Last update 04 Nov 2024

Palonosetron hydrochloride

Last update 04 Nov 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

+ [17]

Target

5-HT3 receptor

Mechanism

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

Therapeutic Areas

Other DiseasesNeoplasms

Active Indication

NauseaPostoperative Nausea and VomitingVomiting+ [2]

Inactive Indication

Acute Myeloid LeukemiaGliomaLymphoma+ [3]

Originator Organization

Helsinn Healthcare SA

Active Organization

Accord Healthcare SLUAvyxa Pharma

Xiamen LP Pharmaceutical Co., Ltd.

+ [3]

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

235

Clinical Trials associated with Palonosetron hydrochloride

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-

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 Oct 2024

Sponsor / Collaborator

University of Malaya

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

860

Literatures (Medical) associated with Palonosetron hydrochloride

01 Nov 2024·JOURNAL OF CHROMATOGRAPHY A

Economical and rapid enantioselective, diastereoselective and achiral separation of palonosetron hydrochloride and its impurities using supercritical fluid chromatography

Article

Author: Liu, Yitong ; Xing, Jianguo ; Zheng, Ruifang ; Lian, Xiaofang ; Zhao, Xuejia ; Qiu, Xiaodan ; Shan, Guangzhi ; Yao, Jing

Simultaneous separation of compounds with multiple chiral centers and highly similar structures presents significant challenges. This study developed a novel supercritical fluid chromatography (SFC) method with reduced organic solvent consumption and robust separation capabilities to address these challenges. The method was applied to simultaneously achieve enantioselective, diastereoselective, and achiral separation of palonosetron hydrochloride and its six impurities. The effects of the polysaccharide-based chiral stationary phase (CSP), modifier, additive, and column temperature on retention and separation were comprehensively evaluated. It was found that a combination of a polysaccharide-based CSP and a single modifier or a mixture of protonic modifiers could not achieve complete separation due to high structural similarity. However, an ADH column and a ternary solvent mixture containing acetonitrile (methanol: acetonitrile: diethylamine, 60:40:0.2, v/v/v) provided satisfying separation, particularly for the enantiomer and diastereomers of palonosetron. Using the optimized method, the enantioselective, diastereoselective, and achiral separation of palonosetron hydrochloride and its six impurities can be accomplished in 18 min under gradient elution. Thermodynamic results indicated that the separation process was entropy driven. A molecular docking study revealed that the separation was mainly achieved through the differences in hydrogen bond and π - π interactions between the analytes and CSP. This study lays the foundation for SFC analysis of palonosetron hydrochloride and provides a reference for the simultaneous SFC separation of the enantiomers, diastereoisomers and structurally similar compounds.

01 Nov 2024·International Journal of Clinical Oncology

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

Review

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

BACKGROUND:

Chemotherapy-induced nausea and vomiting (CINV) are common side effects, classified according to timing and severity. Conventional agents such as dexamethasone are effective but have various side effects. For moderately emetogenic chemotherapy, dexamethasone-sparing antiemetic therapies have been developed to minimize these side effects. This systematic review evaluated the efficacy and safety of dexamethasone-sparing antiemetic therapy for highly emetogenic chemotherapy (HEC).

METHODS:

We performed a thorough literature search for studies related to dexamethasone-sparing antiemetic therapy with neurokinin-1 antagonists (NK₁RA) for HEC using the PubMed, Cochrane Library, and Ichushi-Web databases. A qualitative analysis of the combined data was performed and risk differences with confidence intervals were calculated.

RESULTS:

Two reviewers independently assessed the 425 records and 12 full-text articles were evaluated for eligibility. Two studies were included in the qualitative and meta-analyses. These studies included anthracycline-cyclophosphamide (AC) regimens and cisplatin-based regimens, with palonosetron as the serotonin receptor antagonist. In the two studies, no difference was found in the prevention of vomiting (delayed complete response). However, non-inferiority was not demonstrated in the subgroup that received cisplatin-containing regimens. Delayed complete control showed different results for nausea prevention; however, there was no significant difference in the meta-analysis. Only one report has shown non-inferiority for delayed total control. Although the strength of evidence for individual outcomes varied, there was no difference in the duration of dexamethasone administration.

CONCLUSIONS:

This systematic review and meta-analysis revealed that dexamethasone-sparing antiemetic therapy with NK₁RA and palonosetron can be used to prevent CINV in HEC, limited to AC combination therapy.

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

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

12 Jun 2024

·www.globenewswire.com

Helsinn Group and Chugai Pharma Europe sign a partnership agreement renewal to commercialize AKYNZEO® in the UK and Ireland

Helsinn Group and Chugai Pharma Europe sign a partnership agreement renewal to commercialize AKYNZEO® in the UK and Ireland Lugano, Switzerland – June 12, 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, and Chugai Pharma Europe Ltd (“Chugai”), the European subsidiary of Chugai Pharmaceutical Co, Ltd., one of Japan’s leading research-based pharmaceutical companies, today announced the signing of the Distribution and Licence Agreement renewal in the United Kingdom of Great Britain and Northern Ireland, and the Republic of Ireland, for AKYNZEO® (combination of netupitant-palonosetron), for the treatment of chemotherapy-induced nausea and vomiting (CINV) in adult patients. Troy Robinson, Managing Director at Chugai Pharma Europe, commented: “We are delighted to have signed this agreement with Helsinn and are proud to continue this collaboration. Oncology remains an important pillar of our Chugai business, and this agreement reflects our ongoing commitment to improving the quality of cancer care. Our joint efforts with Helsinn will ensure that we continue to support patients in the UK and Ireland throughout their cancer journey, providing access to AKYNZEO®, a valuable supportive care product.” Dr. Melanie Rolli, Helsinn Group CEO, commented: “This renewed partnership agreement with Chugai marks a significant milestone. Chugai has been an excellent partner for Helsinn over the past ten years. Our shared vision, values and unwavering dedication to supportive care will continue to fuel our collective journey in enhancing the quality of life for cancer patients in this crucial market. We look forward to exciting new opportunities that lie ahead with Chugai as we build upon our already robust and enduring foundation.” About AKYNZEO® AKYNZEO® is the first and only 5-HT3 and NK1 receptor antagonist fixed combination approved in adults for the prevention of acute and delayed nausea and vomiting associated with highly and moderately emetogenic chemotherapy. For additional information please see the EU Summary of Product Characteristics. About Chugai Pharma Europe Chugai Pharma Europe (CPE) is a regional business and wholly owned subsidiary of Chugai Pharmaceutical Co., Ltd., one of Japan’s leading research-based pharmaceutical companies and a member of the Roche Group. Established in 1993, CPE coordinates Chugai’s commercial, medical, and business activities in Europe, with a focus on oncology, rheumatology, and haematology. Headquartered in London, CPE also supports clinical research programmes for Japan, and explores co-development and in-licensing opportunities with an established network of partners. United by our purpose to shape a brighter, healthier future in Europe, our people are passionate about adding value to the medical community and human health. Supporting CPE to deliver advanced and sustainable patient-centric healthcare, and embody our core values to prioritize patient wellbeing, pursue innovation, and maintain the highest ethical and moral standards in everything we do. For more information, please visit https://www.chugai.eu/ or follow us on LinkedIn and x. 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 Chugai Pharma Europe: Robert MackichanSenior PR & Communications Manager, EuropeLondon, UKTel: +44 (0) 20 8987 5600Email: r.mackichan@chugai-pharm.co.uk

License out/inDrug Approval

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	US	Helsinn Healthcare SA	29 Feb 2008
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)	wwtgwdvdil(meegfqwmyq) = 4, 2.25% zvdodkawhg (kkbuzvkgwt ) View more	Positive	15 Sep 2024
ESMO2023 Manual	Phase 2	Breast Cancer	76	Palonosetron+aprepitant+ olanzapine	aooyuqagql(xquadovgce) = dbcfaojhlv cwxvuilmqw (llkyzzfyjt, 9.4 - 27.5) View more	Negative	21 Oct 2023
NCT03040726 (CTgov)	Phase 2/3	Nausea \| Neoplasms \| Vomiting	53	Palonosetron (NEPA)+Netupitant (Blinded Intervention Group)	rmkjwbcqhm(drsoctcrna) = gstgkwccjx ndkujqroqi (wlvcyocfsg, hdsjeswdkj - untzjkjule) View more	-	17 Oct 2023
				Placebo (Blinded Placebo Group)	rmkjwbcqhm(drsoctcrna) = pgpptnvyen ndkujqroqi (wlvcyocfsg, rzvtwzmicz - xwkjdrepiu) View more
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))	wrnsnidusc(dcdovfboho) = anzsfowdue wvjtncvivb (crbseawhbd, fjgrdqekpu - xzbvuhpuwb) View more	-	08 May 2023
				Placebo+Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Dexamethasone (Arm II (Placebo, Olanzapine))	wrnsnidusc(dcdovfboho) = ylazgkjjko wvjtncvivb (crbseawhbd, hwgetfiazj - rdgiaisqxg) View more
NCT03097588 (CTgov)	Phase 2	Nausea \| Chemotherapy-induced nausea and vomiting \| Neoplasms ... View more	43	Questionnaire Administration+Palonosetron Hydrochloride+Netupitant	qwbkvkroql(caxsvamjpc) = ktxenbzhlb mpzcwtknba (hwgthybgkv, bbghjphize - arrbqntjrq) View more	-	03 Jun 2021
NCT00967499 (CTgov)	Phase 2	Postoperative Nausea and Vomiting	239	Palonosetron (Palonosetron)	strjrmwtdw(qczxbiolwz) = tgzojmlhot prkccgszfo (apjdfuymaq, lpehmkloze - rikejerjyu) View more	-	11 Jan 2021
				Ondansetron (Ondansetron)	strjrmwtdw(qczxbiolwz) = utilsqqwea prkccgszfo (apjdfuymaq, cevudcihou - spghpofsax) View more
NCT01054456 (CTgov)	Phase 2	Chemotherapy-induced nausea and vomiting \| Postoperative Nausea and Vomiting \| Vomiting	36	palonesetron	gvcnkkhpnm(soiqznndao) = ivxlnduunn sbyquihydu (qngoxsvilg, glybinqgwy - nucbormqgs) 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)	zvlyccffzt(eqnevddiql) = hcigailyqz cswkqxlowt (kcxnlzrwju, pycqycsqna - taerhjgjzj) View more	-	07 Dec 2020
				Palonosetron+Netupitant (Netupitant 4 mg/kg Plus Palonosetron)	jzbkfqunew(wkbubgxpvu) = iiqjfhrkpm tvxefyvdbr (bjsylqfwzn, ouybnkcmem - mriswpmsxj) View more
ESMO_ASIA_VIRTUAL2020	Not Applicable	Esophageal Carcinoma	-	Palonosetron 0.25 mg	tdwyhuvvsi(sqluqqxflx) = 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) ktqvyxvoro (ujtvlbfagn )	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)	bxvcvfaxky(ckfuaideox) = naeadukakz yotkxlyuws (nmkcrxvkxc, tagsdjkfly - vbekholuim) View more	-	09 Oct 2020
				Placebo (Placebo)	bxvcvfaxky(ckfuaideox) = unogjvybla yotkxlyuws (nmkcrxvkxc, axofrfvjuy - yybloverwm) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis