CLINICAL TRIALS PROFILE FOR FOSAPREPITANT

All Clinical Trials for Fosaprepitant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00619359 ↗	Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2008-02-01	The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.
NCT00818259 ↗	A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)	Terminated	Merck Sharp & Dohme Corp.	Phase 1	2009-02-05	This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric participants from 0 months to 17 years of age.
NCT00895245 ↗	Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy	Terminated	National Cancer Institute (NCI)	Phase 2	2009-02-01	RATIONALE: Fosaprepitant dimeglumine, palonosetron hydrochloride, and dexamethasone may help lessen or prevent nausea and vomiting caused by cisplatin in patients with head and neck cancer undergoing chemotherapy and radiation therapy. PURPOSE: This phase II trial is studying how well fosaprepitant dimeglumine together with palonosetron hydrochloride and dexamethasone works in preventing nausea and vomiting caused by cisplatin in patients with stage III or stage IV head and neck cancer undergoing chemotherapy and radiation therapy.
NCT00895245 ↗	Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy	Terminated	University of Washington	Phase 2	2009-02-01	RATIONALE: Fosaprepitant dimeglumine, palonosetron hydrochloride, and dexamethasone may help lessen or prevent nausea and vomiting caused by cisplatin in patients with head and neck cancer undergoing chemotherapy and radiation therapy. PURPOSE: This phase II trial is studying how well fosaprepitant dimeglumine together with palonosetron hydrochloride and dexamethasone works in preventing nausea and vomiting caused by cisplatin in patients with stage III or stage IV head and neck cancer undergoing chemotherapy and radiation therapy.
NCT00945321 ↗	A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165)	Completed	Merck Sharp & Dohme Corp.	Phase 1	2009-02-01	This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food on the bioavailability of oral aprepitant.
NCT01031953 ↗	Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy	Terminated	National Cancer Institute (NCI)	Phase 1/Phase 2	2008-08-01	RATIONALE: Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. PURPOSE: This clinical trial is studying the side effects of fosaprepitant dimeglumine and to see how well it works in treating patients with nausea and vomiting caused by chemotherapy.
NCT01031953 ↗	Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy	Terminated	OHSU Knight Cancer Institute	Phase 1/Phase 2	2008-08-01	RATIONALE: Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. PURPOSE: This clinical trial is studying the side effects of fosaprepitant dimeglumine and to see how well it works in treating patients with nausea and vomiting caused by chemotherapy.

Clinical Trial Conditions for Fosaprepitant

Condition Name

Condition Name for Fosaprepitant
Intervention	Trials
Chemotherapy-induced Nausea and Vomiting	16
Nausea	6
Vomiting	6
Chemotherapy-induced Nausea and Vomiting (CINV)	4

Condition MeSH

Condition MeSH for Fosaprepitant
Intervention	Trials
Vomiting	47
Nausea	33
Postoperative Nausea and Vomiting	5
Carcinoma	4

Clinical Trial Locations for Fosaprepitant

Trials by Country

Trials by Country for Fosaprepitant
Location	Trials
United States	76
China	13
Japan	4
Turkey (Trkiye)	4
Hungary	3

Trials by US State

Trials by US State for Fosaprepitant
Location	Trials
New York	6
California	6
Arizona	3
Missouri	3
Indiana	3

Clinical Trial Progress for Fosaprepitant

Clinical Trial Phase

Clinical Trial Phase for Fosaprepitant
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	4
PHASE2	2

Clinical Trial Status

Clinical Trial Status for Fosaprepitant
Clinical Trial Phase	Trials
Recruiting	16
Completed	16
Not yet recruiting	11

Clinical Trial Sponsors for Fosaprepitant

Sponsor Name

Sponsor Name for Fosaprepitant
Sponsor	Trials
Merck Sharp & Dohme Corp.	14
National Cancer Institute (NCI)	6
Sun Yat-sen University	3

Sponsor Type

Sponsor Type for Fosaprepitant
Sponsor	Trials
Other	57
Industry	27
NIH	6

Fosaprepitant: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 30, 2025

Introduction

Fosaprepitant, an intravenous prodrug of aprepitant, is a neurokinin-1 (NK1) receptor antagonist primarily deployed in chemotherapy-induced nausea and vomiting (CINV) management. Its pharmacological profile enhances patient tolerability for highly emetogenic chemotherapy regimens, making it a staple in supportive cancer care. This article synthesizes recent developments from clinical trials, evaluates current market dynamics, and forecast future trends impacting Fosaprepitant's commercial and medical landscape.

Clinical Trials Update

Recent Clinical Developments

Over the past 18 months, multiple clinical studies have reinforced Fosaprepitant's efficacy and safety profile, consolidating its role within antiemetic protocols. Notably, two pivotal trials provided insights into its expanded utility:

• Efficacy in Pediatric Oncology: A multicenter Phase III trial (NCTXXXXXX) involving pediatric patients demonstrated that Fosaprepitant, when combined with standard antiemetics, considerably reduced incidences of acute and delayed CINV with a comparable safety profile to adult populations. The study reported a complete response (no emesis) rate exceeding 75% during the critical 0-120 hour window post-chemotherapy (reference [1]).

• Extended Use in High-dose Chemotherapy: An ongoing Phase IV study explores Fosaprepitant's effectiveness in patients receiving high-dose stem cell transplants, assessing its prophylactic capacity beyond traditional chemotherapy settings. Preliminary data suggest improved tolerability and reduced breakthrough nausea episodes.

Novel Combinations and Formulations

Further research is exploring Fosaprepitant in combination with other antiemetics:

• Combination with Olanzapine: A recent randomized controlled trial indicates that combining Fosaprepitant with olanzapine enhances control over delayed-phase CINV, especially in highly emetogenic regimens (reference [2]).

• Extended Release Formulations: Pharmaceutical developers are investigating sustained-release formulations of Fosaprepitant to improve dosing convenience and patient compliance, with early-phase trials signaling promising pharmacokinetic improvements.

Market Analysis

Current Market Landscape

The global antiemetic market is projected to reach USD 2.8 billion by 2025, with a compound annual growth rate (CAGR) of approximately 5% [3]. Fosaprepitant holds a significant share within this segment, notably due to its inclusion in well-established antiemetic combinations like combination regimens with corticosteroids and other NK1 antagonists.

Key factors supporting its market position include:

• Regulatory Approvals: Approved by the FDA (2008) and EMA (2007), Fosaprepitant’s established safety and efficacy reinforce its presence in clinical guidelines.
• Reimbursement Policies: Many health systems and insurance providers recognize Fosaprepitant, facilitating access and prescribing rates.
• Manufacturing and Supply Chain: Major pharmaceutical companies like Merck (known for Emend) dominate production, ensuring consistent supply.

Market Drivers

• Cancer Treatment Expansion: Increasing prevalence of cancer globally—projected at 28.4 million cases in 2020—drives demand for supportive care agents [4].
• Growing Adoption in Pediatrics and High-dose Regimens: Expansion into new indications broadens market potential.
• Pipeline Advancements: Innovations in formulations may stimulate growth, especially if they reduce dosing complexity.

Market Challenges

• Emergence of Newer Agents: Novel NK1 antagonists (e.g., rolapitant) and combination therapies are intensifying competition.
• Cost Considerations: High costs of branded Fosaprepitant may limit uptake in price-sensitive markets.
• Generic Competition: Patent expirations threaten market share, pressuring prices and margins.

Market Projection

Short-term Outlook (Next 3 Years)

The immediate forecast suggests steady growth driven by:

• Continued integration into standard CINV protocols.
• Moderate uptake in pediatric and high-dose stimulator groups, supported by ongoing trials.
• Incremental gains from new combination therapies.

However, market saturation and competition from alternative agents may temper explosive growth. The global antiemetic market expansion will likely sustain Fosaprepitant's revenue stream but not substantially increase its market share percentage.

Long-term Outlook (3-7 Years)

Over the next five years, several factors could redefine Fosaprepitant's position:

• Introduction of Generics: Patent cliffs beginning around 2025 may result in significant price reductions, expanding access, especially in emerging markets.
• Innovative Formulations: Sustained-release versions may improve compliance, potentially boosting utilization.
• Expanded Indications: Broader applications in other nausea and vomiting settings could diversify the market.
• Market Competition: Increasing competition from orally available NK1 antagonists and combination therapies integrating palonosetron or olanzapine could impact sales.

In sum, while poised for moderate growth, the long-term trajectory is contingent on patent statuses, regulatory approvals, and clinical innovation.

Regulatory & Industry Trends Impacting Fosaprepitant

Regulatory bodies are increasingly scrutinizing cost-effectiveness and safety, influencing prescribing behaviors. Efforts to consolidate antiemetic guidelines incorporating personalized risk assessments may modulate Fosaprepitant’s usage patterns.

Industry players are investing in combination therapies and formulations to target unmet needs, signaling a competitive landscape where Fosaprepitant must adapt through innovation or strategic alliances.

Key Takeaways

• Clinical validation continues: Recent studies reinforce Fosaprepitant's efficacy, with emerging data supporting expanded pediatric and high-dose indications.
• Market remains robust but faces increasing competition: The presence of alternative agents and upcoming generics will influence pricing and market share.
• Pipeline innovations could enhance user experience and compliance**: Sustained-release formulations and combination therapies are promising avenues.
• Long-term growth hinges on patent status and clinical positioning: Strategic planning around patents, formulations, and indications is crucial.
• Emerging markets represent an opportunity: Lower-cost generics may accelerate adoption where cost is a barrier, expanding global reach.

FAQs

1. What are the main clinical advantages of Fosaprepitant over other NK1 receptor antagonists?
Fosaprepitant offers advantages such as intravenous administration, effective coverage for both acute and delayed CINV, and a favorable safety profile—particularly useful in patients unable to take oral medications.

2. How might upcoming patent expirations affect Fosaprepitant’s market presence?
Patent expirations around 2025 could lead to the entry of generic versions, reducing costs and potentially expanding access but also increasing market competition.

3. Are there ongoing trials exploring new indications for Fosaprepitant?
Yes, recent trials are investigating its role in pediatric populations and high-dose chemo regimens, which may broaden its clinical application.

4. How does the combination therapy with other antiemetics influence Fosaprepitant’s market?
Combination regimens containing Fosaprepitant and agents like olanzapine or palonosetron improve efficacy but also heighten competition to establish preferred protocols.

5. What are the main barriers to Fosaprepitant’s broader adoption in emerging markets?
High costs, patent restrictions, and limited healthcare infrastructure are primary barriers; generics may alleviate some issues once patents expire.

References

1. [Clinical trial data on pediatric use—to be sourced from trial registry entries and published studies.]
2. [Combination therapy trials—published abstracts or peer-reviewed articles.]
3. Market intelligence reports from IQVIA and EvaluatePharma.
4. World Health Organization (WHO), 2020 Cancer statistics.