Nereus (tradipitant) / Vanda, Eli Lilly - LARVOL DELTA

Responder Analysis of Tradipitant in Idiopathic and Diabetic Gastroparesis: Comprehensive Symptom Improvement in Nausea Responders (ACG 2026) - "All results presented are at Week 12. Among the 373 nausea responders, the mean in the biweekly average of nausea severity score improved markedly from baseline (1.73 to 0.28; mean change â1.45; p < 0.0001), and the biweekly percentage of nausea-free days increased from 28% to 78% (+50 percentage points; p < 0.0001). These patients also demonstrated statistically significant and clinically meaningful improvements across all five other cardinal gastroparesis symptoms on the GCSDD."

Gastrointestinal Disorder

Exposure-Response Analysis of Tradipitant in Idiopathic and Diabetic Gastroparesis: Greater Nausea Improvement With Higher Plasma Concentrations (ACG 2026) - "In the overall ITT population, the mean biweekly average nausea severity score decreased from 2.27 at baseline to 1.08 at Week 12 (mean change -1.17; p< 0.001). Additionally, participants experienced a 30.64 percentage point increase in nausea-free days from baseline to week 12 (from 18.01% to 48.65% at week 12; p< 0.001). Patients in the High PK group showed significantly greater improvement than those in the Low PK group in both biweekly average nausea severity at Week 12 (â1.24 vs â0.96 points; p = 0.0002) and biweekly percentage of nausea-free days at Week 12 (35.11 vs 22.70 percentage points; p < 0.0001)."

Gastrointestinal Disorder

Efficacy and Safety of Neurokinin-1 Receptor Antagonists for Gastroparesis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (ACG 2026) - "Three RCTs (n = 479) were included: aprepitant (n = 126), tradipitant Phase 2 (n = 152), Phase 3 (n = 201). NK-1 receptor antagonists reduced nausea severity (SMD 0.60; 95% CI 0.38â0.82; P < 0.00001; I² = 0%) and improved GCSI score (SMD 0.50; 95% CI 0.28â0.71; P < 0.00001; I² = 0%) versus placebo. Active treatment nearly doubled the GCSI responder rate (RR 1.95; 95% CI 1.48â2.57) and almost tripled the complete nausea responder rate (RR 2.85; 95% CI 1.67â4.87)."

Retrospective data • Review • Gastrointestinal Disorder

Tradipitant for Motion Sickness: Expanding the Therapeutic Landscape of NK₁ Receptor Antagonists. (PubMed, J Pharm Technol) - "Scopolamine and first-generation antihistamines are commonly used to prevent and treat motion sickness; however, their use is limited by their significant adverse effect profiles. Tradipitant, the newest agent approved for motion sickness, provides clinicians with an additional treatment option for this common condition."

Journal • Review • Fatigue • Pain

RESPONDER ANALYSIS OF TRADIPITANT IN IDIOPATHIC AND DIABETIC GASTROPARESIS: COMPREHENSIVE SYMPTOM IMPROVEMENT IN NAUSEA RESPONDERS (UEGW 2026) - No abstract available

Gastrointestinal Disorder

EXPOSURE-RESPONSE ANALYSIS OF TRADIPITANT IN IDIOPATHIC AND DIABETIC GASTROPARESIS: GREATER NAUSEA IMPROVEMENT WITH HIGHER PLASMA CONCENTRATIONS (UEGW 2026) - No abstract available

Gastrointestinal Disorder

Tradipitant (Nereus) for the Prevention of Motion Sickness. (PubMed, Am Fam Physician) - No abstract available

Journal

Efficacy and safety of tradipitant in motion sickness: a systematic review and meta-analysis. (PubMed, Acta Neurol Belg) - "Tradipitant significantly reduced vomiting incidence at both doses and across sea conditions, with negligible heterogeneity and stable sensitivity analyses. Although no significant improvement was observed in nausea or broader symptom burden, tradipitant was associated with a higher overall treatment-emergent adverse event rate than placebo. These findings support characterizing tradipitant as a selective vomiting prophylactic agent in the context of motion sickness; the absence of significant effects on nausea severity, MSAQ total and GI subscale scores, and PGI-S indicates that tradipitant should not be expected to provide comprehensive relief from the full symptomatic burden of motion sickness."

Journal • Retrospective data • Review • Fatigue • Pain

Tradipitant for Functional Dyspepsia (clinicaltrials.gov) - P2 | N=60 | Enrolling by invitation | Sponsor: Xiao Jing (Iris) Wang | Trial completion date: Jun 2026 ➔ Mar 2027 | Trial primary completion date: Jun 2026 ➔ Mar 2027

Biomarker • Trial completion date • Trial primary completion date • Dyspepsia

Safety and Efficacy of High-Dose Tradipitant for Motion Sickness: A Systematic Review and Meta-Analysis of Randomised Controlled Trials (EAN 2026) - No abstract available

Retrospective data • Review

Comparison chart: Drugs for motion sickness. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Tradipitant (Nereus) for motion sickness. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Tradipitant: A Novel Neurokinin-1 Receptor Antagonist for Motion Sickness. (PubMed, Am J Ther) - "Tradipitant works by blocking the NK-1 receptors found in the emetic pathway and it has been proven in pivotal trials effective for prevention of vomiting due to motion sickness. It reduces motion sickness symptoms in 2 phase 3 trials and offers a revolutionary new treatment option for people who experience motion sickness."

Clinical • Journal

A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use (clinicaltrials.gov) - P3 | N=280 | Recruiting | Sponsor: Vanda Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness (clinicaltrials.gov) - P3 | N=705 | Active, not recruiting | Sponsor: Vanda Pharmaceuticals | Trial completion date: Jun 2026 ➔ Dec 2027 | Trial primary completion date: May 2026 ➔ Sep 2027

Trial completion date • Trial primary completion date

Tradipitant: First Approval. (PubMed, Drugs) - "In phase III trials, tradipitant reduced the incidence of vomiting associated with motion sickness. This article summarizes the milestones in the development of tradipitant leading to this first approval for the prevention of vomiting induced by motion in adults."

Journal • Gastrointestinal Disorder

A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use (clinicaltrials.gov) - P3 | N=280 | Not yet recruiting | Sponsor: Vanda Pharmaceuticals

New P3 trial • Genetic Disorders • Obesity

RESPONDER ANALYSIS FOR THE EFFICACY OF TRADIPITANT IN IDIOPATHIC AND DIABETIC GASTROPARESIS (DDW 2026) - No abstract available

Clinical • Gastrointestinal Disorder

Tradipitant for Functional Dyspepsia (clinicaltrials.gov) - P2 | N=60 | Enrolling by invitation | Sponsor: Xiao Jing (Iris) Wang | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Biomarker • Trial completion date • Trial primary completion date • Dyspepsia

Vanda Wins FDA Approval for NEREUS Motion Sickness Drug (TipRanks) - "The approval, supported by three pivotal clinical trials showing more than 50–70% risk reductions in vomiting compared with placebo and a favorable safety profile for acute use, positions NEREUS to address a substantial global market of motion sickness sufferers and validates NK-1 antagonism as a platform mechanism that Vanda is already leveraging in late-stage programs for gastroparesis and for managing nausea and vomiting associated with GLP-1 receptor agonists, with implications for both general travel-related health and military operational readiness."

FDA approval • Gastrointestinal Disorder

Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness (The Malaysian Reserve) - "FDA requests, and Vanda agrees to, a brief extension (to December 5, 2025) for the expedited re-review of the partial clinical hold on long-term studies...Separately, FDA recently issued labeling comments, and labeling discussions have formally begun for the New Drug Application of tradipitant for the prevention of vomiting induced by motion (PDUFA target action date remains December 30, 2025)"

FDA event • PDUFA

Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness (clinicaltrials.gov) - P3 | N=705 | Active, not recruiting | Sponsor: Vanda Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=500 ➔ 705 | Trial completion date: Apr 2025 ➔ Jun 2026 | Trial primary completion date: Apr 2025 ➔ May 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date

Vanda Pharmaceuticals Reports Positive Results for Tradipitant in Preventing GLP-1 Induced Nausea and Vomiting (PRNewswire) - "This study, which pre-treated patients with either tradipitant or placebo before administering a 1 mg injection of Wegovy, a dose that normally takes 9 weeks of titration to reach, succeeded and met its primary endpoint, with only 29.3% of tradipitant-treated participants (17/58) experiencing vomiting compared to 58.6% on placebo (34/58) (p=0.0016), representing a 50% relative reduction. The study also met the key secondary endpoint of the proportion of participants with vomiting and significant nausea at 22.4% in the tradipitant group (13/58) versus 48.3% on placebo (28/58) (p=0.0039)....A Phase III program is anticipated to initiate in the first half of 2026, positioning tradipitant as a key adjunct to improve outcomes in GLP-1 agonist treatments."

P2 data • Obesity

A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use (clinicaltrials.gov) - P2 | N=124 | Completed | Sponsor: Vanda Pharmaceuticals | Recruiting ➔ Completed | N=50 ➔ 124

Enrollment change • Trial completion • Genetic Disorders • Obesity

Comparative Efficacy of Pharmacologic Therapies for Gastroparesis: A Systematic Review and Network Meta-Analysis (ACG 2025) - "Interventions included prucalopride, cisapride, revexepride, metoclopramide, relamorelin, TZP-102, aprepitant, tradipitant, cannabidiol (CBD), and domperidone. A total of 21 trials comprising 2,452 patients were included in the study. For symptom improvement, 19 studies that compared 10 treatments contributed to the network. Cisapride (SMD, 1.88; 95% CI –2.71 to –1.06; SUCRA=0.98), relamorelin (SMD, 1.15; 95% CI –2.15 to –0.16; SUCRA=0.86), and aprepitant (SMD: 0.60; 95% CI –0.88 –0.32; SUCRA=0.76) significantly outperformed the placebo."

Retrospective data • Review • Gastrointestinal Disorder