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Last Updated: July 17, 2025

Investigational Drug Information for Mizoribine


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What is the drug development status for Mizoribine?

Mizoribine is an investigational drug.

There have been 6 clinical trials for Mizoribine. The most recent clinical trial was a Phase 3 trial, which was initiated on January 1st 2023.

The most common disease conditions in clinical trials are Arthritis, Rheumatoid, Arthritis, and Nephrosis. The leading clinical trial sponsors are Lee's Pharmaceutical Limited, Asahi Kasei Pharma Corporation, and Chong Kun Dang Pharmaceutical.

There are seven hundred and eighteen US patents protecting this investigational drug and zero international patents.

Recent Clinical Trials for Mizoribine
TitleSponsorPhase
Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation RecipientsLee's Pharmaceutical LimitedPhase 4
An Open Study on the Preventive Effect of Early Mizoribine Conversion on BKV Nephropathy in Renal Transplant RecipientsLee's Pharmaceutical LimitedPhase 4
A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)Regeneron PharmaceuticalsPhase 3

See all Mizoribine clinical trials

Clinical Trial Summary for Mizoribine

Top disease conditions for Mizoribine
Top clinical trial sponsors for Mizoribine

See all Mizoribine clinical trials

US Patents for Mizoribine

Drugname Patent Number Patent Title Patent Assignee Estimated Expiration
Mizoribine ⤷  Try for Free Small molecules for the modulation of MCL-1 and methods of modulating cell death, cell division, cell differentiation and methods of treating disorders Dana-Farber Cancer Institute, Inc. (Boston, MA) ⤷  Try for Free
Mizoribine ⤷  Try for Free Ethylsulfonated hyaluronic acid biopolymers and methods of use thereof The Regents of the University of California (Oakland, CA) ⤷  Try for Free
Mizoribine ⤷  Try for Free Compounds useful for the treatment of metabolic disorders and synthesis of the same North Carolina Central University (Durham, NC) The University of North Carolina at Chapel Hill (Chapel Hill, NC) ⤷  Try for Free
Mizoribine ⤷  Try for Free Cellulose micropowder ASAHI KASEI KABUSHIKI KAISHA (Tokyo, JP) ⤷  Try for Free
Mizoribine ⤷  Try for Free Cured gel and method of making ATRIUM MEDICAL CORPORATION (Merrimack, NH) ⤷  Try for Free
>Drugname >Patent Number >Patent Title >Patent Assignee >Estimated Expiration

International Patents for Mizoribine

Drugname Country Document Number Estimated Expiration Related US Patent
Mizoribine Australia AU2011210567 2030-01-29 ⤷  Try for Free
Mizoribine Canada CA2787784 2030-01-29 ⤷  Try for Free
Mizoribine European Patent Office EP2528893 2030-01-29 ⤷  Try for Free
Mizoribine European Patent Office EP3138838 2030-01-29 ⤷  Try for Free
Mizoribine Japan JP2013518816 2030-01-29 ⤷  Try for Free
>Drugname >Country >Document Number >Estimated Expiration >Related US Patent

Mizoribine: Development Updates and Market Projections

Last updated: January 5, 2025

Introduction to Mizoribine

Mizoribine, also known as Bredinin, is an immunosuppressive agent that belongs to the imidazole nucleoside class. It was first isolated from the ascomycete Eupenicillium brefeldianum, found in the soil of Hachijo Island, Tokyo, Japan, in 1971. Mizoribine has been approved in Japan for the treatment of various autoimmune diseases, including lupus nephritis, rheumatoid arthritis, and primary nephritic syndrome[1].

Mechanism of Action

Mizoribine exerts its immunosuppressive effects by inhibiting the synthesis of guanine nucleotides. After phosphorylation, mizoribine-5’-monophosphate (MZB-P) blocks the enzymes inosine monophosphate dehydrogenase (IMPDH) and GMP-synthetase, which are crucial in the purine synthesis pathway. This inhibition significantly reduces the production of guanine nucleotides, thereby suppressing cell growth, particularly in lymphocytes. This mechanism makes mizoribine less toxic compared to other immunosuppressants like azathioprine[1].

Clinical Uses

Mizoribine has been approved for several clinical applications:

  • Lupus Nephritis: Approved in Japan in 1990, mizoribine is used to manage this autoimmune kidney disease.
  • Rheumatoid Arthritis: Approved in 1992, it is used in combination with corticosteroids and anti-inflammatory drugs to treat this condition.
  • Primary Nephritic Syndrome: Approved in 1995, mizoribine is used to treat this kidney disorder.
  • Renal Transplantation: It is also used to prevent rejection in renal transplant patients.
  • Steroid-Resistant Nephrotic Syndrome: Mizoribine has shown efficacy in treating this condition as well[1].

Market Trends and Projections

Global Market Outlook

The global mizoribine market is anticipated to experience significant growth driven by several key factors:

  • Increasing Prevalence of Autoimmune Diseases: The rising incidence of autoimmune diseases such as lupus nephritis, rheumatoid arthritis, and other inflammatory conditions is expected to drive the demand for immunosuppressive agents like mizoribine[5].
  • Growing Demand in Organ Transplantation: The increasing number of organ transplant procedures globally will also contribute to the growth of the mizoribine market[5].
  • Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure, particularly in North America and the Asia Pacific region, will facilitate better access to mizoribine and other immunosuppressive drugs[5].

Regional Analysis

  • North America: This region is expected to dominate the mizoribine market due to its well-established healthcare infrastructure and high prevalence of autoimmune diseases. Significant investments in research and development activities also contribute to this dominance[5].
  • Asia Pacific: Countries like China and Japan are expected to witness significant growth, driven by increasing healthcare expenditure, a growing geriatric population, and rising awareness about autoimmune diseases[5].

Market Size and Growth Rate

The global mizoribine market size was valued at several million dollars in 2023, with a projected compound annual growth rate (CAGR) that is expected to drive the market to new heights by 2031. While the exact CAGR figures are not specified, the overall trend indicates a positive outlook for the industry[2][5].

Key Drivers and Barriers

Key Drivers

  • Increasing Prevalence of Autoimmune Diseases: The growing number of patients with autoimmune diseases is a major driver.
  • Growing Demand for Immunossuppressant Drugs: The need for effective immunosuppressants in organ transplantation procedures.
  • Advancements in Healthcare Infrastructure: Improvements in healthcare facilities and access to treatments.
  • Research and Development Activities: Ongoing research to expand the therapeutic applications of mizoribine[5].

Key Barriers

  • Regulatory Challenges: Strict regulatory approvals and monitoring can slow market growth.
  • Competition from Other Immunossuppressants: The presence of other immunosuppressive agents in the market can pose competition.
  • Economic Factors: High costs associated with research, development, and marketing can be a barrier[5].

Development Updates

Novel Formulations and Dosage Forms

There is a focus on developing novel formulations and dosage forms to improve patient compliance and efficacy. This includes oral and injectable forms that are more convenient and effective for patients[5].

Expanding Therapeutic Applications

Research and development activities are aimed at expanding the therapeutic applications of mizoribine beyond its current uses. For example, studies have shown that mizoribine can inhibit hepatitis C virus RNA replication and has potential in treating other viral infections when combined with other antiviral drugs[1].

Clinical Trials and Studies

Several clinical trials and studies have been conducted to evaluate the efficacy and safety of mizoribine in various conditions. For instance, mizoribine has been found to reduce urinary protein excretion in rats with puromycin aminonucleoside nephrosis and has shown promise in treating steroid-dependent nephrotic syndrome in children[1].

Geographical Spread

The mizoribine market is geographically spread across:

  • North America: Dominating the market due to its advanced healthcare infrastructure.
  • Asia Pacific: Expected to witness significant growth, particularly in China and Japan.
  • Europe: Countries like Germany, France, and the UK are also significant markets.
  • Latin America: Countries such as Mexico and Brazil are emerging markets.
  • Middle East & Africa: Countries like Turkey, Saudi Arabia, and the UAE are also part of the growing market[5].

Key Takeaways

  • Mizoribine is an immunosuppressive agent with a unique mechanism of action that inhibits guanine nucleotide synthesis.
  • It is approved for treating various autoimmune diseases and is used in organ transplantation.
  • The global mizoribine market is expected to grow significantly driven by the increasing prevalence of autoimmune diseases and advancements in healthcare infrastructure.
  • North America and the Asia Pacific region are key markets, with a focus on developing novel formulations and expanding therapeutic applications.

FAQs

What is mizoribine used for?

Mizoribine is used for the treatment of autoimmune diseases such as lupus nephritis, rheumatoid arthritis, and primary nephritic syndrome. It is also used in renal transplantation and steroid-resistant nephrotic syndrome.

How does mizoribine work?

Mizoribine works by inhibiting the synthesis of guanine nucleotides through the blockade of enzymes IMPDH and GMP-synthetase, thereby suppressing cell growth.

What are the key drivers of the mizoribine market?

The key drivers include the increasing prevalence of autoimmune diseases, growing demand for immunosuppressant drugs in organ transplantation, and advancements in healthcare infrastructure.

Which regions are expected to dominate the mizoribine market?

North America and the Asia Pacific region are expected to dominate the market due to their well-established healthcare infrastructure and growing demand for immunosuppressive agents.

What are the potential barriers to the growth of the mizoribine market?

Potential barriers include regulatory challenges, competition from other immunosuppressants, and economic factors such as high research and development costs.

Is mizoribine available globally?

Mizoribine is primarily approved and used in Japan but is expected to see increased global availability as the market grows and more countries recognize its therapeutic benefits.

Sources

  1. Inxight Drugs: Mizoribine - Inxight Drugs.
  2. Cognitive Market Research: Global Mizoribine Market Report 2024 Edition.
  3. GlobeNewswire: Plaque Psoriasis Drug Forecast and Market Analysis to 2030.
  4. FDA: 761123Orig1s000 - accessdata.fda.gov.
  5. Hashnode: Mizoribine Market: Exploring Market Share, Market Trends, and Future Growth.

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