Akynzeo oral (netupitant/palonesteron FDC) / Helsinn, Roche, Otsuka, Glenmark, Mundipharma, Fosun Pharma, Knight Therap, Immedica - LARVOL DELTA

Reduced-Dose Dexamethasone(Dex) Plus Netupitant/Palonosetron (NEPA) for Prevention of Nausea and Vomiting in Cervical Cancer Patients Undergoing Concurrent Chemoradiotherapy(CCRT): An Interim Analysis (ESMO 2026) - No abstract available

Clinical • Cervical Cancer • Oncology • Solid Tumor

Akynzeo versus standard anaesthesia care for nausea, vomiting and pain after weight-loss (bariatric) surgery (ANZCTR) - P4 | N=135 | Recruiting | Sponsor: A/Prof Michael Talbot, St George Private Hospital

New P4 trial • Anesthesia • Pain

Extended physicochemical stability of ready-to-administer fosnetupitant/palonosetron infusion solutions and admixtures with dexamethasone injection. (PubMed, Eur J Hosp Pharm) - "Reconstituted FNET/PAL (Akynzeo) infusion solutions and FNET/PAL/DEX admixtures diluted with 30 mL and 100 mL NS in prefilled PO bags are physicochemically stable for at least 5 days (subvisible particle count specification fulfilled) and 28 days (subvisible particle count not tested) when stored light-protected at 25°C. Results allow pharmacy-based preparation of RTA FNET/PAL and RTA FNET/PAL/DEX infusion solutions in advance."

Journal • Oncology

Steroid sparing regimen with inj palonosetron–fosnetupitant (Akynzeo) for CINV in patients receiving ≥2 chemotherapy cycles: An observational study (MASCC-ISOO 2026) - "All patients received oral ondansetron for three days post-chemotherapy. These findings suggest that routine dexamethasone may be avoidable in selected patients, including those with diabetes, without adversely affecting CINV outcomes or quality of life. Larger, controlled studies are warranted to confirm these results."

CINV • Clinical • Observational data • Chemotherapy-Induced Nausea and Vomiting • Diabetes • Metabolic Disorders

Risk Factors Associated With Breakthrough Emesis in Mexican Women Receiving NEPA (Netupitant/Palonosetron): A Real-World Analysis (MASCC-ISOO 2026) - "Methods We conducted a real-world observational analysis including 50 adult Mexican women receiving moderately or highly emetogenic chemotherapy (MEC/HEC) with NEPA plus dexamethasone as primary antiemetic prophylaxis...Younger age, highly emetogenic regimens, low BMI, and prior CINV were strongly associated with emesis despite guideline-based prophylaxis. These findings support a risk-adapted antiemetic strategy, even when NEPA is used, to further optimize CINV prevention in vulnerable populations."

Clinical • Real-world • Real-world evidence • Chemotherapy-Induced Nausea and Vomiting

NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens (clinicaltrials.gov) - P3 | N=644 | Completed | Sponsor: Fudan University | Not yet recruiting ➔ Completed | Trial completion date: May 2026 ➔ Aug 2025 | Trial primary completion date: May 2025 ➔ Aug 2025

Head-to-Head • Trial completion • Trial completion date • Trial primary completion date • Chemotherapy-Induced Nausea and Vomiting

AKY15-HK-301_NEPA Study (clinicaltrials.gov) - P2 | N=55 | Active, not recruiting | Sponsor: Chinese University of Hong Kong | Trial completion date: Dec 2026 ➔ Dec 2028 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

Helsinn Healthcare SA…announced that the European Commission (EC) has granted marketing authorization for the new oral suspension formulation of AKYNZEO (netupitant/palonosetron) on 12th of February 2026. (GlobeNewswire) - "Following today’s EC decision, the commercial launch of the AKYNZEO oral suspension in Europe is anticipated in the coming months."

EMA approval • Launch Europe • Chemotherapy-Induced Nausea and Vomiting • Oncology

PRO-NEPA: NEPA in Patients With HER2-positive or HER2-low Advanced Breast Cancer Treated With T-DXd (clinicaltrials.gov) - P=N/A | N=100 | Enrolling by invitation | Sponsor: Yeon Hee Park | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Exploratory Analysis of Nausea and Vomiting Probability over Multiple Cycles of NEPA (netupitant/palonosetron) Prophylaxis in Metastatic Breast Cancer Patients Treated withTrastuzumab Deruxtecan (SABCS 2025) - "Since MBC patients may receive T-DXd for an extended period, effective management of NV could help maintain dose intensity, reduce the risk of treatment discontinuation, and improve quality-of-life.Preventing NV can also contribute to reduce other adverse events, like fatigue Effective NV control from the first cycle with a NK1 receptor antagonist (RA)-based regimen is crucial for optimal management throughout subsequent cycles.This exploratory retrospective analysis examined the probability of patients experiencing NV over multiple cycles of T-DXd following antiemetic prophylaxis with NEPA, a fixed-combination of an NK1 RA (netupitant/fosnetupitant) and 5-HT3 RA (palonosetron).Occurrence and severity of NV in patients with HER2-positive or HER2-low MBC over the first 5 cycles of T-DXd for each patient were extracted and analyzed from clinical records at a single-center in Italy.Probability of NV occurring in each of 5 cycles of T-DXd was estimated using a logistic..."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Cost-conscious control of CINV: A retrospective analysis of oral netupitant and palonosetron (NEPA) in Indian oncology practice (ESMO Asia 2025) - "The use of generic oral NEPA (netupitant and palonosetron), administered 30 minutes before chemotherapy, was highly effective in preventing both acute and delayed CINV across various regimens. These findings support its use as a cost-effective alternative in real-world oncology practice."

CINV • Retrospective data • Breast Cancer • Cervical Cancer • Chemotherapy-Induced Nausea and Vomiting • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Ovarian Cancer • Solid Tumor

PRO-NEPA: NEPA in Patients With HER2-positive or HER2-low Advanced Breast Cancer Treated With T-DXd (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: Yeon Hee Park

New trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

The safety and efficacy of NEPA in preventing postoperative nausea and vomiting after general anesthesia during gastrointestinal cancer surgery: a single-center retrospective study. (PubMed, Transl Cancer Res) - "All patients received one NEPA capsule orally the evening before surgery...NEPA demonstrated high efficacy and convenience, with vomiting occurring in only 15% of patients and nausea in 40% within 72 hours after surgery and more patients showed a trend toward a favorable response over time. NEPA has proven to be a safe, effective, and convenient option for preventing PONV in GI cancer surgeries."

Journal • Retrospective data • Anesthesia • Gastrointestinal Cancer • Oncology • Pain • Solid Tumor

Efficacy and safety of oral NEPA versus fosaprepitant combined with palonosetron for preventing highly emetogenic chemotherapy-induced nausea and vomiting in patients with nasopharyngeal carcinoma. (ASCO 2025) - "Funded by Prognostic evaluation and individualized treatment strategies for nasopharyngeal carcinoma based on recursive attention mechanisms (RAMs) and multimodal deep learning, Study of the antitumor effect of marine docosahexaenoic acid on the miR-26a/EZH2 axis in NSCLC, A non-inferiority, parallel design, randomized controlled study of saperine versus dexamethasone nebulized inhalation in the prevention and treatment of radiation oral mucositis in nasopharyngeal carcinoma Background: Oral NEPA, a fixed combination of netupitant (300 mg) and palonosetron (0.5 mg), is a highly effective antiemetic agent used in patients with cancer undergoing highly emetogenic chemotherapy (HEC)...156 patients (Oral NEPA group) received a single dose of NEPA capsules orally 1 hour before each chemotherapy cycle, while 156 patients (APR + PALO group) received once intravenous drip of FosAPR (150 mg) for 30 minutes followed by once intravenous injection of PALO (0.25 mg). In addition,..."

CINV • Clinical • Chemotherapy-Induced Nausea and Vomiting • Constipation • Gastroenterology • Gastrointestinal Disorder • Lung Cancer • Mucositis • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Pain • Solid Tumor • Stomatitis • MIR26A1

A Retrospective Study on the Efficacy and Safety of Oral NEPA Capsules in Preventing Nausea and Vomiting in Nasopharyngeal Carcinoma Patients after Cisplatin Chemotherapy (ChiCTR) - P=N/A | N=246 | Completed | Sponsor: Affiliated Hospital of Guangdong Medical University; Affiliated Hospital of Guangdong Medical University

New trial • Chemotherapy-Induced Nausea and Vomiting • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Helsinn Group submits a new formulation of AKYNZEO to the European Medicines Agency (EMA) (GlobeNewswire) - "Helsinn Group....today announced the submission of a new formulation for AKYNZEO to the European Medicines Agency (EMA)....The new AKYNZEO formulation is expected to be launched in H1 2026."

EMA approval • Launch Europe • Chemotherapy-Induced Nausea and Vomiting

A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 Mg and Metabolites in Healthy Volunteers (clinicaltrials.gov) - P1 | N=50 | Terminated | Sponsor: Helsinn Healthcare SA

New P1 trial

Helsinn Group and ESTEVE sign a partnership agreement renewal to commercialize AKYNZEO and ALOXI in Germany (GlobeNewswire) - "Helsinn Group...and ESTEVE...announced the signing of the Distribution and Licence Agreement renewal in Germany for AKYNZEO (combination of netupitant-palonosetron) and ALOXI (palonosetron) for the treatment of chemotherapy-induced nausea and vomiting (CINV) in adult patients."

Licensing / partnership • Chemotherapy-Induced Nausea and Vomiting

NOEME: Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer (clinicaltrials.gov) - P4 | N=84 | Recruiting | Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

New P4 trial • Endometrial Cancer • Oncology • Solid Tumor

AKY15-HK-301_NEPA Study (clinicaltrials.gov) - P2 | N=55 | Active, not recruiting | Sponsor: Chinese University of Hong Kong | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

Comparison of efficacy of single agent netupitant plus palonosetron (NEPA) vs fosaprepitant in prevention of chemotherapy induced nausea and vomiting (CINV) in patients receiving high dose chemotherapy for auto-SCT In a tertiary care center from South India (ESMO Asia 2024) - "As part of conditioning regimen, high dose melphalan and BEAM regimen were used in 31 and 9 patients respectively...The overall complete response (CR-O) was also higher in NEPA arm (77.8 % vs 60%). Conclusions Single agent oral NEPA is more effective in preventing CINV in acute, delayed, overall phases in patients receiving high dose chemotherapy as conditioning regimen for Auto-SCT."

CINV • Clinical • Chemotherapy-Induced Nausea and Vomiting • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) (clinicaltrials.gov) - P4 | N=414 | Completed | Sponsor: Helsinn Healthcare SA | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jul 2024

Trial completion • Trial completion date • Chemotherapy-Induced Nausea and Vomiting

Exploratory study on a single-day low-dose dexamethasone combined with a single or double standard dose of netupitant palonosetron capsules for preventing nausea and vomiting in patients undergoing moderately to highly emetogenic chemotherapy (LD-NEPA1/2 study) (ChiCTR) - P=N/A | N=164 | Not yet recruiting | Sponsor: Zhongshan Hospital Affiliated to Xiamen University; Zhongshan Hospital Affiliated to Xiamen University

New trial • Chemotherapy-Induced Nausea and Vomiting

Clinical effect of different doses of olanzapine combined with triple antiemetic therapy on the prevention of nausea and vomiting caused by high emetogenic chemotherapy for malignant tumors (ChiCTR) - P=N/A | N=400 | Not yet recruiting | Sponsor: Zhoukou Center Hospital; Zhoukou Center Hospital

New trial • Chemotherapy-Induced Nausea and Vomiting • Oncology • Solid Tumor

Knight Therapeutics Reports Second Quarter 2024 (GlobeNewswire) - "Oncology/Hematology: The oncology/hematology portfolio grew by $7,690 due to the continued growth of key promoted products including Lenvima, Akynzeo, Trelstar and the launch of Minjuvi in Brazil."

Sales • Diffuse Large B Cell Lymphoma • Endometrial Cancer • Hematological Malignancies • Hepatocellular Cancer • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor