Nereus (tradipitant) is filed as NK1 receptor antagonist. The sections below restate public label fields stored for this profile.
1 INDICATIONS AND USAGE NEREUS is indicated for the prevention of vomiting induced by motion in adults. NEREUS is a substance P/neurokinin 1 (NK1) receptor antagonist indicated for the prevention of vomiting induced by motion in adults. ( 1 )
12.1 Mechanism of Action Tradipitant is a selective, high-affinity antagonist of human substance P/neurokinin 1 (NK1) receptors. Tradipitant does not have affinity for NK2 and NK3 receptors, serotonin (5-HT3), dopamine (D2), cholinergic, or histamine (H1) receptors. Tradipitant has been shown in animal models to inhibit drug induced emesis. Human Positron Emission Tomography (PET) studies with tradipitant have shown that tradipitant crosses the blood brain barrier and occupies brain NK-1 receptors. The exact mechanism by which tradipitant exerts its therapeutic effect is not fully established.
5 WARNINGS AND PRECAUTIONS Effects on the Ability to Drive or Operate Machinery: May impair mental and/or physical abilities required for driving a motor vehicle or operating heavy machinery. Concomitant use of other drugs that cause central nervous system depression and strong CYP3A4 inhibitors may increase this effect. If concomitant use is unavoidable, warn patients against driving and other activities requiring complete mental alertness. ( 5.1 , 7.1 ) 5.1 Effects on the Ability to Drive or Operate Machinery In placebo-controlled clinical trials, somnolence (6%, 12%) and fatigue (6%, 8%) were adverse reactions reported in subjects who took a single dose of 85 mg or 170 mg NEREUS, respectively [see Adverse Reactions (6.1) ] . NEREUS may impair the mental and/or physical abilities required for driving a motor vehicle or operating heavy machinery. Concomitant use of other drugs that cause central nervous system depression and strong CYP3A4 inhibitors may increase this effect [see Drug Interactions (7.1) ] . If concomitant use is unavoidable, warn patients against driving and other activities requiring complete mental alertness.
4 CONTRAINDICATIONS None. None. ( 4 )
Somnolence (≥5%); Headache (≥5%); Fatigue (≥5%)
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥5%) are: somnolence, headache, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vanda Pharmaceuticals Inc. at 1-844-GO-VANDA (1-844-468-2632) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of a single 85 mg or 170 mg dose of NEREUS was evaluated in adult subjects with a history of motion sickness in two randomized, double-blind, placebo-controlled trials, Study 1 and Study 2 [see Clinical Studies (14) ] . Additional safety data for the 170 mg dose of NEREUS were obtained from a randomized, double-blind, placebo-controlled trial, Study 3 (NCT03772340). Adverse reactions reported in at least 5% of subjects treated with a single NEREUS 85 mg or 170 mg dose and at a higher frequency than subjects who received placebo, are shown in Table 1 . Table 1: Adverse Reactions a in Adult Subjects with a History of Motion Sickness in Single-Dose, Placebo-Controlled Studies Among Subjects Receiving NEREUS a Reported in at least 5% of subjects and at a higher frequency than placebo. b NEREUS was administered as a single 85 mg dose approximately 60 minutes prior to a boat trip and without food. c NEREUS was administered as a single 170 mg dose approximately 60 minutes prior to a boat trip and without food. Studies 1 and 2 Studies 1, 2, and 3 Adverse Reaction NEREUS 85 mg b N=227 n (%) Placebo N=228 n (%) NEREUS 170 mg c N=289 n (%) Placebo N=291 n (%) Somnolence 14 (6) 9 (4) 36 (12) 17 (6) Headache 16 (7) 12 (5) 28 (10) 17 (6) Fatigue 14 (6) 6 (3) 24 (8) 6 (2) In a 12-month randomized, open-label study, 382 subjects with a history of motion sickness were instructed to administer NEREUS 85 mg (N=199) or 170 mg (N=183) as a single dose 60 minutes before a travel event of at least 60 minutes in duration expected to induce symptoms of motion sickness. Subjects were allowed to take up to 90 doses during the study. The median exposure was 18 doses and the majority of subjects (69%) did not take more than 30 doses. Most subjects (95%) did not take more than 8 doses in any 30-day period. Adverse reactions were consistent with those observed in Study 1, Study 2, and Study 3.
2 DOSAGE AND ADMINISTRATION The recommended dosage of NEREUS is 85 mg or 170 mg as a single oral dose approximately 60 minutes before an event expected to cause vomiting induced by motion. 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. ( 2.1 ) The maximum dosage in a 24-hour period is a single dose of 85 mg or 170 mg. ( 2.1 ) Administer on an empty stomach, at least 1 hour prior to or 2 hours after a full meal. ( 2.1 ) 2.1 Recommended Dosage and Administration The recommended dosage of NEREUS is 85 mg or 170 mg as a single oral dose. Use the lowest effective dose. 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 [see Adverse Reactions (6.1) ] . Administer NEREUS orally approximately 60 minutes before an event expected to cause vomiting induced by motion. The maximum dosage in a 24-hour period is a single dose of 85 mg or 170 mg. Administer NEREUS on an empty stomach, at least 1 hour prior to or 2 hours after a full meal [see Clinical Pharmacology (12.3) ] .
7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors: May increase tradipitant exposure and the risk of adverse reactions. ( 7.1 ) 7.1 Effects of Other Drugs on NEREUS Strong CYP3A4 Inhibitors Tradipitant is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase tradipitant exposure, which may increase the risk of adverse reactions to NEREUS.
17 PATIENT COUNSELING INFORMATION Effects on the Ability to Drive or Operate Machinery Advise patients NEREUS may cause somnolence and/or fatigue and impair the mental and/or physical abilities required for driving a motor vehicle or operating heavy machinery and to avoid concomitant use of other drugs with NEREUS as it may increase this effect [see Drug Interactions (7.1) ] . If concomitant use is unavoidable, warn patients against driving and other activities requiring complete mental alertness [see Warnings and Precautions (5.1) ] . Administration Information Advise the patient: Take NEREUS approximately 60 minutes before an event expected to cause vomiting induced by motion. The maximum dosage in a 24-hour period is a single dose of 85 or 170 mg. Administer NEREUS on an empty stomach, at least 1 hour prior to or 2 hours after a full meal [see Clinical Pharmacology (12.3) ] . Lactation Advise breastfeeding women using NEREUS to monitor infants for somnolence and to seek medical care if they notice this sign [see Use in Specific Populations (8.2) ] . Distributed By: Vanda Pharmaceuticals Inc. Washington, D.C. 20037 USA
According to its FDA label, Nereus (tradipitant) is approved for: 1 INDICATIONS AND USAGE NEREUS is indicated for the prevention of vomiting induced by motion in adults. NEREUS is a substance P/neurokinin 1 (NK1) receptor antagonist indicated for the prevention of vomiting induced by motion in adults. ( 1 ) For medical advice, please talk to your prescriber or pharmacist.
Nereus (tradipitant) belongs to the NK1 receptor antagonist class of medications.
The FDA label lists Nereus (tradipitant) as: 3 DOSAGE FORMS AND STRENGTHS Capsules: 85 mg, supplied as a white opaque body capsule with “VANDA 85mg” printed on the black opaque cap. Capsules: 85 mg ( 3 ); oral route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Nereus. Availability changes as patents expire.
Our ingest of the FDA label for Nereus (tradipitant) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Nereus (tradipitant) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Nereus (tradipitant) as 2025-12-30.
The FDA label lists Vanda Pharmaceuticals Inc. as a labeler/manufacturer of Nereus (tradipitant). Multiple firms may market generics of the same molecule.
The FDA label states: "Store NEREUS capsules at controlled room temperature, 25°C (77°F); excursions permitted to 15°C to 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Protect NEREUS capsules from exposure to light and moisture." Follow the packaging insert for the authoritative guidance.
Loading full data from Know Your Drugs Institute…