CLINICAL TRIALS PROFILE FOR AKYNZEO

All Clinical Trials for Akynzeo

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03008213 ↗	Combination of Netupitant and Palonosetron (Akynzeo®) in the Treatment of Refractory CINV	Terminated	Joseph Ma	Phase 2	2017-01-01	Prevention and control of Chemotherapy-Induced Nausea and Vomiting (CINV) are most important in treatment of cancer patients. CINV is one of the most distressing severe side effects of cancer treatment and can have a significant impact on a patient's quality of life. The chemotherapy agents that cause the worst degree of nausea and vomiting are categorized into two groups: moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC). Nausea and vomiting that occurs within the first day of the administration of chemotherapy agents is considered acute CINV, while nausea and vomiting following 24 hours of the administration of chemotherapy agents is considered delayed CINV. Refractory CINV occurs when patients develop CINV during subsequent cycles of chemotherapy when drugs preventing vomiting and nausea (antiemetic prophylaxis) has not been successful in controlling CINV in earlier cycles. The purpose of this study is to assess the efficacy of Akynzeo in the treatment of refractory CINV
NCT03008213 ↗	Combination of Netupitant and Palonosetron (Akynzeo®) in the Treatment of Refractory CINV	Terminated	University of California, San Diego	Phase 2	2017-01-01	Prevention and control of Chemotherapy-Induced Nausea and Vomiting (CINV) are most important in treatment of cancer patients. CINV is one of the most distressing severe side effects of cancer treatment and can have a significant impact on a patient's quality of life. The chemotherapy agents that cause the worst degree of nausea and vomiting are categorized into two groups: moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC). Nausea and vomiting that occurs within the first day of the administration of chemotherapy agents is considered acute CINV, while nausea and vomiting following 24 hours of the administration of chemotherapy agents is considered delayed CINV. Refractory CINV occurs when patients develop CINV during subsequent cycles of chemotherapy when drugs preventing vomiting and nausea (antiemetic prophylaxis) has not been successful in controlling CINV in earlier cycles. The purpose of this study is to assess the efficacy of Akynzeo in the treatment of refractory CINV
NCT03040726 ↗	Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer	Active, not recruiting	Helsinn Healthcare SA	Phase 2/Phase 3	2017-05-03	This randomized phase II/III trial studies how well netupitant and palonosetron hydrochloride works in preventing chronic nausea and vomiting in patients with cancer. Netupitant and palonosetron hydrochloride may reduce nausea and vomiting.
NCT03040726 ↗	Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 2/Phase 3	2017-05-03	This randomized phase II/III trial studies how well netupitant and palonosetron hydrochloride works in preventing chronic nausea and vomiting in patients with cancer. Netupitant and palonosetron hydrochloride may reduce nausea and vomiting.
NCT03040726 ↗	Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer	Active, not recruiting	M.D. Anderson Cancer Center	Phase 2/Phase 3	2017-05-03	This randomized phase II/III trial studies how well netupitant and palonosetron hydrochloride works in preventing chronic nausea and vomiting in patients with cancer. Netupitant and palonosetron hydrochloride may reduce nausea and vomiting.
NCT03367572 ↗	Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer	Recruiting	National Cancer Institute (NCI)	Phase 3	2018-03-09	This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in patients with breast cancer. Antiemetic drugs, such as prochlorperazine and olanzapine, may help lessen nausea and vomiting in patients with breast cancer treated with chemotherapy.
NCT03367572 ↗	Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer	Recruiting	University of Rochester NCORP Research Base	Phase 3	2018-03-09	This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in patients with breast cancer. Antiemetic drugs, such as prochlorperazine and olanzapine, may help lessen nausea and vomiting in patients with breast cancer treated with chemotherapy.

Clinical Trial Conditions for Akynzeo

Condition Name

Condition Name for Akynzeo
Intervention	Trials
Chemotherapy-induced Nausea and Vomiting	3
Breast Carcinoma	1
Oncology	1
Cervical Cancer	1

Condition MeSH

Condition MeSH for Akynzeo
Intervention	Trials
Vomiting	7
Nausea	4
Uterine Cervical Neoplasms	1
Breast Neoplasms	1

Clinical Trial Locations for Akynzeo

Trials by Country

Trials by Country for Akynzeo
Location	Trials
United States	34
Denmark	1
Czechia	1
Georgia	1
Korea, Republic of	1

Trials by US State

Trials by US State for Akynzeo
Location	Trials
South Carolina	2
Pennsylvania	2
Ohio	2
Louisiana	2
Illinois	2

Clinical Trial Progress for Akynzeo

Clinical Trial Phase

Clinical Trial Phase for Akynzeo
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Akynzeo
Clinical Trial Phase	Trials
Recruiting	4
Completed	2
Terminated	1

Clinical Trial Sponsors for Akynzeo

Sponsor Name

Sponsor Name for Akynzeo
Sponsor	Trials
Helsinn Healthcare SA	5
National Cancer Institute (NCI)	2
M.D. Anderson Cancer Center	1

Sponsor Type

Sponsor Type for Akynzeo
Sponsor	Trials
Industry	9
Other	7
NIH	2

AKYNZEO: Clinical Trials, Market Analysis, and Projections

Last updated: January 2, 2025

Introduction to AKYNZEO

AKYNZEO is a medication designed to prevent chemotherapy-induced nausea and vomiting (CINV), a common and debilitating side effect of cancer treatment. The drug is a combination of netupitant and palonosetron, and it is available in both oral and intravenous (IV) formulations.

Clinical Trials Overview

Trial Design and Participants

The approval of AKYNZEO, particularly the IV formulation, was based on several clinical trials. Trial 1, which enrolled 440 patients, was conducted to assess the efficacy of AKYNZEO in preventing CINV. This trial was carried out at 76 centers across 9 countries, including Belarus, Bosnia and Herzegovina, Bulgaria, Georgia, Greece, Hungary, Lithuania, Romania, and Russia[1].

Trial 2, involving 404 patients, focused on the safety profile of AKYNZEO IV compared to the oral capsule formulation. This trial was conducted at 80 centers in 11 countries, including Austria, Croatia, Czech Republic, Germany, Israel, Italy, Poland, Serbia, Spain, Ukraine, and the US[1].

Efficacy and Safety Findings

In the clinical trials, AKYNZEO demonstrated significant efficacy in preventing CINV. A Phase 3 study involving 1455 chemotherapy-naïve patients showed that AKYNZEO plus dexamethasone had a higher complete response (CR) rate in the delayed phase compared to oral palonosetron plus dexamethasone (76.9% vs 69.5%, P = 0.001)[3].

The safety profile of AKYNZEO IV was generally similar to that of the oral capsules. The most common adverse events reported in at least 2% of patients included headache, dizziness, and constipation[1].

Comparative Studies

AKYNZEO was compared to other antiemetic regimens in several studies. For instance, a double-blind, randomized controlled trial (NETU 8-18) showed that AKYNZEO was statistically superior to palonosetron alone in both the acute and delayed phases of CINV in multiple chemotherapy cycles[4].

Market Analysis

Global Market Size and Growth

The global antiemetics drugs market, which includes AKYNZEO, was valued at USD 7.49 billion in 2023 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.98% from 2024 to 2030. This growth is driven by increasing cancer cases, rising chemotherapy treatments, and the introduction of new antiemetic drugs[2].

Regional Market Trends

The Asia Pacific region is anticipated to grow significantly due to the rising incidence of cancer and gastroenteritis, along with the increasing availability of various antiemetics medications. For example, the number of cancer cases in India is projected to increase by 12.8% from 2020 to 2025, which will drive the demand for antiemetic drugs in this region[2].

Application Segments

The chemotherapy segment dominated the antiemetics market in 2023, with a market share of 45.70%. This is due to the high use of antiemetics to treat nausea and vomiting associated with chemotherapy. The launch of new products, such as AKYNZEO IV, further supports this segment's growth[2].

Market Projections

Product Launches and Approvals

Recent launches, such as the introduction of AKYNZEO IV in India by Glenmark Pharmaceuticals Ltd in January 2023, are expected to boost market growth. Similar product introductions and approvals, like the authorization of Arokaris by Taiho Pharmaceutical Co., Ltd. in March 2022, will continue to drive the market forward[2].

Competitive Landscape

The antiemetics market is competitive, with several key players involved in research, development, and marketing of antiemetic drugs. Companies like Helsinn, Mundipharma, and Astellas Pharma Inc. are actively presenting research findings and launching new products, which enhances market awareness and growth[2].

Patent and Exclusivity

Generic Entry Dates

The patents for AKYNZEO are expected to expire around September 25, 2035, although this date may change due to various factors. This expiration will open up opportunities for generic entry, potentially altering the market dynamics[5].

Key Takeaways

• Efficacy and Safety: AKYNZEO has demonstrated significant efficacy in preventing CINV with a safety profile similar to other antiemetic drugs.
• Market Growth: The global antiemetics market is expected to grow at a CAGR of 5.98% from 2024 to 2030, driven by increasing cancer cases and new product launches.
• Regional Trends: The Asia Pacific region is expected to see significant growth due to rising cancer incidence and increasing availability of antiemetics.
• Product Launches: Recent and upcoming product launches, such as AKYNZEO IV, will continue to drive market growth.
• Patent Exclusivity: The patents for AKYNZEO are set to expire around 2035, which may lead to generic entry and changes in market dynamics.

FAQs

What is AKYNZEO used for?

AKYNZEO is used to prevent chemotherapy-induced nausea and vomiting (CINV), a common side effect of cancer treatment.

What are the key components of AKYNZEO?

AKYNZEO is a combination of netupitant and palonosetron, available in both oral and intravenous formulations.

How effective is AKYNZEO in preventing CINV?

AKYNZEO has shown higher complete response rates compared to other antiemetic regimens, particularly in the delayed phase of CINV[3].

What is the expected growth rate of the global antiemetics market?

The global antiemetics market is expected to grow at a CAGR of 5.98% from 2024 to 2030[2].

When are the patents for AKYNZEO expected to expire?

The patents for AKYNZEO are expected to expire around September 25, 2035, although this date may change due to various factors[5].

Which region is expected to see significant growth in the antiemetics market?

The Asia Pacific region is anticipated to see significant growth due to rising cancer incidence and increasing availability of antiemetics medications[2].

Sources

1. FDA: Drug Trials Snapshots: AKYNZEO - FDA
2. Grand View Research: Antiemetics Drugs Market Size & Share Analysis Report 2030
3. Stabiopharma: TGA Approves AKYNZEO® (netupitant/palonosetron) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)
4. CADTH: CDR Clinical Review Report for Akynzeo
5. DrugPatentWatch: When will the AKYNZEO patents expire, and ... - DrugPatentWatch