tradipitant (VLY-686) / Vanda, Eli Lilly - LARVOL DELTA

OPEN LABEL EFFICACY ANALYSIS OF TRADIPITANT IN IDIOPATHIC AND DIABETIC GASTROPARESIS (DDW 2025) - "Discussion : Tradipitant demonstrated statistically significant improvement from baseline in average nausea severity and percentage of nausea-free days in this 12 week open label study in both idiopathic and diabetic gastroparesis subjects. Additionally, a strong exposure response in nausea improvement was observed when comparing subjects with high drug exposure vs low drug exposure."

Clinical • Gastrointestinal Disorder

Vanda sues FDA over hearing delay as agency points to mass layoffs, other litigation with the biopharma (FierceBiotech) - "Vanda Pharmaceuticals is suing the FDA again, this time alleging the agency is unlawfully delaying a hearing to discuss the rejection of the biotech's stomach disorder drug last year. The FDA has asked the commissioner’s office to set a hearing by mid-September 2025 for Vanda's request, which was prompted by a complete response letter (CRL). In a letter to the biotech last week, the agency cited multiple reasons for the delay—including the company’s numerous ongoing legal cases with the agency, plus the recent mass federal layoffs. Vanda has filed a lawsuit against the federal agency for the 'unlawful delay' that is currently pending in Washington, D.C., courts, a Vanda spokesperson told Fierce. The drug at the heart of the dispute is tradipitant, an investigational NK-1R antagonist that the FDA rejected as a gastroparesis treatment in September 2024."

Corporate lawsuit • Gastrointestinal Disorder

Motion Syros: tradipitant effective in the treatment of motion sickness; a multicenter, randomized, double-blind, placebo-controlled study. (PubMed, Front Neurol) - P3 | "Tradipitant 170 mg and 85 mg have been confirmed to be effective in the prevention of vomiting associated with motion sickness across varied sea conditions. ClinicalTrials.gov, identifier NCT04327661."

Clinical • Journal

A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Vanda Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Tradipitant Effective in the Reduction of Vomiting Associated with Motion Sickness Across Varied Sea Conditions (S3.003). (PubMed, Neurology) - "Dr. Polymeropoulos has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Vanda Pharmaceuticals ."

Clinical • Journal

A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Vanda Pharmaceuticals

New P2 trial • Genetic Disorders • Obesity

Vanda Pharmaceuticals Accepts FDA Opportunity for a Hearing on New Drug Application for Tradipitant in Gastroparesis (PRNewswire) - "Vanda Pharmaceuticals Inc...today provides an update on the tradipitant development program...Today, Vanda accepted FDA's offer of an opportunity for a hearing. Under the statute, a hearing must commence within 120 days after receipt of the NOOH. Vanda hopes that, in break from prior practice, the FDA will adhere to this statutorily mandated time frame. Regardless, Vanda will continue to insist that the FDA apply proper legal criteria to Vanda's NDA to make its new therapy available to patients."

FDA event • Gastrointestinal Disorder

Motion Serifos: a Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness (clinicaltrials.gov) - P3 | N=316 | Completed | Sponsor: Vanda Pharmaceuticals | Recruiting ➔ Completed

Trial completion

Open Label Efficacy Analysis of Tradipitant in Idiopathic and Diabetic Gastroparesis (ACG 2024) - "Patients improved the average nausea score significantly from baseline after 12 weeks tradipitant (improvement of -1.01 vs 2.14 at baseline, p< 0.0001). A significant improvement was also seen in the percent of nausea free days (an addition of 51.76% of days for tradipitant vs. 19.62% at baseline, p< 0.0001)."

Clinical • Gastrointestinal Disorder

Exposure-Response Analysis of Open Label Tradipitant in Idiopathic and Diabetic Gastroparesis in Study VP-VLY-686-3301 (ACG 2024) - "Patients in the High PK subgroup had statistically improved nausea severity at Week 12 compared to the Low PK subgroup (-1.19 vs. -0.78, respectively; p< 0.0001), including at baseline nausea severity scores of ≥2 (-1.61 vs. -0.98, respectively; p< 0.0001) and ≥2.5 (-1.77 vs."

Clinical • Gastrointestinal Disorder

OPEN LABEL EFFICACY ANALYSIS OF TRADIPITANT IN IDIOPATHIC AND DIABETIC GASTROPARESIS (UEGW 2024) - "Tradipitant demonstrated statistically significant improvement from baseline in average nausea severity and percentage of nausea-free days in this 12 week open label study in both idiopathic and diabetic gastroparesis subjects. Additionally, a strong exposure response in nausea improvement was observed when comparing subjects with high drug exposure vs low drug exposure."

Clinical • Gastrointestinal Disorder

MOTION SERIFOS: TRADIPITANT EFFECTIVE IN THE PREVENTION OF VOMITING IN MOTION SICKNESS DURING SEA TRAVEL (UEGW 2024) - "Tradipitant could be of significant utility for motion sickness affected travelers in both civilian and military settings across air, land, and sea. Given the adverse effects and incomplete efficacy of currently available therapies, there remains a need for a novel efficacious therapeutic with a desirable tolerability profile."

Late-breaking abstract • Pain

EXPOSURE-RESPONSE ANALYSIS OF OPEN LABEL TRADIPITANT IN IDIOPATHIC GASTROPARESIS IN STUDY VP-VLY-686-3301 (UEGW 2024) - "A significant exposure response was seen in idiopathic gastroparesis patients receiving open label tradipitant for 12 weeks. Patients with higher blood levels of tradipitant significantly improved in average nausea severity and in endpoints measuring overall gastroparesis symptoms compared to subjects with low drug blood levels."

Clinical • Gastrointestinal Disorder • Rare Diseases

VP-VLY-686-2301: Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis (clinicaltrials.gov) - P2 | N=152 | Completed | Sponsor: Vanda Pharmaceuticals | Unknown status ➔ Completed

Trial completion • Gastrointestinal Disorder

OPEN LABEL EFFICACY ANALYSIS OF TRADIPITANT IN IDIOPATHIC AND DIABETIC GASTROPARESIS (DDW 2024) - "Discussion : Tradipitant demonstrated statistically significant improvement from baseline in average nausea severity and percentage of nausea-free days in this 1 week open label study in both idiopathic and diabetic gastroparesis subjects. Additionally a strong exposure response in nausea improvement was observed when comparing subjects with high drug exposure vs low drug exposure."

Clinical • Gastrointestinal Disorder

TRADIPITANT EFFECTIVE IN THE REDUCTION OF VOMITING ASSOCIATED WITH MOTION SICKNESS ACROSS VARIED SEA CONDITIONS (DDW 2024) - "Tradipitant has been confirmed to be effective in the reduction of vomiting associated with motion sickness across varied sea conditions with a range of wave heights. Motion sickness remains a significant unmet medical need given existing treatments' limitations in alleviating symptoms and their frequent adverse effects."

EPIONE 2: Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2) (clinicaltrials.gov) - P3 | N=87 | Terminated | Sponsor: Vanda Pharmaceuticals | Completed ➔ Terminated; Business Decision

Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation, and Gastric Emptying in Healthy Volunteers (clinicaltrials.gov) - P1/2 | N=27 | Completed | Sponsor: Vanda Pharmaceuticals | Recruiting ➔ Completed | Phase classification: P1 ➔ P1/2

Phase classification • Trial completion

Tradipitant for Functional Dyspepsia (clinicaltrials.gov) - P2 | N=60 | Enrolling by invitation | Sponsor: Xiao Jing (Iris) Wang | Not yet recruiting ➔ Enrolling by invitation

Biomarker • Enrollment open • Dyspepsia

Tradipitant Effective in the Reduction of Vomiting Associated with Motion Sickness Across Varied Sea Conditions (AAN 2024) - "Tradipitant has been confirmed to be effective in the reduction of vomiting associated with motion sickness across varied sea conditions with a range of wave heights. Motion sickness remains a significant unmet medical need, given existing treatments' limitations in alleviating symptoms and their frequent adverse effects."

Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Vanda Pharmaceuticals | Trial completion date: Jun 2023 ➔ Apr 2024 | Trial primary completion date: Jun 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date

VP-VLY-686-3301: Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis (clinicaltrials.gov) - P3 | N=201 | Recruiting | Sponsor: Vanda Pharmaceuticals | N=900 ➔ 201

Enrollment change • Gastrointestinal Disorder

Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Vanda Pharmaceuticals | Trial completion date: Jul 2024 ➔ Apr 2025 | Trial primary completion date: Jul 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date

Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness (clinicaltrials.gov) - P3 | N=365 | Completed | Sponsor: Vanda Pharmaceuticals | Unknown status ➔ Completed | Trial completion date: Sep 2020 ➔ Apr 2023 | Trial primary completion date: Aug 2020 ➔ Apr 2023

Trial completion • Trial completion date • Trial primary completion date

Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Vanda Pharmaceuticals | N=300 ➔ 500

Enrollment change