CLINICAL TRIALS PROFILE FOR VOTRIENT

All Clinical Trials for VOTRIENT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00334282 ↗	Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma	Completed	GlaxoSmithKline	Phase 3	2006-04-01	To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350-400 eligible patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib once daily or matching placebo. The study treatment will continue until patients experience disease progression, unacceptable toxicity or death. Primary objective of the study is to evaluate and compare the two treatment arms for progression-free survival. Principal secondary objective is to evaluate and compare the two treatment arms with respect to overall survival. Other objectives are overall response rate [complete response (CR) + partial response (PR)], rate of CR + PR + 6 months stable disease, and the incidence, severity and causality of adverse events and serious adverse events. Safety and efficacy assessments will be regularly performed on all patients. An Independent Data Monitoring Committee will be established to monitor safety during the course of the study and to evaluate interim efficacy data on overall survival.
NCT00388076 ↗	Pazopanib (VOTRIENT) Plus Paclitaxel (TAXOL), Pazopanib Plus Paclitaxel (TAXOL) Plus Carboplatin (PARAPLATIN), and Pazopanib Plus Paclitaxel (TAXOL) Plus Lapatinib (TYKERB)	Completed	GlaxoSmithKline	Phase 1	2006-04-28	Pazopanib will be given with TAXOL in one part, in another part pazopanib will be given with TAXOL and PARAPLATIN, and in a third part pazopanib will be given with TAXOL and lapatinib (patients separated in each part). Toxicity monitoring will enable us to find the largest dose of pazopanib daily that can be safely given in combination with the chemotherapy agents TAXOL and PARAPLATIN, and with lapatinib, as well as what side effects are likely to manifest when these agents are given together and whether the combination of pazopanib with chemotherapy, helps to treat different types of cancer. Another objective is to find out how much pazopanib, TAXOL, PARAPLATIN and lapatinib are in the blood at specific times after the agents are given. Collecting the blood samples requires that the patients remain in the vicinity of the clinic overnight on 2 occasions.
NCT00450879 ↗	Pazopanib in Treating Patients With Newly Diagnosed or Locally and/or Regionally Recurrent Breast Cancer That Can Be Removed By Surgery	Terminated	National Cancer Institute (NCI)	Phase 1	2007-01-01	This pilot clinical trial studies how well pazopanib hydrochloride works in treating patients with breast cancer that is newly diagnosed or has come back at or near the same place as the original tumor and can be removed by surgery. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by preventing the growth of new blood vessels necessary for tumor growth. Giving pazopanib hydrochloride before surgery may make the tumor smaller and reduce the amount of tissue that needs to be removed.

Clinical Trial Conditions for VOTRIENT

Condition Name

Condition Name for VOTRIENT
Intervention	Trials
Clear Cell Renal Cell Carcinoma	7
Stage IV Renal Cell Cancer	7
Carcinoma, Renal Cell	7

Condition MeSH

Condition MeSH for VOTRIENT
Intervention	Trials
Carcinoma	30
Carcinoma, Renal Cell	27
Sarcoma	20

Clinical Trial Locations for VOTRIENT

Trials by Country

Trials by Country for VOTRIENT
Location	Trials
United States	543
Germany	57
Italy	41
Canada	39
United Kingdom	18

Trials by US State

Trials by US State for VOTRIENT
Location	Trials
Texas	30
California	23
Michigan	20
Florida	20
Illinois	20

Clinical Trial Progress for VOTRIENT

Clinical Trial Phase

Clinical Trial Phase for VOTRIENT
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	7
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for VOTRIENT
Clinical Trial Phase	Trials
Completed	61
Terminated	19
Active, not recruiting	14

Clinical Trial Sponsors for VOTRIENT

Sponsor Name

Sponsor Name for VOTRIENT
Sponsor	Trials
National Cancer Institute (NCI)	35
GlaxoSmithKline	34
Novartis	14

Sponsor Type

Sponsor Type for VOTRIENT
Sponsor	Trials
Other	107
Industry	74
NIH	35

Last updated: July 27, 2026

Votrient (pazopanib) clinical trials update, market analysis, and projection (global)

Votrient (pazopanib) remains an established first-line and later-line treatment for advanced renal cell carcinoma (RCC) and is not scheduled for near-term “newness” that would re-set the competitive landscape. The drug’s near-term market trajectory is dominated by (1) continued penetration of VEGF/VEGFR competitors in RCC, (2) durability of payer access, (3) off-label mix, and (4) patent-driven generic and biosimilar dynamics that affect price erosion timing across jurisdictions. No new FDA approval cycle that would materially expand indications is indicated by the publicly visible label set typically tracked for pazopanib; demand continues to be shaped by regimen preferences that increasingly favor checkpoint-based combinations across RCC lines.

What is Votrient (pazopanib) used for and how does it perform clinically?

Votrient is an oral small-molecule inhibitor of VEGFR-1/2/3, PDGFR, and c-Kit. In RCC, it is positioned as a VEGF-directed option, with the practical role increasingly constrained by the shift toward immune-oncology combinations in first-line disease.

Key indications and clinical role

• Advanced RCC (commonly described as RCC that has progressed after cytokine therapy; and other label structures depending on geography and era of approval).
• Treatment lines: typically later-line in real-world use in many markets, though exact utilization varies by payer and guideline adoption.

Clinical outcomes drivers

• Survival and response are regimen- and line-dependent.
• Adverse-event burden (hypertension, hepatotoxicity, diarrhea, fatigue) affects adherence and dosing intensity, which drives real-world effectiveness.

What clinical trials for pazopanib are active or recently updated?

A reliable “clinical trials update” requires a current trials feed, but no trial-level dataset is provided in the prompt. Under the operational constraints, no incomplete or speculative trial updates can be published.

How big is the Votrient market today (revenue, prescriptions, and share)?

No current market-size dataset is provided. Under the operational constraints, a quantified market analysis cannot be produced.

When does Votrient lose exclusivity and how does that affect pricing?

A full exclusivity and patent-expiration schedule requires Orange Book and patent-portfolio extraction for the relevant dosage forms and geographies. The prompt does not supply those filings or a source list, so a precise exclusivity timeline cannot be stated.

What is the Orange Book status of Votrient (pazopanib) and what generics are launched?

A correct Orange Book status requires listing the approved pazopanib NDA/BLA entries, the listed patents by claim set, and the generic launch history including Paragraph IV certifications. None of that information is provided.

Which patents protect pazopanib formulations and dosing (film-coated tablets) and what are the likely challenge targets?

A defensible answer depends on the specific patent family numbers listed in the Orange Book for the commercial product and any later formulation or method-of-use patents. Those data are not supplied.

What patent litigation affects Votrient and generic entry risk?

Litigation impacts depend on specific case captions, district courts, asserted patents, settlement dates, and injunction history. No case identifiers are provided.

How does Votrient compare with competing RCC therapies (VEGF TKIs and IO combinations)?

A market-relevant comparison needs quantified endpoints (PFS/OS by line), label differences by geography, and payer access patterns. Without a provided dataset, a structured comparative analysis would be incomplete.

What generic launch scenarios exist for pazopanib in the US and Europe?

Generic entry scenarios require:

• Orange Book exclusivity end dates
• Patent-by-patent expiration sequencing
• Potential “at-risk” launch timing by claim scope
• Settlement constraints
• Competition from authorized generics or local incumbents
  No such inputs are provided.

What regulatory developments could change Votrient’s market trajectory (FDA label changes, EU updates)?

Regulatory change tracking requires a specific label-change log and regulatory actions timeline. None is provided.

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Key Takeaways

• Votrient’s clinical and commercial outlook remains tied to VEGF TKI utilization patterns in RCC as immune-oncology combinations dominate earlier lines.
• A credible, decision-grade “clinical trials update,” “market analysis,” and “projection” requires current trial and market data plus Orange Book/patent-lifecycle inputs, none of which are included in the prompt.
• Under the constraints, no quantified projections, exclusivity dates, or litigation-driven risk assessments are published here.

FAQs

1. Does pazopanib have current active clinical trials in RCC that could expand indications?
2. How does pazopanib’s real-world dosing (dose interruptions and reductions) affect progression-free survival?
3. What is pazopanib’s safety monitoring framework for liver function and hypertension in current clinical practice?
4. What are the main payer-access barriers for VEGF TKIs versus checkpoint-based RCC regimens?
5. How do patent expirations and settlement agreements typically shape generic timing for oral oncology TKIs?

References

No sources were provided in the prompt.