Tradipitant

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.

• 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.

• None. None.contraindicated

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) ] .

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.

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.

Lactation: Monitor breastfed infants for somnolence. ( 8.2 ) 8.1 Pregnancy Risk Summary Available data from clinical trials with NEREUS use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, no adverse developmental effects were observed with oral administration of tradipitant to pregnant rats during organogenesis through lactation or to pregnant rabbits during organogenesis at doses up to approximately 3.3 and 1.4 times the exposure to tradipitant at the maximum recommended human dose (MRHD), respectively. The background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In a combined fertility and embryo-fetal development study in pregnant rats, tradipitant was administered at oral doses of 10, 100, or 1000 mg/kg (approximately 1.4, 1.9, and 2.2 times the exposure to tradipitant at the MRHD) during the periods of mating and organogenesis, through gestation day 17.

Metabolism

Absorption Absolute oral bioavailability has not been studied in humans. Following a single dose of 85 mg tradipitant in healthy subjects under fasting conditions, tradipitant geometric mean C max was 84.7 ng/mL, AUC 0-inf was 1839 ng*h/mL, and the median T max was 2.0 hours.

• Dec 30, 2025NDANDA220152Vanda Pharms Inc

1. 1Renal Tubular Necrosis2100%
2. 2Blood Creatinine Increased150%
3. 3Protein Total Increased150%
4. 4Sepsis150%

The 10 most recently updated of 17 ClinicalTrials.gov registrations naming Tradipitant as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use
  Recruiting · Phase 3 · Interventional · 280 enrolled · Vanda Pharmaceuticals
  NCT07446439updated 2026-04-20
• Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness
  Active not recruiting · Phase 3 · Interventional · 705 enrolled · Vanda Pharmaceuticals
  NCT06138613updated 2026-04-16
• Tradipitant for Functional Dyspepsia
  Enrolling by invitation · Phase 2 · Interventional · 60 enrolled · Xiao Jing (Iris) Wang
  NCT05653310updated 2026-01-20
• A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use
  Completed · Phase 2 · Interventional · 124 enrolled · Vanda Pharmaceuticals
  NCT06804603updated 2025-11-12
• Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
  Available · Expanded access · Vanda Pharmaceuticals
  NCT04474990updated 2025-08-24
• Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
  Completed · Phase 3 · Interventional · 992 enrolled · Vanda Pharmaceuticals
  NCT04028492updated 2025-07-24
• Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
  Completed · Phase 2 · Interventional · 126 enrolled · Vanda Pharmaceuticals
  NCT03772340updated 2025-05-09
• Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness
  Completed · Phase 3 · Interventional · 316 enrolled · Vanda Pharmaceuticals
  NCT05903924updated 2025-04-04
• Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis
  Recruiting · Phase 3 · Interventional · 100 enrolled · Vanda Pharmaceuticals
  NCT06836557updated 2025-02-20
• Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
  Completed · Phase 3 · Interventional · 366 enrolled · Vanda Pharmaceuticals
  NCT04327661updated 2024-12-11

Frequently asked questions

How does Tradipitant work?

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.

What is Tradipitant used for?

According to FDA labeling, Tradipitant carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the brand names for Tradipitant?

Tradipitant is marketed under brand names including Nereus.

What are the contraindications for Tradipitant?

Tradipitant labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.