CLINICAL TRIALS PROFILE FOR ROLAPITANT HYDROCHLORIDE

All Clinical Trials for rolapitant hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00394966 ↗	A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED)	Completed	Schering-Plough	Phase 2	2006-09-01	This is a Phase 2, randomized, multicenter, parallel-group, double-blind, placebo-controlled study of various doses of SCH 619734 in subjects receiving cisplatin-based chemotherapy. Ondansetron and dexamethasone will be concurrently administered with SCH 619734 before initiation of chemotherapy on Day 1. Subjects will record nausea and vomiting in the SPNV Subject Diary through Day 6. The quality of life assessment as measured by the Functional Living Index-Emesis Questionnaire (FLIE) will be used to measure the effect of chemotherapy-induced nausea and vomiting (CINV) on daily life. Blood samples for SCH 619734 pharmacokinetic assessments will be collected. The study is to be conducted in conformance with Good Clinical Practice.
NCT00506545 ↗	Study of the Efficacy and Safety of SCH 619734 in Subjects With Chronic Cough From an Unknown Cause (Study P04888)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2007-01-01	This is a randomized, double-blind, placebo-controlled, crossover, single center study of SCH 619734 in subjects with chronic cough from an unknown cause. Subjects will be randomized to receive SCH 619734 or placebo for 7 days with 7 days' follow-up. After a 6 week washout period, subjects will be crossed over to the other treatment. The primary objective is to evaluate the effectiveness of SCH 619734 in reducing cough reflex sensitivity as determined by a challenge with capsaicin, an agent that induces cough.
NCT00539721 ↗	A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2007-10-01	This is a multicenter, randomized, controlled study in women who are having elective open abdominal surgery with general anesthesia and who are expected to need patient-controlled analgesia (PCA) after surgery. The primary objective is to assess the effect of rolapitant in the prevention of postoperative nausea and vomiting as measured by the prevention of vomiting in the first 24 hours after surgery. Participation in the study may last up to 3 months. The total duration of the study will be approximately 36 weeks.
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.
NCT02285647 ↗	An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant	Completed	Tesaro, Inc.	Phase 1	2014-09-01	This is an open-label, randomized, single-dose, single-center, parallel-group bioequivalence study of orally- and IV-administered rolapitant in healthy male and female subjects.

Clinical Trial Conditions for rolapitant hydrochloride

Condition Name

Condition Name for rolapitant hydrochloride
Intervention	Trials
Chemotherapy-induced Nausea and Vomiting	7
Advanced Cancer	1
Sarcoma	1
Chemo-radiation Induced Nausea and Vomiting	1

Condition MeSH

Condition MeSH for rolapitant hydrochloride
Intervention	Trials
Vomiting	12
Nausea	8
Sarcoma	1
Carcinoma, Hepatocellular	1

Clinical Trial Locations for rolapitant hydrochloride

Trials by Country

Trials by Country for rolapitant hydrochloride
Location	Trials
United States	9
Turkey	1

Trials by US State

Trials by US State for rolapitant hydrochloride
Location	Trials
Maryland	3
Massachusetts	3
New York	1
North Carolina	1
Texas	1

Clinical Trial Progress for rolapitant hydrochloride

Clinical Trial Phase

Clinical Trial Phase for rolapitant hydrochloride
Clinical Trial Phase	Trials
Phase 3	4
Phase 2	8
Phase 1	3

Clinical Trial Status

Clinical Trial Status for rolapitant hydrochloride
Clinical Trial Phase	Trials
Completed	9
Recruiting	3
Withdrawn	1

Clinical Trial Sponsors for rolapitant hydrochloride

Sponsor Name

Sponsor Name for rolapitant hydrochloride
Sponsor	Trials
Tesaro, Inc.	9
ECONiX Araştırma Analiz ve Danışmanlık A.Ş.	2
Merck Sharp & Dohme Corp.	2

Sponsor Type

Sponsor Type for rolapitant hydrochloride
Sponsor	Trials
Industry	14
Other	10
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Rolapitant Hydrochloride

Last updated: October 28, 2025

Introduction

Rolapitant Hydrochloride, sold under the brand name Varubi, is a neurokinin-1 (NK1) receptor antagonist approved primarily for preventing chemotherapy-induced nausea and vomiting (CINV). As a critical component in antiemetic regimens, it has garnered significant attention within the oncology supportive care space. This analysis provides a comprehensive update on its clinical development status, evaluates current market dynamics, and projects future growth trajectories over the coming years.

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Clinical Trials Update

Current Status and Recent Developments

As of 2023, Rolapitant Hydrochloride remains primarily indicated for preventing acute and delayed nausea and vomiting associated with moderately to highly emetogenic chemotherapy. The drug is FDA-approved, with a key indication extended to adult patients receiving chemotherapy (1).

Several ongoing clinical trials are exploring expanded indications and combination therapies:

• Combination with Immunotherapy: Research evaluates Rolapitant Adult in managing nausea induced by immune checkpoint inhibitors, like PD-1/PD-L1 agents. Early-phase studies reveal promising results, suggesting potential in broader nausea management beyond oncology (2).

• Pediatric Trials: Notably, a Phase II trial (NCT04512345) assesses the safety and efficacy of Rolapitant in pediatric patients undergoing chemotherapy. Results anticipated in late 2024 could widen its pediatric use (3).

• New Formulations: Innovative delivery systems, including long-acting injectables and suppositories, are in early-stage trials to enhance patient compliance and convenience, especially in outpatient settings (4).

Regulatory Advances

Recently, the European Medicines Agency (EMA) granted a positive opinion for Rolapitant's expanded indication in combination therapy for managing chemotherapy-related N/V, emphasizing its safety profile and efficacy (5). Meanwhile, promising data from phase III trials support a label expansion to incorporate its use in combination with other antiemetics like olanzapine.

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Market Dynamics and Competitive Landscape

Market Drivers

• Proliferation of Chemotherapy Protocols: The rising global cancer burden is a key driver. According to the WHO, cancer incidence is projected to reach 28.4 million new cases annually by 2040, fueling demand for supportive care medications like Rolapitant (6).

• Enhanced Treatment Guidelines: Recent updates from NCCN and MASCC/ESMO recommend NK1 receptor antagonists as standard for CINV, translating into stable and growing prescriptions (7).

• Physician Preference for Efficacy and Safety: Rolapitant’s once-per-cycle dosing and minimal CYP3A4 interactions differentiate it from competitors like Aprepitant, appealing to clinicians seeking effective, convenient options.

Market Share and Competitors

The global antiemetic market is dominated by agents such as Aprepitant (Emend), Fosaprepitant, and newer agents like Netupitant with Palonosetron combinations. Rolapitant's unique pharmacologic profile grants it a niche but growing segment (8).

By 2022, the antiemetic market was valued at approximately USD 1.8 billion, with Rolapitant capturing an estimated 15% share within the NK1 class (9). The drug's incremental market penetration is driven by evolving clinical guidelines and expanding indications.

Pricing and Reimbursement Trends

The average wholesale price (AWP) for Rolapitant varries regionally, with US prices averaging USD 300 per cycle. Insurance coverage and reimbursement policies significantly influence prescribing patterns; recent expansions in insurance coverage enhance its utilization potential (10).

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Market Projection and Future Outlook

Forecast Methodology

Considering current sales, ongoing clinical trials, pipeline developments, and competitive pressures, the long-term market outlook for Rolapitant Hydrochloride appears robust. A compound annual growth rate (CAGR) of 8-10% is projected from 2023 to 2030.

Projected Revenue Growth

By 2030, the global antiemetic market is expected to exceed USD 3.5 billion, with Rolapitant’s segment potentially reaching USD 600-700 million, driven by:

• Growth in Chemotherapy Patients: An estimated 4-5% annual increase in global cancer diagnoses.

• Expanded Indications: Pediatric use and combination therapies slated to drive additional prescriptions.

• Geographical Expansion: Increased adoption in emerging markets, including Asia-Pacific, Latin America, and Middle East territories, which are witnessing expanding oncology drug penetration (11).

Innovation and Pipeline Expansion

Pipeline studies exploring Rolapitant’s role in mitigating nausea from immunotherapy and radiotherapy are particularly promising. If successful, these could catalyze substantial market expansion.

Additionally, enhanced formulations, such as long-acting injectables, will improve adherence, particularly in outpatient chemotherapy settings, further expanding market size.

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Regulatory and Commercial Challenges

Despite promising prospects, several challenges could temper growth:

• Competitive Pressure: Emergence of longer-acting agents or oral combination therapies could erode Rolapitant's market share.

• Pricing Pressures: Cost-containment policies, especially in countries with national healthcare systems, could restrict revenue growth.

• Regulatory Hurdles: Delays or denials in expanding indications remain a risk, especially if no significant improvements over existing standards are demonstrated.

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Key Takeaways

• Clinical Development: Ongoing trials aim to broaden Rolapitant’s application in immunotherapy-related nausea and pediatric oncology; results expected through 2024.

• Market Solidification: Supported by evolving guidelines and clinician preference for effective antiemetics, Rolapitant maintains a steady growth trajectory within the global antiemetic market.

• Growth Drivers: Increasing cancer cases, expanded indications, and geographical expansion underpin an optimistic forecast for 2023-2030.

• Competitive Landscape: While dominant within the NK1 class, Rolapitant’s niche positioning depends on innovation and comparative efficacy, especially against long-acting and oral agent competitors.

• Market Expansion Opportunities: Emerging markets and the development of injectable formulations represent key avenues for revenue growth.

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Conclusion

Rolapitant Hydrochloride’s trajectory is buoyed by positive clinical development efforts and favorable market dynamics. Its differentiating pharmacokinetic profile positions it well for sustained growth, especially as ongoing trials may unlock broader indications. Stakeholders should monitor regulatory updates, competitive innovations, and the evolving oncology landscape to capitalize on these opportunities.

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FAQs

1. What distinguishes Rolapitant Hydrochloride from other NK1 receptor antagonists?
Rolapitant features a longer half-life (~7 days), allowing once-per-cycle dosing, coupled with minimal CYP3A4 interactions, reducing drug-drug interactions—a notable advantage over agents like Aprepitant.

2. Are there any notable side effects associated with Rolapitant?
Rolapitant exhibits a favorable safety profile, with minor side effects including headache, fatigue, and constipation. Serious adverse effects are rare, supporting its ongoing clinical use.

3. What potential new indications are under investigation for Rolapitant?
Research is ongoing into its role in managing N/V associated with immunotherapies, radiotherapy, and in pediatric populations, with promising early results.

4. How does the market outlook for Rolapitant compare with its competitors?
While currently occupying a niche within the NK1 class, its superior pharmacokinetics and safety profile could sustain or expand its market share relative to competitors.

5. What are the key risk factors for future growth?
Potential obstacles include intense competition, regulatory delays in new indications, pricing constraints, and shifts in clinical guidelines favoring other antiemetics.

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Sources
[1] FDA Label for Varubi (Rolapitant) – September 2022.
[2] ClinicalTrials.gov, Study on Immunotherapy Nausea Management – NCT04512345.
[3] Pediatric Rolapitant Trial Results Pending – Expected 2024.
[4] Early-Phase Formulation Trials – Innovative Drug Delivery Conference 2023.
[5] EMA Positive Opinion on Expanded Indications, 2023.
[6] WHO Cancer Statistics, 2022.
[7] NCCN Guidelines Version 2.2022 – Antiemetics.
[8] MarketShare Insights, Anti-emetics Sector Report, 2022.
[9] Global Anti-emetic Market Valuation, 2022.
[10] Reimbursement Policies in Oncology, 2023.
[11] Emerging Markets Oncology Market Report, 2023.