in collagen type IV genes that can lead to progressive loss of kidney function and end-stage kidney disease. This Phase 2a trial (NCT06274489) enrolled 20 patients aged 12-40 years with genetically confirmed Alport syndrome, a urine protein-creatinine ratio (UPCR) of ≥ 0.8 g/g, and an estimated glomerular filtration rate (eGFR) of ≥ 30 mL/min/1.73 m². Patients were randomized 2:1 to receive oral setanaxib (800 mg BID [18-40 years]/800 + 400 mg/day [12-17 years], n=13; or placebo, n=7) plus background therapy for 24 weeks, with a four-week follow-up period on background therapy alone. The primary endpoints were serious adverse events (SAEs) and adverse events of special interest (AESIs); secondary endpoints included the change in UPCR and eGFR from baseline. The primary safety endpoints were met with AEs occurring at similar frequencies in both treatment groups, and no AESIs were reported. One SAE was reported for a patient in the setanaxib group that was not deemed treatment-related. Patients receiving setanaxib had a 15% mean reduction in UPCR at 24 weeks and a 27% mean reduction in UPCR at four weeks post-dosing compared to placebo. At Week 24, two patients (15.4%) in the setanaxib group achieved a ≥25% reduction in UPCR from baseline, compared with none in the placebo group. There was a 5% mean reduction in eGFR with setanaxib at 24 weeks and a 4% reduction at four weeks post-dosing versus placebo. Further research is needed to investigate setanaxib's clinical efficacy and confirm its benefit/risk profile in a larger Alport syndrome patient population. "These findings represent an important step toward establishing the safety of setanaxib in patients with Alport syndrome, an underserved patient group for whom no approved therapies currently exist," said Professor Daniel Gale of Royal Free Hospital, London, who presented the findings. About setanaxib Setanaxib is a novel enzyme-dependent hydrogen peroxide-depleting agent with anti-fibrotic and anti-inflammation properties. Setanaxib is in development for rare diseases such as Alport syndrome, where targeting inflammation and fibrosis may potentially slow disease progression. About Calliditas Calliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs. Visit Calliditas.com for further information. About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 50,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Healthcare, Homes, and Material. Its Healthcare operations include devices and systems for acute critical care, and manufacture of biotherapeutics, as well as pharmaceuticals. For further information, please visit asahi-kasei.com. SOURCE Calliditas Therapeutics 21% more press release views with Request a Demo

Clinical ResultPhase 2

04 Nov 2025

·www.prnewswire.com

Calliditas Therapeutics to Present at the American Society of Nephrology Kidney Week

STOCKHOLM, Nov. 4, 2025 /PRNewswire/ -- Calliditas Therapeutics (Calliditas), an Asahi Kasei company, announced today that new data will be presented at the 2025 American Society of Nephrology Kidney Week, taking place from November 6 to 9 in Houston, Texas. The presentations will include new secondary analyses from the Phase 3 NefIgArd study of Nefecon (marketed as TARPEYO® [budesonide] delayed-release capsules in the United States in patients with primary immunoglobulin A nephropathy [IgAN] who are at risk for disease progression) as well as initial demographics of the PERFORM registry of IgAN patients that have received TARPEYO. Additional real-world treatment and management evidence, derived from the Veterans Health Administration and the Cure Glomerulopathy Network (CureGN) registry, will also be presented. Data from a Phase 2a, randomized, double-blind, placebo-controlled trial studying setanaxib for the treatment of Alport Syndrome, will be presented in a High-Impact Clinical Trials session on November 8. Alport Syndrome is a rare genetic kidney disease resulting from mutations in collagen type IV genes that can lead to progressive loss of kidney function and end-stage kidney disease. A total of eight abstracts were accepted for presentation, including one selected as a High-Impact Clinical Trial, one oral presentation, five poster presentations, and one informational poster. High-impact Clinical Trial: Abstract No. 3345 Title: "Safety and preliminary efficacy findings from a Phase 2a randomized, double-blind, placebo-controlled trial of setanaxib in patients with Alport syndrome" Date and time: November 8, 10 am to 12 pm CT (presentation scheduled for 10:30-10:45 am) Location: Hall A Presenter: Daniel Gale, University College London Oral Presentation: Abstract No. SA-OR047 Title: "Duration of Absolute Proteinuria Response with Nefecon in Patients with Primary IgAN: Results from the Two-Year NefIgArd Trial" Date and time: November 8, 4:30 to 6 pm CT (presentation scheduled for 4:40-4:50 pm) Location: Room 310A Presenter: Brad Rovin, The Ohio State University Wexner Medical Center Poster Presentations: Abstract No. FR-PO0804 Title: "Absolute Proteinuria over Time with Nefecon vs. Placebo in Patients with IgAN: Results from the Phase 3 NefIgArd Trial" Date and time: November 7, 10 am to 12 pm CT Presenter: Heather Reich, University of Toronto Abstract No. FR-PO0849 Title: "Real-World Treatment for IgA Nephropathy in the Veterans Health Administration" Date and time: November 7, 10 am to 12 pm CT Presenter: Lucile Gregg, Baylor College of Medicine Abstract No. SA-PO0789 Title: "Creation and Initial Demographics of the PERFORM Patient Registry: Novel Real-World Registry of Patients Treated for IgAN in the United States" Date and time: November 8, 10 am to 12 pm CT Presenter: Russell Jones, Calliditas Therapeutics Abstract No. SA-PO0804 Title: "Kidney outcomes in immunoglobulin A nephropathy (IgAN) across the age spectrum in the Cure Glomerulopathy Network (CureGN)" Date and time: November 8, 10 am to 12 pm CT Presenter: Myda Khalid, Indiana University School of Medicine Abstract No. SA-PO0840 Title: "Therapies for Immunoglobulin A Nephropathy (IgAN) in Cure Glomerulopathy Network (CureGN)" Date and time: November 8, 10 am to 12 pm CT Presenter: Terri Madison, Madison Epi Solutions LLC Abstract No. INFO14-TH Title: "Investigating Extended Nefecon Treatment Beyond Nine Months in Patients with IgAN: The Phase 4 NefXtend Trial" Date and time: November 6, 10 am to 12 pm CT (display only) Kidney Week is the world's premier nephrology meeting, hosted by the American Society of Nephrology (ASN), that brings together thousands of kidney health professionals to share the latest advances in kidney science, research, and treatments. About TARPEYO® /Kinpeygo® TARPEYO is an oral 4mg delayed-release formulation of budesonide, designed to dissolve in the pH of the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer's patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1), causing IgA nephropathy. About Primary Immunoglobulin A Nephropathy Primary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger's Disease) is a rare, progressive, chronic immune-mediate disease that attacks the kidneys and occurs when galactose-deficient IgA1 is recognized by autoantibodies, creating IgA1 containing immune complexes that become deposited in the glomerular mesangium of the kidney. This deposition in the kidney can lead to progressive kidney damage, potentially resulting in end-stage kidney disease. IgAN most often develops between late teens and late 30s. IMPORTANT SAFETY INFORMATION INDICATION TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS TARPEYO is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions, including anaphylaxis, have occurred with other budesonide formulations. WARNINGS AND PRECAUTIONS Hypercorticism and adrenal axis suppression: When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. When discontinuing therapy or switching between corticosteroids, monitor for signs of adrenal axis suppression. Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure to oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B). Immunosuppression and Increased Risk of Infection: Corticosteroids, including TARPEYO, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: reduce resistance to new infections, exacerbate existing infections, increase the risk of disseminated infections, increase the risk of reactivation or exacerbation of latent infections, and mask some signs of infection. Corticosteroid-associated infections can sometimes be serious. Monitor for infection and consider TARPEYO withdrawal as needed. Avoid corticosteroid therapy, including TARPEYO, in patients with active or quiescent tuberculosis or hepatitis B infection; untreated fungal, bacterial, systemic viral, or parasitic infections; ocular herpes simplex; or Kaposi's sarcoma. Avoid exposure to active, easily-transmitted infections (e.g., chickenpox, measles). Corticosteroid therapy may decrease the immune response to some vaccines. Other corticosteroid effects: TARPEYO is a systemically available corticosteroid and is expected to cause related adverse reactions. Monitor patients with hypertension, prediabetes, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where corticosteroids may have unwanted effects. ADVERSE REACTIONS In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO treated patients, and ≥2% higher than placebo) were peripheral edema (17%), hypertension (12%), muscle spasms (12%), acne (11%), headache (10%), upper respiratory tract infection (8%), face edema (8%), weight increased (7%), dyspepsia (7%), dermatitis (6%), arthralgia (6%), and white blood cell count increased (6%). DRUG INTERACTIONS Budesonide is a substrate for CYP3A4. Avoid use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine. Avoid ingestion of grapefruit juice with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4 activity, can increase the systemic exposure to budesonide. USE IN SPECIFIC POPULATIONS Pregnancy: The available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with IgAN. Infants exposed to in-utero corticosteroids, including budesonide, are at risk for hypoadrenalism. Please see Full Prescribing Information About Setanaxib Setanaxib is a novel enzyme-dependent hydrogen peroxide depleting agent with anti-fibrotic and anti-inflammation properties. Setanaxib is in development for fibrotic rare diseases, such as Alport Syndrome, where targeting inflammation and fibrosis may potentially slow disease progression. About Calliditas Calliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs. Visit Calliditas.com for further information. About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 50,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Healthcare, Homes, and Material. Its Healthcare operations include devices and systems for acute critical care, and manufacture of biotherapeutics, as well as pharmaceuticals. For further information, please visit asahi-kasei.com. SOURCE Asahi Kasei Corporation 21% more press release views with Request a Demo

Phase 3Phase 2Clinical Result

100 Deals associated with Setanaxib

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Primary Biliary Cholangitis	Phase 3	Greece	Calliditas Therapeutics AB	07 Dec 2021
Nephritis, Hereditary	Phase 2	-	Calliditas Therapeutics AB	30 Nov 2023
Squamous cell carcinoma of head and neck metastatic	Phase 2	Spain	Calliditas Therapeutics AB	08 Mar 2022
Idiopathic Pulmonary Fibrosis	Phase 2	Sweden	Calliditas Therapeutics France SAS	30 Jan 2022
Type 1 diabetes mellitus with established diabetic nephropathy	Phase 2	Australia	Calliditas Therapeutics France SAS	12 Dec 2017
Albuminuria	Phase 2	United States	Calliditas Therapeutics AB	01 Oct 2013
Albuminuria	Phase 2	Australia	Calliditas Therapeutics AB	01 Oct 2013
Albuminuria	Phase 2	Canada	Calliditas Therapeutics AB	01 Oct 2013
Albuminuria	Phase 2	Czechia	Calliditas Therapeutics AB	01 Oct 2013
Albuminuria	Phase 2	Germany	Calliditas Therapeutics AB	01 Oct 2013

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05323656 (GSN000400, CTgov)	Phase 2	Squamous cell carcinoma of head and neck metastatic	55	Pembrolizumab+Setanaxib (Setanaxib 1600 mg and Pembrolizumab 200 mg)	upmmxzwnyv(jncjucepbp) = vgcuyllyhx cwxiumgvax (kwcqvqqzkj, 9.323) View more	-	09 May 2025
				Placebo+Pembrolizumab (Placebo and Pembrolizumab 200 mg)	upmmxzwnyv(jncjucepbp) = ktozmltxxl cwxiumgvax (kwcqvqqzkj, 8.977) View more
NCT05014672 (TRANSFORM, CTgov)	Phase 2	Primary Biliary Cholangitis \| Stiffness	76	Setanaxib (Setanaxib 1200 mg/Day)	ymutjesoas(lxprndgacj) = oueegqmypq twumktixbv (uhdlkcuxck, hyimyvtyfv - hnlqpvbtxp) View more	-	24 Apr 2025
				Setanaxib (Setanaxib 1600 mg/Day)	ymutjesoas(lxprndgacj) = lxhldbqtlc twumktixbv (uhdlkcuxck, vzhzbfrkvx - lqugqaghkd) View more
NCT02010242 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Type 2 diabetes mellitus with established diabetic nephropathy \| Albuminuria	136	GKT137831 (GKT137831)	sqohyptucx(wcieauklcg) = zcomxfmhly gyaltcxghi (ckcojntvoj, imkiqjxqgs - jmgmkwaghr) View more	-	28 Feb 2025
				Placebo (Placebo)	sqohyptucx(wcieauklcg) = uynpxcqmzs gyaltcxghi (ckcojntvoj, blmsmwrtgo - ujgemsckbn) View more
NCT05323656 (GSN000400, ESMO2024) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck First line	55	Setanaxib 800 mg BID + Pembrolizumab 200 mg IV every 3 weeks	ngbpyuceko(fbuzvgcsir) = fbkqhcoqcc dtmsypcygl (wzuggfazzx, 9.323) View more	Positive	14 Sep 2024
				Placebo + Pembrolizumab 200 mg IV every 3 weeks	ngbpyuceko(fbuzvgcsir) = pmbvtagnqm dtmsypcygl (wzuggfazzx, 8.997) View more
NCT05014672 (TRANSFORM, PRNewswire) Manual	Phase 2	Primary Biliary Cholangitis	76	setanaxib	wkdhpjlkiz(intejqtqfk) = Patients treated with setanaxib showed statistically significant improvements in the primary endpoint of ALP of 19% in the 1600mg arm and 14% in the 1200mg arm and showed positive trends on liver stiffness assessed by FibroScan® at 24 weeks. njvcrmkwen (ufvtzbnxlx ) Met View more	Positive	26 Jul 2024
				Placebo
NCT05323656 (PRNewswire) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck	55	Setanaxib+Pembrolizumab	plrzvjbinu(qshahxeahk) = mrdkepsixx nevuecvwzz (ougwjcyspj ) View more	Positive	06 May 2024
				Pembrolizumab + Placebo	plrzvjbinu(qshahxeahk) = lmijisdyvd nevuecvwzz (ougwjcyspj ) View more
NCT03226067 (Pubmed)	Phase 2	Primary Biliary Cholangitis Second line	111	Setanaxib 400 mg OD	mkpudqqhhw(xyhqdleslf) = dmhgmqtbdx iuefbghysn (hsxscjfjcu, 59.6) View more	Positive	15 May 2023
				Setanaxib 400 mg BID	mkpudqqhhw(xyhqdleslf) = kyuhgupcov iuefbghysn (hsxscjfjcu, 28.9) View more
NCT03226067 (CTgov)	Phase 2	Primary Biliary Cholangitis	111	Placebo oral capsule+GKT137831 (GKT137831 400mg Once Daily)	wairekcthb(wemxpmhpwr) = ghjhtcdwmj zshaielncp (bmbzwiztbe, 59.58) View more	-	31 Mar 2022
				GKT137831 (GKT137831 400mg Twice Daily)	wairekcthb(wemxpmhpwr) = zboudeiqyc zshaielncp (bmbzwiztbe, 28.89) View more
NCT03226067 (GlobeNewswire) Manual	Phase 2	Primary Biliary Cholangitis	111	Setanaxib	csnrzdtbvv(pinzcvaxct): P-Value = <0.002 View more	Positive	24 Jun 2019
				Placebo
EASL2019	Phase 2	Primary Biliary Cholangitis ALP \| GGT \| liver transaminases ... View more	111	GKT831 400 mg BID	pvdkxxomgl(rxkrujrwdq) = bvhsjulxgy gqoboqghwq (xryrqbwafb )	Positive	11 Apr 2019
				Placebo	roltyftxxx(xdrserpqat) = ngoxcgswko oxtxfihdvs (roontxxxrg ) View more

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