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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.
NCT02732015 ↗	Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy	Terminated	M.D. Anderson Cancer Center	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.
NCT02991456 ↗	Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide	Recruiting	TerSera Therapeutics	Phase 2	2017-10-09	The purpose of this phase 2 study is to assess the efficacy and patient satisfaction of oral rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG) patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. This is a randomized phase 2 trial of rolapitant plus ondansetron vs. ondansetron monotherapy for the prevention of chemo-radiation induced nausea and vomiting in primary MG subjects receiving RT and concomitant multi-dose TMZ.

Clinical Trial Conditions for varubi

Condition Name

Condition Name for varubi
Intervention	Trials
Chemotherapy-induced Nausea and Vomiting	3
Advanced Cancer	1
Chemo-radiation Induced Nausea and Vomiting	1
Germ Cell Tumor	1

Condition MeSH

Condition MeSH for varubi
Intervention	Trials
Vomiting	5
Nausea	5
Lung Neoplasms	1
Carcinoma, Non-Small-Cell Lung	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
ECONiX Araştırma Analiz ve Danışmanlık A.Ş.	2
PlusVitech S.L.	2

Sponsor Type

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

Varubi Market Analysis and Financial Projection

VARUBI: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to VARUBI

VARUBI, also known as rolapitant, is a neurokinin-1 (NK-1) receptor antagonist developed by TESARO, Inc. (now part of GSK) for the prevention of chemotherapy-induced nausea and vomiting (CINV). This drug has been a significant addition to the antiemetic regimen for cancer patients undergoing chemotherapy.

Clinical Trials Overview

The FDA approval of VARUBI was based on evidence from three clinical trials involving 2,595 cancer patients who were receiving chemotherapies known to cause nausea and vomiting. Here are the key points from these trials:

Trial Design and Participants

• The trials were conducted in multiple regions including Europe, North, Central, and South America, Asia, and South Africa.
• Patients were randomly assigned to receive either VARUBI or a placebo in addition to their regular medications for nausea and vomiting. The trials were double-blind, meaning neither the patients nor the healthcare providers knew which treatment was being given until after the trial was complete[1][2][4].

Trial Objectives and Endpoints

• The primary objective was to evaluate the benefits and side effects of VARUBI in preventing delayed-phase CINV, which occurs 25 to 120 hours after chemotherapy.
• The trials measured the number of patients who had no vomiting and used no medications for nausea or vomiting during this period[1][2].

Trial Results

• In the trials, VARUBI demonstrated a significant reduction in episodes of vomiting or the use of rescue medication during the delayed phase of CINV.
• Patients who received VARUBI reported experiencing less nausea that interfered with their daily life and fewer episodes of vomiting or retching over multiple cycles of chemotherapy[2][4].

Specific Trial Details

• For Highly Emetogenic Chemotherapy (HEC), two identical Phase 3 studies (HEC1 and HEC2) compared VARUBI with a control therapy (placebo, intravenous granisetron, and dexamethasone) in patients receiving cisplatin-based regimens. Both trials met their primary endpoint, showing statistical superiority of VARUBI over the control therapy[2].
• For Moderately Emetogenic Chemotherapy (MEC), one trial compared VARUBI with a control therapy (placebo, oral granisetron, and dexamethasone). This trial also showed a significant reduction in CINV episodes in the VARUBI group[1][2].

Mechanism of Action

VARUBI works by blocking the substance P/neurokinin-1 (NK-1) receptors, which are highly concentrated in the brain and play a central role in nausea and vomiting induced by emetogenic stimuli, including certain cancer chemotherapies. A Positron Emission Tomography (PET) study demonstrated that rolapitant crosses the blood-brain barrier and occupies brain NK-1 receptors at high levels for up to 120 hours[2].

Market Analysis

Market Size and Growth

• The global market for CINV drugs, including VARUBI, is projected to grow significantly, reaching $4.3 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 8.2%. This growth is driven by advances in medications and an increase in highly effective agents[3].

Geographical Presence

• North America, particularly the U.S., represents the largest market share for CINV drugs, followed by Europe. The Asia Pacific region is also expected to exhibit significant growth due to increasing market penetration by generic manufacturers[3].

Product Performance

• The oral formulation of VARUBI has seen substantial growth. In the fourth quarter of 2017, unit demand for VARUBI oral tablets increased by 43% compared to the same period in 2016, indicating strong market penetration in the U.S. oral NK-1 market[3].
• However, the intravenous (IV) formulation of VARUBI faced challenges due to reports of serious hypersensitivity reactions, leading to the suspension of its distribution and a redirection of resources to support the oral tablets[3].

Financial Performance

• In 2017, VARUBI sales contributed significantly to TESARO's revenue, with net product sales totaling $11.9 million for the full year. This was a marked increase from 2016, when VARUBI sales were $2.3 million[3].

Market Dynamics and Financial Trajectory

Market Drivers

• Increasing cancer incidence and technological advancements in antiemetic medications are key drivers of the CINV market. However, high drug costs remain a significant challenge[3].

Competitive Landscape

• VARUBI competes with other antiemetic drugs in the CINV market. The competitive landscape includes other NK-1 receptor antagonists and 5-HT3 receptor antagonists, among others[3].

Future Projections

• The market for CINV drugs is expected to continue growing, driven by the increasing need for effective antiemetic agents. VARUBI, with its proven efficacy in clinical trials, is well-positioned to capture a significant share of this growing market[3].

Key Takeaways

• Clinical Trials: VARUBI was approved based on three clinical trials showing significant reduction in delayed-phase CINV.
• Mechanism of Action: VARUBI blocks NK-1 receptors, reducing nausea and vomiting induced by chemotherapy.
• Market Size and Growth: The CINV market is projected to reach $4.3 billion by 2031, with VARUBI contributing substantially.
• Geographical Presence: Strong presence in North America and Europe, with growing penetration in the Asia Pacific region.
• Product Performance: Oral formulation has seen strong growth, while IV formulation faced challenges.
• Financial Performance: Significant contribution to TESARO's revenue, despite costs associated with inventory write-downs and R&D expenses.

FAQs

1. What is VARUBI used for?

VARUBI (rolapitant) is used for the prevention of chemotherapy-induced nausea and vomiting (CINV), specifically the delayed phase that occurs 25 to 120 hours after chemotherapy[2][4].

2. What are the different formulations of VARUBI?

VARUBI is available in both oral and intravenous (IV) formulations, although the IV formulation has faced challenges due to adverse reactions[3].

3. How does VARUBI work?

VARUBI works by blocking the substance P/neurokinin-1 (NK-1) receptors in the brain, which are involved in the induction of nausea and vomiting by emetogenic stimuli[2].

4. What were the results of the clinical trials for VARUBI?

The clinical trials showed that VARUBI significantly reduced episodes of vomiting and the use of rescue medication during the delayed phase of CINV, and improved patients' quality of life by reducing nausea[1][2][4].

5. What is the market outlook for VARUBI?

The market for CINV drugs, including VARUBI, is expected to grow significantly, reaching $4.3 billion by 2031, driven by advances in medications and increasing cancer incidence[3].

Sources

1. FDA: Drug Trials Snapshots: VARUBI - FDA.
2. FiercePharma: TESARO Announces U.S. FDA Approval of VARUBI(TM) (rolapitant ...
3. DrugPatentWatch: VARUBI Drug Patent Profile - DrugPatentWatch.
4. HOAFredericksburg: Varubi Approved for Chemotherapy-Induced Nausea and Vomiting.
5. BusinessWire: Varubi - Drug Insight, 2019-2021 - ResearchAndMarkets.com.