TheraRadar
Data updated: May 26, 2026

NEREUS (tradipitant)

Trial Activity: Expansion 5 active trials
CNS Approved 2025-12-30

NEREUS is indicated for the prevention of vomiting induced by motion in adults.

Source: FDA Label • VANDA PHARMS INC

Development Insights

Vanda Pharmaceuticals conducting 14 trials (93%)
11 indications explored (Broad Platform)
motion sickness (4 trials)
atopic dermatitis (3 trials)
obesity (2 trials)
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2025-12-30
Patent Cliff
2036

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE

Companies

Active Ingredient: TRADIPITANT

NEREUS Approval History

2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
Dec 2025 ORIGINAL
New Drug · Type 1 - New Molecular Entity

What NEREUS Treats

1 FDA approvals

Originally approved for its first indication in 2025 .

  • Other (1)
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Clinical Trial Registry

15 trials
Trial Sponsor ID Phase Status Title
NCT07446439 VP-VLY-686-3601 Ph 3 recruiting A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use
NCT06138613 VP-VLY-686-3403 Ph 3 active not recruiting Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness
NCT05653310 21-012527 Ph 2 enrolling by invitation Tradipitant for Functional Dyspepsia
NCT06804603 VP-VLY-686-2601 Ph 2 completed A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use
NCT04028492 VP-VLY-686-3301 Ph 3 completed Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
NCT03772340 results posted VP-VLY-686-2401 Ph 2 completed Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
NCT05903924 results posted VP-VLY-686-3404 Ph 3 completed Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness
NCT06836557 VP-VLY-686-3304 Ph 3 recruiting Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis
NCT04327661 results posted VP-VLY-686-3401 Ph 3 completed Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
NCT02651714 results posted VP-VLY-686-2102 Ph 2 completed Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis
NCT04140695 results posted VP-VLY-686-3102 EPIONE2 Ph 3 terminated Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2)
NCT03568331 results posted VP-VLY-686-3101 EPIONE Ph 3 completed Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE)
NCT04849559 results posted VP-VLY-686-1301 Ph 1, Ph 2 completed Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation, and Gastric Emptying in Healthy Volunteers
NCT04326426 VLY-686-3501 Ph 3 enrolling by invitation ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection
NCT02621385 VP-VLY-686-1102 Ph 1 completed Study to Assess the Effect of Multiple Doses of Tradipitant on CYP3A4 Using Midazolam as a Substrate in Healthy Subjects
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.

NEREUS FDA Label Details

Indications & Usage

FDA Label (PDF)

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.

View full patent landscape →
4 OB patents · 2 families · 58 international docs across 21 countries

NEREUS Patents & Exclusivity

Latest Patent: Aug 2036
Exclusivity: Dec 2030

Patents (4 active)

US12318375 Expires Aug 9, 2036
US11324735 Expires Mar 4, 2036
US10821099 Expires Mar 4, 2036
US10772880 Expires Mar 4, 2036

Exclusivity

NCE Until Dec 2030
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for NEREUS

Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2036
  • 4 active patents

Trial Analysis

  • 15 total trials
  • Stage: Expansion

Competitive Landscape

  • Competitor tracking
  • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment