Last Updated: June 25, 2026

CLINICAL TRIALS PROFILE FOR VARUBI


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

Condition MeSH for VARUBI
Intervention Trials
Vomiting 5
Nausea 5
Carcinoma, Non-Small-Cell Lung 1
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Clinical Trial Locations for VARUBI

Trials by Country

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

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

Clinical Trial Phase

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

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

Sponsor Type for VARUBI
Sponsor Trials
Industry 8
Other 6
NIH 1
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Last updated: April 27, 2026

Varubi clinical trial update, market analysis and projections

What is Varubi and what is its current clinical status?

Varubi is rolapitant, an NK1 (substance P) receptor antagonist used to prevent chemotherapy-induced nausea and vomiting (CINV). Varubi is marketed in multiple regions for CINV prevention and is generally positioned around multi-day control of emesis and nausea when combined with standard-of-care antiemetics.

Clinical development and trial activity

  • The most visible late-stage development around rolapitant focused on CINV prevention in multi-day chemo settings, including pivotal registration programs that supported approvals (no current, widely indexed phase-3 readouts are consistently published in public trial registries in the way that would support an active “new phase” market-shaping cycle in 2024-2026).
  • The current public signal for “clinical trial updates” for rolapitant has largely shifted toward post-authorization evidence (real-world use, safety follow-through, label maintenance, and combination/regimen implementation studies) rather than novel late-stage efficacy endpoints.

What this means for near-term clinical catalysts

  • For an investment or R&D decision, rolapitant’s market momentum is less dependent on brand-new phase-3 efficacy data cycles and more dependent on formulary uptake, continued guideline inclusion, and competitive dynamics against other NK1 antagonists and non-NK1 antiemetics.

What is the patent and exclusivity context that shapes future supply?

Rolapitant’s competitive future depends on a mix of primary compound patent coverage and regulatory exclusivity periods in each jurisdiction, plus any secondary IP (formulations, polymorphs, combinations) if pursued.

Practical implications for market projection

  • If primary patents expire in major markets without strong, enforceable secondary coverage, pricing pressure increases and generics or authorized competitors can enter.
  • If approvals persist but exclusivity is near-term, the commercial curve typically shifts from volume growth to margin defense and then declines as substitutes enter.

Key business takeaway: For Varubi, market projections must be scenario-based around jurisdiction-specific expiry and launch timing of follow-on products. (No jurisdiction-specific expiry dates can be stated here without risking incorrect legal facts.)


What does the CINV market landscape look like for rolapitant?

CINV market structure

  • The antiemetic market for oncology is split between:
    • NK1 antagonists (e.g., rolapitant and comparators in the class)
    • 5-HT3 antagonists (e.g., palonosetron-class)
    • NK1 plus corticosteroid combinations and multi-drug regimens
    • Other agents used depending on guideline evolution and payer preferences

Competitive benchmarks that shape rolapitant demand

  • NK1 rivals compete on:
    • emesis control in delayed phase
    • nausea outcomes (harder to separate empirically across trials)
    • dosing convenience
    • payer access and bundled regimen pricing
  • Non-NK1 competitors increasingly pressure the market through regimen optimization and biosimilar-era cost reductions in steroid and older supportive care categories.

Where Varubi typically wins

  • Multi-day chemo cycles where delayed CINV control matters.
  • Settings where clinicians want a sustained NK1 receptor blockade across the chemo-to-follow-up window.

How should the market be modeled: base, bull, bear scenarios

Because rolapitant’s near-term clinical “event risk” appears lower than a first-in-class development program, the correct modeling approach is commercial and policy-driven rather than efficacy-driven.

Below is a scenario framework you can map to your own geography-specific assumptions (channel access, tender pricing, formulary inclusion, and generic launch probability). It is structured to guide investment decisions without relying on uncertain, unlabeled trial claims.

Scenario Demand drivers Price and mix drivers Net outcome over 24-48 months
Bear Faster payer substitution to competing NK1 agents and non-NK1 optimized regimens Margin compression due to competitive pricing and increased tender pressure Volume erosion and profitability decline
Base Continued guideline inclusion and steady clinician adoption; limited disruptive competition Moderate mix shifts toward lower-cost regimens Flattish unit volume with pressured gross margin
Bull Stronger-than-expected payer access and protocol adherence in multi-day settings Limited channel substitution; premium pricing holds longer Volume stability or growth with better margin resilience

What is the projection horizon and what to watch?

24-month lens (tactical):

  • Formulary decisions and tender cycles for antiemetic regimens in oncology centers.
  • Switching behavior among hospital pharmacies between NK1 agents.
  • Real-world persistence and dose adherence data if published by stakeholders.

48-month lens (strategic):

  • Patent/exclusivity milestones in top markets.
  • Generic and authorized competitor entry risk.
  • Guideline updates that change delayed-phase management.

Clinical trial update: what counts as a true “market-moving” signal

For Varubi, a trial update is market-moving when it changes at least one of:

  1. Delayed-phase efficacy relative to key comparators
  2. Safety profile that alters label or payer acceptance
  3. Regimen positioning that shifts practice patterns (e.g., de-emphasizing NK1 or changing combination standards)

If a public trial report does not impact those dimensions, it typically influences evidence weight more than it changes unit demand.


Market projections (ranges)

A numbers-forward projection requires specific baselines (current revenues/units by region, channel mix, payer coverage, and patent timelines). Those inputs are not provided here, and stating them would produce potentially incorrect financial claims.

What can be projected with high business validity without fabricating numbers

  • Trajectory direction depends on exclusivity and competition:
    • With protected brand access, volume holds longer and margins compress gradually.
    • Approaching exclusivity loss, the market tends to decelerate then decline after entry.
  • Clinical tailwinds are secondary for rolapitant unless a new trial repositions efficacy or safety.

Key Takeaways

  • Varubi (rolapitant) is an NK1 antagonist for CINV prevention, with market success tied to multi-day delayed-phase control and regimen adoption rather than a new late-stage efficacy cycle.
  • “Clinical trial updates” are likely to be post-authorization and practice-integration rather than new phase-3 readouts that directly reset the sales outlook.
  • Market projections should be modeled around exclusivity and competitive switching, using bear/base/bull scenarios that reflect tender and formulary dynamics more than incremental clinical evidence.

FAQs

1) Is Varubi still considered a core therapy for CINV?

Yes, rolapitant remains positioned within NK1-based CINV prevention strategies, particularly where delayed-phase control and multi-day regimen adherence matter.

2) What competitor categories most threaten Varubi’s share?

Other NK1 antagonists and non-NK1 optimized multi-drug antiemetic regimens that reduce delayed-phase breakthrough nausea and emesis while lowering overall regimen cost.

3) Do clinical trials typically move Varubi’s market price directly?

Not usually. Payer and formulary access, plus exclusivity and competitive launch timing, are the direct levers for pricing and unit economics.

4) What is the most important risk to watch for future sales?

Jurisdiction-specific patent and exclusivity expiry and subsequent generic or authorized competitor entry.

5) What would be the strongest sign of upside for Varubi?

Evidence that payer protocols increase NK1-based multi-day regimen adoption, sustaining both unit demand and pricing power.


References

[1] ClinicalTrials.gov. “Rolapitant” (search results for ongoing and completed studies). U.S. National Library of Medicine. (Accessed 2026-04-27).

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