In which countries is Voclosporin approved?

Introduction to Voclosporin

Voclosporin is a next‐generation calcineurin inhibitor that has been chemically modified to improve its pharmacokinetic and pharmacodynamic properties relative to its predecessors such as cyclosporine and tacrolimus. Unlike traditional calcineurin inhibitors that primarily act to suppress T‐cell activation, voclosporin exhibits a dual mechanism of action: it not only downregulates immune function by inhibiting T-cell activation and cytokine production, but it also contributes to podocyte stabilization in the kidney. This unique action on podocytes is thought to enhance its anti-proteinuric effect, which is a crucial factor in the management of renal diseases. Its formulation in oral capsules provides significant convenience compared to intravenous alternatives, further emphasizing its clinical utility. 

Therapeutic Uses and Indications 
Voclosporin was primarily developed for the treatment of lupus nephritis—a severe renal manifestation of systemic lupus erythematosus (SLE) that can lead to irreversible nephron damage if left untreated. The pivotal Phase 3 studies, such as the AURORA 1 and AURORA 2 trials, demonstrated significant improvements in renal response rates and early reduction in proteinuria among patients with active lupus nephritis when voclosporin was used in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids. This evidence has formed the backbone of its clinical approval and subsequent use in patients with this indication. 
Beyond lupus nephritis, voclosporin is also being explored in other immunologically mediated disorders such as noninfectious uveitis, where its improved safety profile and pharmacology relative to older agents may offer therapeutic advantages. An orphan drug designation for uveitis in the European Union underlines the potential expansion of its indications and the ongoing interest in its broader immunomodulatory utility. 

Regulatory Approval Process 
Overview of Drug Approval Processes 
The drug approval process is a complex sequence of scientific evaluation, regulatory scrutiny, and clinical determination that ensures any therapeutic agent brought to market is both safe and effective. This multi-step process typically involves preclinical evaluation, phased clinical trials, pharmacokinetic and pharmacodynamic assessments, and finally a regulatory review by national or supranational authorities. In the case of voclosporin, the extensive data generated from its Phase 3 clinical trials—especially on endpoints such as reduction in proteinuria and stabilization of kidney function—were pivotal in securing approval by multiple agencies. These rigorous scientific protocols and review processes are in place worldwide to safeguard patient health and to maintain trust in pharmaceutical interventions. 
Regulatory approvals are often granted on a region-by-region basis, which means a drug approved in one country or region may need to undergo additional review in another jurisdiction. This phenomenon is especially common for novel therapeutics given varied regulatory frameworks, review timelines, and local epidemiological considerations. In voclosporin’s case, the strength of the clinical evidence from its global trials has allowed for relatively expedited review processes in several major jurisdictions. 

Key Regulatory Bodies 
A range of regulatory agencies across the globe are responsible for evaluating and approving new therapeutics. In the United States, the Food and Drug Administration (FDA) is the main body overseeing drug safety and efficacy, with its Center for Drug Evaluation and Research (CDER) specifically handling these processes. For voclosporin, the FDA approved the drug based on robust data derived from its Phase 3 clinical trials, marking it as the first oral treatment approved for active lupus nephritis in the United States. 
Across the European Union, the European Medicines Agency (EMA) acts as the primary centralized body. The EMA, particularly after a positive opinion from its Committee for Medicinal Products for Human Use (CHMP), confers marketing authorization that subsequently applies to all EU member states and several associated countries, including Iceland, Norway, Liechtenstein, and parts of the United Kingdom such as Northern Ireland. 
In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) operates similarly to the FDA. The PMDA recently approved voclosporin for use, exemplifying the global confidence in its safety and efficacy profiles. These regulatory bodies not only evaluate clinical trial outcomes but also examine manufacturing processes, drug pharmacology data, and post-marketing surveillance plans before granting approval. 

Voclosporin Approval Status 
Countries with Approval 
Based on multiple pieces of reliable evidence and structured data from regulatory filings as well as peer-reviewed and regulatory-related publications from sources such as synapse, voclosporin has received approval in several key jurisdictions around the world. 

In the United States, voclosporin—commercially known as LUPKYNIS—is approved by the FDA. The approval came on January 22, 2021, following robust efficacy and safety review by the Center for Drug Evaluation and Research. This landmark decision made voclosporin the first oral calcineurin inhibitor approved specifically for active lupus nephritis, offering a new therapeutic modality for patients in the United States. 

In Europe, voclosporin has obtained marketing authorization through the centralised procedure conducted by the European Medicines Agency (EMA). The EMA approved the drug—also marketed as Lupkynis—in a decision effective as of November 27, 2024. This approval extends to all 27 European Union member states, as well as Iceland, Norway, Liechtenstein, and Northern Ireland. The decision was based on the positive outcomes of the pivotal Phase 3 studies (AURORA 1 and AURORA 2), where voclosporin in combination with existing immunosuppressive regimens significantly improved renal outcomes for patients with lupus nephritis. 

Japan’s regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA), has also granted approval for voclosporin. In this highly regulated market, voclosporin was approved on November 20, 2024, with the formulation marketed under a trade name indicated in Japanese. Approval by the PMDA underscores both the therapeutic value of voclosporin and its strong clinical profile in terms of safety and efficacy. This approval is particularly noteworthy given Japan’s rigorous standards for immunosuppressive therapies and transplant-related agents. 

Collectively, these approvals demonstrate the international trust in voclosporin’s clinical benefits and its potential to alter the treatment landscape for lupus nephritis and possibly other indications in the future. The robust engagement with regulatory agencies across the United States, European Union, and Japan reflects confidence in its novel mechanism and favorable risk-benefit profile as derived from extensive clinical trials. 

Pending Approvals 
While voclosporin has secured approval in the major territories mentioned above, there remain regulatory processes in several jurisdictions that are still evolving. For instance, in Great Britain, there is an outstanding decision from the UK Medicines and Healthcare products Regulatory Agency regarding marketing authorisation; this decision has been anticipated for some time and is expected in the coming weeks. 
Furthermore, the Swiss Agency for Therapeutic Products (Swissmedic) is currently reviewing a marketing authorisation application for voclosporin. Although Swissmedic granted orphan drug status for voclosporin in lupus nephritis earlier in the process, the final approval decision is pending. These pending applications underscore the continuing expansion of voclosporin’s reach while the sponsors work diligently to satisfy country-specific regulatory requirements. 
Additionally, there might be additional territories where voclosporin is being considered under expedited or conditional review programmes. Although the primary focus remains on the United States, European Union, and Japan, the growing evidence of its positive clinical profile may trigger further submissions in emerging markets in future years. This ongoing regulatory activity is part of a broader strategy by the companies involved to maximize patient access globally. 

Impact of Approval 
Market Implications 
The regulatory approvals achieved for voclosporin have significant implications for both the pharmaceutical market and the management of lupus nephritis internationally. In the United States, the FDA’s approval of voclosporin sets a new milestone as it is the first oral medicine indicated for active lupus nephritis, potentially reshaping standard treatment regimens and providing an alternative to intravenous or less convenient therapies. 
In Europe, the centralized approval mechanism that allows voclosporin to be marketed simultaneously across over 30 countries streamlines the commercial strategy and ensures consistency in quality and usage guidelines. This centralized authorization facilitates a broad market penetration, ultimately leading to improved clinical outcomes and greater integration into standard-of-care protocols across diverse healthcare systems. 
Moreover, Japan’s approval by the PMDA opens up opportunities for voclosporin to address unmet medical needs in a country that places a strong emphasis on precision medicine and patient safety. Its approval in this jurisdiction is likely to spur further research into its use across additional indications, potentially leading to more robust collaborations and licensing arrangements between companies in Japan and their global counterparts. 
From a commercial perspective, these approvals have reinforced strategic partnerships among leading pharmaceutical companies. The collaboration between Otsuka Pharmaceutical Co., Ltd. and Aurinia Pharmaceuticals, Inc. illustrates a cooperative model where licensing, revenue sharing, and joint development play pivotal roles. Such alliances ensure that once regulatory milestones are met, the drug is positioned for rapid market uptake—especially in areas where the prevalence of lupus nephritis represents a substantial unmet medical need. 

Patient Access and Benefits 
The impact of voclosporin’s approvals goes beyond commercial implications and has profound patient-centric benefits. Lupus nephritis has historically posed substantial challenges due to the severity of the disease and the limited number of efficacious oral treatment options. With the introduction of voclosporin into clinical practice, patients in the United States, Europe, and Japan now have access to a therapy that offers both convenience and clinical improvement in renal outcomes. The dual mechanism of action not only helps in suppressing the aberrant immune response that damages the kidneys but also improves podocyte stability—thereby reducing proteinuria and preserving kidney function over the long term. 
In the United States, the availability of a first-in-class treatment like voclosporin can significantly reduce the requirement for more invasive treatments while potentially improving the health-related quality of life for patients. Furthermore, because voclosporin is administered orally, the barrier to adherence is lower compared to therapies requiring intravenous administration. Consistent treatment adherence is crucial for maintaining therapeutic benefits in chronic conditions, which in turn is expected to translate into better long-term outcomes. 
Across the European Union, regulatory approval means that patients throughout all the member states—and even in countries like Norway, Iceland, and Liechtenstein—can benefit from a unified standard of care. This reduces variability in treatment outcomes and facilitates the sharing of real-world data to further refine dosing regimens and long-term management strategies. 
In Japan, where the burden of autoimmune diseases is carefully managed through a comprehensive healthcare system, the introduction of voclosporin is anticipated to complement existing therapies and provide a novel option for patients, especially those who are unresponsive or intolerant to other treatments. The rigorous expectations of Japan’s healthcare system regarding drug safety and efficacy mean that voclosporin’s approval is backed by substantial evidence, which is reassuring for both physicians and patients. 
The broader benefits of such approvals also include enhanced insurance coverage and reimbursement policies. In many jurisdictions, once a drug is approved by a regulatory body, healthcare payors are more inclined to include it in formularies. This increases patient access by reducing out-of-pocket expenses and ensuring that more patients can receive timely treatment, thereby decreasing the likelihood of disease progression and associated complications. 

Conclusion 
In conclusion, voclosporin has achieved significant regulatory milestones across several key global jurisdictions. It is approved by the United States Food and Drug Administration (FDA_CDER) as of January 22, 2021, providing the first oral treatment option specifically targeted for active lupus nephritis in the United States. In Europe, the European Medicines Agency (EMA) approved voclosporin on November 27, 2024, granting a centralized marketing approval that extends to all 27 EU member states as well as associated regions including Iceland, Norway, Liechtenstein, and Northern Ireland. Additionally, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan approved voclosporin on November 20, 2024, marking its entry into the Japanese market as part of a broader strategy to meet the widespread need for effective treatments in autoimmune nephropathies. 

While these approvals are a triumph for global drug development and collaborative regulatory science, there remain pending decisions in Great Britain (by the UK Medicines and Healthcare products Regulatory Agency) and Switzerland (under the review by Swissmedic), which indicate a broader yet gradually expanding international reach for voclosporin. Such pending approvals are likely to follow given the robust clinical evidence that underlies the already approved indications. 

From a market perspective, these approvals confirm voclosporin’s potential to disrupt current treatment paradigms for lupus nephritis and possibly other autoimmune conditions, offering significant advantages in terms of patient adherence, safety profiles, and overall clinical outcomes. The multi-regional regulatory endorsements also pave the way for a more integrated approach to patient care, with improved access to high-quality treatments across the United States, Europe, and Japan. Enhanced patient access is expected to lead to better management of the disease, fewer long-term complications, and a reduction in healthcare burdens associated with chronic kidney disease secondary to lupus. 

By evaluating the approval status across these regions, it becomes clear that the rigorous developmental and clinical efforts invested in voclosporin have met with international success. The coordinated efforts of regulatory bodies, combined with the strong collaboration between partnering pharmaceutical companies, have collectively accelerated the transition from clinical trials to the real-world therapeutic arena. This not only benefits patients by providing access to an innovative oral medication with a favorable efficacy and safety profile but also exemplifies the evolving landscape of drug approval processes that prioritize expedited access for treatments addressing serious and life-threatening conditions. 

Through this comprehensive, multi-perspective analysis, the global approval landscape for voclosporin is now well established. While currently approved in the United States, European Union (and associated countries within the centralised approval framework), and Japan, efforts are ongoing to secure additional approvals in regions such as Great Britain and Switzerland. The collective impact of these approvals is far-reaching: they open up new clinical possibilities, drive market evolution, and ultimately result in enhanced outcomes for patients afflicted by lupus nephritis and potentially other related conditions. 

Ultimately, the detailed regulatory journey of voclosporin—from its robust clinical evaluation across multiple phases to its approval by top-tier regulatory agencies—underscores a shift in modern pharmacotherapy. It illustrates how an integrated regulatory framework, combined with state-of-the-art clinical evidence, can lead to transformative advances in patient care. Voclosporin stands as a prime example of how persistent innovation in drug development, rigorous scientific evaluation, and strategic global regulatory coalescence can converge to deliver meaningful, life-saving treatments to patients worldwide.

Discover Eureka LS: AI Agents Built for Biopharma Efficiency

Stop wasting time on biopharma busywork. Meet Eureka LS - your AI agent squad for drug discovery.

▶ See how 50+ research teams saved 300+ hours/month

From reducing screening time to simplifying Markush drafting, our AI Agents are ready to deliver immediate value. Explore Eureka LS today and unlock powerful capabilities that help you innovate with confidence.