Assessing Residual Inflammation and Macrophage Presence in Lupus Nephritis After 3 Months of Intensified Treatment With Prednisolone, Mycofenolate Mofetil and Voclosporin as Compared to Mycofenolate Mofetil and Prednisolone, an Open Label Randomized Controlled Trial

The goal of this clinical trial is to learn how different treatments affect immune cells in the kidney in people with active lupus nephritis (LN), a kidney manifestation of systemic lupus erythematosus (SLE). It will also investigate whether early changes in kidney tissue can predict long-term treatment response and whether blood or urine biomarkers can be used to monitor disease activity without the need for repeat kidney biopsies.
The main questions it aims to answer are:
* Does adding voclosporin to standard treatment with mycophenolate mofetil (MMF) and prednisolone result in greater early improvement of kidney inflammation compared with MMF and prednisolone alone?
* Are specific macrophage and monocyte populations associated with treatment response and long-term kidney outcomes?
* Can blood- or urine-based biomarkers be identified that reflect kidney inflammation and treatment response?
Researchers will compare MMF, prednisolone, and voclosporin (triple therapy) with MMF and prednisolone alone (dual therapy) to determine whether intensified treatment leads to faster and more complete immunological and histological remission.
Participants with newly diagnosed or relapsing proliferative lupus nephritis will:
* Be randomly assigned to receive either triple therapy (MMF, prednisolone, and voclosporin) or dual therapy (MMF and prednisolone).
* Undergo a kidney biopsy before treatment starts and a repeat kidney biopsy after 3 months of treatment.
* Provide blood and urine samples during follow-up for immune cell analyses and biomarker studies.
* Complete patient-reported outcomes questionnaires
* Attend regular study visits and clinical assessments for up to 2 years.
In addition, participants with SLE without lupus nephritis and healthy volunteers will provide blood samples to allow comparison of circulating immune cell populations between groups.

Start Date23 Apr 2026

Sponsor / Collaborator-

NCT07611214

/ RecruitingPhase 4

PRESERVE: A Multi-Center Phase 4 Study of the Efficacy and Safety of LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab at Inducing Rapid Renal Response in Patients With Lupus Nephritis

The goal of this clinical study is to assess the efficacy and safety of LUPKYNIS® in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response in patients with lupus nephritis (LN).

Start Date22 Apr 2026

Sponsor / Collaborator

Aurinia Pharmaceuticals, Inc.

JPRN-jRCTs041250131

/ RecruitingPhase 4

A study on the effects of voclosporin on RNA expression levels in peripheral immune cells of patients with lupus nephritis using single-cell RNA sequencing analysis

Start Date01 Dec 2025

Sponsor / Collaborator-

100 Clinical Results associated with Voclosporin

100 Translational Medicine associated with Voclosporin

100 Patents (Medical) associated with Voclosporin

147

Literatures (Medical) associated with Voclosporin

01 Oct 2026·LUPUS

Navigating the therapeutic landscape: Biologics and immunosuppressive therapy in lupus nephritis during pregnancy

Review

Author: Ćelić, Dejan ; Knežević, Violeta ; Ilić, Tatjana ; Veselinov, Vladimir ; Živković, Siniša ; Golubović, Sonja ; Popović, Milica

Background:

Lupus nephritis (LN) predominantly affects women of reproductive age and carries substantial risks during pregnancy, including disease flare, preeclampsia, acute kidney injury, and adverse fetal outcomes. The therapeutic armamentarium for LN has expanded considerably with the approval of voclosporin, belimumab, and obinutuzumab, yet pregnancy safety data for these agents remain conspicuously absent. Concurrently, the 2024 EULAR recommendations for antirheumatic drugs in reproduction, the 2025 EULAR lupus nephritis update, and the 2024 KDIGO guidelines have reset the landscape of management guidance. This review critically appraises the evidence on the safety and clinical use of all current LN-relevant immunosuppressive and biologic therapies during pregnancy, lactation, and the periconceptional period.

Methods:

A comprehensive narrative review of literature published between January 2000 and May 2025 was conducted using PubMed, MEDLINE, EMBASE, and Cochrane databases. Key guidelines, pregnancy registries, and landmark clinical trial data were incorporated.

Results:

Hydroxychloroquine and azathioprine remain the cornerstones of pregnancy-compatible LN management. Tacrolimus is an acceptable calcineurin inhibitor with appropriate therapeutic drug monitoring. Low-dose aspirin is recommended universally to reduce preeclampsia risk. Mycophenolate mofetil is teratogenic and absolutely contraindicated in the first trimester. Voclosporin and obinutuzumab lack any pregnancy safety data and should be avoided. Belimumab data from the pregnancy registry have not raised major signals; selective use may be considered in refractory cases. Rituximab may be used cautiously for life-threatening disease, avoiding the third trimester due to neonatal B-cell depletion. Anifrolumab has no pregnancy data and should be reserved for situations where no compatible alternative exists.

Conclusion:

The growing number of effective LN therapies creates both opportunities and new dilemmas in pregnancy management. A structured, phase-based approach to drug selection — anchored in preconception counselling, timely medication switches, and multidisciplinary surveillance — is essential to optimise maternal and fetal outcomes. Dedicated pregnancy registries for novel biologics are urgently needed.

01 Oct 2026·JOURNAL OF INTERNAL MEDICINE

Advances in the treatment of systemic lupus erythematosus: Biologicals, small‐molecular agents, and cell‐depleting therapies coming to the clinic

Review

Author: van Vollenhoven, Ronald

Abstract:

Systemic lupus erythematosus (SLE; lupus) remains a particular challenge for the practicing clinician on account of its chronic undulating and unpredictable course, its diverse manifestations, and—until recently—limited treatment options all associated with considerable downsides. However, a major change in this situation is currently taking place. Over the past few years, several new biological therapeutics have been approved for the treatment of SLE (belimumab and anifrolumab) or specifically for its renal organ manifestation (obinutuzumab), along with one new small molecular treatment for the latter (voclosporin). Several additional biologicals (litifilimab and dapirolizumab) and small molecules (deucravacitinib, upadacitinib, and cerenimod) are in late‐stage clinical development. Moreover, multiple case series and case reports have been published in the past years demonstrating excellent individual results following treatments aimed at fully depleting B lymphocytes using chimeric antigen receptor bearing T cells (CAR‐T cells) or bi‐specific T‐cell engagers. These reports have raised hopes that not only solid disease control, but also a more profound state of immunological reset—deep remission—can be attained in at least some patients. In this narrative review, these developments will be described, emphasizing both the promises and the challenges they bring about, leading into some predictions of where they may lead to. A reasonable expectation is that in the coming 1–2 years, several additional biologicals and small‐molecular agents will be approved for the treatment of lupus. The most important conclusion is that the future for our patients with lupus looks brighter than ever before.

01 Oct 2026·LUPUS

Network meta-analysis of triple immunosuppressive therapies and standard of care for induction of remission of active lupus nephritis

Article

Author: Bandes, Miguel ; Mechery, Vinodh ; Zuo, Yiqin ; Munoz Mendoza, Jair ; Contreras, Gabriel ; Kota, Sanjana ; Duque, Juan Camilo ; Dejman, Adriana ; Del Castillo Rix, Daniel

Background:

In patients with active lupus nephritis (LN), 8 different triple immunosuppressive therapies have been compared to the standard of care (SOC) of double immunosuppressive therapy in 12 induction randomized clinical trials (RCTs). The triple immunosuppressive therapies of SOC+Tacrolimus, SOC+Voclosporin, SOC+Belimumab, and SOC+Obinutuzumab compared to SOC alone demonstrated significantly higher remission of LN without excessive risk of serious adverse events (SAEs) and serious infectious events (SIEs) in RCTs. Direct or indirect comparisons among triple immunosuppressive therapies have not been studied. In this network meta-analysis (NMA), we systematically provide indirect comparisons of the relative efficacy and safety of triple immunosuppressive therapies, ranking them according to efficacy achieving primary renal remission (PRR) of LN and safety reducing the risk of SAEs and SIEs.

Results:

The NMA included predominantly women with LN. In direct pairwise comparisons, SOC+Tacrolimus (benefit ratio 1.91 [95% Credible Interval 1.45 to 2.56]), SOC+Voclosporin (1.69 [1.30 to 2.23]), SOC+Obinutuzumab (1.41 [1.09 to 1.84]), and SOC+Belimumab (1.32 [1.04 to 1.69]) had significantly higher PRR compared to SOC alone. In indirect pairwise comparisons, patients who received SOC+Tacrolimus compared to SOC+Rituximab (2.30 [1.27 to 4.20]), SOC+Anifrolumab (1.98 [1.07 to 3.52]), SOC+Ocrelizumab (1.81 [1.12 to 2.82]), and SOC+Abatacept (1.78 [1.07 to 2.91]) had significantly higher PRR. Patients who received SOC+Voclosporin compared to SOC+Rituximab (2.03 [1.14 to 2.68]) had significantly higher PRR. SOC+Belimumab, SOC+Obinutuzumab, SOC+Voclosporin and SOC+Tacrolimus ranked as effective therapies inducing PRR with SUCRA probability scores between 61.14% and 95.12%. Risk ratios of SAE and SIE were not significantly different among the immunosuppressive therapies.

Conclusion:

In patients with LN, induction therapies of SOC with calcineurin inhibitors had the highest relative benefit achieving remission of LN.

196

News (Medical) associated with Voclosporin

22 Oct 2026

·www.fiercepharma.com

Otsuka hit with 11 marketing code breaches after event organizer blunder

The PMCPA has ruled that Otsuka Europe’s involvement with a sponsored symposium webpage breached 11 clauses of the U.K. marketing code. While the PMCPA found fault with many aspects of the webpage, the watchdog opted against hitting Otsuka with its toughest punishment. A complainant calling themselves an ex-employee triggered the case after becoming concerned about online content for an Otsuka-sponsored symposium at a 2025 healthcare congress. The complainant alleged that the webpage included a misleading sponsorship statement and promoted Otsuka’s Lupkynis (voclosporin), a lupus nephritis drug, off-label. The PMCPA broadly agreed with the complainant. “The webpage, which was accessible to the public, promoted voclosporin outside the terms of its marketing authorization and omitted important obligatory information such as the prescribing information and adverse event reporting statement,” the PMCPA said. That finding led the watchdog to conclude that Otsuka had failed to maintain high standards and breached Clause 5.1. Otsuka accepted that its actions amounted to a breach of the clause. However, the PMCPA ruled no breach of Clause 2, which it reserves for failings that bring discredit upon, or reduce confidence in, the pharmaceutical industry. The PMCPA spared Otsuka from that punishment after concluding that the company “appeared to have been let down” by event organizers. Otsuka was ultimately responsible for the content, but its culpability was limited by the omission of the contentious text from the drafts that it checked before publication. Clause 5.1 was one of multiple parts of the code that Otsuka accepted it had breached in its response to the complaint. The PMCPA ruled Otsuka had breached clauses related to advertising a prescription-only medicine to the public, making a misleading claim and failing to certify promotional materials, among other failings. The U.K. watchdog published its findings two years after sharing details of another complaint filed by a former Otsuka employee. In that case, the PMCPA found the company’s Jinarc training website breached Clause 2.

Patent Infringement

21 Oct 2026

·www.biospace.com

IDWeek 2026: New Exploratory Analyses Evaluate XOCOVA® (ensitrelvir) Following COVID-19 Exposure, Including Breakthrough Infections and Infection Present at Baseline

A pooled analysis from the global SCORPIO clinical program showed potent antiviral activity with ensitrelvir across age, vaccination status and risk for severe disease New data underscores that even mild-to-moderate COVID-19 may worsen and exacerbate underlying chronic conditions, supporting the importance of prevention OSAKA, Japan--(BUSINESS WIRE)--Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) will present new exploratory analyses from the global Phase 3 SCORPIO-PEP study, virology data from across the ensitrelvir phase 3 program, and new insights on the continued burden of COVID-19 at IDWeek 2026. XOCOVA ® (ensitrelvir) was approved in May 2026 by the U.S. Food and Drug Administration (FDA) for post-exposure prophylaxis (PEP) of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. 1 The approval was based on positive results from SCORPIO-PEP, a global, double-blind, randomized, placebo-controlled Phase 3 study. In the primary analysis population, XOCOVA significantly reduced the risk of developing symptomatic COVID-19 by 67% in individuals following exposure to an infected individual through Day 10 compared with placebo (ensitrelvir n=1,030; placebo n=1,011). 1,2 In SCORPIO-PEP, XOCOVA was generally well tolerated, with similar rates of adverse events across groups (15.1% in the ensitrelvir group (n=1,190) and 15.5% in the placebo group (n=1,187)). 2 The most common adverse events (regardless of causality) occurring in greater than or equal to 1% of the XOCOVA group and at a greater frequency compared to placebo were headache, diarrhea, and cough. 1,2 There were no reports of altered taste (dysgeusia) attributed to XOCOVA in the trial. 2,3 Exploratory SCORPIO-PEP Analyses Describe Symptom Severity and Viral Outcomes Among Participants with Breakthrough Infection or Infection Present at Baseline In an oral presentation at IDWeek 2026, Shionogi will report new exploratory analyses from the SCORPIO-PEP study evaluating participants who had breakthrough infections or were already infected at baseline. 4 Among breakthrough infection cases (based on RT-PCR positivity regardless of symptoms) in the primary analysis population, the mean maximum viral RNA levels were lower in participants receiving ensitrelvir compared to those receiving placebo (3.1 vs 4.3 mean log10 copies/mL, respectively, seen in 144 and 217 breakthrough infection cases, respectively). 4 In household contacts who were infected with SARS-CoV-2 at the time of enrollment (confirmed positive by baseline central RT-PCR despite testing negative on a local screening test and being asymptomatic; n=237), numerically lower mean viral RNA levels were also observed with ensitrelvir in comparison to placebo on Days 3 and 6. 4 In the primary analysis population, a numerically lower proportion of participants with symptomatic breakthrough infections taking ensitrelvir developed severe symptoms, compared with those taking placebo (severe symptoms were reported in 8/28 or 28.6% of individuals receiving ensitrelvir compared with 48/89 or 53.9% of individuals receiving placebo). 4 Similarly, numerically lower mean total symptom scores earlier in the study and lower mean maximum total symptom scores were observed in participants receiving ensitrelvir compared with placebo (mean maximum total scores were 6.6 vs 8.9 respectively). 4 In participants receiving ensitrelvir who were infected with SARS-CoV-2 at the time of enrollment despite testing negative on a local screening test and being asymptomatic, a numerically lower proportion developed severe symptoms compared with placebo (severe symptoms were reported in 2/18 or 11.1% of individuals receiving ensitrelvir compared with 9/24 or 37.5% of individuals receiving placebo). 4 Similarly, numerically lower mean total symptom scores earlier in the study and mean maximum total symptom scores were observed in those receiving ensitrelvir compared with placebo. 4 “SCORPIO-PEP showed that early administration of ensitrelvir following household exposure reduced the risk of symptomatic COVID-19,” said Simon Portsmouth, MD, FRCP, Senior Vice President, Head of Clinical Development, Shionogi Inc. “This exploratory analysis provides additional insight into the antiviral activity of ensitrelvir on viral load and symptom outcomes among participants who developed COVID-19. These observations add to our understanding of the potential outcomes associated with early administration of ensitrelvir following household exposure.” Pooled Phase 3 Study Data Analysis Shows Potent Antiviral Activity of Ensitrelvir Through Observed Reductions in Infectious Virus In a separate poster presentation, investigators will report findings from a post-hoc pooled analysis of two Phase 3 studies designed to assess infectious-virus-based virologic outcomes across a broad range of participants with confirmed COVID-19 infection. 6 Unlike viral RNA detection by RT-PCR, which may identify noninfectious viral remnants, infectious-virus measurements assess the presence of replication-competent virus and can provide additional insight into antiviral activity. 5,6 By Day 4, participants who received ensitrelvir (375 mg on Day 1, then 125 mg on Days 2–5; n=484) had numerically greater reductions in infectious virus titers than those who received placebo (n=487) (difference in least-squares mean of 0.21 log10 TCID 50 /mL). 6 Similar results were observed across subgroups regardless of age, vaccination status, and risk factors for severe COVID-19. Also on day 4, a higher proportion of ensitrelvir recipients had undetectable infectious viral load compared to those receiving placebo (95.7% [463/484] vs 72.1% [351/487]). 6 “With data pooled from two Phase 3 studies, this analysis represents the most extensive infectious virus dataset reported for a COVID-19 antiviral to date, and it helps to further characterize ensitrelvir’s effect on active viral replication,” said Florin Draica, MD, CMD, MBA, Senior Vice President, U.S. Medical Affairs, Shionogi Inc. “Although these results are exploratory, the observed reductions in infectious virus provide additional support of ensitrelvir’s antiviral activity and warrant further evaluation of their potential implications for infectivity and transmission.” Systematic Literature Review Highlights the Continued Burden of COVID-19 and Its Impact on Underlying Chronic Conditions Shionogi will also present a systematic literature review evaluating the impact of acute COVID-19 on individuals with underlying chronic conditions during the Omicron era or in earlier time periods. The review included 35 observational studies assessing clinical outcomes, health-related quality of life (HRQoL), and healthcare resource utilization (HCRU). 7 Across the studies reviewed, acute COVID-19 was associated with worsening, exacerbation, or relapse of underlying chronic conditions spanning respiratory, neurologic, cardiovascular, renal, and other disease areas. 7 More than half of studies evaluating clinical outcomes (17 out of 33) reported statistically significant worsening of underlying chronic conditions such as asthma, COPD, multiple sclerosis and CKD, following acute COVID-19. 7 COVID-19 was also associated with worsening outcomes in five of eight studies reporting on HRQoL and increased hospitalization frequency or extended hospital length of stay in four of the six studies reporting on HCRU. 7 “Across studies in this review, acute COVID-19 during the Omicron predominance was associated with worsening or exacerbation of underlying chronic conditions. Specifically, we found that COVID-19 infection, even mild or moderate, was associated with reduced health-related quality of life and increased healthcare resource utilization,” said Alpesh N. Amin, M.D., Professor, Founding Chief and Executive Director of Hospital Medicine & Palliative Medicine, and Co-Director & Medical Director of the Institute for Precision Health at the University of California, Irvine. “These findings reinforce the continued burden of COVID-19 and underscore the importance of prevention, especially among people living with chronic conditions.” The Ongoing Impact of COVID-19 COVID-19 remains highly transmissible, driven by Omicron and its subvariants, and up to 47% of people living with an infected individual may develop COVID-19. 8,9 The U.S. Centers for Disease Control and Prevention estimates that between October 1, 2025, and September 26, 2026, there were 5.2-14.6 million new cases in the U.S., resulting in 1.1-2.7 million outpatient visits, 170,000-270,000 hospitalizations and 17,000-48,000 deaths. 10 Beyond acute infection, COVID-19, even mild-to-moderate, may worsen underlying chronic conditions and can have lasting health impacts. Studies have reported increased rates of new and worsening neurologic, cardiovascular, respiratory, and chronic kidney conditions in the year following COVID-19 infection. 11-19 COVID-19 also disproportionately affects older adults with greater risk for severe illness and death in close-community settings, such as long-term care facilities. 20 About SCORPIO-PEP The global, double-blind, randomized, placebo-controlled Phase 3 study, SCORPIO-PEP, assessed the safety and efficacy of XOCOVA as post-exposure prophylaxis for COVID-19. The study was conducted from June 2023-September 2024. It included 2,387 study participants aged 12 years and older with a negative local screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment, who were exposed to a person living in their household with symptomatic COVID-19. More than 98% of household contacts tested positive for antibodies against SARS-CoV-2 N (nucleocapsid) or S (spike) proteins, indicating that nearly all had evidence of previous SARS-CoV-2 infection or vaccination, or both. Study participants were randomly assigned at a 1:1 ratio to receive XOCOVA (375 mg on Day 1 and 125 mg on Days 2-5) or placebo, once daily for five days, and began treatment within 72 hours of when the household member with COVID-19 began showing symptoms. Results from SCORPIO-PEP were published in the New England Journal of Medicine . SCORPIO-PEP is the first and only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing COVID-19 following exposure to an infected individual.* About XOCOVA XOCOVA ® (ensitrelvir) is a SARS-CoV-2 main protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called the main protease, which is essential for the replication of the virus. XOCOVA suppresses the replication of SARS-CoV-2 by selectively inhibiting the main protease. XOCOVA is approved in the U.S., Japan and European Union for post-exposure prophylaxis of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. XOCOVA received emergency regulatory approval in Japan in November 2022 and full approval in March 2024 for the treatment of COVID-19 in adults and adolescents 12 years of age and older. XOCOVA received supplemental approval in Japan in June 2026 for pediatric patients aged 6 to under 12 years who weigh at least 20 kg for the treatment of COVID-19. XOCOVA is not approved for the treatment of COVID-19 in the U.S. U.S. INDICATION XOCOVA (ensitrelvir) is a prescription medicine used to help prevent coronavirus disease 2019 (COVID-19) in adults and children aged 12 years and older following contact with a person who has COVID-19 (post-exposure prophylaxis). It is not known if XOCOVA is safe and effective in children under age 12. IMPORTANT SAFETY INFORMATION Do not take XOCOVA if you are: allergic to ensitrelvir or any of the ingredients in XOCOVA. take any of the following medicines, as these may interact with XOCOVA and may cause severe or life-threatening side effects or death: apalutamide, carbamazepine, colchicine, dihydroergotamine, enzalutamide, eplerenone, ergotamine, finerenone, ivabradine, lomitapide, lumacaftor/ivacaftor, lurasidone, methylergonovine, phenytoin, pimozide, quinidine, rifampin, St. John’s wort, simvastatin, triazolam or voclosporin. These are not the only medicines that may cause serious or life-threatening side effects if taken with XOCOVA. XOCOVA may increase or decrease the levels of many medicines in your body. Tell your healthcare provider (HCP) about all the medicines you take because additional laboratory tests or dose changes of your other medicines may be necessary during XOCOVA use. Your HCP may tell you about specific symptoms to watch for that may indicate you need to stop or decrease the dose of some of your other medicines. Before taking XOCOVA, tell your HCP about all your medical conditions, including if you: are pregnant or plan to become pregnant. XOCOVA may harm your unborn baby. For females who are able to become pregnant, your HCP will check with you to see if you are pregnant before starting XOCOVA. Use effective birth control (contraception) during XOCOVA use and for 2 weeks after the final dose. Tell your HCP right away if you become pregnant or think you may be pregnant during XOCOVA use. are breastfeeding or plan to breastfeed. It is not known if XOCOVA passes into your breast milk. Do not breastfeed during XOCOVA use and for 2 weeks after the final dose. Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your HCP can tell you if it is safe to take XOCOVA with other medicines. Do not start a new medicine without telling your HCP. What are the possible side effects of XOCOVA? XOCOVA may cause serious side effects, including: Allergic reactions, including severe allergic reactions (anaphylaxis). Stop taking XOCOVA and get medical help right away if you get any of the following allergic reaction symptoms: skin rash; hives; itching; swelling of the mouth, lips, tongue, or face; trouble swallowing or breathing; throat tightness; dizziness or feeling lightheaded; stomach-area (abdomen) pain; or vomiting. The most common side effects of XOCOVA include : headache, diarrhea, and cough. These are not all possible side effects of XOCOVA. For more info, ask your HCP or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088 . Please see full Prescribing Information , including Patient Information , for XOCOVA. About Shionogi Inc. Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global research‑driven pharmaceutical company. Since 1878, Shionogi has been developing new treatments to improve patients’ lives worldwide. Today in North America, we are focused on infectious and rare diseases, and our portfolio includes an antibiotic for serious infections caused by susceptible Gram-negative bacteria, an oral antiviral for post-exposure prophylaxis of COVID-19 and a therapy for amyotrophic lateral sclerosis (ALS). Together with our subsidiaries Qpex Biopharma Inc. and Shionogi Canada Inc., we are continuing to innovate across infectious disease, rare disease and additional high‑need therapeutic areas. Learn more at shionogi.com . About Shionogi & Co., Ltd. Shionogi & Co., Ltd. is a 148-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain and CNS disorders. Shionogi’s research and development currently targets two therapeutic areas: infectious diseases and diseases with unmet medical needs, including rare diseases, allergy/inflammation, oncology, hearing loss, and sleep apnea. For more information on Shionogi & Co., Ltd., please visit . Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. * Literature search conducted in May 2026 References 1 XOCOVA (ensitrelvir) Prescribing Information. Available from: . Accessed July 6, 2026. 2 Hayden FG, Shinkai M, et al. Ensitrelvir for COVID-19 postexposure prophylaxis in household contacts. N Engl J Med . 2026;394(19):1905-1915. doi: 10.1056/NEJMoa2509306 . 3 Hayden FG, Shinkai M, Clark TW, et al. Ensitrelvir for COVID-19 postexposure prophylaxis in household contacts. Supplementary Appendix. N Engl J Med . 2026;394(19). Available from: . 4 Fukushi A, Nobori H, Sakaguchi H, et al. Early Pre-Symptomatic Treatment with Ensitrelvir Among PCR-Positive, SARS-CoV-2-Exposed and Infected Household Contacts: SCORPIO-PEP Subpopulation Analysis. Presented at: IDWeek 2026; Washington, D.C., United States. 5 Binnicker MJ. Can Testing Predict SARS-CoV-2 Infectivity? The Potential for Certain Methods To Be Surrogates for Replication-Competent Virus. Journal of Clinical Microbiology . 2021;59(11):e00469-21. doi:10.1128/JCM.00469-21. 6 Hurt AC, Nobori H, Sakaguchi H, et al. Reduction of Infectious SARS-CoV-2 and Viral RNA with Ensitrelvir: A Pooled Analysis of SCORPIO-SR and SCORPIO-HR Trials [poster presentation]. Presented at: IDWeek 2026; Washington, D.C., United States. 7 Draica F, Verdi D, Fedele M, et al. Impact of Acute COVID-19 on Underlying Chronic Conditions: Systematic Literature Review [poster presentation]. Presented at: IDWeek 2026; Washington, D.C., United States. 8 Baker JM, Nakayama JY, O’Hegarty M, et al. Household transmission of SARS-CoV-2 in five US jurisdictions: comparison of Delta and Omicron variants. PLoS One. 2025;20(1):e0313680. doi:10.1371/journal.pone.0313680. 9 Madewell ZJ, Yang Y, Longini IM Jr, et al. Household secondary attack rates of SARS-CoV-2 by variant and vaccination status: an updated systematic review and meta-analysis. JAMA Netw Open. 2022;5(4):e229317. doi:10.1001/jamanetworkopen.2022.9317. 10 Centers for Disease Control and Prevention [Internet]. Preliminary 2025-2026 COVID-19 burden estimates. Available from: 11 Xie Y, Xu E, et al. Long-term cardiovascular outcomes of COVID-19. Nat Med. 2022;28(3):583-590. doi:10.1038/s41591-022-01689-3. 12 Sax PE, Draica F, et al. New onset conditions, exacerbations and worsening of underlying conditions following COVID-19 infection [poster presentation]. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI); 2026; Denver, CO, United States. 13 Graham EL, Clark JR, et al. Persistent neurologic symptoms and cognitive dysfunction in non-hospitalized COVID-19 “long haulers.” Ann Clin Transl Neurol. 2021;8(5):1073-1085. doi:10.1002/acn3.51350. 14 Xie Y, Xu E, Bowe B, et al. Risks of mental health outcomes in people with COVID-19: a cohort study. BMJ. 2022;376:e068993. doi:10.1136/bmj-2021-068993. 15 Srivastava S, Garg I. Post-COVID-19 infection: long-term effects on liver and kidneys. World J MetaAnal. 2021;9(3):220-233. doi:10.13105/wjma.v9.i3.220. 16 Tenforde MW, Kim SS, Lindsell CJ, et al. Symptom duration and risk factors for delayed return to usual health among outpatients with COVID-19 in a multistate health care systems network—United States, March-June 2020. MMWR Morb Mortal Wkly Rep. 2020;69(30):993-998. doi:10.15585/mmwr.mm6930e1. 17 Kwok WC, Chau CH, Tam TCC, et al. Outcomes among patients with chronic obstructive pulmonary disease after recovery from COVID-19 infection of different severity. Sci Rep. 2024;14(1):13881. doi:10.1038/s41598-024-64670-9. 18 Conway SE, Healy BC, Zurawski J, et al. COVID-19 severity is associated with worsened neurological outcomes in multiple sclerosis and related disorders. Mult Scler Relat Disord. 2022;63:103946. doi:10.1016/j.msard.2022.103946. 19 Chen IW, Chang LC, Ho CH, et al. Association between COVID-19 and the development of chronic kidney disease in patients without initial acute kidney injury. Sci Rep. 2025;15(1):10924. doi:10.1038/s41598-025-96032-4. 20 Gravenstein S, Cooke CE, Verdi D, et al. Current impact of COVID-19 in long-term care facilities in the United States: a systematic literature review. Sr Care Pharm. 2026;41(5):167-186. doi:10.4140/TCP.n.2026.167. Contacts For Further Information: SHIONOGI Website Inquiry Form: U.S. Media: ShionogiCommunications@shionogi.com Shionogi Europe Press Office: pressoffice@shionogi.eu

Clinical ResultPhase 3Drug Approval

15 Oct 2026

·www.biospace.com

LifeMine Therapeutics Forms Clinical Advisory Board of Leading Experts in Organ Transplantation

Clinical advisory board brings together world renowned transplant surgeons and physicians to support the clinical development of LIFE-001, a structurally and mechanistically novel calcineurin activation inhibitor (CNai) for the prevention of organ transplant rejection LIFE-001 Phase 2 kidney transplant study and Phase 1b islet cell transplant study to initiate in early 2027 WATERTOWN, Mass.--(BUSINESS WIRE)--LifeMine Therapeutics Inc., a clinical-stage biopharmaceutical company pioneering Top-Down Drug Discovery ™ , which leverages digital genomic search technology from fungi to source next-generation precision medicines, today announced the formation of its clinical advisory board, bringing together leading physicians and researchers with deep expertise across organ transplantation, transplant immunology and immunosuppression. Members will help advise LifeMine on the ongoing clinical development of LIFE-001, a structurally and mechanistically novel calcineurin activation inhibitor (CNai) delivered as a long-acting injectable and designed to avoid the immunophilin-dependent organ damage common to all legacy calcineurin inhibitors (CNis) such as cyclosporin, voclosporin and tacrolimus. LIFE-001 is currently being evaluated in a first-in-human Phase 1 clinical trial, with a Phase 2 study in kidney transplantation and a Phase 1b study in islet cell transplantation planned to initiate in early 2027. “Despite tremendous advances in transplantation, the immunosuppressive therapies used to prevent organ rejection continue to impose a significant lifelong burden on patients,” said Gregory Verdine, Ph.D., Co-founder, President and Chief Executive Officer of LifeMine. “LIFE-001 was designed from the outset to preserve the power of calcineurin inhibition while overcoming fundamental limitations of legacy calcineurin inhibitors. As we prepare to advance LIFE-001 into its next phase of development in transplant recipients, we are honored to bring together this extraordinary group of transplant leaders. Their collective experience caring for patients and advancing the field will be invaluable as we work to realize the full potential of LIFE-001 to transform organ transplantation.” “Calcineurin inhibitors transformed the field of transplantation and remain foundational to preventing organ rejection, but their toxicities can have significant consequences for patients who may require lifelong treatment,” said Andrew Cameron, M.D., Surgeon-in-Chief of Johns Hopkins Hospital and Chair of LifeMine’s Clinical Advisory Board. “LIFE-001 represents a fundamentally different approach to calcineurin inhibition, with the potential to maintain the immunosuppressive activity that has made this pathway so important while reducing the burden associated with current therapies. I am pleased to chair this outstanding group of transplant experts as we work with LifeMine to help guide the clinical development of LIFE-001.” “Kidney transplantation can be transformative for patients with kidney failure, but a transplanted kidney is not necessarily a lifetime solution. Many patients, particularly those transplanted at a younger age, may ultimately require another transplant, underscoring the importance of preserving graft function for as long as possible,” said John Gill, M.D., Professor of Medicine and Academic Head of Kidney Transplantation at the University of British Columbia. “There remains a significant need for new approaches that can provide the immunosuppressive efficacy required to prevent rejection while reducing the toxicities associated with lifelong treatment and improve quality of life for patients. LIFE-001’s differentiated mechanism and emerging clinical pro it a compelling candidate to evaluate in kidney transplantation, and I look forward to helping guide the program as it advances into Phase 2.” LifeMine’s Clinical Advisory Board includes: Andrew Cameron, M.D., Director, Department of Surgery, and Surgeon-in-Chief, The Johns Hopkins Hospital. Dr. Cameron is a transplant surgeon who previously served as Head of the Liver Transplant Program at Johns Hopkins. Andrew Adams, M.D., Professor and Chief, Division of Transplantation, University of Minnesota. Dr. Adams is a transplant surgeon and scientist whose research focuses on the immune mechanisms underlying organ rejection, including costimulation blockade and xenotransplantation. He also helped develop belatacept, a therapy used in kidney transplantation. Roy Bloom, M.D., Professor of Medicine at the University of Pennsylvania and Medical Director, Kidney Transplant Program. Dr. Bloom is a transplant nephrologist whose research interests include clinical immunosuppression, viral infections in transplantation and post-transplant outcomes. Beatrice Concepcion, M.D., Medical Director, University of Chicago Medicine. Dr. Concepcion is a transplant nephrologist whose clinical research focuses on expanding access to transplantation and improving clinical and patient-centered outcomes for kidney transplant recipients. John Gill, M.D., Professor of Medicine and Academic Head of Kidney Transplantation, University of British Columbia. Dr. Gill’s research interests include kidney transplant outcomes, access to transplantation, clinical trials and health services research. Nicolae Leca, M.D., Medical Director, University of Washington Medical Center. Dr. Leca is a transplant nephrologist whose clinical interests include novel immunosuppressive approaches, clinical trials in kidney and pancreas transplantation, antibody-mediated rejection and post-transplant care. Roslyn Mannon, M.D., Vice Chair of Research, Internal Medicine, and Associate Chief of Research, Nephrology, University of Nebraska Medical Center. Dr. Mannon is a transplant nephrologist and researcher with extensive leadership experience in transplantation, including previously serving as president of the American Society of Transplantation. Flavio Vincenti, M.D., Specialist, Kidney & Pancreas Transplantation, UC San Francisco Medical Center. Dr. Vincenti is a transplant nephrologist and longtime investigator in transplantation, including research into immunosuppressive approaches intended to prevent rejection and reduce the burden of immunosuppression. Member bios can be found here on LifeMine’s website. About LIFE-001 LIFE-001 is a structurally and mechanistically novel, organ-sparing, immunophilin-independent calcineurin activation inhibitor (CNai) delivered as a long-acting injectable being developed for the prevention of organ transplant rejection. Unlike currently available calcineurin inhibitors such as cyclosporin, voclosporin, and tacrolimus, LIFE-001 does not depend on intermediary immunophilin chaperone proteins and directly targets and binds calcineurin to keep it inactive and prevent T-cell activation and proliferation. LIFE-001 has demonstrated compelling efficacy in preclinical models and has shown unequivocally improved safety over legacy calcineurin inhibitors. LIFE-001 is currently being evaluated in a first-in-human Phase 1 clinical trial. About LifeMine Therapeutics LifeMine Therapeutics is a clinical-stage biopharmaceutical company pioneering Top-Down Drug Discovery ™ , which leverages evolutionary insights from fungi to unearth next-generation precision medicines. LifeMine’s data-immersive platform integrates the latest advancements in human genetics and genomics, bioinformatics, machine learning and synthetic biology. LifeMine’s lead program, LIFE-001, is a structurally and mechanistically novel calcineurin activation inhibitor (CNai) being developed for the prevention of organ transplant rejection. Headquartered in Watertown, Mass., LifeMine has raised $558 million from leading life science investors. For additional information, please visit . Contacts 1AB Katie Engleman katie@1abmedia.com

Phase 1ImmunotherapyCell Therapy

100 Deals associated with Voclosporin

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KEGG	Wiki	ATC	Drug Bank
D09033	Voclosporin	L04AD03	DB11693

R&D Status

Approved

10 top approved records.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-infectious posterior uveitis	NDA/BLA	European Union	Lux Biosciences, Inc.	10 Feb 2010
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

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACR2026	Not Applicable	Lupus Nephritis	2,726	Voclosporin	pkdanmcrya(chanfrtgon) = kzkddyyott trvhqisblg (jtfcedrooy )	Positive	06 Nov 2026
				Belimumab	pkdanmcrya(chanfrtgon) = slwcurasjq trvhqisblg (jtfcedrooy )
ACR2026	Not Applicable	Lupus Nephritis	430	Voclosporin+MMF+glucocorticoids	ygfzruahao(rsnjpnmqoa) = shkchthdxo qjdccycwwr (ossoejfoms ) View more	Negative	06 Nov 2026
				Belimumab+MMF+glucocorticoids	ygfzruahao(rsnjpnmqoa) = sdsrpywbrn qjdccycwwr (ossoejfoms ) View more
EULAR2026	Not Applicable	Lupus Nephritis	66	Combination immunosuppressive therapy	lyjewkyfda(agnoyjlypv) = cfwszbbasv uhecsyiucf (keoygvzevv ) View more	Positive	11 Jun 2026
NCT03021499 (AURORA 1, EULAR2026)	Phase 3	Lupus Nephritis	356	Voclosporin	zxcirmbabo(cvbbvqlpql) = yqkcszaouu ffcuuqvjgr (sznwqqoons )	Positive	11 Jun 2026
				Placebo	zxcirmbabo(cvbbvqlpql) = ojckbmpxef ffcuuqvjgr (sznwqqoons )
EULAR2026	Not Applicable	Lupus Nephritis	77	Voclosporin 23.7 mg twice daily + mycophenolate mofetil 1 g twice daily	jwqeaomnpt(egcsiliijr) = dcallxzmgg rxtosgnjid (ycjqcghsls ) View more	Positive	11 Jun 2026
				Voclosporin 23.7 mg twice daily + mycophenolate mofetil 1 g twice daily (difficult-to-treat patients)	ujzvhyoimm(yuemdstcvu) = kolktvvjts qlluepactg (vlcsqykdpi ) View more
ASN2025	Not Applicable	Lupus Nephritis	19	Voclosporin (Lupus Nephritis)	aidgvktspc(goxvaylxpe) = ffqjevhmgy honqvbgkio (evrpbwvwir ) View more	Positive	08 Nov 2025
NCT05306873 (DIVERT, CTgov)	Phase 2	Systemic Lupus Erythematosus	12	MMF (Stage 2 MMF)	zfefzjeklt = wzzvpvomke yrwtyqptpn (biswlecsca, mnlslarrub - qrviullynp) View more	-	09 Sep 2025
				MMF (Stage 2 Placebo for MMF)	zfefzjeklt = arzfrddjva yrwtyqptpn (biswlecsca, kcojomatyy - pqikmfyfrb) View more
ERA2025	Not Applicable	Lupus Nephritis \| Systemic Lupus Erythematosus	4	CyclophosphamideVoclosporinRituximabMethylprednisolone + CyclophosphamideVoclosporinRituximabMethylprednisolone + CyclophosphamideVoclosporinRituximabMethylprednisolone + CyclophosphamideVoclosporinRituximabMethylprednisolone	viigsdxrpv(xzupzxcmrx) = mhoctadvpy wxamnxnawo (jlkcdhoxgm ) View more	Positive	04 Jun 2025
AURORA 1 (ACR2024)	Phase 3	Lupus Nephritis	357	Voclosporin 23.7 mg BID	lrqsbhnylt(rjcnojkcyu) = fesfabpbnq hydohpnvxd (ruddglrbtl )	Positive	10 Nov 2024
				Placebo	lrqsbhnylt(rjcnojkcyu) = wlyhvlbvmp hydohpnvxd (ruddglrbtl )
AURA-LV (ERA2024)	Phase 2/3	Lupus Nephritis	358	Voclosporin 23.7 mg BID + MMF (target 2 g/day) + oral GCs (25 mg/day)	cgwoqzgabh(xptuanwzav) = The overall incidence of adverse events (AEs) was higher in IVC- and MMF-treated participants of ALMS, although more participants in AURA-LV and AURORA 1 reported hypertension and anemia. qatqvxsksc (inysyuudmt ) View more	Positive	23 May 2024
				MMF (target 3 g/day) or IVC (0.5 to 1.0 g/m2/month × 6) + oral GCs

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