AKYNZEO (netupitant)
Akynzeo is a fixed-dose combination medication (netupitant/palonosetron) indicated for use with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy. The oral capsules are indicated for chemotherapy regimens including, but not limited to, highly emetogenic chemotherapy (HEC). The injectable formulations (containing fosnetupitant/palonosetron) are specifically indicated for HEC, though they have not been studied for use with anthracycline plus cyclophosphamide regimens.
How AKYNZEO Works
Akynzeo targets two distinct signaling pathways involved in chemotherapy-induced nausea and vomiting (CINV). Palonosetron is a 5-HT3 receptor antagonist that prevents nausea and vomiting during the acute phase by blocking serotonin receptors on vagal afferents. Netupitant (or its prodrug fosnetupitant) is a selective NK-1 receptor antagonist that inhibits substance P signaling; according to the FDA indication, netupitant contributes to the prevention of nausea and vomiting in both the acute and delayed phases following chemotherapy.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-10-10
- Patent Cliff
- 2037
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- CAPSULE, SOLUTION, POWDER
AKYNZEO Approval History
What AKYNZEO Treats
2 indicationsAKYNZEO is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nausea
- Vomiting
AKYNZEO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to AKYNZEO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03204279 CINV results posted | NEPA-15-31 | Ph 2 | completed | PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting |
| NCT03040726 results posted | 2016-0843 NCI-2017-00599, 2016-0843 | Ph 2, Ph 3 | completed | Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer |
| NCT04669132 OLNEPA | 38285020.8.0000.0072 | Ph 2 | completed | Efficacy of Olanzapine, Netupitant and Palonosetron in Controlling Nausea and Vomiting Associated With Highly Emetogenic Chemotherapy in Patients With Breast Cancer |
| NCT03097588 results posted | STUDY00016288 NCI-2017-00548, STUDY00016288 | Ph 2 | completed | Netupitant and Palonosetron Hydrochloride in Preventing Chemotherapy Induced Nausea and Vomiting in Patients With Cancer Undergoing BEAM Conditioning Regimen Before Stem Cell Transplant |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AKYNZEO FDA Label Details
Indications & Usage
FDA Label (PDF)AKYNZEO is indicated for the treatment of Nausea; Vomiting.
AKYNZEO Patents & Exclusivity
Patents (22 active)
Pro Intelligence Preview
Deep insights for AKYNZEO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 60 active patents
Trial Analysis
- • 5 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment