CLINICAL TRIALS PROFILE FOR PALONOSETRON HYDROCHLORIDE

All Clinical Trials for PALONOSETRON HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00359567 ↗	Comparative Study of Palonosetron With Granisetron as a Control in Patients Receiving Highly Emetogenic Chemotherapy	Completed	Taiho Pharmaceutical Co., Ltd.	Phase 3	2006-07-01	To compare palonosetron with granisetron hydrochloride as a control in the efficacy of intravenous single dose in preventing acute and delayed gastro-intestinal disorders, such as nausea and vomiting induced by highly emetogenic chemotherapy.
NCT00343460 ↗	APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer	Completed	Heron Therapeutics	Phase 3	2006-06-01	This randomized phase III trial is studying APF530 and dexamethasone to see how well they work compared with palonosetron and dexamethasone in preventing nausea and vomiting in patients receiving chemotherapy for cancer.
NCT00381862 ↗	Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX	Completed	National Cancer Institute (NCI)	Phase 2	2006-06-01	RATIONALE: Aprepitant, palonosetron, and dexamethasone may help lessen or prevent nausea and vomiting in patients receiving chemotherapy. PURPOSE: This phase II trial is studying how well giving aprepitant together with palonosetron and dexamethasone works in preventing nausea and vomiting caused by chemotherapy in patients receiving chemotherapy for metastatic colorectal cancer.
NCT00306735 ↗	Safety and Efficacy Study for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving Stem Cell Transplantation.	Completed	Helsinn Healthcare SA	Phase 2	2006-03-01	The primary purpose of this study is to explore the efficacy of three different dose schedules of palonosetron for the prevention of emesis over a 7-day study interval in multiple myeloma patients.
NCT00306735 ↗	Safety and Efficacy Study for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving Stem Cell Transplantation.	Completed	Eisai Inc.	Phase 2	2006-03-01	The primary purpose of this study is to explore the efficacy of three different dose schedules of palonosetron for the prevention of emesis over a 7-day study interval in multiple myeloma patients.
NCT00343863 ↗	Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer	Completed	National Cancer Institute (NCI)	N/A	2006-01-01	RATIONALE: Antiemetic drugs, such as dexamethasone, ondansetron hydrochloride, and palonosetron hydrochloride, may help lessen or prevent nausea and vomiting caused by chemotherapy. PURPOSE: This clinical trial studies how well giving dexamethasone together with ondansetron hydrochloride or palonosetron hydrochloride works in preventing nausea and vomiting in patients receiving doxorubicin hydrochloride and cyclophosphamide for early stage breast cancer
NCT00343863 ↗	Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer	Completed	University of Washington	N/A	2006-01-01	RATIONALE: Antiemetic drugs, such as dexamethasone, ondansetron hydrochloride, and palonosetron hydrochloride, may help lessen or prevent nausea and vomiting caused by chemotherapy. PURPOSE: This clinical trial studies how well giving dexamethasone together with ondansetron hydrochloride or palonosetron hydrochloride works in preventing nausea and vomiting in patients receiving doxorubicin hydrochloride and cyclophosphamide for early stage breast cancer

Clinical Trial Conditions for PALONOSETRON HYDROCHLORIDE

Condition Name

Condition Name for PALONOSETRON HYDROCHLORIDE
Intervention	Trials
Chemotherapy-induced Nausea and Vomiting	31
Postoperative Nausea and Vomiting	17
Nausea	14
Vomiting	13

Condition MeSH

Condition MeSH for PALONOSETRON HYDROCHLORIDE
Intervention	Trials
Vomiting	95
Nausea	79
Postoperative Nausea and Vomiting	24
Breast Neoplasms	7

Clinical Trial Locations for PALONOSETRON HYDROCHLORIDE

Trials by Country

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Trials by Country for PALONOSETRON HYDROCHLORIDE
Location	Trials
United States	280
China	29
Italy	22
Korea, Republic of	17
Russian Federation	9

Trials by US State

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Trials by US State for PALONOSETRON HYDROCHLORIDE
Location	Trials
Texas	15
Ohio	15
New York	13
South Carolina	13
Florida	13

Clinical Trial Progress for PALONOSETRON HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for PALONOSETRON HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	34
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for PALONOSETRON HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	72
Unknown status	15
Recruiting	13

Clinical Trial Sponsors for PALONOSETRON HYDROCHLORIDE

Sponsor Name

Sponsor Name for PALONOSETRON HYDROCHLORIDE
Sponsor	Trials
Helsinn Healthcare SA	15
Eisai Inc.	11
National Cancer Institute (NCI)	11

Sponsor Type

Sponsor Type for PALONOSETRON HYDROCHLORIDE
Sponsor	Trials
Other	145
Industry	59
NIH	14

Palonosetron Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Palonosetron hydrochloride is a second-generation 5-HT3 receptor antagonist widely used to prevent nausea and vomiting associated with chemotherapy and postoperative nausea and vomiting (PONV). Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Chemotherapy-Induced Nausea and Vomiting (CINV)

Several clinical trials have evaluated the efficacy and safety of palonosetron hydrochloride in preventing CINV. In a series of double-blind trials involving over 667 patients, palonosetron hydrochloride was compared to ondansetron, another 5-HT3 receptor antagonist. These studies demonstrated that palonosetron hydrochloride was effective in preventing both acute and delayed nausea and vomiting associated with moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC)[1].

• Dose Efficacy: A dose-ranging trial identified 0.25 mg as the lowest effective dose for preventing acute nausea and vomiting associated with HEC. The efficacy was enhanced when prophylactic corticosteroids were administered concomitantly[1].
• Pediatric Patients: A clinical trial in pediatric cancer patients showed that a 20 mcg/kg dose of palonosetron hydrochloride was non-inferior to ondansetron in preventing nausea and vomiting during the first 24 hours after chemotherapy[1].

Postoperative Nausea and Vomiting (PONV)

Palonosetron hydrochloride has also been studied for its efficacy in preventing PONV. A multicenter, randomized trial involving 546 patients undergoing abdominal and gynecological surgery found that palonosetron hydrochloride significantly reduced the incidence of PONV compared to placebo. The lowest effective dose in this setting was identified as 1 mcg/kg[1].

Repeated Dosing

Studies have also investigated the safety and efficacy of repeated dosing of palonosetron hydrochloride. A pharmacokinetic study in healthy subjects showed that daily dosing of palonosetron hydrochloride produced a predictable pharmacokinetic profile, with increasing AUC and Cmax on Day 3 compared to Day 1, consistent with its long elimination half-life[3].

Market Analysis

Market Size and Growth

The palonosetron hydrochloride market has experienced significant growth in recent years and is expected to continue this trend. The market size is projected to increase at a CAGR of 3 to 5% from 2023 to 2031, driven by increasing demand for effective antiemetic treatments[2].

• Segmentation: The market is segmented by application (palonosetron hydrochloride injection and oral capsule), product purity (≥98% and ≥99%), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2].
• Key Players: Major players in the market include Wavelength Pharmaceuticals, Farmihispania Group, Tyche Industries, ALP Pharm, Qilu Pharmaceutical, Tapi Teva, Tecoland, Shanghai Jinhe Bio-Pharmaceutical, and Hubei Nuona Chemical[2][5].

Market Dynamics

The market is influenced by several factors, including the increasing incidence of cancer, advancements in chemotherapy regimens, and the growing need for effective antiemetic treatments. The report also highlights the competitive landscape, with a detailed analysis of Porter's 5 Forces Framework, macroeconomic evaluation, and a comprehensive pricing analysis[2].

Market Projections

Forecast Period

From 2023 to 2031, the palonosetron hydrochloride market is expected to witness robust growth. The forecast period will see an increase in market value, driven by the expanding patient population requiring antiemetic treatments and the introduction of new formulations and delivery methods[2].

• Geographical Trends: The Asia-Pacific region is anticipated to be a significant growth driver due to the large patient population and increasing healthcare expenditure in countries like China and India[2].
• Product Innovations: The market is likely to see innovations in product formulations, such as oral capsules, which could further boost market growth by offering patients more convenient treatment options[2].

Key Takeaways

• Clinical Efficacy: Palonosetron hydrochloride has demonstrated efficacy in preventing CINV and PONV across various clinical trials.
• Market Growth: The market is expected to grow at a CAGR of 3 to 5% from 2023 to 2031, driven by increasing demand and geographical expansion.
• Key Players: Major pharmaceutical companies are actively involved in the production and distribution of palonosetron hydrochloride, contributing to the market's competitive landscape.
• Future Innovations: The market is likely to see innovations in product formulations and delivery methods, further enhancing patient compliance and treatment outcomes.

FAQs

What is the primary use of palonosetron hydrochloride?

Palonosetron hydrochloride is primarily used to prevent nausea and vomiting associated with chemotherapy and postoperative nausea and vomiting (PONV).

What is the recommended dose for palonosetron hydrochloride in preventing CINV?

The recommended dose for palonosetron hydrochloride in preventing CINV is typically 0.25 mg administered intravenously 30 minutes before the start of chemotherapy[1].

How does palonosetron hydrochloride compare to other 5-HT3 receptor antagonists?

Palonosetron hydrochloride has shown efficacy comparable to other 5-HT3 receptor antagonists like ondansetron, especially in the delayed phase of CINV. However, clinical superiority over other 5-HT3 receptor antagonists has not been adequately demonstrated in the acute phase[1].

What are the key players in the palonosetron hydrochloride market?

Major players include Wavelength Pharmaceuticals, Farmihispania Group, Tyche Industries, ALP Pharm, Qilu Pharmaceutical, Tapi Teva, Tecoland, Shanghai Jinhe Bio-Pharmaceutical, and Hubei Nuona Chemical[2][5].

What is the projected growth rate of the palonosetron hydrochloride market?

The palonosetron hydrochloride market is expected to grow at a CAGR of 3 to 5% from 2023 to 2031[2].

Sources

1. Pfizer Medical Information: Palonosetron HCl injection Clinical Studies.
2. Market Research Intellect: Palonosetron Hydrochloride Market Size and Forecast.
3. Australian Government Department of Health and Aged Care: Extract from the Clinical Evaluation Report for palonosetron hydrochloride.
4. Chinese Clinical Trial Register: The efficacy and safety of olanzapine combined with Netupitant and Palonosetron Hydrochloride.
5. Valuates Reports: Global Palonosetron Hydrochloride Market Research Report 2024.