FOCINVEZ (fosaprepitant dimeglumine)
Focinvez (fosaprepitant dimeglumine) is an intravenous neurokinin-1 (NK1) receptor antagonist indicated for use in combination with other antiemetic agents for the prevention of chemotherapy-induced nausea and vomiting (CINV). It is approved for adults and pediatric patients 6 months of age and older undergoing initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), where it prevents both acute and delayed phases. In patients receiving moderately emetogenic cancer chemotherapy (MEC), it is indicated specifically for the prevention of delayed nausea and vomiting. Focinvez is intended for prophylaxis and has not been studied for the treatment of established nausea and vomiting.
How FOCINVEZ Works
Focinvez is a prodrug of aprepitant; its antiemetic effects are derived from its conversion to aprepitant, a selective high-affinity antagonist of human substance P/neurokinin 1 (NK1) receptors. Aprepitant crosses the blood-brain barrier to occupy brain NK1 receptors, thereby inhibiting the signals that trigger emesis during the acute and delayed phases of chemotherapy. Unlike other antiemetics, it has little to no affinity for serotonin (5-HT3), dopamine, or corticosteroid receptors. Clinical data demonstrate that aprepitant augments the antiemetic activity of 5-HT3 receptor antagonists (e.g., ondansetron) and corticosteroids (e.g., dexamethasone).
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-08-22
- Patent Cliff
- 2039
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
FOCINVEZ Approval History
What FOCINVEZ Treats
2 indicationsFOCINVEZ is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nausea
- Vomiting
FOCINVEZ 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 FOCINVEZ
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03578081 results posted | A221602 NCI-2017-02410, UG1CA189823 | Ph 3 | completed | Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy |
| NCT04054193 results posted | 0517-045 MK-0517-045, 2018-004844-43 | Ph 4 | completed | Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045) |
| NCT02732015 results posted | 2015-0587 NCI-2016-00801, 2015-0587 | Ph 2 | terminated | Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy |
| NCT01594749 results posted | 0517-031 | Ph 3 | completed | Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031) |
| NCT01405924 EVADE results posted | 0517-030 | Ph 2 | terminated | Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030) |
| NCT01649258 | 1B-11-5 NCI-2012-01170 | Ph 1 | terminated | Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy |
| NCT00895245 results posted | 6862 NCI-2009-01669 | Ph 2 | terminated | Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy |
| NCT01031953 results posted | CDR0000612580 P30CA069533, OHSU-HEM-08053-L | Ph 1, Ph 2 | terminated | Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy |
| NCT01074697 GAND-emesis | GAND-emesis 2009-014691-21 | Ph 3 | completed | Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin |
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.
FOCINVEZ FDA Label Details
Indications & Usage
FDA Label (PDF)FOCINVEZ is indicated for the treatment of Nausea; Vomiting.
FOCINVEZ Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for FOCINVEZ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 2 active patents
Trial Analysis
- • 9 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