Nereus

Nereus is used to prevent vomiting caused by motion in adults. It is taken as a single oral dose, approximately 60 minutes before an event expected to cause motion-induced vomiting.

Nereus (tradipitant) gained FDA approval on December 30, 2025, and is the first prescription medication for motion sickness to be approved in over 40 years.

Approval was supported by two Phase 3 real-world provocation clinical trials conducted on boats, which demonstrated risk reductions of over 50–70%. Vomiting incidence with Nereus was:

• 18.3–19.5% versus 44.3% with placebo (p<0.0001), Motion Syros (NCT04327661, n=365).
• 10.4–18.3% versus 37.7% with placebo (p≤0.0014), Motion Serifos (NCT05903924, n=316).

Take Nereus approximately 60 minutes before an event expected to cause vomiting induced by motion.

• Take Nereus on an empty stomach, at least 1 hour before or 2 hours after a full meal
• Do not take more than a single dose of 85 or 170 mg in 24 hours.

Before taking Nereus, tell your healthcare provider about all of your medical conditions, including if you:

• Drive, operate heavy machinery, or do other activities that require you to be alert. Nereus may cause drowsiness and impair your ability to drive safely or operate machinery.
• Drink alcohol or take other medicines that can make you sleepy, including sedatives, tranquilizers, sleeping pills, or anxiety medications. Taking Nereus with these substances may increase drowsiness.
• Are taking any other medicines, such as antifungals, certain antibiotics, or HIV medications
• Are pregnant or plan to become pregnant. It is not known if Nereus will harm your unborn baby.
• Are breastfeeding or plan to breastfeed. Nereus may pass into your breast milk and may cause drowsiness in your breastfed baby. Monitor your baby for unusual sleepiness if you are taking Nereus while breastfeeding.

Common side effects

The most common side effects of Nereus are:

• Somnolence (sleepiness)
• Headache
• Fatigue.

Serious side effects and warnings

Effects on the Ability to Drive or Operate Machinery

Nereus may cause somnolence (sleepiness) and/or fatigue and impair your mental and/or physical abilities needed for driving a motor vehicle or operating heavy machinery.

• Avoid taking other medications that also cause sleepiness with Nereus, as this may increase the effect.
• If you feel tired or sleepy after taking Nereus, or you cannot avoid taking other medications that cause or contribute to sedation, do not drive, operate machinery, or perform tasks or activities that require complete mental alertness.

To report suspected adverse reactions, contact Vanda Pharmaceuticals Inc. at 1-844-438-5469 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Adult Dose of Nereus for Prevention of Motion-Induced Vomiting

• 85 mg or 170 mg as a single dose, 60 minutes before an event expected to cause motion-induced vomiting.
• Maximum dosage: 85 mg or 170 mg as a single dose in 24 hours.

Note: The safety of Nereus for the prevention of vomiting induced by motion in adults for more than 90 doses has not been established in clinical trials.

Nereus (tradipitant) works by blocking substance P/neurokinin-1 (NK-1) receptors, proteins in the brain and gut that trigger nausea, vomiting, pain, and stress responses when activated by substance P, a natural chemical messenger. By blocking these receptors, Nereus prevents substance P from binding, thereby preventing nausea and vomiting, although the exact way it works is unknown.

Nereus belongs to the drug class called substance P/neurokinin-1 (NK-1) receptor antagonists. It is a selective, high-affinity NK-1 antagonist.

Tell your healthcare provider or pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take strong CYP3A4 inhibitors, because these may increase blood levels of Nereus and the risk of adverse reactions, such as sleepiness. Examples include:

• Antifungals: ketoconazole, itraconazole, posaconazole
• Antibiotics: clarithromycin, telithromycin
• Antivirals: ritonavir, nelfinavir, cobicistat.

This is not a complete list of interactions. See the Nereus Prescribing Information for a complete list.

Store Nereus capsules at room temperature and protect from light and moisture.

Active ingredients: tradipitant

Inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.

The capsule contains FD&C blue No 1, FD&C red No 40, and FD&C yellow No 6, gelatin, and titanium dioxide.

Nereus is supplied as 85 mg capsules.

Distributed by Vanda Pharmaceuticals Inc., Washington, D.C. 20037 USA.