Last update 12 Dec 2024

Palonosetron hydrochloride

Last update 12 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(3aS)-2-[(3S)-1-azabicyclo[2.2.2]octan-3-yl]-2,3,3a,4,5,6-hexahydro-1H-benzo[de]isoquinolin-1-one, 2-(1-Azabicyclo(2.2.2)oct-3-yl)-2,3,3a,4,5,6-hexahydro-1H-benz(de)isoquinolin-1-one, Aloxi Injection

+ [18]

Target

5-HT3 receptor

Mechanism

5-HT3 receptor antagonists(Serotonin 3 (5-HT3) receptor antagonists)

Therapeutic Areas

Other DiseasesNeoplasms

Active Indication

NauseaVomitingPostoperative Nausea and Vomiting+ [2]

Inactive Indication

Acute Myeloid LeukemiaGliomaLymphoma+ [3]

Originator Organization

Helsinn Healthcare SA

Active Organization

Accord Healthcare SLU

Taiho Pharmaceutical Co., Ltd.

Qilu Pharmaceutical Co., Ltd.

+ [4]

Inactive Organization

Helsinn Healthcare SA

Eisai, Inc.

Zhaoke Pharmaceutical (Hefei) Co., Ltd.

+ [4]

Drug Highest PhaseApproved

First Approval Date

US (25 Jul 2003),

Chemotherapy-induced nausea and vomiting

Regulation-

Structure

Molecular FormulaC19H25ClN2O

InChIKeyOLDRWYVIKMSFFB-SSPJITILSA-N

CAS Registry135729-62-3

236

Clinical Trials associated with Palonosetron hydrochloride

NCT06540885 / Not yet recruitingPhase 4IIT

A Comparison Between Palonosetron Versus Granisetron As Postoperative Nausea and Vomiting Prophylaxis In Idiopathic Scoliosis Surgery: A Randomized Control Trial

The aim of this clinical trial is to compare the effectiveness of two Serotonin (5- HT3) receptor antagonist, palonosetron and granisetron, administered along with dexamethasone as a preventive measure against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent patients with idiopathic scoliosis (IS) undergoing posterior spinal fusion (PSF) surgery under total intravenous anesthesia (TIVA).
The main questions the study aims to answer are:
How effective is palonosetron compared to granisetron, when both combined with dexamethasone, in preventing PONV after scoliosis surgery? Are there any differences in the need for rescue antiemetics, occurrence of adverse effects related to the study drugs, and patient satisfaction between the two treatment groups? Participants in the study will be randomly assigned to receive either palonosetron or granisetron in addition to dexamethasone as part of their anesthesia and antiemetic regimen. The incidence and/ or severity of nausea, vomiting and retching will be assessed at 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery.

Start Date01 Jan 2025

Sponsor / Collaborator

University of Malaya

CTRI/2024/09/074272 / Not yet recruitingNot ApplicableIIT

Comparative Study of the Efficacy of Intravenous Ondansetron Versus Intravenous Palonosetron in the Prevention of Postoperative Nausea and Vomiting in Elective Laparoscopic Surgeries - NIL

Start Date30 Dec 2024

Sponsor / Collaborator-

NCT06554184 / RecruitingPhase 3

A Randomized Phase III Study Evaluating the Efficacy and Safety of HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents

This study is aimed to evaluate the efficacy and safety of HR20013 versus palonosetron for nausea and vomiting associated with moderate emetic risk anticancer agents

Start Date03 Sep 2024

Sponsor / Collaborator

Fujian Suncadia Pharmaceuticals Co Ltd.

100 Clinical Results associated with Palonosetron hydrochloride

100 Translational Medicine associated with Palonosetron hydrochloride

100 Patents (Medical) associated with Palonosetron hydrochloride

885

Literatures (Medical) associated with Palonosetron hydrochloride

01 Dec 2024·International Journal of Clinical Oncology

Efficacy and safety of dexamethasone sparing for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy: a systematic review and meta-analysis of Clinical Practice Guidelines for Antiemesis 2023 from Japan Society of Clinical Oncology

Review

Author: Wada, Makoto ; Nakamura, Naoki ; Tanaka, Ryuhei ; Okita, Kenji ; Takeda, Masayuki ; Okuyama, Ayako ; Nakashima, Kazuhisa ; Nishimura, Junichi ; Imamura, Chiyo K ; Noda, Mayumi ; Higashi, Takahiro ; Iino, Keiko ; Hayashi, Kazumi ; Satomi, Eriko ; Nakajima, Takako Eguchi ; Matsumoto, Yoko ; Sasaki, Hidenori ; Matsumoto, Koji ; Abe, Masakazu ; Kim, Yong-Il ; Imamura, Chiyo K. ; Yamamoto, Nobuyuki ; Aogi, Kenjiro ; Murakami, Michiyasu ; Yokomizo, Ayako ; Iihara, Hirotoshi ; Ozawa, Keiko ; Boku, Narikazu ; Akechi, Tatsuo ; Kim, Yong-il

BACKGROUND:

Palonosetron, a second-generation 5-HT₃ receptor antagonist (5-HT₃RA), is more effective than first-generation 5-HT₃RA. Several studies have investigated whether dexamethasone (DEX), when combined with palonosetron as a 5-HT₃RA, can be spared in the delayed phase after moderately emetogenic chemotherapy (MEC). In this systematic review, we aimed to determine which between 1- and 3-day DEX administration, when combined with palonosetron, is more useful in patients receiving MEC.

METHODS:

The PubMed, Cochrane Library, and Ichushi-Web databases were searched for relevant studies published between 1990 and 2020. We included studies that compared the efficacy of 1- and 3-day DEX administration in preventing nausea and vomiting associated with MEC. Outcomes were "prevention of vomiting (complete response rate and no vomiting rate)," "prevention of nausea" (complete control rate, total control rate, no nausea rate, and no clinically significant nausea rate)" in the delayed phase, "prevention of blood glucose level elevation," and "prevention of osteoporosis."

RESULTS:

Eight studies were included in this systematic review. The no vomiting rate was significantly higher in the 3-day DEX group than in the 1-day DEX group. However, the other efficacy items did not significantly differ between the two groups. Meanwhile, insufficient evidence was obtained for "prevention of blood glucose level elevation" and "prevention of osteoporosis."

CONCLUSIONS:

No significant differences in most antiemetic effects were found between 1- and 3-day DEX administration. Thus, DEX administration could be shortened from 3 days to 1 day when used in combination with palonosetron.

01 Dec 2024·INVESTIGATIONAL NEW DRUGS

A phase II study of ME2136 (Asenapine Maleate) plus standard antiemetic therapy for patients, including diabetic patients, receiving cisplatin-based chemotherapy

Article

Author: Murakami, Haruyasu ; Hamauchi, Satoshi ; Yasui, Hirofumi ; Ono, Akira ; Kado, Nobuhiro ; Mori, Keita ; Takahashi, Toshiaki ; Yamazaki, Kentaro ; Yokota, Tomoya ; Tsushima, Takahiro ; Onozawa, Yusuke ; Hirashima, Yasuyuki ; Fushiki, Kunihiro ; Naito, Tateaki

Olanzapine combined with the neurokinin-1 receptor antagonist, palonosetron and dexamethasone is the standard treatment for chemotherapy-induced nausea and vomiting (CINV) due to highly emetogenic chemotherapy (HEC). However, the use of olanzapine poses challenges in patients with diabetes mellitus (DM) due to the potential risk of hyperglycemia. ME2136, antipsychotic similar to olanzapine, is associated with a lower risk of hyperglycemia. This study investigated the antiemetic efficacy and safety of ME2136 for HEC. This single-arm phase 2 study examined the safety and efficacy of ME2136 5 mg for 4 days in combination with triplet-combination antiemetic therapy. Two cohorts were established for the safety assessment: DM and non-DM. Eligible patients had malignant tumors and were receiving cisplatin-based chemotherapy for the first time. The primary endpoint was the complete response (CR) rate, defined as the percentage of patients without vomiting and not requiring rescue medications in the delayed phase (24-120 h). Between December 2020 and January 2022, 40 patients were enrolled, with 20 in each cohort. All patients were included in the safety analysis and 35 in the efficacy analysis. The CR rate in the delayed phase was 71.4% [60% CI 63.1-78.6%] for all patients, 66.7% in the DM cohort, and 76.5% in the non-DM cohort. No treatment-related adverse events ≥ grade 3, including hyperglycemia, were reported. ME2136, when combined with standard triplet-combination antiemetic therapy, is expected to exert similar antiemetic effects to the standard treatment for CINV due to HEC. Currently, ME2136-02 trial is underway to examine the safety and efficacy of triplet-combination antiemetic therapy and a 5-day treatment with ME2136. This study was registered with the Japan Registry of Clinical Trials (jRCT2041200071) on 10 December 2020. Clinical trial registration: This study was registered with the Japan Registry of Clinical Trials (jRCT2041200071) on 10 December 2020.

01 Nov 2024·SUPPORTIVE CARE IN CANCER

Antiemetic medications for preventing chemotherapy-induced nausea and vomiting in children: a systematic review and Bayesian network meta-analysis

Review

Author: Phillips, R S ; Dias, S. ; Phillips, R. S. ; Dias, S ; Walker, R ; Walker, R.

Abstract:

Purpose:

Children continue to experience chemotherapy-induced nausea and vomiting (CINV), despite effective antiemetic medications. Recommendations in clinical practice guidelines are underpinned by narrative syntheses and meta-analyses that compare only two treatments. This means not all antiemetics have been compared to one another, and estimates remain imprecise. We apply network meta-analysis (NMA) to overcome these limitations by comparing multiple treatments simultaneously.

Methods:

A systematic review identified and critically appraised RCTs comparing antiemetics recommended and licensed for the prevention of CINV in children. Bayesian NMA compared and ranked antiemetic effectiveness for the outcomes complete (CR) and partial response (PR) in the acute, delayed, and overall phases, nausea, and decreased food intake. Antiemetics given with and without dexamethasone were compared in separate networks as their underlying populations differed.

Results:

Sixteen RCTs (3115 patients receiving moderately (MEC) or highly emetogenic chemotherapy (HEC)) were included. When given with dexamethasone, NK1 antagonists with ondansetron ranked highest for CR and PR in the acute and overall phases, PR in the delayed phase, and decreased food intake. Post hoc analysis shows further a benefit of adding olanzapine to regimens of aprepitant and ondansetron. Ondansetron ranked lower than palonosetron, for CR in the delayed and overall phases, and ondansetron was less effective than palonosetron for nausea prevention. Rankings for other regimens, including those given without dexamethasone, were uncertain or inconsistent across outcomes.

Conclusions:

Our findings serve to support the current recommendations of olanzapine (when given with aprepitant and ondansetron) and NK1 antagonists’ regimens receiving HEC, but note that evidence of a significant difference in relative benefit, between patients receiving MEC and HEC, does not yet exist. Recommendations for palonosetron as the preferred 5HT3 antagonists may be extended, particularly, to those who are at high risk of nausea.

News (Medical) associated with Palonosetron hydrochloride

07 Nov 2024

·www.prnewswire.com

Fosun Attends CIIE for the Seventh Time - Guo Guangchang: Confident that China's High-Level Openness is a Historical Opportunity

HONG KONG, Nov. 7, 2024 /PRNewswire/ -- On November 5, the 7th China International Import Expo (CIIE) opened at the National Exhibition and Convention Center in Shanghai. As a seven-time attendee of the CIIE, Fosun showcased the latest achievements in innovation and global operations at its Fosun Pharma booth in Hall 7.1, featuring cutting-edge medical devices and innovative pharmaceuticals that made their debut in China. Guo Guangchang, Chairman of Fosun International, remarked, "Over the past seven years, CIIE has improved every year, becoming a window for China to build a new development framework, a platform for high-level openness, and an international public product for global sharing. Fosun has been a participant, witness, and beneficiary of the CIIE. Leveraging the CIIE platform, our long-term innovations have continually been put into practice, transforming many 'exhibits' into 'products', and converting many overseas partners from 'exhibitors' into 'investors'. This year, we continue to showcase our latest achievements in integrated innovation in the medical device and health sector, including several 'world's firsts' and 'China's firsts'. We firmly believe that China remains a significant opportunity for global development. Together with more overseas companies and global partners, we will promote more cutting-edge innovations to take root in China, moving forward and achieving mutual success on the grand stage of the CIIE." Stars of CIIE Taking Root, Transforming Ion from "Exhibit" to "Product" Healthcare is one of Fosun's main businesses. With CIIE's "spillover effect," several star products from Fosun, supported by the CIIE "accelerator" effect, have successfully entered the market to serve Chinese patients, transforming from "exhibits" into "products". This year, following the popular da Vinci Surgical System, the Ion Robotic Bronchoscopy made its CIIE debut after receiving domestic approval. Since its first appearance at the CIIE in 2019, Ion caught the attention of visitors. By the end of 2022, Ion entered the National Medical Products Administration's 'Green Channel' for innovative products and gained approval in March 2024, with the first commercial application completed in September. Lung cancer is considered the leading cause of cancer deaths, with 1.06 million new cases in China in 2022. The five-year survival rate is only 19.7%, and bronchoscopy is a key diagnostic tool for early lung cancer detection. The Ion bronchoscopy navigation control system offers innovative features for precise, convenient clinical diagnosis, providing new options for patients. By the third quarter of this year, 736 Ion systems had been installed globally, with over 150,000 Ion procedures performed. Outside the CIIE exhibition hall, Fosun is accelerating the localization of advanced medical devices. In June this year, Intuitive Fosun's headquarter industrial base was launched in Shanghai, marking Intuitive's largest R&D, production, and training center in the Asia-Pacific region. At this base, in addition to the Ion shape-sensing bronchoscopy control system, advanced products and core components, including the da Vinci surgical robot, are gradually achieving "Made in China, joint R&D, and global sales." Accelerating Integrated Innovation to Lead in Neurological Disease Treatment Transformation Fosun has long committed to investing in cutting-edge areas of healthcare, fostering a continuous stream of breakthrough "solid achievements" through an open innovation ecosystem involving independent R&D, collaborative development, licensing, and industry investment. These innovations are continually transformed into new drivers of growth. At this year's CIIE, Fosun introduced several latest products that are leading industry transformation. In the field of neurological disease treatment, especially for conditions like essential tremor and Parkinson's disease, patients have long faced challenges with unmet clinical needs. Traditional drug and surgical treatments often have limitations, but advancements in non-invasive treatment technologies have brought new hope to these patients. Fosun has actively responded to this unmet clinical need. At this year's CIIE, the new V2 model of the CNS (Central Nervous System) innovative treatment technology, the V2 model of "Exablate Neuro FUS system" made its debut in China, generating high expectations within the industry. This new model has already received CE certification in Europe and FDA approval in the United States and submitted a registration application to China's National Medical Products Administration in 2024. The V2 model's innovation lies in providing a non-invasive surgical solution for clinically drug-resistant essential tremor and tremor-dominant Parkinson's disease, while also being compatible with a broader range of MRI models, further enhancing the accessibility of this technology. Last year, Fosun, in partnership with Insightec, showcased the "Exablate Neuro" at CIIE, drawing much attention and continuous interest in collaboration. Leveraging the CIIE's "spillover effect", Fosun Pharma and Insightec established a joint venture, Fosun-Insightec, in February this year. The venture is focused on the marketing and developing clinical efforts of Exablate Neuro FUS system in improving the lives of patient living with essential tremor and Parkinson's disease, working to help them regain their quality life and wellbeing. Focusing on innovating to meet real customer needs is a core methodology for Fosun. Data shows that Fosun has made long-term investments in technological innovation, with an investment of RMB 3.5 billion in the first half of this year. Connecting Globally to Enhance Accessibility of Innovative Drugs, Benefiting more Patients Leveraging the CIIE's openness, Fosun also presented innovative products focused on solid tumors, hematological tumors, and immune-inflammatory conditions. Fosun's seven-year journey at CIIE has facilitated the introductions of global products and enabled the export of local innovations to benefit more patients worldwide. In 2017, Fosun introduced China's first CAR-T cell therapy product, Yi Kai Da (ejilunsai injection). Since then, by continuously participating in the CIIE, Fosun has enabled the public to gain an in-depth understanding of this advanced therapy. At this year's CIIE, Fosun highlighted Yi Kai Da's latest developments in the "accessibility and treatability" in lymphoma treatment. Yi Kai Da is now included in over 110 urban customized commercial health insurances and more than 80 commercial insurances, created a new path of payment mode for patients; and over 170 high-standard treatment centers across 28 regions in China providing treatments for over 900 lymphoma patients, achieving revolutionary innovative breakthroughs for cancer care. As a global company rooted in China, Fosun has an extensive industrial presence in over 35 countries and regions worldwide, with robust global R&D capabilities and impressive progress. This year, Fosun also showcased several innovative products, including the world's first and only dual-channel fixed-dose combination oral formulation, Akynzeo® oral (Netupitant and Palonosetron hydrochloride), which blocks both NK-1 and 5-HT3 receptors; the immunoglobulin Thymoglobulin® for improving transplant patient outcomes; the world's first oral targeted medication for psoriasis, Otezla® (apremilast tablets); a new third-generation COMT inhibitor Ongentys® (Opicapone) for managing symptom fluctuations in adult Parkinson's disease patients; and Parsabiv® (Etelcalcetide Hydrochloride Injection), the only peptide-based calcimimetic for treating secondary hyperparathyroidism in adult dialysis patients with chronic kidney disease. Guo Guangchang concluded, "Participating in CIIE has been a top priority for Fosun for seven consecutive years. We have witnessed CIIE become a crucial platform for global companies to share in China's development opportunities and deepened our global partnerships through this platform. We believe the CIIE stage will continue to expand, and Fosun's journey of innovation and globalization will grow broader." SOURCE Fosun WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalImmunotherapy

23 Sep 2024

·www.businesswire.com

Avenacy to Share Company’s Year One Progress at CPHI Milan 2024

SCHAUMBURG, Ill.--( BUSINESS WIRE )--Avenacy, a specialty pharmaceutical company focused on supplying critical medications, looks forward to celebrating its first year of growth and success since launching in October 2023. Backed by a robust global network of development and FDA-inspected contract manufacturing partners, Avenacy has already brought 13 injectable products to the U.S. market to address key gaps in the drug supply chain. “We are incredibly proud of the achievements and progress we have made at Avenacy since launching nearly a year ago as a trusted partner and provider of critical injectable medicines for the U.S. healthcare system,” said Jeff Yordon, Co-Founder and CEO of Avenacy. “We have acted swiftly and decisively to bring over a dozen medications to the U.S. market to help meet the needs of patients, strengthened our financial position with the addition of esteemed pharmaceutical investor and businessman, Dr. Patrick Soon-Shiong, and built out our infrastructure and leadership to support scaling up our business. As we look to usher in the next phase of growth for Avenacy, we will remain steadfast in our goal of enhancing patient care and enabling access to safe, high-quality essential medications.” Through a rigorous and optimized selection process, Avenacy has launched thirteen products in the U.S. market, including: Melphalan Hydrochloride for Injection Bivalirudin for Injection Fosaprepitant for Injection Fulvestrant Injection Furosemide for Injection Desmopressin Acetate for Injection Eptifibatide for Injection Magnesium Sulfate in Water for Injection Isoproterenol Hydrochloride Injection, USP Tranexamic Acid Injection, USP Prochlorperazine Edisylate Injection, USP Palonosetron Hydrochloride Injection, USP Metoclopramide Injection, USP The Company is well-positioned to continue expanding its differentiated portfolio to meet the needs of today’s dynamic drug supply chain while ensuring quality of care to patients. All of Avenacy’s products feature unique packaging and labeling designed to assist healthcare providers with accurate medication selection, thereby supporting a reduction in administration errors and improper dosing. The Company also utilizes ready-to-use formulations of essential medications to help address dosing inaccuracies, enhance patient safety, and streamline efficiency – all with the ultimate goal of improving patient care. Avenacy will be sharing its first year progress, differentiated business model, and diverse partner network at this year’s CPHI 2024 Conference, taking place in Milan from October 8-10. During this time, the Company will be hosting meetings with potential partners, customers, and investors, as it seeks to expand its global presence and portfolio of critical injectable medicines. About Avenacy Avenacy is a U.S.-based specialty pharmaceutical company focused on supplying critical injectable medications used to treat patients in various medically supervised settings, from acute care hospitals to outpatient clinics and physician offices. Through a rigorous and optimized selection process, the Company is building out a pipeline of high-quality FDA approved injectable products in order to ensure a resilient portfolio that can meet the needs of today’s dynamic drug supply chain. With an experienced team, commitment to quality and reliability, and product offerings intended to facilitate safe and efficient patient care, Avenacy strives to be a trusted partner for essential medications. Avenacy was launched in 2023 and is headquartered in Schaumburg, IL. For more information, please visit http://www.avenacy.com/ .

Executive Change

24 Jun 2024

·www.globenewswire.com

Helsinn Group announces AKYNZEO® (fosnetupitant/palonosetron) injection is now available in a ready-to-use vial in the US

Helsinn Group announces AKYNZEO® (fosnetupitant/palonosetron) injection is now available in a ready-to-use vial in the US Lugano, Switzerland – June 24, 2024 – Helsinn Group (“Helsinn”), a global pharmaceutical company with a track record of over forty-five years of commercial execution and a strong focus in supportive care, oncology and dermato-oncology, is pleased to announce that AKYNZEO® (fosnetupitant/palonosetron) injection is now available in the US in a ready-to-use vial. AKYNZEO injection (Ready-to-Use) is a new method of administration and contains the same formulation as the prior AKYNZEO Injection (To-be-Diluted). The features of the new ready-to-use presentation of AKYNZEO injection include: No reconstitution or dilution required; infuse directly from the vial using a built-in hanging strapNo refrigeration required at any point during distribution, storage, or preparationAccessible via automated dispensing machine, allowing the product to be stored and available near the location of patient care AKYNZEO injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. It has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO injection does not contain polysorbate 80 or allergenic excipients such as soy or egg lecithin. It can be administered simultaneously with intravenous dexamethasone sodium phosphate. Dr. Melanie Rolli, Helsinn Group CEO, commented: “As a pioneer in cancer supportive care, Helsinn continues to be unwavering in our pursuit to help patients and clinicians in cancer care. We are very pleased to launch the new AKYNZEO Ready-to-Use vial, building on our legacy of innovation.” Ordering information Clinicians wishing to order the new vial should contact their GPO or distributor. The National Drug Code (NDC) number for AKYNZEO injection vial with hanger (Ready-to-Use) is 69639-106-01 and the J Code is J1454 (Injection, fosnetupitant 235 mg and palonosetron 0.25 mg); billing unit (single dose vial [SDV]). About AKYNZEO® AKYNZEO is the first and only 5-HT3 and NK1 receptor antagonists fixed combination approved for the prevention of chemotherapy-induced acute and delayed nausea and vomiting. A single dose of AKYNZEO given with dexamethasone has been shown to prevent chemotherapy-induced nausea and vomiting for up to 5 days. INDICATION AKYNZEO (fosnetupitant/palonosetron) injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Limitations of Use AKYNZEO injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and fosnetupitant, a substance P/neurokinin-1 (NK-1) receptor antagonist: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. IMPORTANT SAFETY INFORMATION Warnings and Precautions Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron, one of the components of AKYNZEO, with or without known hypersensitivity to other 5-HT3 receptor antagonists.Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO is used concomitantly with other serotonergic drugs. Adverse Reactions Most common adverse reactions (≥3%) for AKYNZEO capsules are headache, asthenia, dyspepsia, fatigue, constipation and erythema. The safety profile of AKYNZEO injection was generally similar to AKYNZEO capsules. Drug Interactions Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO. The inhibitory effect on CYP3A4 can last for multiple days Dexamethasone doses should be reduced when given with AKYNZEO. A more than two- fold increase in the systemic exposure of dexamethasone was observed 4 days after a single infusion of fosnetupitant.Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO. When administered with netupitant, the systemic exposure to midazolam was significantly increased. Avoid concomitant use of AKYNZEO in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of AKYNZEO. Use in Specific Populations Avoid use of AKYNZEO in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease.Advise women of potential risk to fetus; limited data are available; may cause fetal harm. For more information about AKYNZEO® please see the full US Prescribing Information. About Helsinn Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic disease, with a focus on supportive care, oncology and dermato-oncology. Helsinn, headquartered in Lugano, Switzerland, has direct commercial operations in the U.S. and an extensive network of long-standing trusted partners enabling a commercial presence in more than 90 countries. Established in 1976, Helsinn is a third-generation family-owned company with broad pharmaceutical and technical expertise. Helsinn is proud of its history of operating with great integrity, passion and quality. The company is committed to continuously striving for innovation for its patients and embracing sustainable growth as a core element of its strategic vision. To learn more about Helsinn, please visit www.helsinn.com or follow us on LinkedIn and X. For more information: Helsinn Group Media Contact:Sabrina PerucchiGroup Communication ManagerLugano, Switzerland Tel: +41 (0) 91 985 21 21 Email: Info-hhc@helsinn.com

Drug ApprovalClinical Result

100 Deals associated with Palonosetron hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D05343	Palonosetron hydrochloride	A04AA05	DB00377

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Nausea	CN	Qilu Pharmaceutical Co., Ltd.	04 May 2008
Vomiting	CN	Qilu Pharmaceutical Co., Ltd.	04 May 2008
Postoperative Nausea and Vomiting	AU	Juniper Biologics Pte Ltd.	26 Jun 2006
Chemotherapy-induced nausea and vomiting	US	Helsinn Healthcare SA	25 Jul 2003

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 3	US	Helsinn Healthcare SA	03 May 2017
Glioma	Phase 2	US	Eisai, Inc.	01 May 2008
Malignant glioma of brain	Phase 2	US	Eisai, Inc.	01 May 2008
Lymphoma	Phase 2	US	Eisai, Inc.	01 Oct 2007
Metastatic melanoma	Phase 2	US	Eisai, Inc.	01 Nov 2006
Multiple Myeloma	Phase 2	US	Helsinn Healthcare SA	01 Mar 2006
Multiple Myeloma	Phase 2	US	Eisai, Inc.	01 Mar 2006
Acute Myeloid Leukemia	Phase 2	US	Eisai, Inc.	01 Sep 2005

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTRI/2023/04/051951 (phase IV Indian study, ESMO2024)	Phase 4	-	178	IntraVenous (Fos)NEtupitant and Palonosetron (IV NEPA)	okwwmfiqyu(nrxbegtioc) = 4, 2.25% hxhxaxjtrz (nasiwrlgdr ) View more	Positive	15 Sep 2024
ESMO2023 Manual	Phase 2	Breast Cancer	76	Palonosetron+aprepitant+ olanzapine	ydcnyxoega(gbicevbuxn) = dcnmzbdwad wtqffzczlc (lixwcoijga, 9.4 - 27.5) View more	Negative	21 Oct 2023
NCT03578081 (CTgov)	Phase 3	Nausea \| Chemotherapy-induced nausea and vomiting \| Neoplasms ... View more	690	Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Dexamethasone+Fosaprepitant Dimeglumine (Arm I (Fosaprepitant Dimeglumine, Olanzapine))	htfaswrppg(xfmvdlosre) = olinclwfxp ovpgjsjdmm (kmypwgwpcd, skcnnvmugg - ypcujfrrvo) View more	-	08 May 2023
				Placebo+Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Dexamethasone (Arm II (Placebo, Olanzapine))	htfaswrppg(xfmvdlosre) = iuhjvnqzda ovpgjsjdmm (kmypwgwpcd, aggdeczbff - mhxazibqbk) View more
NCT03817970 (ASN2022)	Phase 3	Nephrotoxicity	23	Ondansetron 8 mg p.o.	rdvjqhwvaw(jsglopqmmn) = whqulljxzp ikbpwwlemg (fcqcrugiek ) View more	Negative	04 Nov 2022
				Palonosetron 0.25 mg i.v.	rdvjqhwvaw(jsglopqmmn) = miwjthsojs ikbpwwlemg (fcqcrugiek ) View more
NCT04669132 (OLNEPA, ASCO2022) Manual	Phase 2	Chemotherapy-induced nausea and vomiting	48	Olanzapine + Netupitant + Palonosetron	dkaevqvtaj(heovcuyjbh) = gflkfavjqd hijzpowizt (jcvwjswcmn, 32 - 59) View more	Positive	02 Jun 2022
NCT00967499 (CTgov)	Phase 2	Postoperative Nausea and Vomiting	239	Palonosetron (Palonosetron)	evumpiwkco(auxadjnqdh) = eujdkubxdj cuvteianjr (ixgkfuwfgy, zfxydmlrjs - rtnaebrary) View more	-	11 Jan 2021
				Ondansetron (Ondansetron)	evumpiwkco(auxadjnqdh) = vbiqijwqjz cuvteianjr (ixgkfuwfgy, cffpjgnttx - kqavcpgcvi) View more
NCT01054456 (CTgov)	Phase 2	Chemotherapy-induced nausea and vomiting \| Postoperative Nausea and Vomiting \| Vomiting	36	palonesetron	afuntjeucx(dteydxbgar) = qwqovehqfz qrpxiitlfm (gqrrijagib, ciudwkgfzx - rxvzngxera) View more	-	23 Dec 2020
NCT03204279 (CINV, CTgov)	Phase 2	Nausea \| Chemotherapy-induced nausea and vomiting \| Neoplasms ... View more	67	Palonosetron+Netupitant (Netupitant 1.33 mg/kg Plus Palonosetron)	bzyrdhxpxm(kgmumwhyhe) = ygasiojzyc ldsinpjoai (elwpqggipi, awaoszbdtc - cbjtptqgij) View more	-	07 Dec 2020
				Palonosetron+Netupitant (Netupitant 4 mg/kg Plus Palonosetron)	lxlquseamx(hswrilzlly) = rwzcvasldp qfbedvmsaw (xeexltshhy, apcfiehsbo - wzrwpglkpa) View more
ESMO_ASIA_VIRTUAL2020	Not Applicable	Esophageal Carcinoma	-	Palonosetron 0.25 mg	lgewhvydju(btrmvgspms) = Grade 2-3 constipation and any grade of aspartate aminotransferase increase were more frequently observed in 0.75 mg group (38% vs. 58%, p < 0.05; 7% vs. 22%, p < 0.05) qrzznjbocq (yrfzcfsybt )	Positive	22 Nov 2020
				Palonosetron 0.75 mg
NCT00553059 (CTgov)	Phase 3	Chemotherapy-induced nausea and vomiting \| Nausea \| Solid tumor ... View more	62	Dronabinol (Dronabinol)	xlvfvqrarn(ietkkolwsw) = dzldiocwfm kosotmjiew (hsrdvniweo, bxomvwpvfs - poizeoicid) View more	-	09 Oct 2020
				Placebo (Placebo)	xlvfvqrarn(ietkkolwsw) = lkuuyyicvq kosotmjiew (hsrdvniweo, patfqofymc - tokrrdjcyr) View more

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