考察健康受试者在空腹条件下，单次口服1粒由杭州中美华东制药有限公司提供的伏环孢素软胶囊（受试制剂T，规格：7.9mg）与单次口服1粒由Aurinia Pharmaceuticals, Inc.持证的伏环孢素软胶囊（参比制剂R，商品名：Lupkynis®，规格：7.9mg）的药动学特征，评价两制剂的生物等效性及安全性，为该受试制剂注册申请提供依据。

[Translation]

To investigate the pharmacokinetic characteristics of a single oral dose of cyclosporine soft capsule (test preparation T, specification: 7.9 mg) provided by Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd. and a single oral dose of cyclosporine soft capsule (reference preparation R, trade name: Lupkynis®, specification: 7.9 mg) certified by Aurinia Pharmaceuticals, Inc. in healthy subjects under fasting conditions, and to evaluate the bioequivalence and safety of the two preparations, so as to provide a basis for the registration application of the test preparation.

Start Date16 Feb 2025

Sponsor / Collaborator

Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.

NCT05962788

/ Enrolling by invitationPhase 3

An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Voclosporin in Adolescent Subjects with Lupus Nephritis

The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescents with active lupus nephritis.

Start Date27 Mar 2024

Sponsor / Collaborator

Aurinia Pharmaceuticals, Inc.

[+1]

CTR20234324

/ RecruitingPhase 3

评价伏环孢素治疗活动性狼疮肾炎患者的有效性和安全性—多中心、随机、双盲、安慰剂平行对照III期临床研究

[Translation] Evaluation of the efficacy and safety of cyclosporine in the treatment of patients with active lupus nephritis: a multicenter, randomized, double-blind, placebo-controlled phase III clinical study

主要研究目的：以安慰剂为对照，评价伏环孢素软胶囊治疗活动性狼疮肾炎患者52周后的疗效。次要研究目的：以安慰剂为对照，评价伏环孢素软胶囊治疗活动性狼疮肾炎患者的安全性和耐受性。

[Translation]

The main purpose of the study is to evaluate the efficacy of cyclosporine soft capsules in the treatment of patients with active lupus nephritis after 52 weeks, with placebo as the control. The secondary purpose of the study is to evaluate the safety and tolerability of cyclosporine soft capsules in the treatment of patients with active lupus nephritis, with placebo as the control.

Start Date18 Mar 2024

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Voclosporin

100 Translational Medicine associated with Voclosporin

100 Patents (Medical) associated with Voclosporin

153

Literatures (Medical) associated with Voclosporin

04 Mar 2025·Expert Opinion on Investigational Drugs

A focused report on IFN-1 targeted therapies for lupus erythematosus

Review

Author: Gupta, Pramiti ; Furie, Richard ; Vashistha, Himanshu ; Bhatt, Anushka

INTRODUCTIONPatients with Systemic Lupus Erythematosus (SLE) experience varied manifestations and unpredictable flares, complicating treatment and drug development. Despite these challenges, anifrolumab, voclosporin, and belimumab were approved by FDA. These treatments complement, but don't replace, traditional therapies like NSAIDs, corticosteroids, antimalarials, and immunosuppressives. Therefore, there remains an unmet need for more effective medications targeting excessive proinflammatory cytokines in SLE patients.AREAS COVEREDThis review summarizes the clinical trial outcomes of four upcoming medications targeting cytokine activity: Litifilimab showed a 7-point reduction in CLASI-A in its phase II trial. Daxdilimab was unsuccessful in its phase II trial. Anifrolumab reduced SLE activity in both phase II and III trials. Deucravacitinib decreased disease activity by multiple measures in its phase II trial.EXPERT OPINIONHigh levels of IFN-I (type 1 interferon) are present in most SLE patients, making this pathway an attractive target for drug development. Litifilimab downregulates IFN-I by targeting BDCA2, while dexadilimab targets ILT7 to recruit effector cells, reducing IFN-I production by killing PDCs. Anifrolumab binds to the IFN-I receptor, blocking the activity of all IFN-Is, and deucravacitinib reduces IFN-I by inhibiting TYK2, thereby interfering with downstream signaling. Therapies that target IFN-I represents a promising class of medications for SLE patients.

01 Mar 2025·Journal of Pharmaceutical and Biomedical Analysis

Dried blood spot LC-MS/MS quantification of voclosporin in renal transplant recipients using volumetric dried blood spot sampling

Article

Author: Teng, Y K O ; Moes, D J A R ; de Vries, A P J ; Metscher, E ; Swen, J J ; Meziyerh, S ; Arends, E J

Voclosporin is a potent immunosuppressive agent currently approved for treating active lupus nephritis. Based on its potential antiviral activity, it has also been investigated as immunosuppressive agent in an investigator-initiated study in SARS-CoV2 positive kidney transplant recipients. As with many immunosuppressive agents, optimizing dosing regimens to achieve therapeutic efficacy while minimizing toxicity remains a critical challenge in clinical practice. To prevent organ rejection as well as infections, the prescribed immunosuppression needs to be well balanced. Dried blood spot (DBS) sampling has enabled development of remote voclosporin therapeutic drug monitoring. Here, we report on the development and analytical validation of a liquid chromatography tandem mass spectrometry (LC-MS/MS) assay for quantification of voclosporin in dried blood spots. Method development was based on previously developed assays for the quantification of tacrolimus, everolimus, sirolimus, cyclosporin, mycophenolic acid, creatinine and iohexol in DBS and voclosporin in whole blood using LC-MS/MS. HemaXis™ volumetric blood spot devices were used for sample collection. The sample purification was based on the extraction of voclosporin from the DBS samples. Stable isotopically labeled voclosporin-D4 was used as an internal standard prior to sample purification. Bland Altman and Passing bablok analysis were performed for cross validation between whole blood and DBS samples. The method was successfully validated following the current ICH M10 guidelines. The dynamic range for the analyte was 10-600 µg/L with an excellent mean coefficient of correlation of 0.9978. The within run and between run precision and accuracy were both within the acceptance criteria. The cross-validation against the whole blood method shows that the quantified voclosporin results are promising. This developed dried blood spot LC-MS/MS method was successfully validated and provides an easy, efficient workflow for therapeutic drug monitoring in kidney transplant patients or remote pharmacokinetic studies in lupus nephritis patients treated with voclosporin.

07 Jan 2025·Clinical Kidney Journal

Ten tips in lupus nephritis management

Review

Author: Teoh, Selene T Y ; Chan, Tak Mao ; Yap, Desmond Y H

ABSTRACTLupus nephritis is an important cause of severe glomerulonephritis, and a leading cause of kidney failure in young adults. While the disease can lead to rapid destruction of nephrons if untreated, there are effective therapies to reverse the severe acute kidney injury and prevent the lifetime risk of kidney failure. Early diagnosis and timely intervention are therefore of critical importance. Clinical management of lupus nephritis has improved considerably over the past two decades. The advent of mycophenolate as standard immunosuppressive therapy was a major paradigm shift that improved the safety and convenience of treatment and also patients' quality of life. Effective therapeutic options continue to increase, such as belimumab (a monoclonal antibody that inhibits B-cell activating factor, BAFF) and voclosporin (a calcineurin inhibitor) which have obtained regulatory approval in U.S.A. and Europe. There is also accumulating experience on tacrolimus, which has regulatory approval for lupus nephritis treatment in Japan and commonly used off-label in many countries. Ironically, the increasing therapeutic options have resulted in uncertainties in deciding which medication, and which treatment regimen, is best for a patient. In this context, one needs to take into consideration the distinct characteristics and the risk profile of each patient, and adopt a holistic and long-term perspective, so that treatment can be personalized to achieve favourable clinical outcomes.

157

News (Medical) associated with Voclosporin

03 Dec 2024

·www.prnewswire.com

Lupus Nephritis Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 30+ Companies Working in the Domain

The lupus nephritis market is poised for growth, driven by rising disease prevalence, advancements in therapeutics such as biologics and targeted therapies, and increased investment in R&D. Heightened awareness and robust support from governments and key industry players further create a dynamic environment for innovation and better patient outcomes. LAS VEGAS, Dec. 3, 2024 /PRNewswire/ -- DelveInsight's ' Lupus Nephritis Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline lupus nephritis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the lupus nephritis pipeline domain. Key Takeaways from the Lupus Nephritis Pipeline Report DelveInsight's lupus nephritis pipeline report depicts a robust space with 30+ active players working to develop 35+ pipeline therapies for lupus nephritis treatment. Key lupus nephritis companies such as AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others are evaluating new lupus nephritis drugs to improve the treatment landscape. Promising lupus nephritis pipeline therapies such as Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others are under different phases of lupus nephritis clinical trials. In November 2024, Adicet Bio announced that the first LN patient had been dosed in the Phase I clinical trial evaluating ADI-001 in autoimmune diseases. In November 2024, Kyverna Therapeutics announced that it would present updated clinical data from LN patients treated with KYV-101 in ongoing Kyverna-sponsored KYSA-1 and KYSA-3 Phase I/II studies and named patient treatments. In October 2024, Kezar Life Sciences suspended subject enrolment and patient dosing in the Phase II PALIZADE trial of zetomipzomib for active lupus nephritis. In June 2024, Nkarta announced the initiation of Ntrust-I, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening. The company also announced the clearance by the U.S. Food and Drug Administration (FDA) of its second Investigational New Drug (IND) application for NKX019 in autoimmune disease. In June 2024, Adicet Bio announced that the US Food and Drug Administration (FDA) had granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis. In April 2024, Caribou Biosciences announced that it had received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024. In March 2024, Artiva Therapeutics is looking to dose the first patient in a Phase I/II trial assessing its cell therapy AlloNK in lupus nephritis (LN). Request a sample and discover the recent advances in lupus nephritis treatment drugs @ Lupus Nephritis Pipeline Report The lupus nephritis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage lupus nephritis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the lupus nephritis clinical trial landscape. Lupus Nephritis Overview Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE), an autoimmune disease that can affect multiple organ systems. In lupus nephritis, the immune system mistakenly attacks the kidneys, leading to inflammation and damage. The exact cause is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors, including infections and exposure to certain drugs or UV light. Symptoms of lupus nephritis can vary but often include swelling in the legs and feet, high blood pressure, foamy urine, and in severe cases, hematuria. Patients may also experience fatigue, joint pain, and skin rashes, typical of lupus. Diagnosis usually involves a combination of blood tests, urinalysis, and imaging studies. A kidney biopsy may be necessary to evaluate the extent of kidney damage and guide treatment. Treatment for lupus nephritis aims to reduce inflammation and prevent kidney damage. It often involves corticosteroids and immunosuppressive medications such as mycophenolate mofetil or azathioprine. In severe cases, more aggressive treatments, including cyclophosphamide or biologic therapies like belimumab, may be utilized. Regular monitoring of kidney function and overall health is crucial for managing the disease effectively. Find out more about lupus nephritis treatment drugs @ Drugs for Lupus Nephritis Treatment A snapshot of the Lupus Nephritis Pipeline Drugs mentioned in the report: Learn more about the emerging lupus nephritis pipeline therapies @ Lupus Nephritis Clinical Trials Lupus Nephritis Therapeutics Assessment The lupus nephritis pipeline report proffers an integral view of the lupus nephritis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Lupus Nephritis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Interferon alpha-beta receptor antagonists, Cell death inhibitors, Cell death stimulants, Antibody-dependent cell cytotoxicity, B-cell activation factor receptor antagonists, Glucokinase stimulants, Dendritic cell inhibitors, Complement factor D inhibitors, Complement C3 inhibitors, Proteasome inhibitors, Natural killer cell replacements, Immunologic cytotoxicity; T lymphocyte replacements Key Lupus Nephritis Companies: AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others. Key Lupus Nephritis Pipeline Therapies: Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others. Dive deep into rich insights for new drugs for lupus nephritis treatment, visit @ Lupus Nephritis Drugs Table of Contents For further information on the lupus nephritis pipeline therapeutics, reach out @ Lupus Nephritis Treatment Drugs Related Reports Lupus Nephritis Epidemiology Lupus Nephritis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted lupus nephritis epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, CABALETTA BIO, among others. Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

IND

20 Nov 2024

·www.otsuka.co.jp

Otsuka launches Lupkynis® in Japan

RSS Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that Lupkynis® (voclosporin) has been launched today for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus, an autoimmune disease. Lupkynis is a novel, oral immunosuppressive agent developed for the treatment of LN. It suppresses the immune system by inhibiting calcineurin, an enzyme that is crucial for the proliferation and activation of T cells, an important element of the immune system. In December 2020, Otsuka and Aurinia Pharmaceuticals Inc. entered into a collaboration and license agreement for the development and commercialization of oral voclosporin for the treatment of LN in Japan and European countries. In September 2022 Otsuka received European Commission approval for Lupkynis as a treatment for active LN in EU member countries. Otsuka subsequently received approval for Lupkynis in Japan in Septermber this year. In the U.S., Aurinia received FDA marketing approval in January 2021 for Lupkynis as a treatment for active LN in adults. Otsuka Pharmaceutical is committed to research and development that contributes to patients and their families in order to meet unmet medical needs worldwide. Our research priorities, in addition to autoimmune diseases, include mental, renal and cardiovascular health, and the often-ignored disease tuberculosis.

Drug ApprovalLicense out/inImmunotherapy

18 Nov 2024

·www.auriniapharma.com

Aurinia Commends 2024 Updated ACR Guidelines for Screening, Treatment, and Management of Lupus Nephritis

New Guidelines Presented at ACR Convergence 2024 Recommend First-Line Therapy with LUPKYNIS® (voclosporin) as Part of a Triple Immunosuppressive LN Treatment Regimen ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) commends the American College of Rheumatology (ACR) for their 2024 evidence-based guidelines for the screening, treatment, and management of lupus nephritis (LN), which prioritize the urgent need to use efficacious treatments to avoid nephron loss and preserve kidney function. The guidelines call for a triple immunosuppression treatment regimen for LN, with first line use of advanced therapies like LUPKYNIS for three to five years. Importantly, the guidelines suggest that steroids should be rapidly tapered to <5 mg/day by six months as the highest acceptable maintenance dose of steroids. The guidelines also call for achieving a proteinuria target of <0.5g/g urine protein creatinine ratio (UPCR) by 12 months of treatment. The recommendations included within the guidelines for use of LUPKYNIS to treat LN were based on the AURORA Clinical Program, including the Phase 3 AURORA 1 clinical study. In AURORA 1, patients were 81% more likely to achieve a complete renal response1 at 52 weeks (40.8 vs 22.5 – OR 2.7) with LUPKYNIS in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids, compared to MMF and low-dose glucocorticoids alone. Additionally, > 80% of patients were tapered to a steroid dose of <2.5mg / day by 16 weeks per the AURORA protocol, making LUPKYNIS the only therapy to meet and exceed the new guideline steroid target of <5mg /day by 6 months in randomized clinical trials. LUPKYNIS, the only FDA-approved CNI therapy for the treatment of adult patients with active LN in combination with other immunosuppressive therapies, has demonstrated broad clinical utility across biopsy class, baseline eGFR, proteinuria range, race, ethnicity, age, and gender. Please see Indication and Important Safey Information, including Boxed Warning, below. The guidelines recommend routine urine screening for proteinuria at least every six to 12 months in patients with SLE without known kidney disease, or when experiencing extra-renal flares. They also conditionally recommend performing a kidney biopsy in patients with SLE who have high levels of protein in the urine (> 0.5 g/g) and/or impaired kidney function not otherwise explained. “We applaud ACR’s critical and timely guidelines to improve the management of lupus nephritis for this underserved patient population. They provide clear guidance for the importance of early diagnosis and starting with triple immunosuppression therapy with CNIs like LUPKYNIS to help achieve a complete renal response and aid in preserving kidney function for adults living with lupus nephritis,” said Dr. Greg Keenan, Chief Medical Officer at Aurinia. The updated ACR guidelines for the diagnosis and treatment of LN are based on systematic evidence reviews, feedback from a panel of people living with LN, and input from rheumatologists and nephrologists. About LUPKYNIS LUPKYNIS is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The AURORA Clinical Program, comprised of the AURORA 1 pivotal trial and AURORA 2 extension trial, demonstrated the importance of LUPKYNIS plus standard of care to preserve kidney health in patients with active LN without reliance on chronic high-dose glucocorticoids. It is the only clinical program to include three years of LN treatment and follow-up with mycophenolate mofetil (MMF) and steroids. About Aurinia Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand). INDICATION AND IMPORTANT SAFETY INFORMATION INDICATION LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation. IMPORTANT SAFETY INFORMATION BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death. CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients. WARNINGS AND PRECAUTIONS Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent. Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections which lead to serious, including fatal outcomes. Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity. Monitor eGFR regularly. Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy. Monitor blood pressure regularly. Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions. Monitor for neurologic symptoms. Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia. Monitor serum potassium levels periodically. QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation. Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS. Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS. Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Co-administration of LUPKYNIS with strong CYP3A4 inhibitors is contraindicated. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Avoid use of LUPKYNIS with strong or moderate CYP3A4 inducers. ADVERSE REACTIONS The most common adverse reactions (≥3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite. SPECIFIC POPULATIONS Pregnancy: Avoid use of LUPKYNIS. Lactation: Consider the mother’s clinical need for LUPKYNIS and any potential adverse effects to the breastfed infant when prescribing LUPKYNIS to a lactating woman. Renal Impairment: LUPKYNIS is not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m 2 unless benefit exceeds risk. If used in this population, reduce LUPKYNIS dose. Hepatic Impairment: For mild or moderate hepatic impairment, reduce LUPKYNIS dose. Avoid use with severe hepatic impairment. Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS. References ________________________ 1 In the AURORA clinical program, complete renal response is defined as UPCR of 0.5 mg/mg or less, along with other criteria: stable renal function, defined as an estimated glomerular filtration rate (eGFR) of at least 60 mL/min/1.73 m2, or no more than a 20% decrease from baseline in eGFR; no rescue medication; no more than 10 mg prednisone equivalent per day for at least 3 consecutive days, or 7 or more days between weeks 44 and 52. View source version on businesswire.com: https://www.businesswire.com/news/home/20241118903839/en/ Media & Investor Inquiries: Andrea Christopher Corporate Communications & Investor Relations Aurinia Pharmaceuticals Inc. achristopher@auriniapharma.com General Investor Inquiries: ir@auriniapharma.com Source: Aurinia Pharmaceuticals Inc. Released November 18, 2024

Clinical ResultDrug ApprovalPhase 3Immunotherapy

100 Deals associated with Voclosporin

External Link

KEGG	Wiki	ATC	Drug Bank
D09033	Voclosporin	L04AD03	DB11693

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Lupus Nephritis	United States	Aurinia Pharmaceuticals, Inc.	22 Jan 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Uveitis, Intermediate	Phase 1	Austria	Lux Biosciences, Inc.	01 Jan 2007
Uveitis, Intermediate	Phase 1	France	Lux Biosciences, Inc.	01 Jan 2007
Uveitis, Posterior	Phase 1	India	Lux Biosciences, Inc.	01 Jan 2007
Uveitis, Posterior	Phase 1	Austria	Lux Biosciences, Inc.	01 Jan 2007
Uveitis, Posterior	Preclinical	Germany	Lux Biosciences, Inc.	01 Jan 2007
Uveitis, Posterior	Preclinical	France	Lux Biosciences, Inc.	01 Jan 2007
Uveitis, Posterior	Preclinical	Canada	Lux Biosciences, Inc.	01 Jan 2007
Uveitis, Posterior	Preclinical	United States	Lux Biosciences, Inc.	01 Jan 2007
Uveitis, Posterior	Preclinical	United Kingdom	Lux Biosciences, Inc.	01 Jan 2007
Plaque psoriasis	Preclinical	Canada	Aurinia Pharmaceuticals, Inc.	01 Dec 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03021499 (AURORA, Biospace) Manual	Not Applicable	Lupus Nephritis	-	LUPKYNIS	(dspgoohdop) = rowacmekdl vzybrjjmuq (ocimuyxgao )	Positive	09 May 2024
NCT03021499 (AURORA, Biospace) Manual	Not Applicable	Lupus Nephritis	25	LUPKYNIS, MMF, and steroids	(acpnfcqxnq) = ogfrnvxhns cgrdwmjosa (yoayobmqic )	Positive	09 May 2024
				MMF and glucocorticoids	(acpnfcqxnq) = stdkjrxfkd cgrdwmjosa (yoayobmqic )
NCT03021499 (phase 3 study, Pubmed)	Phase 3	Lupus Nephritis	148	Voclosporin	rxvcccvfuf(zdgottjdey) = The incidence of adverse events was similar between the arms; mean eGFR values remained stable and within normal range in both arms ycrzkmylep (xjmsqbyuel ) View more	Positive	18 Dec 2023
				Placebo
ACR2023	Not Applicable	Proteinuria	-	Voclosporin	(qlvtiwjnnr) = wrmzzmhyub pkgwvythyv (ueepmssvco ) View more	-	14 Nov 2023
				Placebo	(qlvtiwjnnr) = ypgmyhxswp pkgwvythyv (ueepmssvco ) View more
NCT03021499 \| NCT02141672 (AURORA 1, Biospace) Manual	Phase 2/3	Lupus Nephritis	-	LUPKYNIS® + MMF+ glucocorticoids (proteinuria >=2 g/day)	(riqrtucfjv) = greater numeric achievement of complete renal response across biopsy classes, races, and ethnicities in LN patients with proteinuria >=2 g/day isenozdlbv (dzwwkgnhrb ) View more	Positive	07 Nov 2023
				LUPKYNIS® + MMF+ glucocorticoids (UPCR ≥2 g/g at baseline)
NCT03021499 (AURORA, Biospace) Manual	Not Applicable	Lupus Nephritis	-	LUPKYNIS + MMF + glucocorticoids (Black patients)	(ampifdujzz) = akuetalhqb bymfqeejyw (krydcjrpev )	Positive	07 Nov 2023
				MMF + glucocorticoids (Black patients)	(ampifdujzz) = ibljagdqlu bymfqeejyw (krydcjrpev )
AURA-LV and AURORA 1 (EULAR2023)	Phase 2/3	Proteinuria	-	Voclosporin	(thvclqfxaw) = bqmaqczajy pfuwlfkepq (aysdyplggr ) View more	Positive	31 May 2023
				Placebo	(thvclqfxaw) = kizbelbmbn pfuwlfkepq (aysdyplggr ) View more
NCT03597464 (AURORA 2, CTgov)	Phase 3	Lupus Nephritis	216	Voclosporin (Voclosporin)	gijslroqjg(hjdjdqnvmz) = jshwgcjrzb uvqdaamuip (kxaturzukt, eokqrkhtiz - ddpsqloimr) View more	-	14 Dec 2022
				Placebo Oral Capsule (Placebo Oral Capsule)	gijslroqjg(hjdjdqnvmz) = mikcqskuxt uvqdaamuip (kxaturzukt, ocawlhbcmh - xxiyfcxsuv) View more
NCT03021499 \| NCT03597464 (AURORA 2, ASN2022)	Phase 3	Lupus Nephritis UPCR \| eGFR	80	Voclosporin	(dvzucaqjro) = aqwvehcsub mszhcarvax (fymwnoyeji ) View more	Positive	04 Nov 2022
				Placebo	(dvzucaqjro) = zddydrdvrz mszhcarvax (fymwnoyeji ) View more
AURORA 1 and AURORA 2 (ASN2022)	Not Applicable	Lupus Nephritis urine protein creatinine ratio (UPCR)	-	Voclosporin	(avogfwyhga) = The rates of serious adverse events were similar in the voclosporin (21.3%) and control (27.0%) arms, with one death occurring in a control-treated patient drrjcnbmkm (wdmzstofab ) View more	Positive	04 Nov 2022
				Placebo

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