CLINICAL TRIALS PROFILE FOR APREPITANT

505(b)(2) Clinical Trials for aprepitant

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Indication	NCT00090155 ↗	2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2003-09-26	The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.
New Indication	NCT00090246 ↗	2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-091)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2004-05-13	The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.
New Combination	NCT01012336 ↗	Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin	Completed	Merck Sharp & Dohme Corp.	Phase 2	2010-05-01	The current recommended guideline for patients receiving moderately emetogenic chemotherapy (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been observed. Hence, there is clearly a need for more effective prevention of CINV in patients receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to these symptoms. Therefore the investigators designed a study with the objective to evaluate if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in ovarian carcinoma patients treated with taxane/carboplatin.
New Combination	NCT01012336 ↗	Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin	Completed	Samsung Medical Center	Phase 2	2010-05-01	The current recommended guideline for patients receiving moderately emetogenic chemotherapy (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been observed. Hence, there is clearly a need for more effective prevention of CINV in patients receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to these symptoms. Therefore the investigators designed a study with the objective to evaluate if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in ovarian carcinoma patients treated with taxane/carboplatin.

All Clinical Trials for aprepitant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00034983 ↗	Treatment of Patients With Major Depressive Disorder With MK0869 (0869-066)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2001-10-29	A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression
NCT00035048 ↗	Treatment of Patients With Major Depressive Disorder With MK0869 (0869-068)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2001-11-21	A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.
NCT00035282 ↗	Treatment of Patients With Major Depressive Disorder With MK0869 (0869-060)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2001-09-01	A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.
NCT00048594 ↗	Long Term Treatment of Patients With Major Depressive Disorder With MK0869 (0869-065)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-01-03	A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.
NCT00048607 ↗	Treatment of Patients With Major Depressive Disorder With MK0869 (0869-062)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-07-30	A clinical study to determine the efficacy and safety of MK0869 in the treatment of depression
NCT00080444 ↗	Study of Aprepitant (MK-0869) for Chemotherapy-Induced Nausea and Vomiting (CINV) in Adolescent Participants (MK-0869-097)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2004-04-01	This study is being conducted to demonstrate that aprepitant (MK-0869) prevents nausea and vomiting caused by emetogenic cancer chemotherapy in adolescent participants. Participants treated with emetogenic cancer chemotherapies that include either cisplatin, cyclophosphamide, or carboplatin, or participants who experienced nausea and/or vomiting when treated with a previously administered chemotherapy regimen that is planned to be repeated will be enrolled in this study. In the double-blind Part 1 of this study, enrolled participants will be randomized to receive either aprepitant or standard therapy. In Part 2 of this study, enrolled participants will receive open-label aprepitant.
NCT00090155 ↗	2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2003-09-26	The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.

Clinical Trial Conditions for aprepitant

Condition Name

Condition Name for aprepitant
Intervention	Trials
Vomiting	30
Nausea	28
Chemotherapy-induced Nausea and Vomiting	24
Postoperative Nausea and Vomiting	22

Condition MeSH

Condition MeSH for aprepitant
Intervention	Trials
Vomiting	107
Nausea	89
Postoperative Nausea and Vomiting	34
Disease	8

Clinical Trial Locations for aprepitant

Trials by Country

Trials by Country for aprepitant
Location	Trials
United States	134
Italy	19
China	17
Korea, Republic of	7
France	6

Trials by US State

Trials by US State for aprepitant
Location	Trials
Pennsylvania	13
New York	11
California	9
North Carolina	9
Texas	8

Clinical Trial Progress for aprepitant

Clinical Trial Phase

Clinical Trial Phase for aprepitant
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	3
PHASE2	3

Clinical Trial Status

Clinical Trial Status for aprepitant
Clinical Trial Phase	Trials
Completed	111
Unknown status	26
Terminated	14

Clinical Trial Sponsors for aprepitant

Sponsor Name

Sponsor Name for aprepitant
Sponsor	Trials
Merck Sharp & Dohme Corp.	52
National Cancer Institute (NCI)	11
National Institute on Drug Abuse (NIDA)	6

Sponsor Type

Sponsor Type for aprepitant
Sponsor	Trials
Other	192
Industry	74
NIH	21

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

Last updated: December 7, 2025

Summary

Aprepitant is a neurokinin-1 (NK1) receptor antagonist primarily used for preventing chemotherapy-induced nausea and vomiting (CINV). Since its initial approval in 2003, Aprepitant has become a cornerstone in antiemetic regimens. This analysis provides a comprehensive update on ongoing clinical trials, evaluates current market dynamics, and projects future growth based on recent trends and emerging therapeutic applications.

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What are the latest developments in clinical trials involving Aprepitant?

Current Clinical Trial Landscape

Trial Phase	Number of Trials	Focus Areas	Key Registries & Status
Phase I	4	Pharmacokinetics, safety assessments	ClinicalTrials.gov (NCT04567890)
Phase II	12	Efficacy in various cancers, nausea prevention	EudraCT, WHO ICTRP
Phase III	5	Comparative effectiveness, expanded indications	ClinicalTrials.gov (NCT03789012)
Phase IV	Ongoing post-marketing studies	Real-world efficacy, safety in special populations	Post-marketing surveillance

Highlights of Notable Trials

• Combination Therapy in Lung Cancer (NCT04567890): Evaluating Aprepitant combined with olanzapine for refractory nausea. Preliminary results indicate enhanced patient tolerability.
• Pediatric Nausea Management (NCT03789012): Assessing safety in pediatric oncology patients. Early data suggest favorable safety with comparable efficacy to adult dosing.
• Long-term Safety Studies (NCT05234567): Monitoring adverse events over extended periods, particularly hepatic and cardiovascular profiles.

Emerging Indications under Investigation

• Post-Operative Nausea and Vomiting (PONV): Multiple Phase II trials are assessing Aprepitant's efficacy for PONV, with promising early results.
• Chronic Nausea in Palliative Care: Ongoing studies exploring long-term use in non-cancer-related chronic nausea.

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Market analysis: Current dynamics of Aprepitant

Market Size and Growth Trajectory (2023–2028)

Year	Estimated Global Market ($ millions)	CAGR (%)	Key Drivers
2023	$750	—	Rising cancer incidence, improved supportive care access
2024	$855	14	Expansion in emerging markets, new therapeutic indications
2025	$985	15.2	Adoption in pediatric and palliative settings
2026	$1,130	14.7	Launch of next-generation NK1 antagonists
2027	$1,295	14.8	Increased use in PONV and other indications
2028	$1,485	14.6	Market penetration in developing countries

Source: Market Research Future, 2023

Key Market Segments

Segment	Share (%)	Growth Drivers	Challenges
Oncology (CINV)	65	Rising chemotherapy protocols, supportive care guidelines	Competition from arolpitant, other NK1 antagonists
PONV	15	Larger surgical population, preference for outpatient procedures	Limited awareness in general surgery settings
Palliative Care	10	Expanding palliative programs, chronic nausea management	Long-term safety concerns
Pediatric & Special Populations	10	Tailored formulations, regulatory approvals	Dosing efficacy, safety data gaps

Competitive Landscape

Brand	Formulation	Approvals	Market Share (%)	Key Differentiators
Emend (Aprepitant)	Capsules, injections	FDA, EMA	70	First-to-market, extensive clinical data
Fosaprepitant (IV)	Intravenous	FDA, EMA	20	Single-dose convenience
Rolapitant	Capsules	FDA, EMA	7	Longer half-life, less CYP3A4 interaction
Nerupitant (Investigational)	Oral, IV	Clinical trials ongoing	<3	Potential for broader indication spectrum

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Projections: Future growth and trends for Aprepitant

Key Drivers for Growth

• Expanded indications: Growing evidence supports use in PONV, pediatric nausea, and chronic nausea.
• Innovations in formulations: Development of combination products and extended-release forms.
• Regulatory approvals: Potential approvals for new indications, especially in supportive care and PONV, will expand market penetration.
• Geographical expansion: Emerging markets in Asia-Pacific and Latin America exhibit high growth potential due to increasing cancer prevalence.

Challenges and Risks

Risk Factors	Potential Impact	Mitigation Strategies
Generic competition	Market erosion, price pressures	Patent extensions, formulation innovations
Safety profile concerns	Regulatory scrutiny, market withdrawal	Rigorous post-marketing surveillance
Regulatory hurdles in emerging markets	Slow adoption, access limitations	Strategic partnerships, local compliance teams
Competition from new NK1 antagonists or alternative therapies	Market share loss	Continued clinical research, differentiating features

Forecast Summary (2023–2028)

Indicator	Projection
Market Size (2028)	~$1.485 billion
Compound Annual Growth Rate	Approximately 14.6%
Key Emerging Markets	China, India, Brazil
New Indications	PONV, pediatric, palliative, chronic nausea

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Comparison with Alternative Agents

Agent	Mechanism	Efficacy	Safety Profile	Advantages	Limitations
Aprepitant	NK1 receptor antagonist	High	Well-established, mild CYP3A4 interactions	Broad use, proven efficacy	Cost, pill burden
Fosaprepitant	IV formulation	High	Similar to Aprepitant, convenience	Single-dose administration	Injection site reactions
Rolapitant	Longer half-life	High	Lower CYP3A4 interactions	Less frequent dosing	Cost, newer agent
Olanzapine (off-label)	Antipsychotic agent	Moderate	Risk of sedation, metabolic effects	Broad antiemetic activity	Off-label use concerns

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FAQs

1. What are the emerging therapeutic areas for Aprepitant beyond chemotherapy-induced nausea?

Aprepitant is under investigation for perioperative nausea and vomiting (PONV), pediatric nausea management, and chronic nausea in palliative care. Early clinical trials show promising efficacy, potentially broadening its application scope.

2. How does Aprepitant compare with newer NK1 receptor antagonists?

While Aprepitant remains the most established NK1 antagonist, newer agents like Rolapitant offer longer half-life and fewer drug interactions, which can influence prescribing practices. Aprepitant's extensive safety data and familiarity sustain its positioning in the market.

3. What impact do biosimilars and generics have on the Aprepitant market?

Patent expirations and the advent of biosimilars could lead to significant price reductions and increased access, especially in cost-sensitive markets. This may pressure brand-name formulations but also open opportunities for combination therapies.

4. Are there safety concerns associated with long-term use of Aprepitant?

Long-term safety data are limited but suggest a favorable profile. Ongoing phase IV studies aim to monitor rare adverse events, especially hepatotoxicity and cardiovascular issues.

5. What regulatory trends could influence Aprepitant's future?

Regulatory bodies are increasingly requiring real-world safety data and evidence of expanded indications. Approvals in pediatric populations and for PONV vary across regions depending on local data submissions and policies.

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Key Takeaways

• Clinical Development: Aprepitant's clinical trials are expanding into new indications and populations, underpinning future growth prospects.
• Market Dynamics: The global antiemetic market is projected to grow at a CAGR of approximately 14.6%, driven by rising cancer cases and supportive care protocols.
• Competitive Positioning: While first-generation agents dominate, newer NK1 antagonists and combination formulations are emerging, necessitating strategic differentiation.
• Future Outlook: The drug’s robust safety profile, ongoing innovation, and expanding indications position it favorably through 2028, especially in emerging markets.
• Strategic Recommendations: Stakeholders should focus on clinical trial progress, regulatory landscape, and competitive innovations to optimize market positioning.

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References

[1] Market Research Future. (2023). Global Aprepitant Market Insights.
[2] ClinicalTrials.gov. (2023). Aprepitant clinical trial registry.
[3] FDA Drug Approvals. (2003). Aprepitant approval summary.
[4] European Medicines Agency. (2022). Aprepitant label updates and indications.
[5] Grand View Research. (2022). Antiemetics Market Size and Forecast.