The purpose of this study is to survey the safety of LUPKYNIS in patients with lupus nephritis under actual use conditions. In addition, information on efficacy will be collected.

Start Date01 Jul 2025

Sponsor / Collaborator

Otsuka Pharmaceutical Co., Ltd.

CTR20250444

/ CompletedNot Applicable

伏环孢素软胶囊在空腹条件下的人体生物等效性试验

[Translation] Bioequivalence study of cyclosporine soft capsules in humans under fasting conditions

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 and Pediatric 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 adolescent and pediatric subjects with lupus nephritis.

Start Date27 Mar 2024

Sponsor / Collaborator

Aurinia Pharmaceuticals, Inc.

100 Clinical Results associated with Voclosporin

100 Translational Medicine associated with Voclosporin

100 Patents (Medical) associated with Voclosporin

149

Literatures (Medical) associated with Voclosporin

08 Aug 2025·JOURNAL OF NEPHROLOGY

Effective management of lupus nephritis using a novel combination therapy with low-dose steroids: a case report.

Article

Author: Geetha, Duvuru ; Reyes-Bahamonde, Joselyn ; Abdipour, Amir ; Zuppan, Craig W ; Ebrahimi, Niloufar ; Norouzi, Sayna

Lupus nephritis (LN) is the predominant severe manifestation of systemic lupus erythematosus (SLE). The approach to managing LN is highly heterogeneous due to the clinical heterogeneity of the disease. Here, we report a 28-year-old Caucasian female with refractory biopsy-proven active LN class III and V, diagnosed approximately six years prior to presentation who was successfully managed with both belimumab and voclosporin. Her laboratory findings were significant for high-titer anti-dsDNA antibodies (> 300), low complements, and increasing proteinuria despite ongoing treatment with MMF and low-dose prednisone. The patient fulfilled the EULAR/ACR classification criteria for SLE, achieving a score of 28, reflecting significant systemic disease involvement. The patient tolerated the combination of volcosporin and belimumab well for nine months. She did not report any specific side effects during this time and was in clinical remission with no signs of systemic flare-up based on the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). This case highlights the potential of combining belimumab, voclosporin, mycophenolate mofetil (MMF), and low-dose steroids in selected patients.

20 Jun 2025·MEDICINE

Voclosporin: A comprehensive review of its role as a novel calcineurin inhibitor in the management of systemic lupus erythematosus.

Review

Author: Edache, Akogwu Ocholi ; Wireko, Andrew Awuah ; Eniola, Akande ; Abdul-Rahman, Toufik ; Ashinze, Patrick ; Ozioma, Chukwu Bethrand ; Banerjee, Suvam ; Obafemi, Eniola ; Mafua, Nelson ; Emmanuel, Egbunu

Systemic lupus erythematosus is an autoimmune disease with diverse clinical manifestations, including lupus nephritis. Calcineurin inhibitors (CNIs) are a treatment option, but traditional CNIs have limitations. Voclosporin, a novel oral CNI, inhibits calcineurin to modulate T-cell activation and stabilize podocytes in lupus nephritis. This review assesses voclosporin's therapeutic potential in treating SLE (lupus nephritis), examining its mechanism of action, clinical efficacy, safety profile, and advantages over other CNIs. A broad search was conducted to identify studies published from 2009 to 2024 on voclosporin and other CNIs in lupus nephritis, using databases such as PUBMED, SCOPUS, Google Scholar and Cochrane Library. MeSH Keywords included "voclosporin," "lupus nephritis," "systemic lupus erythematosus," and "calcineurin inhibitors." Studies were included if they reported relevant clinical outcomes, evaluated voclosporin in lupus nephritis, or provided comparative data on voclosporin versus other CNIs, focusing on randomized controlled trials, systematic reviews, meta-analyses, retrospective studies and cohort studies. Voclosporin demonstrated higher renal response rates at 52 weeks than standard treatment alone (40.8% vs 22.5%). It has stable pharmacokinetics, reducing the need for individualized dose adjustments and frequent monitoring. Safety outcomes show a lower incidence of adverse effects like hypertension and hyperlipidemia compared to traditional CNIs. Voclosporin offers superior efficacy and safety compared to traditional CNIs for managing lupus nephritis, with predictable dosing and a favorable side effect profile. Continued research is needed to optimize voclosporin's use and support personalized medicine approaches.

01 Jun 2025·INFLAMMOPHARMACOLOGY

Voclosporin promotes neurological function recovery by inhibiting inflammation and maintaining blood–brain barrier integrity following rtPA reperfusion after MCAO in mice

Article

Author: Sun, Wei ; Ma, Shubei ; Zheng, Yangmin ; Luo, Yumin ; Yan, Feng

Hemorrhagic transformation (HT) is the most serious complication after rtPA thrombolytic therapy in patients with acute ischemic stroke, which greatly limits the clinical application of rtPA. rtPA disruption of the blood-brain barrier (BBB) by inducing inflammation after cerebral ischemia may be an important mechanism for the development of HT, and maintaining BBB integrity can significantly reduce the risk of HT. Our study found that a new generation of calcineurin inhibitors, voclosporin can improve neurological function, reduce neuronal damage, and reduce cerebral infarction volume in mice. By Evans blue extravasation assay and cerebral water content measurement, it was found that voclosporin could improve BBB injury and reduce brain edema caused by rt-PA. The ELISA and immunofluorescence experiments further proved that voclosporin can reduce the expression of IL-1β/TNF-α, increase the expression of IL-10/IL-4, and protect the integrity of the BBB by promoting microglia/macrophage to M2 type polarization, providing new thinking for clinical rtPA combined therapy to alleviate BBB damage.

161

News (Medical) associated with Voclosporin

31 Jul 2025

·www.businesswire.com

Aurinia Pharmaceuticals Reports Financial Results for the Three and Six Months Ended June 30, 2025

ROCKVILLE, Md.& EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced financial results for the three and six months ended June 30, 2025. Financial Results Total Revenue: For the three and six months ended June 30, 2025, total revenue was $70.0 million and $132.5 million, up 22% and 23%, respectively, from $57.2 million and $107.5 million, respectively, for the same periods of 2024. Net Product Sales: For the three and six months ended June 30, 2025, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $66.6 million and $126.5 million, up 21% and 23%, respectively, from $55.0 million and $103.1 million, respectively, for the same periods of 2024. License, Collaboration and Royalty Revenue: For the three and six months ended June 30, 2025, license, collaboration and royalty revenue, which includes manufacturing services revenue from Aurinia’s collaboration partner, Otsuka, was $3.4 million and $5.9 million, up 55% and 34%, respectively, from $2.2 million and $4.4 million, respectively, in the same periods of 2024. Net Product Sales: For the three and six months ended June 30, 2025, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $66.6 million and $126.5 million, up 21% and 23%, respectively, from $55.0 million and $103.1 million, respectively, for the same periods of 2024. License, Collaboration and Royalty Revenue: For the three and six months ended June 30, 2025, license, collaboration and royalty revenue, which includes manufacturing services revenue from Aurinia’s collaboration partner, Otsuka, was $3.4 million and $5.9 million, up 55% and 34%, respectively, from $2.2 million and $4.4 million, respectively, in the same periods of 2024. Net Income (Loss): For the three and six months ended June 30, 2025, net income (loss) was $21.5 million and $44.9 million, respectively, compared to $0.7 million and $(10.0) million, respectively, in the same periods of 2024. Cash Flow Provided by (Used in) Operating Activities: For the six months ended June 30, 2025, cash flow provided by (used in) operating activities was $45.5 million, compared to $(2.8) million in the same period of 2024. Excluding $11.5 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $57.0 million for the six months ended June 30, 2025. Cash Position As of June 30, 2025, Aurinia had cash, cash equivalents, restricted cash and investments of $315.1 million, compared to $358.5 million at December 31, 2024. For the six months ended June 30, 2025, the Company repurchased 11.2 million of its common shares for $90.8 million. The Board has approved an increase to the previously announced share repurchase plan of an additional $150 million of common shares. Purchases under the share repurchase plan, which to date have totaled 18.3 million of its common shares for $138.4 million, began on February 21, 2024. The expiry date of the share repurchase plan is not currently known. This program is being and will continue to be implemented through open market or privately negotiated purchases, including under a plan intended to benefit from the affirmative defense under Rule 10b5-1, Rule 10b-18 or an automatic securities purchase plan, an accelerated share repurchase program, or other mechanisms. The timing and amount of repurchase transactions will be determined by the Company based on its evaluation of market conditions, share price, legal requirements, including applicable blackout period restrictions, and other factors. The purchase price of any common shares will be determined in accordance with applicable U.S. securities laws. The Company is relying on the exemptive relief granted by the Canadian Securities Authorities as described in its February 29, 2024 press release. Full Year 2025 Total Revenue and Net Product Sales Guidance For 2025, Aurinia is increasing total revenue guidance from a range of $250 million to $260 million to a range of $260 million to $270 million and net product sales guidance from a range of $240 million to $250 million to a range of $250 million to $260 million. “We continue to see solid growth for LUPKYNIS, partially driven by the new 2024 American College of Rheumatology lupus nephritis treatment guidelines, which recommend the incorporation of drugs like LUPKYNIS into first-line therapy in order to preserve kidney function,” stated Peter Greenleaf, President and Chief Executive Officer of Aurinia. “Additionally, we are excited about the positive results from our Phase 1 study of aritinercept, a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL). Aritinercept was well tolerated at all dose levels tested and single doses led to robust and long-lasting reductions in immunoglobulins (antibodies). We look forward to initiating clinical studies in at least two autoimmune diseases in the second half of this year.” Webcast & Conference Call Details A webcast and conference call will be hosted today, July 31, at 8:30 a.m. ET. The link to the audio webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. A replay of the webcast will be available on Aurinia’s website. About Aurinia Aurinia is a 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 for the treatment of adult patients with active lupus nephritis. Aurinia is also developing aritinercept (AUR200), a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases. Forward-Looking Statements This press release contains forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable U.S. securities law. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with: LUPKYNIS net product sales, the timing of clinical study results and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia’s most recent Annual Report on Form 10-K and its other public available filings available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedarplus.ca or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, and on Aurinia’s website at www.auriniapharma.com. AURINIA PHARMACEUTICALS INC. AND SUBSIDIARY CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) June 30, 2025 December 31, 2024 (Unaudited) ASSETS Current assets: Cash, cash equivalents and restricted cash $ 53,002 $ 83,433 Short-term investments 262,131 275,043 Accounts receivable, net 40,091 36,544 Inventory, net 46,503 39,228 Prepaid expenses and deposits 6,578 11,219 Other current assets 665 1,129 Total current assets 408,970 446,596 Finance right-of-use lease assets 83,195 92,072 Intangible assets, net 4,046 4,355 Operating right-of-use lease assets 3,837 4,068 Property and equipment, net 2,421 2,731 Other noncurrent assets 93 823 Total assets $ 502,562 $ 550,645 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 3,312 $ 5,187 Accrued expenses 49,704 64,971 Finance lease liabilities, current portion 16,167 14,046 Deferred revenue 5,499 11,002 Operating lease liabilities, current portion 1,047 1,026 Other current liabilities 2,537 1,531 Total current liabilities 78,266 97,763 Finance lease liabilities, less current portion 59,282 58,554 Deferred revenue, less current portion 12,349 1,699 Deferred compensation and other noncurrent liabilities 12,030 9,408 Operating lease liabilities, less current portion 5,334 5,743 Total liabilities 167,261 173,167 Shareholders' equity Common shares - no par value, unlimited shares authorized, 132,668 and 140,883 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively 1,122,582 1,187,696 Additional paid-in capital 105,337 126,999 Accumulated other comprehensive loss (905 ) (647 ) Accumulated deficit (891,713 ) (936,570 ) Total shareholders' equity 335,301 377,478 Total liabilities and shareholders' equity $ 502,562 $ 550,645 AURINIA PHARMACEUTICALS INC. AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (in thousands, except per share data) Three months ended Six months ended June 30, June 30, 2025 2024 2025 2024 Revenue Net product sales $ 66,574 $ 55,028 $ 126,545 $ 103,101 License, collaboration and royalty revenue 3,434 2,164 5,928 4,394 Total revenue 70,008 57,192 132,473 107,495 Operating expenses Cost of revenue 7,115 8,909 15,689 16,661 Selling, general and administrative 26,018 44,934 46,357 92,629 Research and development 7,432 4,080 13,175 9,631 Restructuring 114 1,072 1,647 7,755 Other expense (income), net 9,246 (290 ) 13,675 (4,415 ) Total operating expenses 49,925 58,705 90,543 122,261 Income (loss) from operations 20,083 (1,513 ) 41,930 (14,766 ) Interest income 3,190 4,189 6,759 8,715 Interest expense (1,117 ) (1,198 ) (2,184 ) (2,481 ) Net income (loss) before income taxes 22,156 1,478 46,505 (8,532 ) Income tax expense 643 756 1,648 1,495 Net income (loss) $ 21,513 $ 722 $ 44,857 $ (10,027 ) Earnings (loss) per share Basic $ 0.16 $ 0.01 $ 0.33 $ (0.07 ) Diluted $ 0.16 $ 0.01 $ 0.32 $ (0.07 ) Shares used in computing earnings (loss) per share Basic 134,873 143,327 136,878 143,507 Diluted 137,526 144,110 140,193 143,507 AURINIA PHARMACEUTICALS INC. AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (in thousands) Six Months Ended June 30, 2025 2024 Cash flows from operating activities: Net income (loss) $ 44,857 $ (10,027 ) Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: Share-based compensation 2,031 14,323 Amortization and depreciation 9,720 9,690 Foreign exchange loss (gain) on revaluation of Monoplant finance lease liability 9,265 (5,705 ) Net amortization of premiums and discounts on investments (5,219 ) (6,331 ) Other, net 4,132 919 Net changes in operating assets and liabilities: Accounts receivable, net (3,547 ) (1,433 ) Inventory, net (7,275 ) 852 Prepaid expenses and other current assets 5,106 (4,305 ) Other noncurrent operating assets 730 (12 ) Accounts payable (1,875 ) 4,088 Accrued expenses and other liabilities (17,136 ) (3,805 ) Deferred revenue 5,147 (644 ) Lease liabilities (395 ) (365 ) Net cash provided by (used in) operating activities 45,541 (2,755 ) Cash flows from investing activities: Proceeds from the sale and maturities of investments 255,285 328,877 Purchases of investments (237,411 ) (318,126 ) Purchases of property, equipment and intangible assets (115 ) (140 ) Net cash provided by investing activities 17,759 10,611 Cash flows from financing activities: Repurchase of common shares (89,485 ) (18,435 ) Principal portion of finance lease payments (6,201 ) (6,001 ) Proceeds from issuance of common shares from exercise of stock options and vesting of RSUs and performance awards 10,590 6,134 Proceeds from issuance of common shares under ESPP 401 703 Taxes paid related to net settlement of exercises of stock options and vesting of RSUs and performance awards (9,036 ) (5,725 ) Net cash used in financing activities (93,731 ) (23,324 ) Net decrease in cash, cash equivalents and restricted cash (30,431 ) (15,468 ) Cash, cash equivalents and restricted cash, beginning of the period 83,433 48,875 Cash, cash equivalents and restricted cash, end of the period $ 53,002 $ 33,407

Phase 1Drug ApprovalFinancial StatementClinical Result

08 May 2025

·www.prnewswire.com

LUPKYNIS Strengthens Market Position as Demand for Lupus Nephritis Treatment Grows | DelveInsight

As a novel calcineurin inhibitor with proven efficacy in improving renal outcomes, LUPKYNIS addresses a high unmet medical need. With increasing awareness, supportive guidelines, and potential global expansion, it is well-positioned for steady market growth. LAS VEGAS, May 8, 2025 /PRNewswire/ -- DelveInsight's " LUPKYNIS Market Size, Forecast, and Market Insight Report" highlights the details around LUPKYNIS, the first oral lupus nephritis-specific treatment, which has expanded the therapeutic arsenal. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of LUPKYNIS. The report also highlights the historical and forecasted sales from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Aurinia Pharmaceuticals/Otsuka Pharmaceutical's LUPKYNIS (voclosporin) Overview LUPKYNIS (voclosporin) is an oral immunosuppressant classified as a calcineurin inhibitor (CNI), shown to improve both short- and long-term outcomes in adult patients with active lupus nephritis when used alongside standard immunosuppressive therapies. By targeting calcineurin, LUPKYNIS helps suppress cytokine activity, inhibits interleukin-2 (IL-2) production, and reduces T-cell driven immune responses. Although the exact mechanism by which voclosporin inhibits calcineurin is not fully understood, it is known that lymphocyte activation increases intracellular calcium, which binds to calcineurin's regulatory site. This activates the calmodulin-binding catalytic subunit, leading to dephosphorylation and activation of the transcription factor NFATc (nuclear factor of activated T-cells, cytoplasmic). The drug's immunosuppressive effect results in decreased lymphocyte proliferation, reduced cytokine production, and lower expression of T-cell activation markers. The recommended initial dose of LUPKYNIS is 23.7 mg twice daily. It should be used in conjunction with mycophenolate mofetil (MMF) and corticosteroids. Learn more about LUPKYNIS projected market size for lupus nephritis @ LUPKYNIS Market Potential Lupus nephritis is a serious and potentially life-threatening complication of systemic lupus erythematosus (SLE), affecting 40–60% of those diagnosed with the disease. It is typically characterized by symptoms such as hematuria (blood in the urine) and proteinuria (protein in the urine). This condition is more prevalent in women, particularly between the ages of 20 and 40. In 2023, the United States recorded the highest number of lupus nephritis cases among the 7MM, with approximately 211K cases, a figure projected to grow by 2034. Treatment strategies for lupus nephritis depend on the kidney biopsy classification of the disease. Standard therapy often includes corticosteroids in combination with immunosuppressive drugs like cyclophosphamide, mycophenolate mofetil, azathioprine, and calcineurin inhibitors. Rituximab, a monoclonal antibody, is widely used, especially for patients with relapsing or treatment-resistant LN, due to its ability to reduce reliance on steroids. Currently, there are only two FDA-approved medications for lupus nephritis: BENLYSTA (belimumab), available as an intravenous or subcutaneous formulation, and LUPKYNIS (voclosporin), a novel oral calcineurin inhibitor. Leading pharmaceutical companies such as Novartis, AstraZeneca, Roche, and Kezar Life Sciences, among others, are actively developing innovative therapies that could redefine the treatment paradigm for lupus nephritis. The treatment landscape is rapidly evolving, shifting away from broad immunosuppression toward more precise, targeted approaches. Recent drug approvals and a strong pipeline of candidates highlight both advancements and the ongoing challenges in creating treatments that are effective, safe, and long-lasting. Emerging therapies ranging from anti-CD20 antibodies and complement inhibitors to interferon-blocking agents and CAR-T cell therapies hold promise but must address key issues such as safety, sustained efficacy, and accessibility. As our understanding of the disease's underlying mechanisms continues to grow, the future of lupus nephritis treatment is expected to become increasingly personalized, offering renewed hope to patients battling this complex disorder. Discover more about the lupus nephritis market in detail @ Lupus Nephritis Market Report Emerging Competitors of LUPKYNIS The developing pipeline for lupus nephritis treatments shows a growing variety of approaches. Multiple candidates, both in early and late stages of development, are underway, including ianalumab (VAY736) (Novartis), GAZYVA (obinutuzumab) (Roche), SAPHNELO (anifrolumab) (AstraZeneca), FABHALTA (iptacopan) (Novartis), ULTOMIRIS (ravulizumab) (AstraZeneca), as well as advanced cellular therapies like CABA-201 (Cabaletta Bio) and YTB323 (Novartis). In March 2025, the FDA accepted a supplemental Biologics License Application based on data from the Phase III REGENCY trial, where obinutuzumab demonstrated a 46.4% Complete Renal Response (CRR), compared to 33.1% for placebo. Unlike previous anti-CD20 therapies such as rituximab, it provides enhanced B-cell depletion and is the first in its class to show efficacy in a randomized Phase III lupus nephritis trial. If approved, it will become the first CD20-targeted treatment specifically indicated for lupus nephritis, with anticipated sales of USD 400 million by 2034. To know more about the number of competing drugs in development, visit @ LUPKYNIS Market Positioning Compared to Other Drugs Key Milestones of LUPKYNIS In September 2024, Japan's Ministry of Health approved it for Lupus Nephritis treatment alongside mycophenolate mofetil. In September 2022, the European Commission approved LUPKYNIS for active Class III, IV, or V Lupus Nephritis. In January 2021, Aurinia Pharmaceuticals received US FDA approval for LUPKYNIS to treat adult lupus nephritis patients in combination with immunosuppressive therapy. Discover how LUPKYNIS is shaping the lupus nephritis treatment landscape @ LUPKYNIS Lupus LUPKYNIS Market Dynamics LUPKYNIS, developed by Aurinia Pharmaceuticals, is the first FDA-approved oral therapy specifically indicated for active lupus nephritis, a serious manifestation of systemic lupus erythematosus. Approved in January 2021 in the US, LUPKYNIS entered a previously underserved market where treatment was largely dependent on off-label use of immunosuppressants like mycophenolate mofetil and corticosteroids. The drug represents a significant advancement in lupus nephritis care, offering both improved efficacy and a better safety profile compared to existing options, especially in reducing proteinuria and preserving kidney function. The market dynamics for LUPKYNIS are shaped by several key factors. On the positive side, there is a strong unmet medical need, a growing prevalence of lupus nephritis, and increasing physician awareness about early diagnosis and intervention. Moreover, LUPKYNIS benefits from a relatively high pricing strategy, supported by its novel mechanism and disease-modifying potential. Aurinia has also built a dedicated commercial infrastructure and patient support programs to drive uptake and adherence. However, LUPKYNIS faces competitive and reimbursement challenges. One of the main competitors is BENLYSTA (belimumab) from GSK, which gained FDA approval for lupus nephritis in December 2020, just a month before LUPKYNIS. Benlysta has the advantage of brand recognition and a longer track record in treating systemic lupus. Additionally, payers have shown some hesitancy in approving LUPKYNIS due to its cost, requiring extensive prior authorizations and documentation of clinical need. Patient compliance also remains an issue, given the need for frequent monitoring of kidney function and drug levels. Looking ahead, the market potential for LUPKYNIS will depend on its ability to expand its label, demonstrate long-term real-world effectiveness, and potentially enter international markets. Aurinia is also exploring lifecycle management strategies, including combination therapies and expanded indications. Partnerships or acquisitions could further boost market access and penetration. Overall, while LUPKYNIS is a pioneering therapy with strong clinical value, its commercial success will be defined by navigating payer landscapes, physician adoption, and sustained differentiation from competing therapies. Dive deeper to get more insight into LUPKYNIS's strengths & weaknesses relative to competitors @ LUPKYNIS Market Drug Report Table of Contents Related Reports 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 Hoffmann-La Roche, Chugai Pharmaceutical, Novartis Pharmaceuticals, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Hoffmann-La Roche, Qilu Pharmaceutical, Vera Therapeutics, Kyverna Therapeutics, Cabaletta Bio, Takeda, Nkarta Therapeutics, Annexon, Century Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, Inflection Biosciences, 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 – 2025 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

Drug ApprovalPhase 3Clinical ResultImmunotherapy

30 Apr 2025

·www.businesswire.com

Glass Lewis Recommends That Aurinia Shareholders Vote “FOR” All Proposals at 2025 Annual General Meeting

ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (“Aurinia” or the “Company”) (NASDAQ: AUPH) today announced that leading independent proxy advisor Glass, Lewis & Co. LLC (“Glass Lewis”) has recommended that Aurinia shareholders vote FOR all proposals put forth by the Board of Directors (the “Board”) at the Company’s 2025 Annual General Meeting (the “Meeting”) on Thursday, May 15, 2025, at 12:00 p.m., Eastern Time. Glass Lewis supports all of the proposals in the Company’s proxy statement and management information circular (the “Proxy Statement/Circular”), including approving the six director nominees, the proposed auditor, the non-binding advisory vote on the Company’s approach to executive compensation, and an amendment to the Company’s Equity Incentive Plan. Shareholders of record at the close of business on April 12, 2025, are entitled to notice of, and to vote on the proposals described in the Proxy Statement/Circular. All votes must be received no later than 12:00 PM EST on May 13, 2025, to be counted for the Meeting. The proposals and details on how to vote are more fully described in the Proxy Statement/Circular, which can be found on the Company's profiles on EDGAR at www.sec.gov and SEDAR+ at www.sedarplus.ca. About Aurinia Aurinia is a 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 for the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a dual inhibitor of B cell activating factor (BAFF) and a proliferation inducing ligand (APRIL) for the potential treatment of autoimmune diseases.

Drug Approval

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
Dry Eye Syndromes	Phase 3	United States	Aurinia Pharmaceuticals, Inc.	14 Oct 2019
Kerato conjunctivitis sicca	Phase 3	United States	Aurinia Pharmaceuticals, Inc.	14 Oct 2019
Acute rejection of renal transplant	Phase 3	-	Aurinia Pharmaceuticals, Inc.	01 Mar 2013
Uveitis	Phase 3	United States	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	Austria	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	Brazil	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	Canada	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	Czechia	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	France	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	Germany	Lux Biosciences, Inc.	01 Feb 2011

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	zeqlqaqbdk(dbzogidhbm) = lyzvzkanpa cgabovnjtv (yjoayfqvkr )	Positive	09 May 2024
NCT03021499 (AURORA, Biospace) Manual	Not Applicable	Lupus Nephritis	25	LUPKYNIS, MMF, and steroids	lzrlbjyjbe(scymkjsexy) = itcjsdqhnr iuqtgrplyw (hrxhtidfhu )	Positive	09 May 2024
				MMF and glucocorticoids	lzrlbjyjbe(scymkjsexy) = hehlysdozl iuqtgrplyw (hrxhtidfhu )
NCT03021499 (phase 3 study, Pubmed)	Phase 3	Lupus Nephritis	148	Voclosporin	wfpknvqyjx(vztpcgvfbw) = The incidence of adverse events was similar between the arms; mean eGFR values remained stable and within normal range in both arms sxurvdwzyx (jbjawnzssf ) View more	Positive	18 Dec 2023
				Placebo
ACR2023	Not Applicable	Proteinuria	-	Voclosporin	msvjdjeqmj(yhelrtmugg) = hrodelsdjl knlcqfkqwn (ddmdmucivq ) View more	-	14 Nov 2023
				Placebo	msvjdjeqmj(yhelrtmugg) = cletjvfbcc knlcqfkqwn (ddmdmucivq ) View more
NCT03597464 (AURORA 2, Biospace) Manual	Phase 3	Lupus Nephritis	26	LUPKYNIS® in combination + MMF + glucocorticoids	ebnkmnphge(vzjkwoemvi) = experienced numerically greater mean reductions hyfjwvwkri (kigumliywy ) View more	Positive	07 Nov 2023
				MMF + glucocorticoids
NCT03021499 (AURORA, Biospace) Manual	Not Applicable	Lupus Nephritis	-	LUPKYNIS + MMF + glucocorticoids (Black patients)	qasecmqukq(dbyctmxhet) = rdmncmvwmu aernevzbuc (rizkwhvpxq )	Positive	07 Nov 2023
				MMF + glucocorticoids (Black patients)	qasecmqukq(dbyctmxhet) = tbbnpjnoep aernevzbuc (rizkwhvpxq )
NCT03021499 \| NCT02141672 (AURORA 1, Biospace) Manual	Phase 2/3	Lupus Nephritis	-	LUPKYNIS® + MMF+ glucocorticoids (proteinuria >=2 g/day)	tdibuzfksf(asxxcjjdwf) = greater numeric achievement of complete renal response across biopsy classes, races, and ethnicities in LN patients with proteinuria >=2 g/day ajrkugzlxe (ejiqjzrwbm ) View more	Positive	07 Nov 2023
				LUPKYNIS® + MMF+ glucocorticoids (UPCR ≥2 g/g at baseline)
AURA-LV and AURORA 1 (EULAR2023)	Phase 2/3	Proteinuria	-	Voclosporin	qxrywgapig(yaeqbgchbu) = grlwzixtfs cxbcrhmijs (abftddtztl ) View more	Positive	31 May 2023
				Placebo	qxrywgapig(yaeqbgchbu) = vftccnufyq cxbcrhmijs (abftddtztl ) View more
NCT03597464 (AURORA 2, CTgov)	Phase 3	Lupus Nephritis	216	Voclosporin (Voclosporin)	nwygdiesnk = znxgojkkfm pxljwnduds (uzfhinmizb, opxakucime - wuzdfpqmxw) View more	-	14 Dec 2022
				Placebo Oral Capsule (Placebo Oral Capsule)	nwygdiesnk = rvvpxjdqyh pxljwnduds (uzfhinmizb, kbnkmgmkhk - ydmakfvhag) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis