Last Updated: May 11, 2026

CLINICAL TRIALS PROFILE FOR NETUPITANT; PALONOSETRON HYDROCHLORIDE


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All Clinical Trials for netupitant; palonosetron hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01339260 ↗ An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting Completed Parexel Phase 3 2011-04-01 NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles of chemotherapy.
NCT01339260 ↗ An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting Completed Helsinn Healthcare SA Phase 3 2011-04-01 NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles of chemotherapy.
NCT01376297 ↗ A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting Completed Parexel Phase 3 2011-07-01 NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two antiemetic drugs, both given with oral dexamethasone. The objective of the study is to evaluate if netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.
NCT01376297 ↗ A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting Completed Helsinn Healthcare SA Phase 3 2011-07-01 NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two antiemetic drugs, both given with oral dexamethasone. The objective of the study is to evaluate if netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for netupitant; palonosetron hydrochloride

Condition Name

Condition Name for netupitant; palonosetron hydrochloride
Intervention Trials
Chemotherapy-induced Nausea and Vomiting 10
Nausea Post Chemotherapy 2
Malignant Neoplasm 2
Chemotherapy-induced Nausea and Vomiting (CINV) 1
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Condition MeSH

Condition MeSH for netupitant; palonosetron hydrochloride
Intervention Trials
Vomiting 17
Nausea 12
Breast Neoplasms 3
Neoplasms 2
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Clinical Trial Locations for netupitant; palonosetron hydrochloride

Trials by Country

Trials by Country for netupitant; palonosetron hydrochloride
Location Trials
United States 72
Italy 7
Poland 4
Ukraine 4
Turkey (Trkiye) 4
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Trials by US State

Trials by US State for netupitant; palonosetron hydrochloride
Location Trials
South Carolina 5
Ohio 5
Florida 4
California 4
New York 4
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Clinical Trial Progress for netupitant; palonosetron hydrochloride

Clinical Trial Phase

Clinical Trial Phase for netupitant; palonosetron hydrochloride
Clinical Trial Phase Trials
PHASE4 1
PHASE3 1
PHASE2 1
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Clinical Trial Status

Clinical Trial Status for netupitant; palonosetron hydrochloride
Clinical Trial Phase Trials
Recruiting 7
Completed 7
NOT_YET_RECRUITING 2
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Clinical Trial Sponsors for netupitant; palonosetron hydrochloride

Sponsor Name

Sponsor Name for netupitant; palonosetron hydrochloride
Sponsor Trials
Helsinn Healthcare SA 10
National Cancer Institute (NCI) 3
Consorzio Oncotech 2
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Sponsor Type

Sponsor Type for netupitant; palonosetron hydrochloride
Sponsor Trials
Other 23
Industry 15
NIH 3
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Clinical Trials Update, Market Analysis, and Projection: Netupitant + Palonosetron Hydrochloride

Last updated: April 25, 2026

What is netupitant plus palonosetron used for?

Netupitant + palonosetron hydrochloride is a fixed-dose combination for the prevention of chemotherapy-induced nausea and vomiting (CINV). In practice, the regimen targets both acute and delayed CINV across highly emetogenic chemotherapy (HEC), moderately emetogenic chemotherapy (MEC), and mixed CINV settings, typically given as a single-day oral dose paired with guideline-based adjuncts (e.g., corticosteroids and/or other antiemetics depending on emetogenic risk and regimen).

The combination is marketed in major jurisdictions as Akynzeo (and related brand naming by country). The core pharmacology is a neurokinin-1 (NK1) receptor antagonist (netupitant) plus a 5-HT3 receptor antagonist (palonosetron).

Commercial product identity (regulatory label anchor):

  • Drug components: netupitant + palonosetron hydrochloride
  • Brand: Akynzeo
  • Indication class: prevention of CINV (acute and delayed)

What do the recent clinical-trials signals show?

A comprehensive “recent trials update” for this specific combination requires a full search across clinical-trials registries (e.g., ClinicalTrials.gov, EU CTR, WHO ICTRP) with trial-by-trial extraction of status, design, endpoints, and results. That level of registry-specific detail is not available in the current input set, so a complete update cannot be produced here without risking inaccuracy.

What is the market size and growth outlook for CINV antiemetic regimens?

CINV supportive care is a mature, recurring market tied to oncology drug utilization and chemotherapy cycles. The netupitant + palonosetron combination sits in the premium segment where payers and providers increasingly favor regimens that simplify dosing (reduced visit burden) and improve control of delayed symptoms.

Market drivers

  • Chemotherapy incidence and regimen intensity: Higher emetogenicity increases the need for multi-mechanism prophylaxis.
  • Guideline adherence: Many CINV protocols favor NK1 + 5-HT3 + corticosteroid approaches for HEC and for delayed-phase control.
  • Treatment continuity: CINV prevention is given with each cycle in the prophylaxis window, making demand cycle-linked.

Market constraints

  • Generic and biosimilar dynamics: The underlying molecules face different competitive pressures by jurisdiction and patent status. The combination’s ability to sustain pricing depends on exclusivity duration, manufacturing economics, and payer restrictions.
  • Formulary competition: Competing NK1/5-HT3 regimens (and newer fixed-dose or single-molecule strategies depending on market) can pressure uptake.

How does the combination compete in the CINV landscape?

Netupitant + palonosetron’s positioning depends on the regimen’s ability to cover both acute and delayed phases with a convenient dosing schedule. In payer and hospital formularies, selection typically depends on:

  • clinical outcomes for delayed CINV control
  • dosing simplicity
  • safety and tolerability profile
  • total regimen cost (including corticosteroid scheduling and other protocol antiemetics)

Competitive set (functional, not brand-by-brand claims)

  • NK1 + 5-HT3 combinations for HEC/MEC protocols
  • NK1 antagonists paired with other 5-HT3 agents in variable fixed-dose or co-administered formats
  • Alternative delayed-phase strategies where local practice diverges

What is the commercial trajectory for netupitant plus palonosetron?

Without access to the required combination-specific commercial data (sales by geography and channel, payer coverage changes, and cycle-share trends), a numerically grounded trajectory cannot be produced. Market projections require at minimum:

  • historical revenue series by brand and geography
  • current share vs comparator regimens
  • exclusivity status and key patent-landscape events
  • reimbursement environment and tender dynamics

This information is not present in the current input set.

What patent and exclusivity facts matter for projection?

A projection for this product’s revenue durability hinges on patent term structure across key markets and on any regulatory exclusivity events affecting generic entry timelines. Those facts require a dedicated, sourced patent and regulatory package for netupitant + palonosetron (brand-by-region). That package is not provided here, so a complete, accurate exclusivity map cannot be compiled.

Clinical development pipeline: what is in late-stage or pivotal work?

A complete pipeline update requires extracted registry entries with statuses such as recruiting, active, not recruiting, completed, terminated, and with posted results. Those registry records are not included in the current input set. A definitive “what is next” statement cannot be made without generating unsupported content.

Actionable market projection framework (cycle-linked, premium antiemetic segment)

Even without exact numbers, a projection can be structured around quantifiable drivers that investors and planners use:

Key forecasting inputs

  • Oncology drug volumes (proxies for chemotherapy cycles)
  • HEC/MEC mix shift toward regimens with stronger CINV prophylaxis needs
  • Formulary penetration rate (hospital and oncology center adoption)
  • Protocol adherence and substitution rate (how often prescribers switch to alternative NK1/5-HT3 strategies)
  • Net price trend (rebates, tendering, and payer restrictions)
  • Time-to-generic or competitor substitution (exclusivity expiration and launch curves)

Scenario logic

  • Base case: stable formulary share within premium prophylaxis protocols; pricing pressure offsets volume growth
  • Downside: faster substitution due to formulary tightening, competitor uptake, or loss of premium reimbursement tiers
  • Upside: improved delayed-phase outcomes and regimen simplification support deeper penetration; fewer restrictive formulary changes

What are the key takeaways for business planning?

  • Netupitant + palonosetron is a mature, fixed-dose CINV prophylaxis regimen positioned for acute and delayed control in guideline-based chemotherapy settings.
  • A full “clinical trials update” and a numeric “market analysis and projection” require registry-level and commercial-series inputs that are not present in the current dataset; providing them would risk inaccuracies.
  • Projection should be built on cycle-linked demand, formulary penetration, and net price dynamics rather than only growth in oncology drug approvals.
  • Competitive outcomes will be driven by protocol substitution rates and payer coverage decisions in HEC/MEC prophylaxis pathways.

Key Takeaways

  1. Netupitant plus palonosetron is a premium CINV prophylaxis combination (NK1 + 5-HT3) used for acute and delayed prevention.
  2. Clinical-trials status and pipeline direction cannot be stated accurately without registry-specific extraction.
  3. Market growth is tied to chemotherapy cycle volume and protocol adherence, with premium pricing balanced against formulary substitution and rebate pressure.
  4. A credible forecast depends on historical sales/cycle-share, net price trend, and time-to-exclusivity changes by major geography.

FAQs

  1. What cancers or chemotherapy settings use netupitant plus palonosetron?
    It is used for prevention of chemotherapy-induced nausea and vomiting (CINV), typically aligned to HEC and MEC prophylaxis protocols covering acute and delayed phases.

  2. How does the drug combination work?
    Netupitant antagonizes NK1 receptors, and palonosetron is a 5-HT3 receptor antagonist, together targeting key emetic pathways.

  3. Is this regimen dosed once per chemotherapy cycle day?
    The combination is used as a prophylactic regimen in the CINV prevention window, commonly as a single-day dosing approach in labeling-aligned schedules.

  4. What determines uptake in hospitals and payers?
    Formulary position, net price after rebates, and protocol outcomes for delayed CINV control.

  5. What most affects revenue projections?
    Chemotherapy cycle demand, formulary penetration and substitution by comparator regimens, and exclusivity or patent-driven generic entry timing by region.


References

[1] EMA. Akynzeo (netupitant/palonosetron) product information. European Medicines Agency.
[2] FDA. Akynzeo (netupitant and palonosetron) prescribing information. U.S. Food and Drug Administration.
[3] ClinicalTrials.gov. Search results and trial records for netupitant/palonosetron combination. National Library of Medicine.

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