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Last Updated: December 18, 2025

Investigational Drug Information for Netupitant


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What is the drug development status for Netupitant?

Netupitant is an investigational drug.

There have been 23 clinical trials for Netupitant. The most recent clinical trial was a Phase 3 trial, which was initiated on February 26th 2024.

The most common disease conditions in clinical trials are Vomiting, Nausea, and Breast Neoplasms. The leading clinical trial sponsors are Helsinn Healthcare SA, National Cancer Institute (NCI), and Consorzio Oncotech.

There are three hundred and eighty-three US patents protecting this investigational drug and zero international patents.

Recent Clinical Trials for Netupitant
TitleSponsorPhase
A Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer PatientsShaanxi Provincial Cancer HospitalPHASE4
A Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer PatientsShanxi Bethune HospitalPHASE4
A Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer PatientsThe First Affiliated Hospital of Henan University of Science & TechnologyPHASE4

See all Netupitant clinical trials

Clinical Trial Summary for Netupitant

Top disease conditions for Netupitant
Top clinical trial sponsors for Netupitant

See all Netupitant clinical trials

US Patents for Netupitant

Drugname Patent Number Patent Title Patent Assignee Estimated Expiration
Netupitant ⤷  Get Started Free Crystalline forms of fosnetupitant Helsinn Healthcare SA (Lugano/Pazzallo, CH) ⤷  Get Started Free
Netupitant ⤷  Get Started Free Cyclohexyl pyridine derivative KISSEI PHARMACEUTICAL CO., LTD. (Matsumoto, Nagano, JP) ⤷  Get Started Free
Netupitant ⤷  Get Started Free .beta.-substituted .beta.-amino acids and analogs as chemotherapeutic agents and uses thereof Quadriga Biosciences, Inc. (Los Altos, CA) ⤷  Get Started Free
Netupitant ⤷  Get Started Free Porous nanoparticle-supported lipid bilayers (protocells) for targeted delivery and methods of using same STC.UNM (Albuquerque, NM) Sandia Corporation (Albuquerque, NM) ⤷  Get Started Free
>Drugname >Patent Number >Patent Title >Patent Assignee >Estimated Expiration

International Patents for Netupitant

Drugname Country Document Number Estimated Expiration Related US Patent
Netupitant Australia AU2016335060 2035-10-06 ⤷  Get Started Free
Netupitant Canada CA2996466 2035-10-06 ⤷  Get Started Free
Netupitant China CN108137626 2035-10-06 ⤷  Get Started Free
Netupitant European Patent Office EP3359547 2035-10-06 ⤷  Get Started Free
>Drugname >Country >Document Number >Estimated Expiration >Related US Patent

Development Update and Market Projection for Netupitant

Last updated: July 27, 2025

Introduction

Netupitant is an emerging pharmaceutical compound primarily developed for the prevention of chemotherapy-induced nausea and vomiting (CINV). As a selective neurokinin-1 (NK1) receptor antagonist, it has been positioned as a strategic alternative or complement to existing antiemetic therapies. This article reviews the latest development updates for Netupitant, assesses the current clinical landscape, and projects its market potential within the broader antiemetics segment.

Development Status of Netupitant

Preclinical and Clinical Trials

Netupitant first entered development by Helsinn Healthcare, with pivotal clinical trials initiated as early as the mid-2010s. The compound underwent various phases of trials to evaluate efficacy, safety, and tolerability in patients receiving highly emetogenic chemotherapy.

Phase III results demonstrated that combined administration of Netupitant with Palonosetron (a 5-HT3 receptor antagonist) significantly improved complete response rates compared to standard treatments, lowering breakthrough nausea and vomiting (Helsinn, 2018). The combination, marketed as NEPA (Netupitant and Palonosetron), received regulatory approval in multiple jurisdictions, including the U.S. and Europe, by 2016-2017.

Regulatory Approvals

The US Food and Drug Administration (FDA) approved NEPA as an oral combination therapy for the prevention of acute and delayed CINV in adult patients receiving chemotherapy. Similar approvals followed in Europe based on its demonstrated efficacy and safety, emphasizing NEPA’s positioning as a first-line preventive agent (FDA, 2016). Regulatory agencies highlighted its convenience and reduced pill burden as key advantages over traditional multi-drug regimens.

Manufacturing and Commercialization

Helsinn continues to oversee NEPA’s manufacturing, often through licensing agreements with larger pharmaceutical firms, reflecting its commercial appeal. The drug’s patented formulation aims to extend exclusivity until 2030, considering potential patent protections and market exclusivity rights.

Pipeline Enhancements and Future Research

While NEPA remains the primary focus, ongoing research seeks to evaluate the potential of Netupitant in other indications, such as post-operative nausea and vomiting (PONV) and as part of combination regimens in pain management and allergic conditions. However, these avenues remain in early-stage or preclinical phases.

Market Analysis & Projection

Current Market Dynamics

The global antiemetics market is valued at approximately USD 1.8 billion as of 2022, driven by increasing cancer incidences and evolving chemotherapy protocols. The segment is expected to grow at a CAGR of about 6% through 2028, supported by technological advancements and expanding indications [1].

NEPA’s rapid adoption repositioned NK1 receptor antagonists as a standard component in antiemetic guidelines. Key competitors include aprepitant (Emend), rolapitant (Varubi), and fosaprepitant. However, NEPA’s fixed-dose combination simplifies administration, offering a competitive edge—especially in outpatient settings and for P&T acceptance.

Growth Drivers

  • Regulatory Acceptance: Proven efficacy and favorable safety profile foster continued prescribing confidence.
  • Patient Convenience: Oral fixed-dose simplifies adherence, reducing compliance issues associated with multi-drug regimens.
  • Expanding Indications: Investigations into broader applications, including PONV and chronic nausea, may broaden market reach.
  • Global Expansion: Developing markets in Asia and Latin America, where chemotherapy protocols escalate, promise growth opportunities.

Challenges and Risks

  • Generic Competition: The expiration of patents around 2025 may lead to generic formulations, pressuring pricing and margins.
  • Market Penetration: Preference for established agents in certain regions could delay NEPA’s adoption.
  • Pricing and Reimbursement: Variability in health care payers' coverage may restrict sales, especially in cost-sensitive markets.

Market Projections (2023–2030)

Based on current trends, Netupitant-containing formulations are projected to account for roughly 25–30% of the total antiemetics market by 2028, driven by their high efficacy and patient-centric formulation. The global sales volume could surpass USD 800 million by 2030, assuming steady penetration and expansion into adjunct indications.

The key growth factors are:

  • Increasing adoption post-approval in emerging markets.
  • Extension into supportive care in broader oncology and non-oncology indications.
  • Strategic licensing agreements facilitating wider access and formulary inclusion.

Strategic Opportunities

Healthcare companies should consider partnerships, especially in regions with growing cancer treatment services, to maximize reach. Additionally, engaging in further clinical trials for secondary indications holds potential for market diversification.

Conclusion

Netupitant’s development trajectory reflects robust clinical validation and strong market positioning. While competitive and patent-related challenges loom, its fixed-dose combination formulation taps into a significant pharmacoeconomic and patient compliance advantage. The compound’s prospects remain promising within the evolving antiemetics landscape, especially if global adoption accelerates alongside expanding indications.

Key Takeaways

  • Regulatory milestones cement NEPA as a standard first-line therapy for CINV, ensuring sustained market relevance.
  • Market growth hinges on regional expansion, competitive pricing post-patent expiry, and potential new indications.
  • Strategic partnerships and ongoing clinical research are critical to maintaining competitive advantage and market share.
  • Patient compliance and convenience differentiation serve as paramount drivers for ongoing adoption.
  • Emerging markets present significant opportunities given rising chemotherapy utilization and healthcare infrastructure development.

FAQs

Q1: What makes Netupitant a preferable option over existing NK1 inhibitors?
A: Its fixed-dose combination with Palonosetron simplifies dosing, enhances compliance, and offers comparable or superior efficacy in preventing both acute and delayed CINV.

Q2: How does patent expiration affect Netupitant’s market outlook?
A: Patent expiry, expected around 2025, may lead to generics entering the market, exerting pricing pressure but also increasing accessibility in cost-sensitive regions.

Q3: Are there ongoing studies exploring new indications for Netupitant?
A: Yes, preliminary research investigates its utility in PONV, supportive care in other treatments, and potentially in managing chronic nausea, although these are still in early phases.

Q4: Which regions are key growth markets for Netupitant?
A: North America and Europe remain mature markets, but rapid growth is anticipated in Asia-Pacific and Latin America due to expanding oncology services.

Q5: How does the competitive landscape influence Netupitant’s market share?
A: While competing with established agents like aprepitant, NEPA’s unique formulation and regulatory acceptance continue to secure its niche, though evolving competition and generics present ongoing challenges.


Sources:

[1] MarketsandMarkets, "Anti-Emetics Market," 2022.
[2] Helsinn Group, "NEPA Regulatory and Clinical Data," 2018.
[3] FDA, "Approval of NEPA," 2016.

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