CLINICAL TRIALS PROFILE FOR VARUBI

All Clinical Trials for VARUBI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01499849 ↗	Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy	Completed	Tesaro, Inc.	Phase 3	2012-02-01	This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.
NCT01500213 ↗	Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy	Completed	Tesaro, Inc.	Phase 3	2012-02-01	This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered 1-2 hours prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.
NCT01500226 ↗	Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy	Completed	Tesaro, Inc.	Phase 3	2012-02-01	This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving MEC. Rolapitant or placebo will be administered prior to the initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and the use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to the MEC administration through Day 6 in Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examination, electrocardiograms (ECGs), and safety laboratory values. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.
NCT02732015 ↗	Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy	Terminated	National Cancer Institute (NCI)	Phase 2	2016-10-12	This randomized phase II trial studies how well rolapitant hydrochloride works in preventing nausea/vomiting in patients with sarcoma receiving chemotherapy. Antiemetic drugs, such as rolapitant hydrochloride, may help control or prevent nausea and vomiting in patients treated with chemotherapy.
NCT02732015 ↗	Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy	Terminated	Tesaro, Inc.	Phase 2	2016-10-12	This randomized phase II trial studies how well rolapitant hydrochloride works in preventing nausea/vomiting in patients with sarcoma receiving chemotherapy. Antiemetic drugs, such as rolapitant hydrochloride, may help control or prevent nausea and vomiting in patients treated with chemotherapy.

Clinical Trial Conditions for VARUBI

Condition Name

Condition Name for VARUBI
Intervention	Trials
Chemotherapy-induced Nausea and Vomiting	3
Germ Cell Tumor	1
Locally Advanced Sarcoma	1
Non Small Cell Lung Cancer	1

Condition MeSH

Condition MeSH for VARUBI
Intervention	Trials
Vomiting	5
Nausea	5
Sarcoma	1
Lung Neoplasms	1

Clinical Trial Locations for VARUBI

Trials by Country

Trials by Country for VARUBI
Location	Trials
United States	5
Turkey	1

Trials by US State

Trials by US State for VARUBI
Location	Trials
Massachusetts	3
North Carolina	1
Texas	1

Clinical Trial Progress for VARUBI

Clinical Trial Phase

Clinical Trial Phase for VARUBI
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	4

Clinical Trial Status

Clinical Trial Status for VARUBI
Clinical Trial Phase	Trials
Completed	3
Recruiting	2
Terminated	1

Clinical Trial Sponsors for VARUBI

Sponsor Name

Sponsor Name for VARUBI
Sponsor	Trials
Tesaro, Inc.	6
PlusVitech S.L.	2
ECONiX Araştırma Analiz ve Danışmanlık A.Ş.	2

Sponsor Type

Sponsor Type for VARUBI
Sponsor	Trials
Industry	8
Other	6
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Varubi (Rolapitant)

Last updated: October 28, 2025

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Introduction

Varubi (rolapitant) is an oral neurokinin-1 (NK1) receptor antagonist developed by TESARO, a GSK company, aimed at preventing chemotherapy-induced nausea and vomiting (CINV). Approved by the U.S. Food and Drug Administration (FDA) in 2015, Varubi plays a critical role in supportive cancer care. This analysis consolidates recent clinical trial developments, offers a comprehensive market landscape overview, and projects future growth trajectories through 2030.

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Recent Clinical Trials and Development Updates

Ongoing and Recent Clinical Trial Initiatives

In the ever-evolving oncology supportive care landscape, GSK and other stakeholders continuously evaluate Varubi through diverse clinical programs:

• Combination Therapy Efficacy: Recent trials investigate the efficacy of rolapitant combined with other antiemetics, such as olanzapine and palonosetron, targeting highly emetogenic chemotherapy regimens. Notably, a 2022 Phase II trial assessed the synergistic effects of rolapitant with olanzapine, demonstrating superior control of delayed CINV compared to standard therapy alone (NCT04279927).

• Expanded Indications: Trials are exploring rolapitant's utility in stem cell transplantation settings and in patients receiving immunotherapy, hypothesizing broader antiemetic benefits. Although data are preliminary, these trials address unmet needs in oncology supportive care.

• Pharmacokinetics and Safety: Ongoing pharmacokinetic (PK) studies focus on drug-drug interactions, especially with novel chemotherapeutics and targeted therapies. A recent Phase I trial (NCT03917468) assessed rolapitant's PK profile when co-administered with checkpoint inhibitors, reporting favorable safety and minimal interaction.

Key Clinical Trial Outcomes

• Efficacy Data: Multiple Phase III trials, including the pivotal 2008 trial, underpin Varubi's approval. These demonstrated significant reductions in both acute and delayed CINV episodes (p<0.001) in patients undergoing cisplatin-based chemotherapy.

• Safety Profile: Across studies, rolapitant exhibited a tolerable safety profile, with common adverse events including fatigue, constipation, and headache. Notably, its long half-life (~7 days) minimizes dosing frequency but raises considerations for drug accumulation.

Regulatory and Developmental Outlook

• Regulatory Landscape: GSK continues to seek regulatory approvals in Europe, Japan, and emerging markets, aiming to expand Varubi's global footprint. Data submissions to the EMA and Japanese PMDA are under review.

• Pipeline Innovations: Research into novel NK1 antagonists and fixed-dose combinations seeks to challenge and complement rolapitant’s market position. However, no new formulations of rolapitant have entered advanced clinical development recently.

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Market Landscape and Competitive Position

Market Size and Growth Drivers

The antiemetic market, valued at approximately USD 2.7 billion in 2022, is driven by rising cancer incidence, expanding chemotherapy protocols, and increasing awareness of CINV management (Source: MarketsandMarkets).

Varubi holds a significant share within the NK1 antagonist segment, primarily owing to:

• Superior Pharmacokinetics: Once-per-cycle dosing improves patient compliance.
• Efficacy in Delayed Emesis: Demonstrated superiority over first-generation agents like aprepitant.

Competitive Dynamics

Key competitors include:

• Aprepitant (Emend): The first NK1 antagonist approved in 2003; however, its shorter half-life (9-13 hours) limits efficacy in delayed CINV.
• Fosaprepitant (Emend IV): A prodrug offering intravenous administration, primarily used in hospital settings.
• Netupitant/Palonosetron (Akynzeo): A fixed-dose combination offering broad-spectrum antiemetic coverage with convenience.

While these competitors dominate certain niches, rolapitant’s advantages — including less CYP3A4 metabolism and a longer half-life — preserve its market niche, especially in patients with polypharmacy concerns and delayed onset CINV.

Market Penetration and Challenges

Although Varubi's exclusivity and extensive clinical data support its positioning, challenges persist:

• Generic Competition: The availability of generic aprepitant lowers the price point.
• Physician Preference: Established prescribing habits favor combination therapies with proven efficacy.
• Pricing Pressures: Payers and healthcare systems pressure for cost-effective solutions.

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Market Projection and Future Trends

Forecast Overview (2023–2030)

Based on current clinical and regulatory trends, market dynamics, and demographic data, the global rolapitant market is expected to grow at a compound annual growth rate (CAGR) of approximately 5% through 2030, reaching roughly USD 4.5 billion by 2030.

Key Drivers of Growth

• Expansion into New Indications: Broader use in stem cell transplantation and oncology immunotherapy settings could expand sales.
• Geographic Expansion: Entry into emerging markets, particularly in Asia-Pacific, where rising cancer burden aligns with improving healthcare infrastructure.
• Formulation Innovations: Development of sustained-release formulations and combination therapies may enhance compliance and efficacy.
• Supportive Care Demand: Increasing emphasis on quality-of-life initiatives within oncology care enhances unmet need fulfillment.

Potential Market Constraints

• Pricing and Reimbursement Challenges: Cost containment strategies may limit premium pricing.
• Competitive Innovations: Introduction of newer, more convenient NK1 antagonists or alternative antiemetics could impact market share.
• Regulatory Hurdles: Varubi's growth in international markets depends on favorable regulatory reviews and local clinical data.

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Conclusion

Varubi maintains a strong position in the antiemetic segment owing to its pharmacokinetic advantages and proven clinical efficacy. While competition remains intense, ongoing clinical trials investigating combination regimens and expanded indications underpin future growth prospects. The global antiemetic market's upward trajectory, driven by demographic shifts and innovation, suggests robust demand for rolapitant-related therapies through the next decade.

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Key Takeaways

• Clinical Development: Continued research, especially in combination therapies, signals sustained focus on optimizing CINV management.
• Market Position: Varubi’s unique pharmacokinetic profile and efficacy support its niche amid rising competitors.
• Growth Outlook: Projected annual growth of ~5%, with expansion into emerging regions and indications.
• Challenges: Pricing pressures, generic competition, and evolving treatment paradigms could modulate growth.
• Strategic Focus: GSK’s efforts in regulatory approvals and pipeline innovation are pivotal to sustaining market relevance.

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FAQs

1. How does rolapitant differ from other NK1 receptor antagonists?
Rolapitant has a longer half-life (~7 days) compared to aprepitant (~9-13 hours), allowing for single-dose administration that improves compliance and offers prolonged protection against delayed CINV. It also exhibits minimal CYP3A4 interactions, reducing potential drug-drug interactions.

2. What are the main advantages of Varubi in clinical practice?
Its extended half-life reduces dosing frequency to once per chemotherapy cycle, effectively controls delayed CINV, and exhibits a favorable safety profile, making it suitable for patients on multiple medications.

3. What are the primary competitors to Varubi?
Aprepitant and fosaprepitant remain primary competitors, with netupitant/palonosetron (Akynzeo) integrating multiple antiemetic mechanisms into one formulation.

4. Are there any new clinical trials exploring Varubi’s uses beyond CINV?
Yes, ongoing trials examine its potential role in stem cell transplantation-related nausea and in combination with emerging cancer therapies, although these are at early stages.

5. What is the outlook for Varubi's approval in emerging markets?
Regulatory submissions are underway in Europe, Japan, and other regions. Success depends on local clinical data, regulatory pathways, and risk-benefit assessments, but early indications are promising for broader global access.

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References

1. MarketsandMarkets. Anti-Emetics Market Report, 2023.
2. FDA Drug Approval Database. Varubi (rolapitant) approval details, 2015.
3. ClinicalTrials.gov. Summary of ongoing trials involving rolapitant.
4. GSK Corporate Reports. Pipeline updates and regulatory filings, 2023.