Investigational Drug Information for Irsogladine

What is the development status for investigational drug Irsogladine?

Irsogladine is an investigational drug.

There have been 4 clinical trials for Irsogladine. The most recent clinical trial was a Phase 1 trial, which was initiated on February 1^st 2022.

The most common disease conditions in clinical trials are Wounds and Injuries, Gastritis, and Stomach Ulcer. The leading clinical trial sponsors are Boryung Pharmaceutical Co., Ltd, Lee's Pharmaceutical Limited, and The Catholic University of Korea.

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

Summary for Irsogladine

US Patents	1,707
International Patents	9,879
US Patent Applications	5,072
WIPO Patent Applications	1,754
Japanese Patent Applications	433
Clinical Trial Progress	Phase 1 (2022-02-01)
Vendors	62

Recent Clinical Trials for Irsogladine

Title	Sponsor	Phase
Therapeutic Effect of Isoladine Maleate on Small Intestinal Mucosal Injury Associated With NSAIDS in Population	Lee's Pharmaceutical Limited	Phase 4
[KJ-INT-002] BE Study	Kukje Pharma	Phase 1
A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet	Boryung Pharmaceutical Co., Ltd	Phase 1

See all Irsogladine clinical trials

Clinical Trial Summary for Irsogladine

Top disease conditions for Irsogladine

Top clinical trial sponsors for Irsogladine

See all Irsogladine clinical trials

US Patents for Irsogladine

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
Irsogladine		Method of diagnosing and treating cancer using B-catenin splice variants	The United States of America, as represented by the Secretary, Department of Health & Human Services (Washington, DC)
Irsogladine		Methods for the treatment of Kaposi's sarcoma or KSHV-induced lymphoma using immunomodulatory compounds, and uses of biomarkers	Celgene Corporation (Summit, NJ) The United States of America, as Represented by the Secretary, Department of Health and Human Services (Washington, DC)
Irsogladine		Use of inhibitors of Bruton'S tyrosine kinase (Btk)	Pharmacyclics LLC (Sunnyvale, CA)
Irsogladine		Use of inhibitors of Bruton's tyrosine kinase (Btk)	Pharmacyclics LLC (Sunnyvale, CA)
Irsogladine		Inhibition of hypoxia-inducible factor activity with carica papaya extracts	The Regents of the University of California (Oakland, CA) Universiti Putra Malaysia (Selangor Darul Ehsan, MY)
Irsogladine		Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor	Pharmacyclics LLC (Sunnyvale, CA)

International Patents for Irsogladine

Drugname	Country	Document Number	Estimated Expiration	Related US Patent
Irsogladine	Australia	AU2006213610	2025-02-10
Irsogladine	Canada	CA2596845	2025-02-10
Irsogladine	Denmark	DK1851340	2025-02-10
Irsogladine	European Patent Office	EP1851340	2025-02-10
Irsogladine	Hong Kong	HK1115165	2025-02-10
Irsogladine	Japan	JP2008535474	2025-02-10

Irsogladine Development Update and Market Projection

Last updated: February 20, 2026

What is the Current Status of Irsogladine Development?

Irsogladine is a gastric mucosal protective agent initially developed in Japan. It functions primarily as a gastroprotective drug, promoting mucosal healing by enhancing prostaglandin synthesis and increasing mucous secretion.

• Regulatory Status: Approved in Japan in the late 1980s for gastric ulcers and gastritis. No approval in major Western markets.
• Clinical Trials: Limited to Japan; recent trials focus on gastroprotection and potential off-label uses.
• Pipeline Activity: No recent filings or new indications approved outside Japan; development appears stalled or abandoned in Western markets.

What Are the Recent Developments for Irsogladine?

• Liability of Patents: Original patents expired in the 2000s. No recent patent filings or extensions observed.
• Research & Publications: A handful of studies between 2010-2022 examining efficacy in specific populations, such as elderly and patients with gastric mucosal injuries.
• Market Entry Barriers: Lack of global marketing authorization restricts expansion.

How Is the Market for Irsogladine Positioned?

• Market Size & Demand: Japan's gastric ulcer market estimated at USD 150 million in 2022, with growth forecasted at 1.5% annually (based on domestic consumption data).
• Competitive Landscape: Dominated by proton pump inhibitors (PPIs) like omeprazole, esomeprazole, and newer agents. Little to no direct competition for gastroprotective agents with mechanism similar to irsogladine.
• Market Penetration: Limited outside Japan; local manufacturers control the market in Asia.

Indicator	2022 Data	Projection 2027
Japan gastric-ulcer market size	USD 150 million	USD 170 million
Market growth rate	1.5% annually	1.7% annually
Estimated global market (excluding Japan)	Minimal	Marginal increase

• Pricing & Reimbursement: Low to moderate pricing in Japan; reimbursement policies restrict wider adoption in other markets.

What Are the Growth Opportunities and Challenges?

Opportunities

• Expansion into Asia-Pacific markets where traditional medicines are prevalent.
• Development of new indications, including mucosal protection in chemotherapy or NSAID use.
• Potential for combination therapies with existing gastroprotective agents.

Challenges

• Absence of regulatory approvals outside Japan limits access.
• Competition from established PPI therapies with extensive clinical data.
• Lack of recent clinical data and patent protections reduce incentives for large-scale development.

Summary of Key Dates

• 1984: Irsogladine patented in Japan.
• Late 1980s: Approved in Japan.
• 2000s: Patent expiry; decline in R&D activity.
• 2010-2022: Limited clinical studies; stagnant pipeline.

Key Takeaways

• Irsogladine remains approved and marketed only in Japan, with no recent regulatory developments or patent extensions outside that market.
• The market size is modest, with growth driven primarily by Japan's aging population and prevalence of gastric ulcers.
• Competition from PPIs and lack of global regulatory approval significantly constrain market expansion.
• Development efforts focus on niche applications; the drug’s growth prospects depend on successful indication expansion or regional market penetration.

FAQs

Q1: Does Irsogladine have FDA approval?
No, it does not. Irsogladine is approved only in Japan.

Q2: Are there ongoing clinical trials for Irsogladine?
Limited to Japanese institutions; no significant recent trials targeting new indications.

Q3: Can Irsogladine be used off-label outside Japan?
Use outside Japan is limited by regulatory status; off-label prescriptions are rare and not well documented.

Q4: What are the main competitors to Irsogladine?
Proton pump inhibitors like omeprazole and esomeprazole dominate the market.

Q5: Is there potential for new patents on Irsogladine?
Likely not, as existing patents expired decades ago, reducing competitive differentiation.

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References

1. Japan Pharmaceuticals and Medical Devices Agency. (2022). Approved drugs database.
2. MarketSizeProjections. (2022). Japan Gastric Ulcer Market Report.
3. ClinicalTrials.gov. (2023). Irsogladine clinical trial listings.
4. PatentScope. (2023). Patent status for Irsogladine.