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.

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
Withdrawn	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 (rolapitant) clinical trials update, market analysis and 2026–2035 projection

Last updated: July 28, 2026

Executive summary

• Varubi is rolapitant, an NK1 receptor antagonist for prevention of chemotherapy-induced nausea and vomiting (CINV), launched in the U.S. by Eisai and originally positioned around HEC (highly emetogenic chemotherapy).
• Rolapitant’s market is structurally smaller than broad NK1 peers (netupitant plus palonosetron, aprepitant, fosaprepitant) because rolapitant is dosed as a single agent-day 1 component and faces competitive intensity from multi-drug, guideline-favored regimens.
• Public clinical-trials signals for rolapitant are limited versus the class, implying incremental development rather than major next-generation launches.
• Market sizing and forward projections are constrained by: (1) CINV regimen commoditization, (2) uptake competition from existing NK1 products and guideline standardization, and (3) likely maturity of the compound with fewer late-stage trials.

What clinical trials update exists for Varubi (rolapitant) in CINV?

Rolapitant’s clinical program is largely established around CINV prevention across acute and delayed phases, including HEC and MEC (moderately emetogenic chemotherapy) settings. Public updates in recent years have been dominated by supplementary analyses (subgroups, endpoints, pooled populations) rather than large new pivotal Phase 3 programs.

Which Phase 3 evidence supports Varubi today?

Commercial positioning for rolapitant is anchored on Phase 3 trials evaluating:

• Acute and delayed CINV control when rolapitant is combined with a 5-HT3 antagonist and dexamethasone-based backbone.
• Consistency of benefit on complete response (no emesis, no rescue medication) across overall, acute, and delayed intervals.

Are there recent Phase 3 or late-stage updates?

Recent “update” activity for rolapitant in public registries has typically been limited to:

• Follow-on analyses and reporting updates.
• Observational or registry-style capture where available.
• Lower-enrollment or non-pivotal studies (when present), often focused on safety maintenance and real-world regimen placement.

What endpoints and patient populations remain most commercially relevant?

For market relevance, the endpoints tied to payer and guideline decisioning remain:

• Complete response in delayed phase (key differentiator in NK1 class value).
• Health resource utilization proxies driven by rescue medication use.
• Safety and tolerability in multi-day CINV regimens, especially for patients receiving emetogenic multi-cycle chemotherapy.

What is the current FDA regulatory status of Varubi (rolapitant) and how is it approved?

Varubi is FDA-approved for the prevention of acute and delayed nausea and vomiting associated with initial and repeat cycles of chemotherapy.

What is the labeled indication and regimen context?

Rolapitant is labeled for CINV prevention in the context of chemotherapy that is highly emetogenic or moderately emetogenic, used with standard antiemetic regimens (typically a 5-HT3 antagonist and dexamethasone).

Is Varubi on the Orange Book?

Orange Book listing status determines generic-entry timelines and patent exclusivity mapping. For this market brief, the specific Orange Book patent bundle (publication and expiration dates) is the driver of Paragraph IV risk, but it is not provided in the input.

What patents protect Varubi (rolapitant) and how strong is the patent estate?

Patent strength drives generic or biosimilar risk for small molecules through:

• Composition-of-matter coverage (primary risk).
• Formulation or method-of-use coverage (secondary risk).
• Exclusivity periods (data and marketing exclusivity) that prevent generic approval timing.

How many patents cover rolapitant and what is the likely expiration stack?

A complete, accurate roll-up requires Orange Book patent numbers and expiration data, plus any relevant Hatch-Waxman litigation dockets. That data is not present in the prompt.

What patent types typically matter for NK1 CINV products?

For CINV NK1 antagonists, the typical coverage map includes:

• Rolapitant active ingredient compositions.
• Solid state, salts, and formulation compositions.
• Regimen or method-of-use claims for CINV prevention.
• Process/manufacturing claims. Absent the specific estate for rolapitant, strength cannot be quantified credibly.

How does Varubi compare with other NK1 antagonists for CINV in efficacy and adoption?

Competitive substitution in CINV depends on:

• Delayed-phase complete response benefit magnitude.
• Dosing convenience (single-day NK1 component vs multi-day).
• Drug-drug interaction profile impacting regimen feasibility.
• Prior authorization and formulary placement.

Which products most directly compete with Varubi?

The most relevant competitors in the NK1 CINV space include:

• Netupitant plus palonosetron (multi-drug, fixed-dose regimen).
• Aprepitant and fosaprepitant regimens.
• Broader 5-HT3 NK1 adoption patterns based on guideline algorithms.

Where does Varubi’s value proposition tend to land?

Rolapitant’s commercial niche is generally:

• Patients or centers seeking a single NK1 dosing on day 1 with dexamethasone and 5-HT3 backbone.
• Institutions with established NK1 formulary policies that support regimen simplification.

What market factors determine Varubi demand (pricing, formulary, and payer behavior)?

Demand for rolapitant is a function of CINV incidence by regimen type and payer willingness to pay for NK1 benefits over alternative antiemetics.

Key demand drivers

• High chemo throughput centers (infusion oncology volumes) and guideline compliance influence NK1 inclusion.
• Conversion of oncology pathways to preferred antiemetic regimens.
• Formularies and step edits tied to delayed-phase control outcomes.

Key demand inhibitors

• Competitive NK1 products with fixed-dose combinations can reduce pill burden and administration complexity.
• As payer networks mature, price pressure increases for mature specialty antiemetics.
• Generic availability of substitute antiemetic components can shift the class economics even if NK1 remains branded.

What is the current market size for Varubi, and what revenue trajectory is realistic?

A defensible market projection requires at least one anchored dataset point: sales history (U.S., EU, global) or unit prescriptions by year. No commercial revenue or prescribing data is included in the prompt, and producing a numeric projection would be speculative.

What clinical trials pipeline exists beyond rolapitant for CINV (and how could it impact Varubi)?

CINV pipelines increasingly include:

• NK1 class competitors and next-generation antiemetics.
• Broader agents targeting additional pathways.
• Combination regimens aligned with payer-evidence frameworks.

How could pipeline activity shift rolapitant share?

If new entrants demonstrate superior delayed-phase control, improved safety in key drug interaction populations, or simpler dosing, rolapitant’s incremental share growth would likely slow and potentially compress margins.

What generic entry risks exist for Varubi (rolapitant) and when could competition start?

Generic risk depends on:

• Orange Book patent status and expiration.
• Any granted exclusivities (data, marketing) that delay ANDA approvals.
• Litigation settlement or ongoing infringement/invalidity proceedings.

What timeline matters for Paragraph IV challenges?

In Hatch-Waxman practice, the market impact typically comes from:

• 180-day exclusivity to the first filer (if triggered).
• Final court rulings affecting patent infringement.
• Labeling carve-outs (if settlements are entered and an approval is allowed before full patent expiration).

Without the Orange Book and litigation docket data, a timeline cannot be stated accurately.

What settlement agreements or patent litigation affect Varubi?

Settlement and litigation can materially change launch timing and product labeling. No litigation case identifiers or settlement terms are included in the prompt, so no factual docket summary can be generated.

Key Takeaways

• Varubi (rolapitant) remains a branded NK1 antagonist option used with standard antiemetic backbone for acute and delayed CINV prevention.
• Public clinical update signals for rolapitant appear limited versus more active late-stage programs in the class, suggesting a mature development phase.
• Market growth prospects are constrained by entrenched CINV regimens, strong NK1 competition, and the absence of new pivotal expansions in the prompt.
• Numeric market projections, generic launch timing, and patent-loss/exclusivity dates cannot be produced from the provided input without Orange Book and sales anchoring data.

FAQs

1. Is Varubi (rolapitant) still the preferred NK1 option for delayed-phase CINV prevention in 2026?
2. What is rolapitant’s drug-drug interaction profile, and how does it affect adoption in multi-oncology regimens?
3. Does Varubi have formulation patents that constrain generic development more than composition-of-matter claims?
4. How do netupitant/palonosetron and aprepitant regimens affect rolapitant’s formulary placement?
5. What Orange Book patents and exclusivities typically drive the timing of generic entry for CINV NK1 antagonists?

References (APA)

1. No sources were provided in the prompt.