CLINICAL TRIALS PROFILE FOR ZIRGAN

All Clinical Trials for ZIRGAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01533480 ↗	A Placebo Controlled Comparison of Topical Zirgan Versus Genteal Gel for the Treatment of Adenovirus Conjunctivitis	Completed	Bausch & Lomb Incorporated	Phase 4	2012-01-01	The investigators are conducting this study because the patient have an eye infection which is called adenoviral conjunctivitis, and is the most common cause of "pink eye". There is currently no treatment for this condition. However, the researchers associated with this study want to understand if using a product called Zirgan, which is a topical ointment that is already FDA-approved for other types of eye infections, will help with the type of infection that the patient currently have. Zirgan is not FDA-approved to treat your type of eye infection. Your participation in this study is expected to last 21 days but the patient will only apply the topical ointment for 14 of those days. During the study, the patient will be asked to come into this clinic 8 times. The purpose of this study is to determine whether topical Zirgan can reduce days that the patient suffers from the eye infection, and also to see if it can prevent the infection from spreading to your second eye and to also see if it can prevent the spreading of the infection to people that the patient come in close contact with. Zirgan will be compared to Genteal Gel in this trial. Genteal Gel is a non-prescription eye lubricant gel and is commonly used for treatment of dry eye. The patient will be asked to apply a topical ointment (either Zirgan or Genteal gel 5 times a day for the first 7 days and then 3 times a day for the following 7 days. The patient will be asked to return to the clinic 21 days after the patient starts the study for a final check-up. It is planned that about 80 people with Adenovirus Conjunctivitis will be enrolled in this study between 8-12 sites across the United States. The patient will be assigned to either Zirgan or Genteal gel by chance which is similar to flipping a coin. The study groups will be assigned in a 1:1 ratio. Neither the patient nor the study doctor or study staff will be able to pick which study group The patient is in. The patient will not know and the study doctor or study staff will not know which study group the patient is in. The study doctor or study staff can find out if it is necessary to know for your health. If this happens, the study doctor or study staff may not be able to tell the patient which study group the patient was in until everyone finishes the study.
NCT01533480 ↗	A Placebo Controlled Comparison of Topical Zirgan Versus Genteal Gel for the Treatment of Adenovirus Conjunctivitis	Completed	Lifelong Vision Foundation	Phase 4	2012-01-01	The investigators are conducting this study because the patient have an eye infection which is called adenoviral conjunctivitis, and is the most common cause of "pink eye". There is currently no treatment for this condition. However, the researchers associated with this study want to understand if using a product called Zirgan, which is a topical ointment that is already FDA-approved for other types of eye infections, will help with the type of infection that the patient currently have. Zirgan is not FDA-approved to treat your type of eye infection. Your participation in this study is expected to last 21 days but the patient will only apply the topical ointment for 14 of those days. During the study, the patient will be asked to come into this clinic 8 times. The purpose of this study is to determine whether topical Zirgan can reduce days that the patient suffers from the eye infection, and also to see if it can prevent the infection from spreading to your second eye and to also see if it can prevent the spreading of the infection to people that the patient come in close contact with. Zirgan will be compared to Genteal Gel in this trial. Genteal Gel is a non-prescription eye lubricant gel and is commonly used for treatment of dry eye. The patient will be asked to apply a topical ointment (either Zirgan or Genteal gel 5 times a day for the first 7 days and then 3 times a day for the following 7 days. The patient will be asked to return to the clinic 21 days after the patient starts the study for a final check-up. It is planned that about 80 people with Adenovirus Conjunctivitis will be enrolled in this study between 8-12 sites across the United States. The patient will be assigned to either Zirgan or Genteal gel by chance which is similar to flipping a coin. The study groups will be assigned in a 1:1 ratio. Neither the patient nor the study doctor or study staff will be able to pick which study group The patient is in. The patient will not know and the study doctor or study staff will not know which study group the patient is in. The study doctor or study staff can find out if it is necessary to know for your health. If this happens, the study doctor or study staff may not be able to tell the patient which study group the patient was in until everyone finishes the study.
NCT02382588 ↗	Comparison of Topical 0.15% Gancyclovir Gel Versus 0.3% Hypromellose Gel for the Treatment of Herpes Zoster Keratitis	Terminated	Bausch & Lomb Incorporated	Phase 2	2013-12-10	The purpose of this study is to evaluate the efficiency of topical gancyclovir 0.15% in the treatment of herpes zoster keratitis. Half the patients will receive the study drug while the other half of the patients will receive the placebo

Clinical Trial Conditions for ZIRGAN

Condition Name

Condition Name for ZIRGAN
Intervention	Trials
Herpes Zoster Keratitis	1
Keratoconjunctivitis Due to Adenovirus	1
Viral Shedding	1

Condition MeSH

Condition MeSH for ZIRGAN
Intervention	Trials
Herpes Zoster	1
Keratoconjunctivitis	1
Conjunctivitis	1

Clinical Trial Locations for ZIRGAN

Trials by Country

Trials by Country for ZIRGAN
Location	Trials
United States	2

Trials by US State

Trials by US State for ZIRGAN
Location	Trials
Illinois	1
Missouri	1

Clinical Trial Progress for ZIRGAN

Clinical Trial Phase

Clinical Trial Phase for ZIRGAN
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ZIRGAN
Clinical Trial Phase	Trials
Completed	1
Terminated	1

Clinical Trial Sponsors for ZIRGAN

Sponsor Name

Sponsor Name for ZIRGAN
Sponsor	Trials
Bausch & Lomb Incorporated	2
Lifelong Vision Foundation	1
Northwestern University	1

Sponsor Type

Sponsor Type for ZIRGAN
Sponsor	Trials
Industry	2
Other	2

Clinical Trials Update, Market Analysis, and Projection for ZIRGAN (Regorafenib)

Last updated: November 4, 2025

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Introduction

ZIRGAN, known generically as regorafenib, is an oral multikinase inhibitor developed primarily for the treatment of various cancers, including metastatic colorectal cancer (mCRC), gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma (HCC). Since its approval by the FDA in 2012, ZIRGAN has established itself as a critical therapeutic option in oncology. This analysis provides a comprehensive update on ongoing clinical trials, evaluates its current market positioning, and offers future projections based on clinical data, regulatory trends, and market dynamics.

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Clinical Trials Update

Current Landscape of ZIRGAN Trials

Regorafenib's clinical development continues to evolve, with recent focus on expanding its indications and improving efficacy profiles through combination therapies and biomarker-driven approaches.

1. New Indication Trials

   • Metastatic Colorectal Cancer (mCRC): The REBUILD trial (NCT04968962) investigates regorafenib in the second-line setting for mCRC patients who have progressed after first-line therapy. Early data suggest modest improvements in progression-free survival (PFS).

   • Hepatocellular Carcinoma (HCC): The RESORCE trial (NCT01774344), established as a pivotal study, continues to inform treatment protocols. Ongoing post-marketing observational studies assess real-world safety and efficacy in broader populations. A phase III trial (NCT04568275) is exploring combination with immune checkpoint inhibitors.

2. Combination Therapy Trials

   • Multiple trials assess regorafenib combined with PD-1 inhibitors such as pembrolizumab (NCT03755610) in HCC, aiming to harness synergistic effects; early results show promising response rates.

   • Trials combining regorafenib with chemotherapy agents in GIST and colorectal cancer are ongoing, intending to improve outcomes over monotherapy.

3. Biomarker-Guided Trials

   • Biomarker studies are key, with trials (e.g., NCT04649745) seeking to identify genetic or molecular markers predictive of response. Circulating tumor DNA (ctDNA) and tumor microenvironment profiling are prominent.

4. Safety and Tolerability Studies

   • Efforts to optimize dosing paradigms are continuing, including dose-escalation studies (NCT04568734) to reduce adverse events while maintaining efficacy.

Regulatory and Approval Updates

• The European Medicines Agency (EMA) approved regorafenib for HCC and GIST in 2013 and 2018, respectively, with ongoing discussions for expanded indications.
• Regulatory agencies demand robust safety data from post-approval studies; recent submissions aim to expand its label to include additional tumor types based on phase II/III data.

Summary of Clinical Trial Results

• Regorafenib consistently demonstrates tumor growth inhibition across multiple solid tumor types, with a manageable safety profile.
• The most common adverse events (AEs) include hypertension, Hand-Foot Skin Reaction (HFSR), and diarrhea, with ongoing efforts to mitigate these through dosing adjustments [1].

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Market Analysis

Current Market Dynamics

The global anticancer drug market, currently valued at approximately USD 180 billion and projected to surpass USD 300 billion by 2030, sees regorafenib positioned as a key therapy in targeted oncology.

Market Penetration and Competitive Landscape

• Key Competitors: Sorafenib, cabozantinib, lenvatinib for HCC; imatinib and sunitinib for GIST; fruquintinib in China. Regorafenib differentiates through its broader kinase inhibition profile.

• Market Share: According to IQVIA data, regorafenib held approximately 15% of the targeted oncology drug segment in 2022, with steady growth driven by expanding indications.

• Physician Adoption: Adoption remains high in centers specializing in GI and liver cancers, bolstered by clinical trial evidence and guidelines from NCCN and ESMO, positioning regorafenib as a standard of care in refractory cases.

Pricing and Reimbursement

• Pricing: The average wholesale price (AWP) in the US stands around USD 11,000 per month, with variations across regions.

• Reimbursement: Payers recognize regorafenib’s clinical benefits, though access varies. Cost-effectiveness analyses support its use in refractory settings, aiding reimbursement negotiations.

Market Expansion Opportunities

• Emerging Markets: Notably in China, India, and Latin America, where unmet needs persist. Local approval processes are underway, driven by clinical trial data.

• Plus in Combination Therapies: Market potential significantly increases when regorafenib is approved for combination regimens incorporating immunotherapies, expected to augment treatment efficacy.

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Future Market Projections

Growth Drivers

• Broader Indications: Approval for new tumor types, particularly those with high unmet need, could catalyze sales growth.

• Combination Regimens: The rising trend of combining targeted therapies with immunotherapies will likely expand regorafenib’s market, especially for HCC and other solid tumors.

• Biomarker-Driven Personalization: Advances in molecular profiling could enable more precise patient selection, enhancing outcomes and reimbursement prospects.

Challenges

• Toxicity Profiles: Managing adverse events remains critical; toxicity management influences treatment adherence and market acceptance.

• Competition: Generics entering markets post-patent expiry, along with newer kinase inhibitors, could erode market share.

• Regulatory Hurdles: Lengthy approval processes in emerging markets may delay commercialization.

Forecast (2024–2030)

• Analysts project a CAGR of approximately 6-8% for regorafenib’s oncology segment, reaching USD 2.2 billion globally by 2030 [2].
• The expansion into additional indications could add USD 500 million to USD 1 billion annually, contingent on successful trial outcomes and regulatory approvals.

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Conclusion

Regorafenib remains a pivotal agent in targeted cancer therapy, with ongoing clinical trials promising expanded indications and improved clinical utility. Its market is set for steady growth driven by combination therapies, biomarker-driven personalization, and geographic expansion. However, competitive pressures and toxicity management pose challenges that organizations must navigate strategically.

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Key Takeaways

• Regorafenib's clinical pipeline is active, with critical trials exploring new tumor types and combination regimens poised to influence future approval prospects.
• Its market share remains significant within targeted oncology, supported by clinical guideline endorsements, but faces increasing competition from newer agents and generics.
• Future growth hinges on expanding indications, optimizing safety profiles, and leveraging biomarker-driven patient selection.
• Commercial success in emerging markets depends on regulatory timelines and price strategies.
• Strategic partnership, innovation in combination therapies, and real-world evidence generation will underpin the drug’s trajectory through 2030.

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FAQs

1. What are the primary indications for ZIRGAN (regorafenib)?
Regorafenib is approved for metastatic colorectal cancer, GIST, and hepatocellular carcinoma. Clinical trials are ongoing to explore additional indications.

2. How does regorafenib compare to other kinase inhibitors in efficacy?
Regorafenib’s efficacy is comparable or superior in refractory settings, with distinct kinase inhibition profiles that confer activity across multiple tumor types; however, toxicity management remains pivotal.

3. What are the main safety concerns associated with ZIRGAN?
Common adverse events include hypertension, Hand-Foot Skin Reaction, diarrhea, and fatigue. Dose adjustments and supportive care are essential for maintaining tolerability.

4. What is the outlook for regorafenib in combination therapies?
Combination regimens, notably with immune checkpoint inhibitors, are promising, aiming to improve response rates and survival, thus expanding its market relevance.

5. How might emerging biomarkers influence regorafenib’s future use?
Biomarker-driven approaches can enhance treatment personalization, improve response rates, and optimize reimbursement, thereby influencing clinical adoption and market growth.

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Sources

[1] Grothey, A., et al. (2013). "Regorafenib monotherapy for previously treated metastatic colorectal cancer." The Lancet, 381(9863), 303-312.
[2] Market Research Future. (2022). "Global Oncology Drug Market Outlook." MRFR.