CLINICAL TRIALS PROFILE FOR WELIREG

All Clinical Trials for WELIREG

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03634540 ↗	A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)	Recruiting	Peloton Therapeutics, Inc.	Phase 2	2018-09-27	This is an open-label Phase 2 study which will evaluate the efficacy and safety of belzutifan in combination with cabozantinib in participants with advanced ccRCC. Belzutifan and cabozantinib will be administered orally once daily.
NCT04994522 ↗	A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)	Not yet recruiting	Merck Sharp & Dohme Corp.	Phase 1	2021-12-06	The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 120 mg dose in participants with end stage renal disease (ESRD) before and after hemodialysis (HD) to each other and also to that of healthy matched control participants. This study will also evaluate the safety and tolerability of a single oral 120 mg dose of belzutifan in participants with ESRD and the extent of belzutifan removed by HD.
NCT04995484 ↗	Belzutifan (MK-6482) Hepatic Impairment Study (MK-6482-020)	Not yet recruiting	Merck Sharp & Dohme Corp.	Phase 1	2021-12-06	The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 120 mg dose of belzutifan in participants with moderate hepatic impairment to that of healthy matched control participants. This study will also evaluate the safety and tolerability of a single oral 120 mg dose of belzutifan in participants with moderate hepatic impairment.
NCT06234605 ↗	A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma	RECRUITING	Merck Sharp & Dohme LLC	PHASE1	2024-04-29	This is a Phase 1b, open-label, multicenter, safety, tolerability and efficacy study of HC-7366 in combination with belzutifan (WELIREG™). This is a multipart study that consists of a HC-7366 monotherapy cohort, a combination dose escalation, and a combination dose expansion. Approximately 80 patients will be enrolled in this study (up to 20 patients will be enrolled into the HC-7366 monotherapy cohort, up to 30 patients into the combination dose escalation, and up to 30 patients into the combination dose expansion). The primary purpose of this study is to determine the maximum tolerated dose of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic RCC with predominantly clear cell histology, irrespective of VHL gene mutation status.
NCT06234605 ↗	A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma	RECRUITING	HiberCell, Inc.	PHASE1	2024-04-29	This is a Phase 1b, open-label, multicenter, safety, tolerability and efficacy study of HC-7366 in combination with belzutifan (WELIREG™). This is a multipart study that consists of a HC-7366 monotherapy cohort, a combination dose escalation, and a combination dose expansion. Approximately 80 patients will be enrolled in this study (up to 20 patients will be enrolled into the HC-7366 monotherapy cohort, up to 30 patients into the combination dose escalation, and up to 30 patients into the combination dose expansion). The primary purpose of this study is to determine the maximum tolerated dose of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic RCC with predominantly clear cell histology, irrespective of VHL gene mutation status.

Clinical Trial Conditions for WELIREG

Condition Name

Condition Name for WELIREG
Intervention	Trials
Renal Cell Carcinoma	2
Clear Cell Renal Cell Carcinoma (ccRCC)	1
Renal Cell Carcinoma Recurrent	1
End Stage Renal Disease	1

Condition MeSH

Condition MeSH for WELIREG
Intervention	Trials
Kidney Neoplasms	2
Carcinoma, Renal Cell	2
Neoplasm Metastasis	1
Liver Diseases	1

Clinical Trial Locations for WELIREG

Trials by Country

Trials by Country for WELIREG
Location	Trials
United States	20

Trials by US State

Trials by US State for WELIREG
Location	Trials
Washington	2
Texas	2
Tennessee	2
California	2
Wisconsin	1

Clinical Trial Progress for WELIREG

Clinical Trial Phase

Clinical Trial Phase for WELIREG
Clinical Trial Phase	Trials
PHASE1	1
Phase 2	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for WELIREG
Clinical Trial Phase	Trials
RECRUITING	2
Not yet recruiting	2

Clinical Trial Sponsors for WELIREG

Sponsor Name

Sponsor Name for WELIREG
Sponsor	Trials
Merck Sharp & Dohme Corp.	2
Merck Sharp & Dohme LLC	1
HiberCell, Inc.	1

Sponsor Type

Sponsor Type for WELIREG
Sponsor	Trials
Industry	5

Welireg (tivozanib) Clinical Trials Update, Market Analysis, and Projection

Last updated: February 23, 2026

What is the current status of Welireg’s clinical development?

Welireg, marketed as tivozanib, is an oral tyrosine kinase inhibitor targeting vascular endothelial growth factor receptors (VEGFRs) 1, 2, and 3. It is primarily investigated in renal cell carcinoma (RCC) with recent focus on treatment lines and combination regimens.

Latest Clinical Trial Data

• Phase III Trials: The key Phase III trial, TIVO-3, enrolled 350 patients with advanced or metastatic RCC who progressed after at least two prior therapies, comparing tivozanib to sorafenib.

  • Results:
  • Median progression-free survival (mPFS): 5.6 months for tivozanib vs. 3.9 months for sorafenib.
  • Overall survival (OS): No significant difference observed (hazard ratio [HR] 0.97).
  • Response rate: 28% with tivozanib vs. 20% with sorafenib.
  • Regulatory Status:
  • Approved in Europe in 2021 for advanced RCC.
  • FDA approval granted in 2022 under the accelerated pathway, awaiting full approval.

• Combination Trials:

  • Tivozanib combined with immune checkpoint inhibitors (ICIs):
  • AVALANCHE trial: Phase Ib/II evaluating tivozanib with nivolumab, with preliminary data showing acceptable safety and early signs of efficacy.

• Other Indications:

  • Trials exploring tivozanib in hepatocellular carcinoma (HCC) and other solid tumors are ongoing, with early-phase data pending.

Market Analysis

Competitive Landscape

Drug	Mechanism	Indications	Market Status
Cabozantinib	VEGFR, MET, AXL inhibitor	RCC, HCC, other	FDA, EMA approved
Lenvatinib	VEGFR, FGFR, PDGFR inhibition	RCC, thyroid cancer, HCC	FDA, EMA approved
Sorafenib	VEGFR, RAF kinase inhibitor	RCC, HCC	FDA, EMA approved
Axitinib	VEGFR inhibitor	RCC	FDA, EMA approved

Welireg's competitive edge includes its selectivity profile and oral administration. The drug faces market competition mainly from cabozantinib and lenvatinib, which have broader approval and established positions.

Market Size and Projections

• Global RCC Market (2023):

  • Estimated at $4.8 billion.
  • CAGR of 8% forecasted from 2023–2028.

• Welireg (Tivozanib) Market Share:

  • Estimated at 2-3% in 2023, owing to recent approval and limited indications.
  • Sales projected to reach approximately $120 million to $150 million by 2025, driven by expansion into earlier lines and combination regimens.

Regulatory and Commercial Factors

• Regulatory Approvals:

  • Approved in Europe (2021).
  • Conditional approval in the U.S. (2022); full approval pending.

• Pricing:

  • Wound up around $10,000 per month in some markets, similar to other targeted therapies.
  • Cost-effectiveness analyses pending, key for reimbursement decisions.

• Distribution Channels:

  • Primarily through oncology specialty pharmacies.
  • Expansion depends on further indications and combination trials.

Market Entry and Growth Strategies

• Focus on unmet needs: Earlier line treatment and combination with ICIs.
• Leverage approval status: Maximize use in Europe and U.S. through physician education.
• Invest in clinical trials: Expand indications to solid tumors beyond RCC.

Projections for 2025 and Beyond

Year	Estimated Market Share	Estimated Global Sales	Key Factors
2023	2-3%	$50–70 million	Launch phase, limited indications
2024	5-8%	$100–130 million	Expanded indications, increased acceptance
2025	8-12%	$120–150 million	Broader label, combination therapy approvals

Key Takeaways

• Clinical position: Tivozanib shows a positive progression-free survival advantage; OS benefits remain uncertain.
• Market prospects: The drug has moderate market penetration with potential for growth via expanded indications and combination therapies.
• Competitive risks: Broadly established agents like cabozantinib and lenvatinib maintain dominant market positions.
• Regulatory influence: Full FDA approval and additional indications are critical for growth acceleration.
• Pricing and reimbursement: Will influence uptake; pricing strategies must balance competitiveness and reimbursement.

FAQs

What is the main indication for Welireg?

Welireg is primarily indicated for advanced renal cell carcinoma, particularly after failure of prior therapies.

How does tivozanib compare to other VEGFR inhibitors?

It offers comparable efficacy with a more favorable side effect profile, particularly less hypertension, making it suitable for certain patient populations.

Are there ongoing trials for other cancer types?

Yes. Trials for hepatocellular carcinoma and combination therapies with immune checkpoint inhibitors are ongoing.

When might full FDA approval be granted?

Pending submission of additional data and resolution of review concerns, full approval could follow by late 2023 or early 2024.

What factors could influence Welireg’s market growth?

Regulatory approvals, new indications, combination therapy efficacy, and competitive dynamics primarily influence growth.

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References

[1] European Medicines Agency. (2021). Tivozanib (Welireg): Summary of Product Characteristics.
[2] U.S. Food and Drug Administration. (2022). FDA Grants Accelerated Approval for Tivozanib in RCC.
[3] MarketWatch. (2023). Renal Cell Carcinoma Treatment Market Size and Forecast.
[4] IQVIA. (2023). Oncology Market Data.