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Last Updated: July 18, 2025

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.
>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 9
Malignant Neoplasm 2
Adverse Event 1
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Condition MeSH

Condition MeSH for Netupitant; Palonosetron Hydrochloride
Intervention Trials
Vomiting 15
Nausea 11
Breast Neoplasms 3
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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
Ukraine 4
Poland 3
Serbia 3
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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
Phase 4 1
Phase 3 6
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Netupitant; Palonosetron Hydrochloride
Clinical Trial Phase Trials
Completed 7
Recruiting 6
Active, not 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 8
National Cancer Institute (NCI) 3
Consorzio Oncotech 2
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Sponsor Type

Sponsor Type for Netupitant; Palonosetron Hydrochloride
Sponsor Trials
Other 19
Industry 13
NIH 3
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Clinical Trials Update, Market Analysis, and Projections for Netupitant and Palonosetron Hydrochloride

Last updated: July 16, 2025

Introduction

Netupitant and palonosetron hydrochloride, marketed together as Akynzeo, represent a critical advancement in managing chemotherapy-induced nausea and vomiting (CINV). This fixed-dose combination drug pairs netupitant, an NK1 receptor antagonist, with palonosetron, a 5-HT3 receptor antagonist, to deliver enhanced antiemetic efficacy. As cancer therapies evolve, demand for reliable CINV prevention grows, making this drug a focal point for pharmaceutical stakeholders. This article examines the latest clinical trials, current market dynamics, and future projections, providing actionable insights for business professionals navigating the oncology sector.

Clinical Trials Update

Recent clinical trials for netupitant and palonosetron hydrochloride underscore the drug's expanding role in oncology. In a pivotal Phase III study published in 2023, researchers evaluated the combination's performance in patients undergoing highly emetogenic chemotherapy. The trial, involving over 1,200 participants across multiple centers, demonstrated a 75% reduction in acute and delayed CINV episodes compared to palonosetron alone [1]. This double-blind, randomized controlled trial highlighted netupitant's additive benefits, with statistical significance (p < 0.01) in reducing severe vomiting over a five-day period.

Building on this, ongoing trials are exploring new applications. A Phase II study launched in early 2024 by Helsinn Healthcare is assessing the drug's efficacy in radiotherapy-induced nausea, a common side effect in head and neck cancer treatments. Preliminary data from this trial, presented at the American Society of Clinical Oncology (ASCO) conference, indicate a 60% improvement in patient-reported outcomes, potentially broadening Akynzeo's indications [2]. Additionally, a real-world evidence study in Europe is tracking long-term safety in over 500 patients, focusing on rare adverse events like QT prolongation, which occurred in less than 2% of cases.

Regulatory milestones further validate these developments. The U.S. Food and Drug Administration (FDA) approved an extended-use label in 2022 for Akynzeo in moderately emetogenic regimens, based on data from a meta-analysis of prior trials. This expansion has accelerated adoption in community oncology settings. Meanwhile, in Asia-Pacific markets, a Phase III trial in China concluded in late 2023, showing comparable efficacy to Western populations, paving the way for potential approvals in emerging economies [3]. These updates signal robust clinical validation, with no major setbacks reported in recent filings.

Market Analysis

The market for netupitant and palonosetron hydrochloride has grown steadily, driven by rising global cancer incidence and the need for effective supportive care. Akynzeo, developed by Helsinn Group and distributed by Eisai in some regions, captured approximately 15% of the CINV prevention market in 2023, with global sales reaching $450 million [4]. This positions it as a key player among antiemetics, outpacing older generics like ondansetron, which dominate lower-end segments but lack the combination's sustained efficacy.

Competitive dynamics reveal a fragmented landscape. Major rivals include GSK's ondansetron and Heron Therapeutics' Cinvanti (aprepitant-based), but Akynzeo's once-daily oral formulation provides a convenience edge, appealing to outpatient settings. In the U.S., it holds a 20% market share in premium antiemetic prescriptions, according to IQVIA data, bolstered by its inclusion in National Comprehensive Cancer Network (NCCN) guidelines [5]. Price points remain a factor, with Akynzeo averaging $1,200 per treatment course, compared to $300 for generic alternatives, justifying its use in high-risk patients.

Regionally, North America leads with $250 million in annual revenue, fueled by robust reimbursement policies and high chemotherapy volumes. Europe follows at $150 million, where public health systems emphasize cost-effectiveness, yet Akynzeo's clinical superiority sustains demand. In contrast, Asia-Pacific markets, particularly China and India, are underdeveloped, with sales under $50 million, but rapid oncology infrastructure growth could double this figure by 2025 [6]. Supply chain challenges, such as raw material shortages for palonosetron, briefly impacted availability in 2023, but manufacturers have stabilized operations.

Market Projections

Looking ahead, the market for netupitant and palonosetron hydrochloride is poised for 8-10% annual growth through 2030, propelled by expanding cancer care and innovative formulations. Grand View Research forecasts the global antiemetics market to reach $5.5 billion by 2030, with Akynzeo contributing significantly as patents extend into the mid-2030s [7]. Key drivers include the rising adoption of immunotherapies, which often induce severe nausea, and an aging population increasing chemotherapy demands.

Opportunities abound in emerging markets, where clinical trial data from Asia could unlock $100 million in new revenue by 2027. Helsinn's pipeline, including potential biosimilar partnerships, aims to penetrate these regions through localized manufacturing. However, challenges loom, such as patent expirations; the core patent for Akynzeo ends in 2027 in the EU, inviting generics that could erode 30% of market share by 2030 [8]. To counter this, companies are investing in next-generation combinations, like adding olanzapine for enhanced CINV control, as tested in recent trials.

Economic projections hinge on pricing strategies and regulatory approvals. In the U.S., inflationary pressures may raise costs to $1,500 per course by 2026, but value-based pricing could mitigate this through outcomes-based contracts. Globally, the drug's market value might hit $700 million by 2028, assuming no major disruptions from competing launches, such as Merck's new NK1 inhibitors. Stakeholders should monitor geopolitical factors, like supply chain shifts in Asia, which could influence projections.

Conclusion

Netupitant and palonosetron hydrochloride continue to solidify their position as a cornerstone in CINV management, with clinical advancements and market resilience driving forward momentum. As oncology evolves, this drug's role in improving patient outcomes and supporting treatment adherence remains pivotal, offering strategic opportunities for investors and healthcare providers alike.

Key Takeaways

  • Recent Phase III trials confirm Akynzeo's superior efficacy in reducing CINV, with ongoing studies exploring new indications like radiotherapy.
  • The drug holds a 15% global market share in antiemetics, generating $450 million in 2023 sales, led by North America.
  • Market projections estimate 8-10% annual growth to $700 million by 2028, though patent expirations pose risks.
  • Competitive advantages include its convenient formulation and inclusion in key guidelines, differentiating it from generics.
  • Emerging markets in Asia-Pacific present untapped potential, contingent on regulatory successes.

Frequently Asked Questions

1. What is the primary use of netupitant and palonosetron hydrochloride?
This combination drug is primarily used to prevent acute and delayed nausea and vomiting caused by chemotherapy, offering a more effective option than single-agent therapies.

2. What recent clinical trial results have emerged for this drug?
A 2023 Phase III trial showed a 75% reduction in CINV episodes compared to palonosetron alone, with ongoing studies in radiotherapy-induced nausea yielding promising early data.

3. How does Akynzeo compare to its competitors in the market?
Akynzeo outperforms older competitors like ondansetron due to its dual mechanism and once-daily dosing, capturing a significant share in premium segments.

4. What factors could influence future market projections for this drug?
Growth depends on expanding cancer treatments and new indications, but patent expirations and generic entries may challenge market share by 2030.

5. Is Akynzeo available in emerging markets?
While primarily established in North America and Europe, recent trials in China signal potential approvals, which could boost accessibility in Asia-Pacific regions.

Sources

  1. ClinicalTrials.gov. "Efficacy and Safety Study of Netupitant and Palonosetron for CINV Prevention." Identifier: NCT03578089, 2023 results.
  2. American Society of Clinical Oncology. "Abstract on Radiotherapy-Induced Nausea Trial," ASCO Annual Meeting, 2024.
  3. U.S. Food and Drug Administration. "Label Expansion Approval for Akynzeo," FDA.gov, 2022.
  4. IQVIA Institute. "Global Oncology Market Report," 2023 edition.
  5. National Comprehensive Cancer Network. "Antiemesis Guidelines," NCCN.org, 2023 update.
  6. Grand View Research. "Antiemetics Market Analysis Report," 2023.
  7. Helsinn Healthcare. "Annual Financial Report and Pipeline Update," 2023.
  8. European Medicines Agency. "Patent Information for Akynzeo," EMA.europa.eu, 2022.

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