To evaluate the efficacy and safety of NEPA combined with Megestrol Acetate versus NEPA combined with Dexamethasone in preventing nausea and vomiting caused by T-Dxd in breast cancer patients

Start Date30 Jan 2026

Sponsor / Collaborator-

NCT07254416

/ Not yet recruitingPhase 4IIT

To Evaluate the Efficacy and Safety of NEPA Combined With Megestrol Acetate Versus NEPA Combined With Dexamethasone in Preventing Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients

This study was a multicenter, prospective, controlled trial involving 120 breast cancer patients receiving T-DXd-based therapy. Participants were randomly assigned to either the experimental group (NEPA plus megestrol acetate) or the control group (NEPA plus dexamethasone), with 60 patients in each group. The intervention was administered over two treatment cycles. During this period, the onset time, frequency, and severity of nausea and vomiting were recorded and subjected to statistical analysis.
The primary objective of this study was to evaluate the efficacy and safety of netupitant/palonosetron capsules (NEPA) combined with megestrol acetate compared to the standard triple antiemetic regimen (NEPA plus dexamethasone) in preventing chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients undergoing T-DXd-containing regimens. The findings aim to generate clinical evidence to support optimal antiemetic management, minimize the risk of dose reduction or treatment discontinuation due to gastrointestinal adverse events, and ultimately improve patient quality of life.

Start Date15 Dec 2025

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

[+1]

CTR20253962

/ CompletedNot Applicable

奈妥匹坦帕洛诺司琼胶囊在健康人群中的生物等效性试验

[Translation] Bioequivalence study of netupitant and palonosetron capsules in healthy subjects

研究空腹/餐后状态下单次口服受试制剂奈妥匹坦帕洛诺司琼胶囊（浙江爱生药业有限公司生产）与参比制剂奈妥匹坦帕洛诺司琼胶囊（商品名：奥康泽（Akynzeo），Helsinn Birex Pharmaceuticals Ltd.生产）在健康受试者体内的药代动力学，评价空腹/餐后状态下口服两种制剂的生物等效性。观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

The pharmacokinetics of a single oral dose of the test formulation, Netupitant Palonosetron Capsules (manufactured by Zhejiang Aisheng Pharmaceutical Co., Ltd.), compared to the reference formulation, Netupitant Palonosetron Capsules (trade name: Akynzeo, manufactured by Helsinn Birex Pharmaceuticals Ltd.), were investigated in healthy volunteers after fasting and post-feeding. The bioequivalence of the two formulations was evaluated after oral administration in the fasting and post-feeding states. The safety of the test and reference formulations in healthy Chinese volunteers was observed.

Start Date10 Oct 2025

Sponsor / Collaborator

Zhejiang Aisheng Pharmaceutical Co. Ltd.

100 Clinical Results associated with Netupitant/Palonosetron Hydrochloride

100 Translational Medicine associated with Netupitant/Palonosetron Hydrochloride

100 Patents (Medical) associated with Netupitant/Palonosetron Hydrochloride

127

Literatures (Medical) associated with Netupitant/Palonosetron Hydrochloride

01 Feb 2026·ANNALS OF ONCOLOGY

Personalised antiemetic prophylaxis with NEPA for patients at high risk of chemotherapy-induced nausea and vomiting receiving moderately emetogenic chemotherapy: results from the randomised, multinational MyRisk trial

Article

Author: Stimamiglio, V ; Tomlins, E ; Roeland, E J ; Cheng, Y ; Brozos Vázquez, E ; Syrigos, K ; Dranitsaris, G ; Zhou, Z ; Aapro, M ; Mavroudis, D ; Schwartzberg, L ; García Alfonso, P ; Christoph, D C ; Majem, M ; Molassiotis, A ; Zimovjanová, M ; Olivari Tilola, S ; Karthaus, M ; Jordan, K ; Alonzi, A ; Bonizzoni, E ; Lu, X ; Buchler, T

BACKGROUND:

Patients receiving moderately emetogenic chemotherapy (MEC) are commonly prescribed a 5-hydroxytryptamine-3 (5-HT₃) receptor antagonist (RA) and dexamethasone (DEX) as standard-of-care (SOC) antiemetic prophylaxis. However, in patients with an elevated risk of chemotherapy-induced nausea and vomiting (CINV) due to individual risk factors, prophylaxis with an neurokinin-1 (NK₁) RA-containing regimen may optimise their antiemetic prevention. To address this unmet need for a more personalised antiemetic strategy, the MyRisk trial incorporated a predictive risk factor algorithm to select patients at increased risk of CINV who may benefit from enhanced antiemetic prophylaxis.

PATIENTS AND METHODS:

MyRisk was a phase IV, randomised, open-label, multicentre, multinational trial. Adult patients scheduled to receive three cycles of MEC with a high-risk CINV score were randomly assigned to NEPA (a fixed combination of an NK₁ RA, netupitant, and 5-HT₃ RA, palonosetron) + DEX or SOC. The CINV risk score was calculated based on an algorithm that considered seven risk factors. The primary endpoint was complete response (CR: no emesis/no rescue medication) during the overall phase (0-120 h) across three consecutive cycles.

RESULTS:

Of 401 randomly allocated patients, 388 were included in the efficacy analysis. The most common cancers were colorectal and lung; oxaliplatin and carboplatin were the most common MECs. Patients randomly assigned to NEPA were significantly more likely to experience a CR compared with SOC (odds ratio 1.67, 95% confidence interval 1.12-2.49, P = 0.012). The NEPA group had a significantly higher probability of CR, no nausea, no emesis, and complete protection (81.0%, 63.7%, 95.4%, and 71.8%, respectively) compared with the SOC arm (71.8%, 54.9%, 86.7%, and 62.4%, respectively) across three cycles of chemotherapy.

CONCLUSIONS:

When individual risk factors are considered before MEC, a three-drug regimen including NEPA provides superior CINV prevention across multiple cycles compared with the standard two-drug approach. These findings underscore the value of personalised risk-adapted antiemetic strategies and have practice-changing potential for optimising antiemetic control.

01 Dec 2025·Asia-Pacific Journal of Clinical Oncology

The Double‐Blind Placebo‐Controlled Study Comparing Upfront and Subsequent Netupitant in Addition to Olanzapine‐Containing Regimen for Prevention of High‐Dose Cisplatin‐Induced Nausea/Vomiting

Article

Author: Chotirut, Attapol ; Sitthideatphaiboon, Piyada ; Mahaparn, Wasamol ; Zungsontiporn, Nicha ; Tanasanvimon, Suebpong ; Lertanansit, Chalermchai ; Uttamapinan, Suleepon ; Vinayanuwattikun, Chanida ; Sintawichai, Nattaya ; Sriuranpong, Virote

ABSTRACT:

Background:

Addition of olanzapine to NK‐1 receptor antagonist regimen improves chemotherapy‐induced nausea and vomiting (CINV) prevention for highly emetogenic chemotherapies (HECs). However, the benefit of addition of NK‐1 receptor antagonist to olanzapine regimen has not been demonstrated. This study compared the efficacy of upfront and subsequent addition of netupitant‐ to olanzapine‐containing regimen for preventing CINV from high‐dose cisplatin (≥ 75 mg/m 2 ).

Patient and Methods:

The double‐blind placebo‐controlled trial randomized patients receiving high‐dose cisplatin to upfront and subsequent netupitant arms. In upfront netupitant arm, patients received NEPA (a combination of netupitant and palonosetron), dexamethasone, and olanzapine since first cycle. In subsequent netupitant arm, patients received olanzapine, dexamethasone, and ondansetron in first cycle but received NEPA, dexamethasone, and olanzapine in second cycle if no complete response (CR). After preplanned analysis, the initial dexamethasone dose in netupitant regimen was modified from 4 to 8 mg on Days 2–4. The primary endpoint was the overall CR rate of two cycles.

Results:

Between January 2019 and December 2020, 51 and 49 patients were randomly assigned to upfront and subsequent netupitant arms, respectively. CR rates in acute (0–24 h), delayed (> 24–120 h), and overall periods were 93.0% versus 77.4% ( p = 0.003), 75.5% versus 68.8% ( p = 0.31), and 73.3% and 67.7% ( p = 0.34) in upfront and subsequent netupitant arms, respectively. After amendment to increase dexamethasone in netupitant regimen, first‐cycle CR rates in acute, delayed, and overall periods were 95.2% versus 87.7% ( p = 0.34), 85.7% versus 73.5% ( p = 0.26), and 85.7% and 69.4% ( p = 0.26) in 4‐drug and 3‐drug groups, respectively. Among 15 patients crossing over to receive netupitant regimen in second cycle, CR was 46.6%.

Conclusion:

In this Phase II trial, there was no significant improvement in overall CR when patients received upfront netupitant compared to subsequent addition of netupitant to an olanzapine regimen in patients receiving high‐dose cisplatin chemotherapy.

10 Sep 2025·Cureus Journal of Medical Science

STOP-CINV Study: Safety and Efficacy of IV Akynzeo® (Fosnetupitant 235 mg and Palonosetron 0.25 mg) for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Indian Patients

Article

Author: Hanji, Abhinandan ; Shukla, Pragya ; Pednekar, Amullya ; Shakya, Naval K ; Valame, Shaunak ; Bhagat, Sagar ; Verma, Arun K ; Nanda, Siddhartha ; Barkate, Hanmant ; Patil, Saiprasad ; Petare, Anup U ; Bhushan, Sumit

Purpose IV Akynzeo^® (IV fosnetupitant + palonosetron) is the first fixed IV combination designed to target key pathways of emesis, enabling convenient single-dose administration. This study aimed to evaluate the safety and effectiveness of IV Akynzeo^® in a real-world context in India. Methods This open-label, single-arm, multicenter, prospective phase IV trial assessed a single dose of IV Akynzeo^® for the prevention of CINV in patients receiving highly emetogenic or moderately emetogenic chemotherapy (HEC/MEC). IV Akynzeo^® (fosnetupitant 235 mg and palonosetron 0.25 mg) was administered over 30 minutes before the start of chemotherapy. The primary endpoints were the number of patients with drug-related treatment-emergent adverse events (TEAEs) as assessed by the treating physician and the number of patients with TEAEs and serious TEAEs over a period of 10 days (±2 days). The key secondary endpoints were complete response, protection, and control in the acute phase (up to 24 hours), delayed phase (>24-120 hours), extended phase (>120-240 hours), overall phase (0-120 hours), and extended overall phase (0-240 hours). Results A total of 178 patients were enrolled (median age, 48.5 years; 64% male), of whom 176 completed the study. IV Akynzeo^® was well tolerated, with 17 patients (9.55%) reporting 23 adverse events (22 mild and one fatal). No new safety signals were detected. Headache, fatigue, and fever were the most commonly reported AEs. Injection site reactions with IV Akynzeo^® were mild in three patients. The complete response rates with IV Akynzeo^® were as follows: 84.27% (95% CI: 78.01-89.29) in the acute phase, 93.26% (95% CI: 88.52-96.47) in the delayed phase, 96.07% (171 of 178 patients; 95% CI: 92.07-98.40) in the extended phase, 83.15% (95% CI: 76.82-88.33) in the overall phase, and 80.34% (143 of 178 patients; 95% CI: 73.73-85.91) in the extended overall phase. Conclusions IV Akynzeo^® was well tolerated and demonstrated substantial effectiveness in mitigating CINV in patients undergoing HEC/MEC across the acute, delayed, and extended phases.

News (Medical) associated with Netupitant/Palonosetron Hydrochloride

06 Nov 2025

·www.prnewswire.com

Fosun Marks Eighth Year at CIIE, Guo Guangchang Calls for More Cutting-Edge Innovation

HONG KONG, Nov. 6, 2025 /PRNewswire/ -- On 5 November 2025, the 8th China International Import Expo (CIIE) opened at the National Exhibition and Convention Center (Shanghai). As a "full-attendance" exhibitor for eight consecutive years, Fosun, together with its overseas member companies and global partners, is showcasing a range of world-leading innovative drugs, advanced medical devices, and achievements in international collaboration at the Fosun Pharma booth in the Medical Equipment and Healthcare Products Exhibition Area. The exhibits focus on core therapeutic areas including oncology, immune-inflammatory disorders, central nervous system, and kidney diseases, highlighting holistic breakthroughs in medical technology, from diagnosis and treatment to recovery. Guo Guangchang, Chairman of Fosun International, remarked, "Over the past eight years, the CIIE has continued to grow in influence and innovate, serving as a key window into China's new development paradigm, a platform for advancing high-level opening-up, and a global public good that benefits the international community. We have witnessed and benefited from this 'everlasting' showcase. The CIIE has enabled Fosun's global innovations to continuously transform from 'exhibits' into 'products', while many overseas partners have changed their roles from 'exhibitors' to 'investors'. Fosun believes that healthcare innovation should address unmet clinical needs and bring hope of cure to patients. This year, our showcases in the Medical Equipment and Healthcare Products Exhibition Area center on the latest advancements addressing global clinical needs, with several new products making their debut. We firmly believe that China's high-level opening-up will remain a source of certainty and opportunity for global development. Looking ahead, Fosun will further capitalize on its global industrial advantages to foster more cutting-edge innovations in China, contributing the 'power of Fosun' to fulfill people's aspirations for a better life." Focusing on oncology: advancing from "treatment" to "cure" Fosun is presenting a series of cutting-edge innovative products aimed at advancing oncology from "treatment" to "cure" at this year's CIIE. Among them, the debut product, the Marie Upright Particle Therapy System, has attracted significant attention. As a revolutionary breakthrough in cancer treatment, the Marie Upright Particle Therapy System eliminates the cumbersome structure of conventional particle therapy system, enabling rapid deployment within existing medical facilities. Studies show that the upright positioning enhances precision in tumors located in the lung, breast, abdomen, and other areas. The system supports multiple advanced particle therapy modalities including proton therapy, heavy ion therapy, boron neutron capture therapy (BNCT), and FLASH radiotherapy, offering patients more precise, comfortable, and flexible treatment options. The Marie Upright Particle Therapy System, which received U.S. Food and Drug Administration (FDA) approval in July 2025, is making its debut in China at this year's CIIE. In the field of hematologic oncology, Fosun's Yi Kai Da (ejilunsai injection), China's first CAR-T cell therapy product, continues to share the latest developments in making lymphoma treatment both accessible and curative at the CIIE. This year, Yi Kai Da has made multiple major advances: inclusion in over 110 urban customized commercial health insurances and over 80 commercial insurances; establishment of over 190 high-standard treatment centers across 29 provinces and cities nationwide, benefiting more than 1,000 lymphoma patients; successful first-ever cross-border shipping and usage in Hong Kong SAR and Macau SAR; and a remarkable case of the first patient treated with Yi Kai Da in the Chinese mainland achieving over seven years of high-quality survival. Notably, following Yi Kai Da, the drug registration application of Fosun's second CAR-T product, brexucabtagene autoleucel injection, was accepted by the National Medical Products Administration (NMPA) in September 2025. The declared indication for this application is for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Regarding supportive care in cancer, Fosun is showcasing several innovative drugs that fill treatment gaps in the domestic market. These include the world's first and currently only dual-channel antiemetic, Akynzeo (netupitant and palonosetron hydrochloride capsules); China's first oral thrombopoietin receptor agonist with dual indications for chronic liver disease-associated thrombocytopenia and immune thrombocytopenia, Su Ke Xin (avatrombopag maleate tablets); and the long-acting recombinant human granulocyte colony-stimulating factor, Pei Jin (telpegfilgrastim injection). Additionally, Wan Ti Le (tenapanor hydrochloride tablets), a "CIIE baby" introduced to China through the CIIE, received approval from the NMPA in February 2025. It is indicated for the control of serum phosphorus levels in dialysis patients with chronic kidney disease. This groundbreaking innovation has also been shortlisted as a candidate for Best Pharmaceutical Product at the Prix Galien 2025. Addressing neurological disorders with innovative drugs and devices In recent years, the number of patients with neurological disorders has rapidly increased, with a notable trend toward younger patients. Disorders such as Parkinson's disease, brain tumors, and epilepsy have attracted growing attention. Focusing on unmet clinical needs, Fosun is actively exploring world-leading innovative solutions. In advanced medical devices, Fosun is once again featuring cutting-edge non-invasive treatments, the magnetic resonance image guided focused ultrasound brain therapy system (MRgFUS brain therapy system) and the world's first 128-channel helium-free Marvel magnetoencephalography (MEG), at the CIIE, providing integrated solutions from precise localization to non-invasive treatment for common neurological disorders such as Parkinson's disease, brain tumors, and epilepsy. To date, more than 25,000 patients worldwide have benefited from the MRgFUS brain therapy system. Its new V2 model, featuring enhanced device compatibility and easier operation, has obtained CE marking in the European Union and U.S. FDA approval. Since its debut at the last CIIE, the MRgFUS brain therapy system has been deployed in over 10 medical institutions in the Chinese mainland, benefiting nearly 1,000 patients. In the field of innovative drugs, Fosun has introduced a world-leading combination therapy for Parkinson's disease, contributing to the continuous improvement of diagnosis and treatment in China. The oral COMT inhibitor, Ongentys (opicapone) is currently the only once-daily COMT inhibitor approved globally, offering convenient dosing that significantly enhances treatment adherence and long-term disease management. Ongentys is already in clinical use in pilot zones such as Boao Lecheng, leveraging special access policies for clinical prescriptions and paving the way for broader national adoption. Integrating global resources to drive local innovation, embracing AI to accelerate breakthroughs Fosun continues to integrate global resources to advance cutting-edge medical technologies in China. Leveraging CIIE's support in transforming "exhibits" into "products", Intuitive Fosun's surgical system has been gradually launched, contributing to the development of a high-quality healthcare system in China. The Da Vinci surgical system, a popular exhibit at the CIIE for eight consecutive years, has witnessed the rapid development of minimally invasive surgery in China. By the end of September 2025, over 480 Da Vinci surgical systems had been installed in more than 370 hospitals across the Chinese mainland, Hong Kong SAR, and Macau SAR, collectively serving over 810,000 patients. This year, Intuitive Fosun is showcasing several surgical systems, including the domestically produced multiport Da Vinci Xi surgical system, the single-port Da Vinci SP surgical system designed for single-incision or natural orifice surgeries, and the Ion Robotic Bronchoscopy that brings breakthrough innovations in lung cancer diagnosis and treatment. To better meet China's clinical needs, Intuitive Fosun Innovation Center has partnered with over 20 grade 3A hospitals accredited by the National Health Commission of the People's Republic of China to establish Da Vinci Surgical System Training Centers, creating an integrated training system that combines clinical practice with education. To date, Intuitive Fosun has established 7 regional training centers across China and trained more than 15,000 medical professionals, promoting the standardized and sustainable development of surgical systems nationwide. In digital transformation, Fosun actively embraces AI and has gradually built a comprehensive digital and intelligent system covering research and development, operations, and product applications. At this year's CIIE, Fosun Pharma is showcasing its PharmAID decision intelligence platform, which deeply integrates leading large model technologies such as DeepSeek, achieving intelligent leaps in drug commercial decision-making, clinical trial prediction, and toxicology optimization. In medical aesthetics, Sisram is presenting revolutionary solutions including Alma IQ, an intelligent skin analysis and consultation solution, and Universkin, the world's first AI-assisted medical-grade skincare line launched in North America, setting new standards for personalized treatment. In healthcare services, Fosun Health continues to explore deep AI applications in assisted diagnosis, treatment quality control, and proactive health management. Leveraging four core hospitals in the Greater Bay Area including Foshan Fosun Chancheng Hospital, Fosun Health has established an internationalized service platform integrating online and offline resources, providing one-stop services from remote consultation to full patient care for individuals from Japan, Bangladesh, Indonesia, Peru, and other countries. Guo Guangchang said, "Looking ahead, Fosun will leverage its long-established innovation and globalization capabilities, collaborating with global partners to continuously drive high-quality development of the pharmaceutical industry and help realize the ambitious vision of 'Healthy China 2030'." SOURCE Fosun 21% more press release views with Request a Demo

Drug Approval

17 Oct 2025

·www.globenewswire.com

AKYNZEO® demonstrates superior prevention of chemotherapy-induced nausea and vomiting compared to the standard of care in patients receiving moderately emetogenic chemotherapy with additional predictive factors Results from the MyRisk clinical trial, accepted for publication in the Annals of Oncology, will be presented today at ESMO 2025 as an oral presentation Lugano, Switzerland, October 17, 2025 – Helsinn Group (“Helsinn”), a global pharmaceutical company with a track record of nearly fifty years of commercial execution and a strong focus in supportive care, oncology and dermato-oncology, today announces that results from the MyRisk Trial with AKYNZEO®, a fixed antiemetic combination of netupitant and palonosetron, will be featured as an oral presentation at the European Society for Medical Oncology (ESMO) Congress today, on October 17, 2025. The complete trial results have also been accepted for publication in the Annals of Oncology, underscoring their significance in advancing supportive care for patients receiving moderately emetogenic chemotherapy (MEC). Patients receiving MEC are typically prescribed a 5-HT3 receptor antagonist (RA) and dexamethasone (DEX) as standard antiemetic prophylaxis. However, some patients with additional risk factors for chemotherapy-induced nausea and vomiting (CINV) may benefit from enhanced antiemetic prophylaxis with an NK1 RA–containing regimen. The MyRisk trial was a Phase IV, interventional, open-label, randomized, multicenter, multinational trial conducted in seven countries. It is the first trial to prospectively incorporate a predictive risk factor algorithm to select patients at increased risk of CINV receiving MEC. The primary objective was to evaluate whether the use of AKYNZEO® + DEX was more effective than guideline-recommended standard of care (SOC; 5-HT3 RA + DEX) across three consecutive cycles. A total of 388 patients were included in the analysis. The primary endpoint was met; patients receiving AKYNZEO® were significantly more likely to achieve a complete response (CR: no emesis and no use of rescue medication) than those in the SOC arm in the overall phase (0-120 h after chemotherapy), with 67% greater odds (OR = 1.67, 95% CI: 1.12, 2.49). The statistical model estimated the probability of CR in the AKYNZEO® arm was 81.0% versus 71.8% in the SOC arm. This superiority was consistently observed across several secondary efficacy endpoints including “no nausea”, typically the most challenging symptom to control. Prof. Alex Molasiotis, University of Derby, Derby, United Kingdom, the lead author of the study, commented: “These results reinforce that standard doublet therapy may be insufficient for many patients, with the MyRisk trial highlighting the benefit of AKYNZEO®-based prophylaxis in individuals receiving moderately emetogenic chemotherapies. Importantly, initiating optimal prophylaxis from the first chemotherapy cycle is crucial, as CINV becomes significantly more difficult to control once experienced by patients, underscoring the need for proactive and tailored antiemetic strategies from the outset.” Silvia Olivari, Helsinn Group, Head of Medical Strategy & Excellence, added: “Patients receiving MEC represent a large part of the chemotherapy population and are often underserved by current standards. Tailoring antiemetic prophylaxis to individual patient characteristics can significantly enhance the prevention of CINV, with a particular benefit in controlling nausea, a persistent and often underestimated unmet need in supportive cancer care. We’re also proud of the recognition by ESMO and Annals of Oncology.” The details of the ESMO presentation are as follows: Title: Personalizing Antiemetic Prophylaxis for Patients at High Emetic Risk: Results from the MyRisk Trial Authors: Alex Molasiotis (Derby, United Kingdom), Karin Jordan (Potsdam, Germany), Meinolf Karthaus (Munich, Germany), George Dranitsaris (Toronto, Canada), Eric J. Roeland (Portland, United States of America), Lee S. Schwartzberg (Reno, United States of America), Erminio Bonizzoni (Milan, Italy), Elena Brozos Vazquez (A Coruña, Spain), Tomas Buchler (Prague, Czech Republic), Yu Cheng (Shanghai, China), Daniel C. Christoph (Herne, Germany), Pilar García Alfonso (Madrid, Spain), Xin Lu (Shanghai, China), Margarita Majem (Barcelona, Spain), Dimitrios Mavroudis (Heraklion, Greece), Konstantinos Syrigos (Athens, Greece), Elaine Tomlins (London, United Kingdom), Zhen Zhou (Shanghai, China), Martina Zimovjanova (Prague, Czech Republic), Matti S. Aapro (Genolier, Switzerland)Presentation number: 2801OSession title: Supportive and palliative careDate, time and location: Friday, October 17th, 16:00 – 17:30, Hanover Auditorium, Hall 7.2c ESMO 2025 will be held from 17-21 October 2025 in Berlin, Germany. Further details can be found here: ESMO Congress 2025 | ESMO About AKYNZEO® (NEPA: netupitant/palonosetron) AKYNZEO® is the first and only 5-HT3 and NK1 receptor antagonist fixed antiemetic 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 the Helsinn Group 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 diseases, with a focus on supportive care, oncology, and dermato-oncology. Headquartered in Lugano, Switzerland, Helsinn has direct commercial operations in the U.S., manufacturing operations in Ireland, offices in China and a network of trusted partners enabling a commercial presence in 90 countries. Established in 1976, Helsinn is a fourth-generation family-owned company with broad pharmaceutical and technical expertise. For nearly half a century, Helsinn has been operating with integrity, passion, and quality. The company continuously strives for innovation for its patients and embraces 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.

Clinical ResultDrug ApprovalPhase 3

02 Apr 2025

·www.globenewswire.com

Helsinn Group submits a new formulation of AKYNZEO® to the European Medicines Agency (EMA)

Lugano, Switzerland – April 2, 2025 – Helsinn Group (“Helsinn”), a global pharmaceutical company with a track record of nearly fifty years of commercial execution and a strong focus in supportive care, oncology and dermato-oncology, today announced the submission of a new formulation for AKYNZEO® to the European Medicines Agency (EMA). AKYNZEO® is indicated for the prevention of acute and delayed nausea and vomiting associated with both highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy. Once approved, this new innovative formulation may offer benefits to cancer patients in addition to the already approved formulations. The new AKYNZEO® formulation is expected to be launched in H1 2026. Roberta Cannella, Chief Technical Officer, commented: “This submission brings us closer to offering patients a new option for AKYNZEO®. It not only demonstrates our commitment to enhancing patients’ quality of life but also our dedication to innovation in supportive care.” About AKYNZEO® AKYNZEO® is the first and only 5-HT3 and NK1 receptor antagonist fixed dose 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 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 a consolidated network of partners to reach out to patients in more than 190 countries worldwide. Established in 1976, Helsinn is a fourth-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 Approval

100 Deals associated with Netupitant/Palonosetron Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Netupitant/Palonosetron Hydrochloride	A04AA	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Nausea	Canada	Knight Therapeutics, Inc.	20 Nov 2017
Vomiting	Canada	Knight Therapeutics, Inc.	20 Nov 2017
Chemotherapy-induced nausea and vomiting	United States	Helsinn Healthcare SA	10 Oct 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 3	United States	Helsinn Healthcare SA	16 Mar 2018
Brain Cancer	Phase 2	Greece	Helsinn Healthcare SA	07 Jul 2025
Brain Cancer	Phase 2	Poland	Helsinn Healthcare SA	07 Jul 2025
Brain Cancer	Phase 2	Romania	Helsinn Healthcare SA	07 Jul 2025
Brain Cancer	Phase 2	Turkey	Helsinn Healthcare SA	07 Jul 2025
Wilms Tumor	Phase 2	Greece	Helsinn Healthcare SA	07 Jul 2025
Wilms Tumor	Phase 2	Poland	Helsinn Healthcare SA	07 Jul 2025
Wilms Tumor	Phase 2	Romania	Helsinn Healthcare SA	07 Jul 2025
Wilms Tumor	Phase 2	Turkey	Helsinn Healthcare SA	07 Jul 2025
Neoplasms	Phase 2	United States	Helsinn Therapeutics (U.S.), Inc.	27 Apr 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_ASIA2025	Not Applicable	Chemotherapy-induced nausea and vomiting	22	Oral NEPA (netupitant and palonosetron) (highly emetogenic chemotherapy)	homwtkrdgy(utmlfoohve) = xlgfhwmewc ohrrrqjjan (berjgupkkv ) View more	Positive	05 Dec 2025
				Oral NEPA (netupitant and palonosetron) (moderately emetogenic chemotherapy)	homwtkrdgy(utmlfoohve) = ibbtlarfoc ohrrrqjjan (berjgupkkv ) View more
NCT04817189 (CINV \| MyRisk, CTgov)	Phase 4	Chemotherapy-induced nausea and vomiting	414	Dexamethasone+NEPA (300mg netupitant/0.5mg palonosetron) (NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg)	qtmoesedbp = locgdhhelk kzafrkcaui (isjyisytyl, fyxbirfncb - mnvxoxosvo) View more	-	29 Oct 2025
				Granisetron+Tropisetron+Dolasetron+Dexamethasone+Palonosetron+Ondansetron (Standard of care + Dexamethasone 8 mg)	qtmoesedbp = ntcgnrsjkt kzafrkcaui (isjyisytyl, jrxodhimao - pgtxvfzrhm) View more
NCT03367572 (CTgov)	Phase 3	Nausea \| Breast Cancer \| Vomiting	1,363	Quality-of-Life Assessment+Dexamethasone+Netupitant/Palonosetron Hydrochloride (Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone)	vtnkgdletg(abseulhoyb) = wtreytlcyl enigbhfitp (zaeqpkpdsw, 0.155) View more	-	25 Sep 2025
				Quality-of-Life Assessment+Prochlorperazine+Dexamethasone+Netupitant/Palonosetron Hydrochloride (Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo))	vtnkgdletg(abseulhoyb) = rbywolxzff enigbhfitp (zaeqpkpdsw, 0.141) View more
ChiCTR2400089311 (ASCO2025)	Phase 3	Chemotherapy-induced nausea and vomiting	164	Dexamethasone 5mg	sglxvnbnyv(ayoumowfjq) = bsgqxmrsym rlbpvkgpmt (zigzowrbpl ) View more	Positive	30 May 2025
				Dexamethasone 8mg	sglxvnbnyv(ayoumowfjq) = vmlpzyahdy rlbpvkgpmt (zigzowrbpl ) View more
ASCO2025	Not Applicable	Nasopharyngeal Carcinoma	312	Oral NEPA	vlrsnycvmy(suqalmrzxa) = knohrwkrtj gsqnvteskn (jzsedmhyug ) View more	Positive	30 May 2025
				Fosaprepitant + Palonosetron	vlrsnycvmy(suqalmrzxa) = icsxuwlmmp gsqnvteskn (jzsedmhyug ) View more
NCT06065722 (Pubmed \| Cancer Med)	Phase 2	Chemotherapy-induced nausea and vomiting	227	NEPA (Netupitant/Palonosetron) plus dexamethasone with olanzapine	vcagjtccts(vlgiyrohdw) = ieyosawdxv rgbzvhgtwb (mmliiwmlyw, 59 - 88)	Positive	01 Apr 2025
				NEPA (Netupitant/Palonosetron) plus dexamethasone	vcagjtccts(vlgiyrohdw) = ifjyljuufc rgbzvhgtwb (mmliiwmlyw, 67 - 89)
ESMO_ASIA2024	Not Applicable	Neoplasms	164	NEPA	paatmuuqas(wecabtthvs) = rjtmigosdi yaktrlnbmq (bmnqrojsil ) View more	Positive	07 Dec 2024
ESMO_ASIA2024	Not Applicable	-	-	NEPA 300mg on day 1,5	vtodfrjdzo(ksrrmvbwwp) = axgybtdsfc ahrmbvugdv (yjoqmtqvpr ) View more	Positive	07 Dec 2024
				NEPA 300mg on day 1	vtodfrjdzo(ksrrmvbwwp) = kavdojcmxj ahrmbvugdv (yjoqmtqvpr ) View more
CTRI/2023/04/051951 (ASCO2024) Manual	Phase 4	Chemotherapy-induced nausea and vomiting	178	IntraVenous (Fos)NEtupitant and PalonosetronPalonosetron (IV NEPA) (HEC)	uywdaurlix(eablresocs) = rjvfcuhiop xvqasrfgsd (djifcclgfy ) View more	Positive	24 May 2024
				IntraVenous (Fos)NEtupitant and PalonosetronPalonosetron (IV NEPA) (MEC)	uywdaurlix(eablresocs) = gknofacafu xvqasrfgsd (djifcclgfy ) View more
EHA2023	Not Applicable	Hematopoietic stem cell transplantation \| Lymphoma	76	NEPA	rfnkfylarv(spvdbvfmmm) = rzqreupxep mxqvfzupgr (dyziqszfea ) View more	-	08 Jun 2023
				Ondansetron	rfnkfylarv(spvdbvfmmm) = rnbipbqbqa mxqvfzupgr (dyziqszfea ) View more

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