Drugs / Voclosporin
Voclosporin
also known as
LX211 · VCS · VOS · ISA-247 · ISATX-247 · LUPKYNIS · QL1074 · voclosporin, ISA247 · +2 more
Other / unclassified targets PPP3CA via inhibition
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed lupus nephritis 5 milestones | |||||
| Filed | Japan (PMDA) | LUPKYNIS | lupus nephritis | 2024-01-05 | “Our collaboration partner, Otsuka Pharmaceuticals Co., Ltd. filed for approval of LUPKYNIS to treat lupus nephritis (LN) with Japanese authorities” auriniapharma.com ↗ “based on the JNDA that Otsuka filed in November 2023 for approval of LUPKYNIS to treat adults with LN.” auriniapharma.com ↗ |
| Filed | EU (EMA) | — | lupus nephritis | 2021-06-24 | “has filed an initial marketing authorization application (MAA) to the European Medicines Agency (EMA) for an oral calcineurin inhibitor, voclosporin, for the treatment of lupus...” otsuka.co.jp ↗ “On June 25, 2021, Aurinia’s licensing partner, Otsuka Pharmaceutical Co., Ltd., filed an initial marketing authorization application (MAA) with the European Medicines Agency (EMA)” auriniapharma.com ↗ “filed an initial Marketing Authorization Application (MAA) for voclosporin for the treatment of lupus nephritis (LN) to the European Medicines Agency (EMA).” auriniapharma.com ↗ “filed an initial Marketing Authorization Application (MAA) for voclosporin for the treatment of lupus nephritis (LN) to the European Medicines Agency (EMA).” auriniapharma.com ↗ “filed an initial Marketing Authorization Application (MAA) for voclosporin for the treatment of LN to the EMA.” auriniapharma.com ↗ |
| Filed | US (FDA) | — | lupus nephritis | 2020-07-21 | “U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for voclosporin, as a potential treatment for lupus nephritis” auriniapharma.com ↗ “the U.S. Food & Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for voclosporin” auriniapharma.com ↗ |
| Filed | US (FDA) | — | lupus nephritis | 2020-05-25 | “completion of the rolling submission of a New Drug Application (“NDA”) to the United States Food and Drug Administration (“FDA”) for voclosporin” auriniapharma.com ↗ “voclosporin’s new drug application (NDA) to the United States Food and Drug Administration (FDA) which was completed on May 25, 2020.” auriniapharma.com ↗ |
| Filed | US (FDA) | — | lupus nephritis | 2020-03-16 | “The U.S. Food and Drug Administration (FDA) accepted the filing of Aurinia’s NDA for voclosporin in the treatment of lupus nephritis (LN)” auriniapharma.com ↗ “initiated a Rolling Submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”)” auriniapharma.com ↗ “has accepted the NDA filing for voclosporin, as a potential treatment for lupus nephritis (LN).” auriniapharma.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | LUPKYNIS | — | 2024-04-29 | fda.gov ↗ |
| Approved | EU (EMA) | Lupkynis | — | 2022-09-15 | europa.eu ↗ |
| Approved | US (FDA) | LUPKYNIS | — | 2021-01-22 | fda.gov ↗ |
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05306379 | Jan → Apr 2022 | — | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02949999 | Oct → Dec 2016 | — | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00851734 | Feb → Mar 2009 | keratoconjunctivitis | Lux Biosciences, Inc. | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT05306873 | Nov 2022 → Jun 2024 | systemic lupus erythematosus | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04701528 | Nov 2020 → Mar 2022 | COVID-19, disease related to solid organ transplantation | Leiden University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03597139 | Aug → Nov 2018 | dry eye syndrome | Aurinia Pharmaceuticals Inc. | Completed | Missed primary |
| Phase 2 | NCT03598036 | Jun 2018 → May 2020 | focal segmental glomerulosclerosis | Aurinia Pharmaceuticals Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02949973 | Jun 2015 → Dec 2016 | lupus nephritis | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02141672 | Jun 2014 → Jul 2016 | lupus nephritis | Aurinia Pharmaceuticals Inc. | Completed | Met primary |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT04147650 | Oct 2019 → Sep 2020 | dry eye syndrome | Aurinia Pharmaceuticals Inc. | Completed | Missed primary |
| Phase 37 trials · 1 met primary | ||||||
| Phase 3 | NCT05962788 | Mar 2024 → Jul 2025 | lupus nephritis | Aurinia Pharmaceuticals Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT06406205 | Dec 2023 → Jun 2027 expected | lupus nephritis | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05288855 | Oct 2023 → Jul 2025 | lupus nephritis | Aurinia Pharmaceuticals Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT03597464 | Sep 2019 → Oct 2021 | lupus nephritis | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03021499 | May 2017 → Sep 2019 | lupus nephritis | Aurinia Pharmaceuticals Inc. | Completed | Met primary |
| Phase 3 | NCT01586845 | Mar 2013 → Dec 2015 | — | Aurinia Pharmaceuticals Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT01243983 | Feb 2011 → Dec 2012 | uveitis | Lux Biosciences, Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07611214 | Apr 2026 → Mar 2029 expected | lupus nephritis | Aurinia Pharmaceuticals Inc. | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01236287 | — | immunodeficiency disease | Weill Medical College of Cornell University | No longer available | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 2 | NCT00270634 Comparator | Jan 2006 → Jul 2009 | kidney disorder | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00404612 Comparator | Jan 2007 → Nov 2008 | intermediate uveitis, panuveitis, posterior uveitis | Lux Biosciences, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00404885 Comparator | Jan 2007 → Nov 2008 | anterior uveitis, panuveitis | Lux Biosciences, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00404742 Comparator | Jan 2007 → Nov 2008 | intermediate uveitis, panuveitis, posterior uveitis | Lux Biosciences, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00408187 Comparator | Dec 2006 → Dec 2008 | psoriasis | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00258713 Comparator | Sep 2005 → Jul 2006 | psoriasis | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00244842 Comparator | Dec 2004 → Oct 2005 | psoriasis | Aurinia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 4 | NCT07225387 Comparator | Oct 2024 → Jan 2027 expected | lupus nephritis | NephroNet, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 46
| Date | Issuer | Release |
|---|---|---|
| 2025-05-22 | Aurinia Pharmaceuticals Inc. | Results New AURORA 1 Analysis: LUPKYNIS-Based Triple Immunosuppressive Therapy Yields Deep Proteinuria Reduction in Lupus Nephritis auriniapharma.com ↗
Of the 357 patients in AURORA 1, 60.9% in the triple immunosuppressive therapy group (N=109) achieved a UPCR of ≤0.4 g/g at least once during the study compared to 37.1% of patients in the control group (N=66). |
| 2025-02-20 | Lotus Pharmaceutical | Regulatory Lotus announces FDA acceptance of Potential First-to-File ANDA Submission for Voclosporin soft gelatin capsules, a generic equivalent to Lupkynis® lotuspharm.com ↗
Lotus Pharmaceuticals, a multinational pharmaceutical company (1795:TT), has announced that U.S. Food and Drug Administration (FDA) has accepted the Potential First-to-File Abbreviated New Drug Application (ANDA) for Voclosporin soft gelatin capsules, a generic equivalent to Lupkynis® from Aurinia Pharmaceuticals Inc. |
| 2024-11-15 | Aurinia Pharmaceuticals Inc. | Results Aurinia Presents New Data Underscoring Critical Importance of Earlier Lupus Nephritis Detection and Intervention and Value of LUPKYNIS® in Managing LN at American College of Rheumatology Convergence 2024 auriniapharma.com ↗
The analysis found that 62% of these SLE patients had ICD-10 coding or clinical laboratory measurements suggestive of LN. |
| 2024-10-11 | Aurinia Pharmaceuticals Inc. | Results Aurinia Presents New Data Highlighting Real-World Utilization and Value of LUPKYNIS® in Treating Lupus Nephritis at American Society of Nephrology Kidney Week 2024 auriniapharma.com ↗
The subset of patients includes high percentages of Black and Hispanic and/or Latino patients, reflecting the larger population of LN in the US and the communities disproportionately affected by lupus and LN. |
| 2024-09-24 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Receives Approval in Japan for Lupkynis as a Treatment for Lupus Nephritis® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus, an autoimmune disease. |
| 2024-09-24 | Aurinia Pharmaceuticals Inc. | Regulatory Aurinia Announces Japan Approval of LUPKYNIS® (Voclosporin) to Treat Lupus Nephritis auriniapharma.com ↗
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the Japanese Ministry of Health, Labour, and Welfare has approved voclosporin, a second-generation calcineurin inhibitor, in combination with mycophenolate mofetil (MMF) to treat lupus nephritis (LN). |
| 2024-06-05 | Aurinia Pharmaceuticals Inc. | Results Aurinia Presents Safety and Efficacy Profile of LUPKYNIS® for People with Lupus Nephritis at European Alliance of Associations for Rheumatology (EULAR) Congress 2024 auriniapharma.com ↗
These patients also achieved >50% UPCR reduction at any time point in the study significantly earlier than their propensity-matched counterparts in ALMS. |
| 2024-05-14 | Aurinia Pharmaceuticals Inc. | Results Analysis Showing LUPKYNIS® is a Cost-Effective Treatment for Lupus Nephritis Presented at National Kidney Foundation’s Spring Clinical Meeting 2024 auriniapharma.com ↗
An updated cost-effectiveness analysis demonstrated that LUPKYNIS continues to be a cost-effective treatment for lupus nephritis (LN). |
| 2024-05-09 | Aurinia Pharmaceuticals Inc. | Results Aurinia Presents Data Reinforcing LUPKYNIS® Safety and Efficacy for People with Lupus Nephritis at Congress of Clinical Rheumatology East 2024 auriniapharma.com ↗
Patients who received the LUPKYNIS-based regimen experienced reductions in exposure to glucocorticoids and more patients achieved a >50% urine protein creatinine ratio reduction from baseline compared to their propensity-matched counterparts in ALMS. |
| 2024-04-30 | Aurinia Pharmaceuticals Inc. | Regulatory The U.S. Food & Drug Administration (FDA) Approves Updated LUPKYNIS® (voclosporin) Label to include Long-Term Data from the AURORA Clinical Program auriniapharma.com ↗
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the FDA has approved a label update for LUPKYNIS. |
| 2023-11-06 | Aurinia Pharmaceuticals Inc. | Results Aurinia Presents Breadth of Data from AURORA Clinical Program Underscoring Value of LUPKYNISⓇ (voclosporin) for Patients with Lupus Nephritis at ACR 2023 auriniapharma.com ↗
A post-hoc, pooled analysis of Phase 2 and 3 studies showed LUPKYNIS® achieved significantly higher complete renal response in lupus nephritis patients with proteinuria >=2 g/day compared to patients treated with MMF and low-dose glucocorticoids alone. |
| 2023-11-02 | Aurinia Pharmaceuticals Inc. | Results Aurinia Presents Breadth of Data at ASN 2023 Demonstrating Clinical Importance of LUPKYNIS® for Managing Lupus Nephritis auriniapharma.com ↗
Patients treated with LUPKYNISⓇ in a repeat kidney biopsy sub-study achieved improvement in histologic activity with stable chronicity scores and no evidence of chronic injury. |
| 2023-10-12 | Aurinia Pharmaceuticals Inc. | Regulatory Aurinia Pharmaceuticals Announces Collaboration Partner Otsuka Filed New Drug Application (NDA) for LUPKYNIS® (Voclosporin) in Japan auriniapharma.com ↗ |
| 2023-07-19 | Aurinia Pharmaceuticals Inc. | Results Long Term Phase 3 Data Published in Arthritis & Rheumatology Shows LUPKYNIS® (voclosporin) Preserved Kidney Function Up to Three Years in Lupus Nephritis Patients with No New or Unexpected Adverse Events auriniapharma.com ↗
Clinical efficacy over three years of treatment was maintained, as observed by maintenance of urine protein creatinine ratio (UPCR) reductions, sustained complete renal response (CRR) and preserved kidney function, suggesting a positive benefit-risk profile for voclosporin in LN patients. |
| 2023-06-20 | Aurinia Pharmaceuticals Inc. | Results Aurinia Showcases Three Oral Presentations for LUPKYNIS® (voclosporin) at 2023 European Renal Association Annual Meeting in Milan, Italy auriniapharma.com ↗
LUPKYNIS® achieved significantly earlier reductions in UPCR and significantly higher renal response rates in lupus nephritis patients with high proteinuria, compared to patients treated with mycophenolate mofetil and low-dose steroids alone, in a pooled, post-hoc analysis. |
| 2023-05-09 | Aurinia Pharmaceuticals Inc. | Results Aurinia Pharmaceuticals Announces Kidney Biopsies Sub-study Data from the LUPKYNIS® (voclosporin) AURORA 2 Clinical Trial Presented at Congress of Clinical Rheumatology East Conference auriniapharma.com ↗
Treatment was not associated with chronic injury, with the average chronicity index remaining stable in both treatment arms from baseline to follow-up |
| 2023-05-03 | Aurinia Pharmaceuticals Inc. | Regulatory Aurinia Pharmaceuticals Announces NICE Recommendation of LUPKYNIS® (Voclosporin) For Adults with Active Lupus Nephritis auriniapharma.com ↗
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the National Institute for Health and Care Excellence (NICE) has recommended LUPKYNIS® (voclosporin) as an option for treating adults with active lupus nephritis (LN) class III, IV or V (including mixed class III/V and IV/V)1, when provided in combination with mycophenolate mofetil (MMF). |
| 2023-05-02 | Aurinia Pharmaceuticals Inc. | Regulatory Aurinia Pharmaceuticals Announces Swissmedic Approval of LUPKYNIS® (voclosporin) auriniapharma.com ↗
We are extremely pleased with the Swissmedic approval of LUPKYNIS for adults with lupus nephritis. |
| 2023-04-05 | Aurinia Pharmaceuticals Inc. | Results Aurinia Pharmaceuticals Announces Promising Topline Data from Renal Biopsy Sub-study of the AURORA Trial auriniapharma.com ↗
The patients in the voclosporin treatment arm demonstrated histologic activity improvement with stable chronicity scores similar to the active control arm of MMF and low dose steroids alone over the 18-months average treatment period at the time of repeat biopsy. |
| 2022-11-30 | Aurinia Pharmaceuticals Inc. | Regulatory Aurinia Announces the Great Britain Marketing Authorization of LUPKYNIS® (voclosporin) for the Treatment of Lupus Nephritis auriniapharma.com ↗
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the trajectory of autoimmune disease, announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted the Great Britain marketing authorization of LUPKYNIS® (voclosporin) to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). |
| 2022-09-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka announces EC approval of Lupkynis® (voclosporin) as first oral treatment for active lupus nephritis otsuka.co.jp ↗
Otsuka Pharmaceutical Europe Ltd. today announces that the European Commission (EC) has approved Lupkynis (voclosporin) in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN). |
| 2022-09-19 | Aurinia Pharmaceuticals Inc. | Regulatory Aurinia Announces European Commission Approval of LUPKYNIS® (voclosporin) for the Treatment of Lupus Nephritis auriniapharma.com ↗
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the trajectory of autoimmune disease, announced that the European Commission (EC) has granted marketing authorization of LUPKYNIS® (voclosporin) to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). |
| 2022-07-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka receives positive CHMP opinion for Lupkynis (voclosporin)for the treatment of active lupus nephritisTM otsuka.co.jp ↗ |
| 2022-07-22 | Aurinia Pharmaceuticals Inc. | Regulatory Aurinia Announces Positive CHMP Opinion for LUPKYNIS® (voclosporin) for the Treatment of Adults with Active Lupus Nephritis in Europe auriniapharma.com ↗
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the course of autoimmune disease, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending voclosporin (brand name, LUPKYNIS) for marketing authorization to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). |
| 2022-06-03 | Aurinia Pharmaceuticals Inc. | Results Aurinia Presents Data Demonstrating LUPKYNIS® (voclosporin) is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations auriniapharma.com ↗
The post-hoc analysis based on the updated treatment recommendations was presented at the EULAR 2022 European Congress of Rheumatology |
| 2022-05-20 | Aurinia Pharmaceuticals Inc. | Results Aurinia Presents Results from the Two-Year AURORA 2 Continuation Study at the 2022 European Renal Association (ERA) Congress auriniapharma.com ↗
In AURORA 2, long-term treatment with LUPKYNIS led to a clinically relevant preservation of kidney function in LN patients |
| 2021-12-09 | Aurinia Pharmaceuticals Inc. | Results Aurinia Announces Positive Topline Results From the AURORA 2 Continuation Study of LUPKYNIS™ (voclosporin) for the Treatment of Adults With Active Lupus Nephritis (LN) auriniapharma.com ↗
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the course of autoimmune disease, today announced positive topline results from the AURORA 2 continuation study evaluating the long-term safety and tolerability of LUPKYNIS™ (voclosporin) for the treatment of adults with active lupus nephritis (LN), a serious complication in patients with systemic lupus erythematosus (SLE). |
| 2021-11-01 | Aurinia Pharmaceuticals Inc. | Results Aurinia Announces Updated Interim Results from the AURORA 2 Continuation Study of LUPKYNIS (voclosporin) for the Treatment of Lupus Nephritis auriniapharma.com ↗
In the interim analysis, patients in the voclosporin group maintained meaningful reductions in proteinuria. |
| 2021-06-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Has Filed a Marketing Authorization Application to the European Medicines Agency for Voclosporin for the Treatment of Patients with Lupus Nephritis otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. announces today that its European subsidiary, Otsuka Pharmaceutical Europe Ltd. has filed an initial marketing authorization application (MAA) to the European Medicines Agency (EMA) for an oral calcineurin inhibitor, voclosporin, for the treatment of lupus nephritis (LN). |
| 2021-06-25 | Aurinia Pharmaceuticals Inc. | Regulatory Aurinia Announces Licensing Partner Otsuka Filed Initial Marketing Authorization Application (MAA) for Voclosporin with the European Medicines Agency (EMA) auriniapharma.com ↗ |
| 2021-06-07 | Aurinia Pharmaceuticals Inc. | Results Aurinia Announces Additional Analysis of its AURORA 1 Phase 3 Study Data Presented at ERA-EDTA 2021 Congress auriniapharma.com ↗
This examination demonstrated that patients treated with voclosporin in addition to mycophenolate mofetil (MMF) and low-dose steroids achieved statistically significant increased renal response rates regardless of the level of UPCR, including at an even more stringent ≤0.3 mg/mg target. |
| 2021-05-20 | Aurinia Pharmaceuticals Inc. | Results Aurinia To Present Supportive AURORA 2 Continuation Study Interim Analysis Demonstrating Long-Term Safety & Efficacy of LUPKYNIS™ (voclosporin) in Subjects with Lupus Nephritis auriniapharma.com ↗
Individuals treated with LUPKYNIS sustained meaningful reductions in proteinuria with no change in mean eGFR at 104 weeks of treatment |
| 2021-05-10 | Aurinia Pharmaceuticals Inc. | Results Aurinia Announces Publication of AURORA 1 Phase 3 Study Results with LUPKYNIS™ (voclosporin) in The Lancet auriniapharma.com ↗
The AURORA 1 study results demonstrate that LUPKYNIS in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids led to statistically superior complete renal response rates at 52 weeks compared to treatment with MMF and low-dose corticosteroids alone, with a comparable safety profile. |
| 2021-04-08 | Aurinia Pharmaceuticals Inc. | Results Aurinia Presents Data Demonstrating LUPKYNIS™ (voclosporin) Efficacy Across Lupus Nephritis Biopsy Classes at National Kidney Foundation 2021 Spring Clinical Meetings auriniapharma.com ↗
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (Aurinia or the Company) today presented additional efficacy data from the AURA-LV and AURORA 1 pivotal trials of LUPKYNIS™ (voclosporin) in lupus nephritis (LN). |
| 2021-01-22 | Aurinia Pharmaceuticals Inc. | Regulatory FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis auriniapharma.com ↗ |
| 2020-11-09 | Aurinia Pharmaceuticals Inc. | Results Aurinia Presents Integrated Time to Renal Response Data from the AURA-LV and AURORA Trials, along with Voclosporin Drug-Drug Interaction Data at ACR Convergence 2020 auriniapharma.com ↗
Integrated analysis confirms addition of voclosporin to standard-of-care resulted in faster Renal Response compared to standard-of-care alone in lupus nephritis |
| 2020-11-02 | Aurinia Pharmaceuticals Inc. | Results Aurinia Announces Outcome of AUDREY™ Clinical Trial in Dry Eye Syndrome auriniapharma.com ↗
The trial did not achieve statistical significance on its primary endpoint of a 10mm or greater improvement in STT at four weeks between active dose groups of VOS compared to vehicle. |
| 2020-10-22 | Aurinia Pharmaceuticals Inc. | Results Aurinia Presents Voclosporin Efficacy and Pharmacokinetic Data from Integrated Analysis of AURA-LV and AURORA Pivotal Trials at ASN Kidney Week 2020 auriniapharma.com ↗
Integrated analysis confirms statistically superior efficacy and safety of voclosporin in combination with MMF and steroids over standard-of-care |
| 2020-07-21 | Aurinia Pharmaceuticals Inc. | Regulatory Aurinia Announces U.S. Food and Drug Administration Acceptance of the Filing of New Drug Application and Priority Review for Voclosporin for the Treatment of Lupus Nephritis auriniapharma.com ↗
The FDA has granted Priority Review for the NDA, which provides an expedited six month review, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 22, 2021. |
| 2020-06-09 | Aurinia Pharmaceuticals Inc. | Results Aurinia Presents Additional AURORA Pivotal Trial Safety Data at the ERA-EDTA Virtual Congress 2020 auriniapharma.com ↗
The data showed that pre-specified confirmed estimated glomerular filtration rate (eGFR) decreases of over 30% were similar in both AURORA trial patient groups, with 10.1% reported in the voclosporin group and 10.2% in the control arm (p=0.971). |
| 2020-06-05 | Aurinia Pharmaceuticals Inc. | Results Aurinia Presents AURORA Pivotal Trial Subgroup Analysis at the EULAR 2020 E-Congress auriniapharma.com ↗
The presented data demonstrated clinically meaningful benefits of voclosporin for trial participants across ethnicities and self-reported race. |
| 2020-05-26 | Aurinia Pharmaceuticals Inc. | Regulatory Aurinia Completes Submission of New Drug Application to the U.S. Food & Drug Administration for Voclosporin for the Treatment of Lupus Nephritis auriniapharma.com ↗ |
| 2020-03-16 | Aurinia Pharmaceuticals Inc. | Regulatory Aurinia Pharmaceuticals Initiates Rolling Submission of a New Drug Application to the U.S. Food and Drug Administration for Voclosporin in the Treatment of Lupus Nephritis auriniapharma.com ↗
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, announced today that the Company has initiated a Rolling Submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for voclosporin, a next-generation calcineurin inhibitor for the treatment of lupus nephritis (“LN”). |
| 2019-12-04 | Aurinia Pharmaceuticals Inc. | Results Aurinia Announces Positive AURORA Phase 3 Trial Results Demonstrating Voclosporin Superiority Over Standard of Care in Lupus Nephritis auriniapharma.com ↗
This global study in which 357 patients with active LN were enrolled, met its primary endpoint of Renal Response rates of 40.8% for voclosporin vs. 22.5% for the control (OR 2.65; p < 0.001). |
| 2019-12-03 | Aurinia Pharmaceuticals Inc. | Results Aurinia to Present Preclinical Voclosporin Data at 2020 Keystone Symposia Conference auriniapharma.com ↗
Voclosporin demonstrated fewer adverse effects on beta cell function as compared to tacrolimus in preclinical model of diabetes |
| 2019-11-07 | Aurinia Pharmaceuticals Inc. | Results Aurinia Completes Voclosporin Drug-Drug Interaction Study Demonstrating No Clinically Significant Interaction With Mycophenolate Mofetil auriniapharma.com ↗
The study results indicate that the coadministration of voclosporin with MMF had no clinically significant impact on MPA blood concentrations. |
All press releases naming this drug 61 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Voclosporin | “Treatment Arm A: voclosporin 0.4 mg/kg p.o. b.i.d., not to exceed 40 mg p.o. b.i.d.” NCT01243983 ↗ |
| Known as | ISA-247 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314379 ↗ |
| Known as | ISATX-247 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314379 ↗ |
| Known as | LUPKYNIS | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07611214 ↗ |
| Known as | LX211 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00404612 ↗ |
| Known as | QL1074 | “Drug: Voclosporin calcineurin inhibitor Other Names: QL1074” NCT06406205 ↗ |
| Known as | VCS | “Voclosporin (VCS, ISA247) is a novel calcineurin inhibitor being developed for organ transplantation.” PMID 21943027 ↗ Sep 20111“anti-viral effect of voclosporin (VCS) with an extended safety follow-up” NCT04701528 ↗ |
| Known as | voclosporin, ISA247 | “voclosporin, ISA247” NCT01586845 ↗ |
| Known as | Voclosporina | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314379 ↗ |
| Known as | Voclosporine | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314379 ↗ |
| Known as | VOS | “0.05% Voclosporin Ophthalmic Solution (VOS)” NCT04147650 ↗1“Voclosporin ophthalmic solution (VOS)” NCT03597139 ↗ |
| Action | Inhibit | “Voclosporin represents the possibility of a calcineurin inhibitor which is not only as efficacious as cyclosporine A, but also has an improved toxicity profile.” NCT00258713 ↗1“Serine/threonine protein phosphatase 2B catalytic subunit, alpha isoform inhibitor” CHEMBL5314379 ↗ |
| Modality | Other / unclassified | “a novel CNI, voclosporin (VCS)” NCT04701528 ↗ |
| Route | Oral | “voclosporin 0.4, 0.6, 0.8 mg/kg po BID” NCT00270634 ↗ |
| Target | PPP3CA | “Serine/threonine protein phosphatase 2B catalytic subunit, alpha isoform inhibitor” CHEMBL5314379 ↗ |