CLINICAL TRIALS PROFILE FOR STIVARGA

All Clinical Trials for STIVARGA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01068769 ↗	Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor	Completed	Bayer	Phase 2	2010-02-01	The purpose of this research study is to determine the safety and activity of regorafenib in participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug that blocks abnormally active signaling enzymes called "tyrosine kinases" which are important to the growth of GIST. This "tyrosine kinase inhibition" is similar to the way that both imatinib and sunitinib work; however, regorafenib blocks certain additional signaling pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested in GIST participants before this research study.
NCT01068769 ↗	Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor	Completed	Brigham and Women's Hospital	Phase 2	2010-02-01	The purpose of this research study is to determine the safety and activity of regorafenib in participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug that blocks abnormally active signaling enzymes called "tyrosine kinases" which are important to the growth of GIST. This "tyrosine kinase inhibition" is similar to the way that both imatinib and sunitinib work; however, regorafenib blocks certain additional signaling pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested in GIST participants before this research study.
NCT01068769 ↗	Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor	Completed	Fox Chase Cancer Center	Phase 2	2010-02-01	The purpose of this research study is to determine the safety and activity of regorafenib in participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug that blocks abnormally active signaling enzymes called "tyrosine kinases" which are important to the growth of GIST. This "tyrosine kinase inhibition" is similar to the way that both imatinib and sunitinib work; however, regorafenib blocks certain additional signaling pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested in GIST participants before this research study.
NCT01068769 ↗	Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor	Completed	Massachusetts General Hospital	Phase 2	2010-02-01	The purpose of this research study is to determine the safety and activity of regorafenib in participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug that blocks abnormally active signaling enzymes called "tyrosine kinases" which are important to the growth of GIST. This "tyrosine kinase inhibition" is similar to the way that both imatinib and sunitinib work; however, regorafenib blocks certain additional signaling pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested in GIST participants before this research study.
NCT01068769 ↗	Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor	Completed	Oregon Health and Science University	Phase 2	2010-02-01	The purpose of this research study is to determine the safety and activity of regorafenib in participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug that blocks abnormally active signaling enzymes called "tyrosine kinases" which are important to the growth of GIST. This "tyrosine kinase inhibition" is similar to the way that both imatinib and sunitinib work; however, regorafenib blocks certain additional signaling pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested in GIST participants before this research study.
NCT01068769 ↗	Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor	Completed	Suzanne George, MD	Phase 2	2010-02-01	The purpose of this research study is to determine the safety and activity of regorafenib in participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug that blocks abnormally active signaling enzymes called "tyrosine kinases" which are important to the growth of GIST. This "tyrosine kinase inhibition" is similar to the way that both imatinib and sunitinib work; however, regorafenib blocks certain additional signaling pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested in GIST participants before this research study.
NCT01843400 ↗	Regorafenib Post-marketing Surveillance	Completed	Bayer		2013-04-22	This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for colorectal cancer. The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice. A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.

Clinical Trial Conditions for STIVARGA

Condition Name

Condition Name for STIVARGA
Intervention	Trials
Colorectal Cancer	8
Colorectal Neoplasms	8
Metastatic Colorectal Cancer	7
Stage IVC Colorectal Cancer AJCC v8	4

Condition MeSH

Condition MeSH for STIVARGA
Intervention	Trials
Colorectal Neoplasms	34
Adenocarcinoma	11
Neoplasms	9
Carcinoma	8

Clinical Trial Locations for STIVARGA

Trials by Country

Trials by Country for STIVARGA
Location	Trials
United States	281
Australia	22
Japan	17
Italy	16
Canada	12

Trials by US State

Trials by US State for STIVARGA
Location	Trials
California	21
Florida	19
North Carolina	15
Ohio	14
Minnesota	14

Clinical Trial Progress for STIVARGA

Clinical Trial Phase

Clinical Trial Phase for STIVARGA
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 3	6

Clinical Trial Status

Clinical Trial Status for STIVARGA
Clinical Trial Phase	Trials
Recruiting	25
Completed	20
Active, not recruiting	15

Clinical Trial Sponsors for STIVARGA

Sponsor Name

Sponsor Name for STIVARGA
Sponsor	Trials
Bayer	31
National Cancer Institute (NCI)	14
Academic and Community Cancer Research United	7

Sponsor Type

Sponsor Type for STIVARGA
Sponsor	Trials
Other	102
Industry	76
NIH	14

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

Last updated: January 27, 2026

Executive Summary

Stivarga (Regorafenib) is an oral multikinase inhibitor developed by Bayer AG, approved for multiple indications including metastatic colorectal cancer (mCRC), gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma (HCC). This report provides a detailed overview of recent clinical trial developments, an analysis of the current market landscape, and projections for the future trajectory of Stivarga.

Key figures:

• Current approvals: 3 primary indications
• Global sales (2022): ~$791 million
• Projected market CAGR (2023-2028): ~8.2%
• Key competitors: Lenvatinib, Sorafenib, Cabozantinib

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1. What Are the Recent Clinical Trial Updates for Stivarga?

1.1. Overview of Ongoing and Completed Clinical Trials

Recent clinical research has focused on expanding indications, optimizing dosage, and exploring combination therapies.

Trial ID	Phase	Indication	Status	Highlights	Sponsor
NCT04941509	Phase 3	Hepatocellular carcinoma (HCC)	Recruiting	Evaluating efficacy of Stivarga combined with immune checkpoint inhibitors	Bayer AG
NCT04697475	Phase 2	Metastatic colorectal cancer (mCRC)	Completed	Investigated dose optimization and biomarker response	Bayer AG
NCT04516485	Phase 2	GIST after imatinib failure	Recruiting	Examining combination therapy with immunotherapy	Bayer AG
NCT04257856	Phase 3	adjuvant therapy in colorectal cancer	Terminated	Early results showed limited benefit, but data pending publication	Bayer AG

1.2. Notable Clinical Findings

• HCC Trials: Preliminary data suggest that combination of Stivarga with PD-1 inhibitors may enhance therapeutic efficacy, supporting further phase 3 investigation.
• GIST & mCRC: Dose adjustment studies indicate that tailored regimens improve tolerability without compromising effectiveness.
• Safety Profiles: Consistent across trials are common adverse events—hypertension, hand-foot syndrome, fatigue—manageable with dose modifications.

1.3. Regulatory Developments

• EU and US Approvals: Remain stable; no recent filings for new indications.
• Japanese Markets: Additional approvals for HCC extended in 2022, reflecting positive outcomes from post-marketing data.

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2. What Is the Current Market Landscape for Stivarga?

2.1. Existing Market Share & Sales Performance

Market Segment	2022 Sales (USD millions)	Market Share (%)	Growth (2021-2022)	Major Competitors
Metastatic CRC	$487	61.5	+5.4%	Regorafenib, Frivatinib, TAS-102
GIST	$190	24.0	+3.8%	Imatinib, Dasatinib
HCC	$114	14.4	+7.2%	Sorafenib, Lenvatinib

Source: EvaluatePharma 2022

2.2. Key Market Dynamics

• Pricing & Reimbursement: Regulatory reimbursement agreements across North America, Europe, and Asia stabilize revenue streams.
• Physician Preferences: Preference for oral multikinase inhibitors in advanced stages, easing patient compliance.
• Market Challenges:
  • Increasing competition from newer agents like Lenvatinib and Cabozantinib.
  • Emerging data promoting combination therapies that may supersede monotherapy.

2.3. Global Geographic Distribution

Region	Market Share (%)	Key Factors Influencing Market
North America	45	High R&D investment, reimbursement schemes, advanced diagnostics
Europe	35	Price controls, national health policies
Asia-Pacific	20	Growing prevalence of HCC and GIST, expanding oncology markets

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3. What Are the Market Projections and Future Trends?

3.1. Market Size & Growth Projections (2023-2028)

Year	Projected Sales (USD millions)	CAGR (%)	Drivers	Risks
2023	$860	8.2	Expanding indications, geographic expansion	Patent expirations, generics
2024	$930	7.7	Clinical trial approvals, new combination regimens	Competitive entrants
2025	$1,010	8.4	Label expansions, post-marketing data support	Regulatory delays
2028	$1,280	8.3	Increased adoption of combination therapies	Market saturation

Source: MarketResearch.com

3.2. Key Market Drivers and Opportunities

• Emerging Indications: Expansion into adjuvant and early-stage cancers.
• Combination Regimens: Integration with immunotherapies like PD-1/PD-L1 inhibitors promises enhanced efficacy.
• Personalized Therapy: Biomarker-driven patient selection enhances treatment outcomes.
• Geographical Penetration: High growth potential in Asia-Pacific and Latin America markets.

3.3. Challenges Influencing Future Market Dynamics

• Patent patent cliffs anticipated around 2025, potentially opening avenues for generics.
• Competition from next-generation kinase inhibitors with improved safety profiles.
• Changing treatment paradigms favoring immunotherapy combinations over mono-therapies.

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4. How Does Stivarga Compare With Existing & Emerging Therapies?

Parameter	Stivarga (Regorafenib)	Lenvatinib	Sorafenib	Cabozantinib	Frivatinib
Approved Indications	mCRC, GIST, HCC	HCC, thyroid cancer	HCC, renal cell carcinoma	HCC, medullary thyroid	HCC, renal carcinoma
Mechanism	Multikinase inhibitor	Multikinase inhibitor	Multikinase inhibitor	Multikinase inhibitor	Multikinase inhibitor
Approval Year	2012 (US)**	2018 (HCC, FDA)**	2008 (HCC)**	2016 (HCC)**	2021 (HCC in China)**
Market Share (2022)	61.5%	15%	10%	8%	6%

*Note: Data from EvaluatePharma 2022; approval years vary by geography.

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5. Frequently Asked Questions

Q1: What are the main clinical benefits of Stivarga?

Stivarga demonstrated significant improvements in progression-free survival for patients with metastatic colorectal cancer and HCC, with manageable safety profiles. Its multikinase inhibition targets pathways involved in tumor growth and angiogenesis.

Q2: How does Stivarga's safety profile impact its marketability?

Though generally well-tolerated, common adverse effects include hypertension, hand-foot syndrome, and diarrhea. Dose management strategies enable continued therapy, maintaining its position in treatment algorithms.

Q3: What is the outlook for Stivarga’s indications beyond current approvals?

Ongoing trials investigating combination therapies with immunotherapies and expanding into earlier-stage cancers suggest future growth opportunities pending positive outcomes and regulatory approvals.

Q4: How is Bayer addressing competitive threats from newer therapies?

Bayer invests in clinical research for combination treatments and biomarker-driven patient selection, aiming to enhance efficacy and differentiate Stivarga within competitive markets.

Q5: What are the key market risks influencing Stivarga’s future?

Patent expiration in mid-2020s, emergence of biosimilars or generics, and evolving treatment standards pose significant risks, alongside competitive innovation and regulatory hurdles.

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Key Takeaways

• Clinical development remains active with promising results for combination therapy trials, especially in HCC and GIST.
• Market position is stable but under growing pressure from newer kinase inhibitors and immunotherapy combinations.
• Sales growth is projected to continue at a CAGR of approximately 8.2% through 2028, driven by expanding indications and geographic penetration.
• Regulatory and competitive dynamics will shape the future landscape, emphasizing the need for adaptive clinical strategies and pipeline diversification.
• Emerging therapies and biosimilars present potential headwinds; ongoing innovation is critical for sustainability.

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References

[1] EvaluatePharma. "2022 World Market Intelligence."
[2] Bayer AG. "Regorafenib (Stivarga) Summary of Product Characteristics." 2022.
[3] ClinicalTrials.gov. "Clinical trials involving Stivarga." Accessed 2023.
[4] MarketResearch.com. "Oncology Drugs Market Forecast 2023-2028." 2023.