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 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.
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 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.

All Clinical Trials for aprepitant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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
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.
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.
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
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.

Clinical Trial Conditions for aprepitant

Condition Name

Condition Name for aprepitant
Intervention	Trials
Vomiting	28
Nausea	26
Chemotherapy-induced Nausea and Vomiting	24
Postoperative Nausea and Vomiting	21

Condition MeSH

Condition MeSH for aprepitant
Intervention	Trials
Vomiting	104
Nausea	87
Postoperative Nausea and Vomiting	32
Disease	8

Clinical Trial Locations for aprepitant

Trials by Country

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−

Trials by Country for aprepitant
Location	Trials
United States	132
Italy	19
China	15
Korea, Republic of	7
Germany	6

Trials by US State

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−

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

Clinical Trial Progress for aprepitant

Clinical Trial Phase

Clinical Trial Phase for aprepitant
Clinical Trial Phase	Trials
Phase 4	35
Phase 3	43
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for aprepitant
Clinical Trial Phase	Trials
Completed	108
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	185
Industry	71
NIH	21

Clinical Trials and Efficacy of Aprepitant

Overview of Aprepitant

Aprepitant, a neurokinin-1 (NK-1) receptor antagonist, has been widely studied and utilized for the prevention of chemotherapy-induced nausea and vomiting (CINV). Here, we delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials

Pediatric Oncology Trial

A significant phase III randomized clinical trial focused on the use of aprepitant in pediatric patients undergoing chemotherapy. The trial involved 307 cancer patients aged 6 months to 17 years, who were randomly assigned to receive either aprepitant plus ondansetron or a placebo plus ondansetron. The results showed that 51% of patients in the aprepitant group achieved a complete response during the delayed phase, compared to 26% in the control group. This study provided strong evidence for the addition of aprepitant to anti-emetic regimens in pediatric oncology[1].

Adult Oncology Trials

In a study involving women receiving moderately emetogenic chemotherapy, aprepitant was combined with palonosetron and dexamethasone. The trial demonstrated that this combination significantly increased the complete response rate in both the acute and delayed phases of CINV. The aprepitant group showed a complete response rate of 87.0% overall, compared to 66.7% in the placebo group. This study highlighted the efficacy and safety of aprepitant in preventing CINV in adult patients[4].

Comparison with Fosaprepitant

Fosaprepitant, an intravenous prodrug of aprepitant, has also been studied in clinical trials. A randomized, double-blind study comparing fosaprepitant with aprepitant in patients receiving cisplatin-based chemotherapy found that both drugs had comparable antiemetic effects. The study indicated that fosaprepitant could be an alternative option for antiemetic therapy, showing similar efficacy and safety profiles to aprepitant[3].

Market Analysis

Global Market Size and Growth

The global aprepitant market is projected to experience significant growth from 2024 to 2031. The market size in 2023 was valued at several million dollars, with a compound annual growth rate (CAGR) expected to drive the market to new heights by 2031. The market analysis includes segments such as type (e.g., purity levels), application (e.g., prevention of postoperative nausea and vomiting), and regional analysis across North America, Europe, Asia Pacific, Middle East & Africa, and Latin America[2].

Key Players

The aprepitant market is dominated by several key players, including Heron Therapeutics, Inc., and Qilu Pharmaceutical. These companies are focusing on expanding their product portfolios and strengthening their market presence through strategic initiatives[5].

Regional Insights

The market is segmented into major regions, each providing insights into revenue share, current trends, and future growth prospects. The report includes detailed analysis at the country level, helping to understand the geographical trends and market opportunities[2].

Market Projections

Forecasted Growth

The global aprepitant market is anticipated to witness substantial growth, driven by increasing demand for effective antiemetic treatments. The forecast period from 2025 to 2031 is expected to see a significant increase in market size, with the CAGR indicating a robust growth trajectory[2].

Application Segments

The market is segmented by application, with the prevention of postoperative nausea and vomiting expected to expand at a significant CAGR. Other applications, such as cancer treatment centers and hospitals, are also projected to contribute to the market growth[5].

Technological and Competitive Analysis

The market report includes a comprehensive analysis of technological trends, competitive landscape, and market attractiveness. Factors such as profit, product price, capacity, production, and supply-demand dynamics are evaluated to provide a clear picture of the future prospects of the aprepitant market[2].

Safety and Adverse Events

Clinical Trial Findings

Clinical trials have shown that aprepitant is generally well-tolerated. Adverse events related to chemotherapy were reported by a similar percentage of patients in both the aprepitant and control groups. Common adverse events included febrile neutropenia, neutropenia, and anemia, with no significant difference in the frequency of these events between the two groups, except for a higher incidence of anemia in the control group[1].

Long-term Safety

Long-term studies have not indicated any significant safety concerns associated with the use of aprepitant. The drug's mechanism of action, which involves selectively blocking the binding of substance P at the NK-1 receptor, has been shown to be safe and effective in controlling both acute and delayed CINV[4].

Conclusion

Aprepitant has established itself as a crucial component in the prevention of chemotherapy-induced nausea and vomiting. Clinical trials have consistently demonstrated its efficacy and safety in both pediatric and adult populations. The market analysis indicates a strong growth trajectory, driven by increasing demand and the expansion of key players in the market.

Key Takeaways

• Efficacy in Clinical Trials: Aprepitant has shown significant efficacy in preventing CINV in both pediatric and adult patients.
• Market Growth: The global aprepitant market is projected to experience substantial growth from 2025 to 2031.
• Safety Profile: Aprepitant is generally well-tolerated, with adverse events similar to those in control groups.
• Market Segmentation: The market is segmented by type, application, and region, providing detailed insights into growth prospects.
• Key Players: Companies like Heron Therapeutics, Inc., and Qilu Pharmaceutical are driving market growth through strategic initiatives.

FAQs

Q: What is the primary use of aprepitant in clinical settings?

A: Aprepitant is primarily used for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Q: How does aprepitant compare to fosaprepitant in clinical trials?

A: Clinical trials have shown that aprepitant and fosaprepitant have comparable antiemetic effects, with fosaprepitant being an alternative option for antiemetic therapy[3].

Q: What are the common adverse events associated with aprepitant?

A: Common adverse events include febrile neutropenia, neutropenia, and anemia, with no significant difference in frequency between aprepitant and control groups, except for a higher incidence of anemia in the control group[1].

Q: Which companies are key players in the aprepitant market?

A: Key players include Heron Therapeutics, Inc., and Qilu Pharmaceutical[5].

Q: What is the projected growth rate of the global aprepitant market?

A: The global aprepitant market is expected to experience significant growth from 2025 to 2031, with a notable CAGR driving the market expansion[2].

Sources

1. National Cancer Institute: "Treatment Prevents Chemotherapy Side Effects for Children with Cancer" - May 13, 2015.
2. Cognitive Market Research: "Global Aprepitant Market Report 2024 Edition".
3. Advances in Clinical and Experimental Medicine: "A review of clinical studies on fosaprepitant" - 2023.
4. JAMA Network Open: "Effect of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting" - April 9, 2021.
5. Valuates Reports: "Global Aprepitant Injection Market Research Report 2024".