NDAORALCAPSULE
Approved
Oct 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
9
Data completeness
6/8 — Strong
AKYNZEO (netupitant and palonosetron) by Helsinn is serotonin 3 receptor antagonists [moa]. First approved in 2014.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AKYNZEO is a fixed-dose oral combination of netupitant (NK1 receptor antagonist) and palonosetron (5-HT3 receptor antagonist) approved in 2014 for chemotherapy-induced nausea and vomiting (CINV) prevention. It works by dual mechanism: blocking serotonin and neurokinin-1 pathways in the chemoreceptor trigger zone and vomiting center. This combination provides superior efficacy compared to single-agent antiemetics in highly emetogenic chemotherapy settings.
$5MPart D
PeakStable
9.3 years to LOEPeak-stage product with modest Medicare utilization signals stable but mature market penetration; likely smaller brand team focused on retention rather than expansion.
Mechanism of Action
Serotonin 3 Receptor Antagonists
Pharmacologic Class:
Serotonin-3 Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk)
Started Feb 2021
414 enrolled
Chemotherapy-induced Nausea and Vomiting
Observational Study on the Use of Akynzeo® in Patients Receiving HEC
Started Oct 2018
207 enrolled
Chemotherapy-Induced Nausea and Vomiting
Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin
Started Sep 2018
80 enrolled
Chemotherapy-induced Nausea and VomitingAdverse EventCervical Cancer
PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting
Started Aug 2017
67 enrolled
Chemotherapy-induced Nausea and Vomiting (CINV)
Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer
Started May 2017
53 enrolled
Malignant NeoplasmNauseaVomiting
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.