NAVITRUX (fosaprepitant dimeglumine) · AVYXA HOLDINGS
NAVITRUX is FDA-approved to treat 2 conditions (same as FOCINVEZ).
Details
- Status
- Prescription
- First Approved
- 2026-06-24
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
NAVITRUX Approval History
What NAVITRUX Treats
2 indicationsNAVITRUX is approved for 2 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.
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.
NAVITRUX FDA Label Details
Indications & Usage
FDA Label (PDF)NAVITRUX is FDA-approved to treat 2 conditions — same approved indications as FOCINVEZ.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.