FDA clears Navitrux, an intravenous fosaprepitant, for chemotherapy nausea

The Food and Drug Administration has approved Navitrux, an intravenous formulation of the anti-nausea drug fosaprepitant. The clearance was recorded in the agency's Drugs@FDA database on 24 June 2026 under new drug application 220436, held by Avyxa Holdings and reviewed on the agency's standard track [s1]. The product is a lyophilised powder reconstituted for infusion, supplied at a strength equivalent to 150 mg of fosaprepitant base per vial [s1].

Fosaprepitant is not a new molecule. It is a prodrug of aprepitant, a substance P/neurokinin-1 (NK-1) receptor antagonist that has been used for more than a decade to blunt the vomiting that follows cancer chemotherapy [s2]. What the approval adds is another manufacturer's intravenous version of that established agent, rather than a new mechanism.

What it is approved to do

Navitrux is cleared for use in combination with other antiemetic agents in adults and in children aged 6 months and older [s2]. The label covers two settings: prevention of acute and delayed nausea and vomiting with highly emetogenic chemotherapy, including high-dose cisplatin, and prevention of delayed nausea and vomiting with moderately emetogenic chemotherapy [s2]. The label is explicit that the drug has not been studied for treating nausea and vomiting once they are already established — it is a preventive, given ahead of chemotherapy, not a rescue medicine [s2].

The recommended adult dose is a single 150 mg intravenous infusion over 20 to 30 minutes on day one, completed roughly 30 minutes before chemotherapy begins [s2]. Paediatric dosing is weight- and age-based, and for multi-day regimens oral aprepitant can be substituted on later days [s2].

The mechanism

Fosaprepitant is converted in the body to aprepitant, and its antiemetic effect is attributed entirely to that active form [s2]. Aprepitant is a selective, high-affinity antagonist at human NK-1 receptors and has little or no affinity for the serotonin, dopamine or corticosteroid receptors targeted by the other drug classes used against chemotherapy-induced nausea and vomiting [s2]. That is why NK-1 blockers are layered on top of, rather than in place of, the serotonin (5-HT3) antagonists and dexamethasone that form the backbone of antiemetic regimens.

What the evidence rests on

The efficacy and safety of Navitrux were established not through fresh trials of this product but on adequate and well-controlled adult studies of another intravenous formulation of fosaprepitant [s2]. In the pivotal comparison, fosaprepitant 150 mg given as a single intravenous infusion (1,147 patients) was tested against a three-day oral aprepitant regimen (1,175 patients) in people receiving a cisplatin-based, highly emetogenic regimen [s2]. Every patient in both arms also received dexamethasone and ondansetron [s2]. Across the 2,322 participants, ages ranged from 19 to 86 years, with a mean of 56 [s2].

The trial was built to show that the single intravenous dose was no worse than the established three-day oral course — a bridging logic that is standard for reformulations of an already-approved active ingredient. It is worth being clear about what that does and does not tell a reader: the design speaks to whether this delivery method matches an existing one, not to whether NK-1 blockade itself is beneficial, a question long since settled for aprepitant.

Safety signals to note

The label carries no boxed warning, but it flags several cautions [s2]. Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, may occur during or soon after the infusion; the label directs clinicians to stop the drug if symptoms appear and not to re-use it in anyone who has reacted [s2]. Infusion-site reactions, including thrombophlebitis and, less commonly, necrosis and vasculitis, are also described [s2]. Because aprepitant interacts with the CYP3A4 enzyme system, the drug is contraindicated with pimozide, where raised levels could cause dangerous heart-rhythm effects [s2]. The most common adverse reactions reported in adults were fatigue, diarrhoea, neutropenia, asthenia and anaemia [s2].

How to read it

For patients and oncology teams, the practical significance is supply and choice rather than a therapeutic leap: another intravenous fosaprepitant on the market. Whether it displaces existing products will turn on price and formulary decisions more than on any difference at the bedside, since the clinical case rests on matching an already-approved formulation.

This article describes a regulatory approval and is not medical advice. Decisions about antiemetic treatment during chemotherapy are for patients and their oncology teams. Anyone who develops signs of a severe allergic reaction — swelling, difficulty breathing, hives — during or after an infusion should seek immediate medical care.

Sources

• Drugs@FDA: Navitrux (fosaprepitant), NDA 220436 — approval record — U.S. Food and Drug Administration, approved 24 June 2026
• Navitrux (fosaprepitant) for injection — US prescribing information — U.S. Food and Drug Administration, label effective 29 July 2026