Viatris Reports Significant Results from VR-205 Clinical Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 29 2026
0mins
Viatris announced top-line results from a Phase 3 clinical trial evaluating the efficacy and safety of VR-205 in Japanese adult patients with primary immunoglobulin A nephropathy at risk of developing end-stage renal disease. The Phase 3 clinical trial was a multicenter, interventional, open-label study designed to evaluate the efficacy and safety of 16 mg of VR-205 in Japanese adult patients with primary IgAN. Patients were treated for nine months, followed by a three-month follow-up period. The study achieved its primary endpoint, with VR-205 demonstrating a 33.75% reduction in geometric mean urine protein-to-creatinine ratio at nine months compared to baseline. These results were statistically significant and clinically meaningful, and were consistent with those observed in the global Phase 3 program for the product. In addition to a statistically significant and clinically meaningful reduction in UPCR at 6 and 12 months, VR-205 demonstrated a significant improvement in estimated glomerular filtration rate and reductions in serum creatinine and urine albumin-to-creatinine ratio at 9 months compared to baseline. The overall therapeutic benefit of VR-205 was further supported by improvements in microhematuria and a sustained proteinuria reduction. No study participants progressed to dialysis, kidney transplant or severe renal impairment by the end of the study. VR-205 was generally well tolerated over the nine-month treatment period, with a safety profile consistent with the known safety profile of targeted-release budesonide in non-Japanese patients. Viatris is targeting submission of a new drug application in Japan by the end of 2026. In 2022, Calliditas Therapeutics and Viatris Pharmaceuticals Japan Inc., a subsidiary of Viatris entered into an exclusive license agreement to obtain marketing authorization and to commercialize VR-205 for the treatment of primary IgAN in Japan. It is currently a specialty drug approved and marketed as Tarpeyo in the U.S. and as Kinpeygo in Europe.
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About VTRS
Viatris Inc. is a global healthcare company. The Company markets branded and generic drugs, including complex drugs. The Company's segments include Developed Markets, Greater China, JANZ, and Emerging Markets. Its Developed Markets segment comprises its operations primarily in North America and Europe. The Company's Greater China segment includes its operations in mainland China, Taiwan and Hong Kong. The Company's JANZ segment consists of its operations in Japan, Australia and New Zealand. Its Emerging Markets segment encompasses its presence in more than 125 countries with developing markets and emerging economies including in Asia, Africa, Eastern Europe, Latin America and the Middle East as well as the Company's ARV franchise. It produces medicines for patients across a broad range of major therapeutic areas. From cardiovascular health to oncology, it offers treatment options across more than 10 major therapeutic areas covering a variety of noncommunicable and infectious diseases.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Investor Participation: Investors and the general public can listen to the live webcast at investor.viatris.com or call 844.308.3344 (U.S.) and 412.317.1896 (international) to join the conference, ensuring broad participation and transparency.
- Replay Availability: A replay of the webcast will be available on the company’s website after the event, allowing those who could not attend live to access the information, thereby enhancing communication between the company and its investors.
- Company Mission and Vision: Viatris is committed to meeting global patient needs through innovation and resolute decision-making, offering a broad portfolio that includes generics, value-added medicines, and innovative drugs aimed at improving health and quality of life.
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See More
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- Clinical Trial Success: Viatris's Nefecon has successfully met primary and secondary endpoints in a Phase 3 trial in Japan for primary immunoglobulin A nephropathy (IgAN), marking a significant advancement in the company's renal disease treatment portfolio.
- Significant Protein Reduction: Patients treated with Nefecon experienced a 33.75% decline in geometric mean urine protein-to-creatinine ratio (UPCR) at nine months, indicating the drug's effectiveness in improving renal function, which could enhance market demand for the product.
- Improved Kidney Function: Nefecon also led to significant improvements in estimated glomerular filtration rate (eGFR) and reductions in serum creatinine and urine albumin-to-creatinine ratio (UACR) at nine months, further demonstrating its potential in renal health management.
- Optimistic Market Outlook: The drug is approved in the US under the name Tarpeyo and marketed by Calliditas Therapeutics, and the successful trial results may drive its acceptance and sales growth in global markets.
See More
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- Clinical Trial Success: Viatris's Phase 3 study in Japan demonstrated that VR-205 achieved a 33.75% reduction in the urine protein-to-creatinine ratio (UPCR) over nine months, successfully meeting its primary endpoint and indicating the drug's efficacy in treating primary immunoglobulin A nephropathy (IgAN).
- Good Tolerability: During the nine-month treatment period, VR-205 was generally well tolerated, with a safety profile consistent with that observed in non-Japanese patients, showcasing the drug's reliability across diverse populations.
- Future Plans: Viatris intends to submit a New Drug Application for VR-205 in Japan by the end of 2026, indicating a strategic move to advance the drug's commercialization in the Japanese market.
- Marketing Authorization Agreement: Under a 2022 licensing agreement with Calliditas Therapeutics AB, Viatris secured exclusive rights to market and commercialize VR-205 in Japan, enhancing its competitive position in the global IgAN treatment landscape.
See More
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- Broad Scope of Litigation: The lawsuit covers 36 defendants and 80 generic drugs, primarily targeting medications for skin conditions, highlighting significant scrutiny on price-fixing practices in the pharmaceutical industry, which could impact regulatory frameworks across the sector.
- Clarification of Greenstone's Role: The judge emphasized that Greenstone existed to generate profit rather than merely acting on behalf of Pfizer, which helps maintain the subsidiary's independence and mitigates potential future liabilities for Pfizer.
- Pfizer's Response: Pfizer expressed satisfaction with the dismissal and reiterated Greenstone's status as a reliable supplier of affordable generic medicines, indicating the company's commitment to vigorously defend against these claims to protect its market reputation.
See More
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- Pipeline Development Opportunities: The company's focus on a non-opioid pain reliever, a potential lupus treatment, and a heart attack 'EpiPen' is expected to significantly drive long-term revenue growth, enhancing investor confidence and shareholder value.
- Cost Control Effectiveness: Strategic cost-cutting measures implemented post-review are projected to save the company $400 million by 2028, further improving profitability and exceeding market expectations, demonstrating enhanced operational efficiency.
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See More
