Also known as: Nereus, NEREUS
Tradipitant is marketed as NEREUS, a substance P/neurokinin-1 receptor antagonist indicated to prevent vomiting induced by motion in adults. It is administered as a single oral dose before expected motion exposure. U.S. initial approval was in 2025.
The FDA approved BYSANTI (milsaperidone) for bipolar I disorder and schizophrenia in adults, and accepted Vanda's BLA filing for imsidolimab to treat Generalized Pustular Psoriasis with a target action date of December 12, 2026.
Vanda Pharmaceuticals announced FDA approval for BYSANTI tablets to treat Bipolar I manic episodes and schizophrenia in adults. The drug has patent protection extending to 2044 and will be commercially available in Q3 2026.
The FDA has approved BYSANTI (milsaperidone), a new chemical entity for treating bipolar I disorder and schizophrenia in adults. The drug is Vanda's second approval in less than two months and is expected to launch in Q3 2026.
Vanda Pharmaceuticals received FDA approval for Bysanti (milsaperidone), an atypical antipsychotic for schizophrenia and manic or mixed episodes in bipolar I disorder. The drug will be available by the third quarter of 2026.
The FDA approved tradipitant (Nereus), an oral NK-1 receptor antagonist, for prevention of motion-induced vomiting on December 30, 2025. The approval marks the first new pharmacologic treatment for motion sickness in over four decades.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07446439 |
A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use |
RECRUITING | PHASE3 |
| NCT06836557 |
Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis |
RECRUITING | PHASE3 |
| NCT06804603 |
A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use |
COMPLETED | PHASE2 |
| NCT06138613 |
Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05903924 |
Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness |
COMPLETED | PHASE3 |
| NCT05653310 |
Tradipitant for Functional Dyspepsia |
ENROLLING_BY_INVITATION | PHASE2 |
| NCT04849559 |
Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation, and Gastric Emptying in Healthy Volunteers |
COMPLETED | PHASE1/PHASE2 |
| NCT04474990 |
Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis |
AVAILABLE | |
| NCT04327661 |
Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness |
COMPLETED | PHASE3 |
| NCT04326426 |
ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection |
ENROLLING_BY_INVITATION | PHASE3 |
