Drugs / Tradipitant
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed idiopathic gastroparesis 3 milestones | |||||
| Rejected (CRL) | US (FDA) | — | idiopathic gastroparesis | 2024-09-18 | “On September 18, 2024 , the U.S. Food and Drug Administration (FDA) declined to approve Vanda's New Drug Application (NDA) of tradipitant” vandapharma.com ↗ |
| Filed | US (FDA) | — | idiopathic gastroparesis | 2023-12-04 | “FDA has accepted the filing of Vanda's New Drug Application (NDA) for tradipitant for the treatment of symptoms of gastroparesis.” vandapharma.com ↗ |
| Clinical hold | US (FDA) | — | idiopathic gastroparesis | 2018-12-19 | “In December 2018 , the FDA imposed a partial clinical hold (PCH) on two of Vanda's proposed clinical studies of tradipitant” vandapharma.com ↗ “The FDA has imposed a partial clinical hold on tradipitant clinical protocols of longer than 12 weeks duration.” vandapharma.com ↗ “The FDA has imposed a partial clinical hold on tradipitant clinical protocols of longer than 12 weeks duration.” vandapharma.com ↗ |
| Filed motion sickness 1 milestone | |||||
| Filed | US (FDA) | — | motion sickness | — | “The NDA for tradipitant for the treatment of motion sickness was submitted to the FDA in the fourth quarter of 2024.” vandapharma.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | NEREUS | — | 2025-12-30 | fda.gov ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02621385 | Nov 2015 → Feb 2016 | — | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01919944 | Aug → Nov 2013 | — | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04849559 | Feb → Sep 2021 | — | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 29 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06804603 | Feb → Oct 2025 | obesity disorder | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT05653310 | Feb 2023 → Mar 2027 expected | dyspepsia | Xiao Jing (Iris) Wang | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT03772340 | Dec 2018 → Jun 2019 | motion sickness | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02970968 | Nov 2016 → Nov 2018 | gastroparesis | Vanda Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT02651714 | Jan 2016 → Aug 2017 | atopic eczema | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02004041 | Dec 2013 → Feb 2015 | atopic eczema | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00805441 | Dec 2008 → Jul 2009 | alcohol dependence | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00310427 | Mar 2006 → Mar 2008 | alcohol dependence | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Completed | No outcome recorded |
| Phase 2 | NCT00191022 | Dec 2004 → Jan 2007 | social phobia | Eli Lilly and Company | Completed | Missed primary |
| Phase 39 trials · 2 met primary · 2 missed | ||||||
| Phase 3 | NCT07446439 | Mar → Dec 2026 expected | obesity disorder | Vanda Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06836557 | Jan 2024 → Dec 2025 overdue | idiopathic gastroparesis | Vanda Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05903924 | Sep 2023 → Apr 2024 | motion sickness | Vanda Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT06138613 | Feb 2023 → Sep 2027 expected | motion sickness | Vanda Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04327661 | Nov 2021 → Apr 2023 | motion sickness | Vanda Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT04326426 | Apr → Aug 2020 overdue | COVID-19 | Vanda Pharmaceuticals | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT04140695 | Oct 2019 → Oct 2020 | atopic eczema | Vanda Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04028492 | Aug 2019 → Feb 2025 | idiopathic gastroparesis | Vanda Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT03568331 | Jul 2018 → Dec 2019 | atopic eczema | Vanda Pharmaceuticals | Completed | Missed primary |
| Phase not stated1 trial | ||||||
| — | NCT04474990 | — | gastroparesis | Vanda Pharmaceuticals | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2025-12-30 | Vanda Pharmaceuticals | Regulatory Vanda Pharmaceuticals Announces FDA Approval of NEREUS™ (tradipitant) for the Prevention of Vomiting Induced by Motion: A Historic Scientific Milestone in the Prevention of Motion Sickness vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved NEREUS™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion. |
| 2025-12-04 | Vanda Pharmaceuticals | Regulatory FDA Lifts Partial Clinical Hold on Tradipitant for Motion Sickness vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on protocol VP-VLY-686-3403, which until today limited the protocol to a maximum of 90 doses of tradipitant. |
| 2025-11-17 | Vanda Pharmaceuticals | Results Vanda Pharmaceuticals Reports Positive Results for Tradipitant in Preventing GLP-1 Induced Nausea and Vomiting vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), a leading biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced positive topline results from its randomized controlled clinical study (VP-VLY-686-2601) evaluating tradipitant, an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of nausea and vomiting induced by GLP-1 receptor agonist Wegovy ® in overweight and obese adults. |
| 2025-05-07 | Vanda Pharmaceuticals | Regulatory Vanda Pharmaceuticals Reports First Quarter 2025 Financial Results vandapharma.com ↗
The NDA for tradipitant for the treatment of motion sickness was accepted for filing by the FDA with a PDUFA target action date of December 30, 2025 . |
| 2025-04-23 | Vanda Pharmaceuticals | Regulatory FDA Bureaucrats Unlawfully Delay Hearing on Vanda Drug and Falsely Blame Commissioner Makary and the reductions in force at FDA vandapharma.com ↗
Vanda Pharmaceuticals Inc. ("Vanda") (Nasdaq: VNDA) today announced that FDA bureaucrats have committed to delay Vanda's request for a hearing on the approvability of tradipitant for gastroparesis. |
| 2025-01-27 | Vanda Pharmaceuticals | Regulatory Vanda Pharmaceuticals Accepts FDA Opportunity for a Hearing on New Drug Application for Tradipitant in Gastroparesis vandapharma.com ↗ |
| 2024-09-19 | Vanda Pharmaceuticals | Regulatory FDA Declines to Approve Vanda's Marketing Application for Tradipitant in Gastroparesis vandapharma.com ↗
On September 18, 2024 , the U.S. Food and Drug Administration (FDA) declined to approve Vanda's New Drug Application (NDA) of tradipitant for the treatment of symptoms in gastroparesis, providing Vanda with a Complete Response Letter (CRL). |
| 2024-05-15 | Vanda Pharmaceuticals | Results Vanda Pharmaceuticals Reports Positive Results from a Second Phase III Study of Tradipitant in Motion Sickness vandapharma.com ↗ |
| 2023-12-04 | Vanda Pharmaceuticals | Regulatory Vanda Pharmaceuticals Announces that U.S. Food and Drug Administration Accepts New Drug Application for Tradipitant for the Treatment of Gastroparesis vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of Vanda's New Drug Application (NDA) for tradipitant for the treatment of symptoms of gastroparesis. |
| 2023-05-25 | Vanda Pharmaceuticals | Results Vanda Pharmaceuticals Reports Results from a Phase III study of Tradipitant in Motion Sickness vandapharma.com ↗
Both 170 mg and 85 mg tradipitant doses were shown to be superior to placebo in preventing vomiting with only 18.3% and 19.5% of participants experiencing vomiting on tradipitant 170 mg and 85 mg respectively, as compared to 44.3% of participants on placebo (p < 0.0001 for both). |
| 2022-05-05 | Vanda Pharmaceuticals | Results Vanda Pharmaceuticals Reports First Quarter 2022 Financial Results vandapharma.com ↗
Today we are sharing details of our advanced analysis of data from the tradipitant clinical program in gastroparesis, which support the efficacy of tradipitant, and we look forward to discussing our planned New Drug Application with the FDA. |
| 2022-02-04 | Vanda Pharmaceuticals | Results Vanda Pharmaceuticals Reports Results from the Phase III Study of Tradipitant in Gastroparesis vandapharma.com ↗
The study did not meet its prespecified primary endpoint which was the difference between drug and placebo on the change of the severity of nausea from baseline at week 12 of treatment. |
| 2021-08-03 | Vanda Pharmaceuticals | Results Vanda Pharmaceuticals Closes Enrollment In The ODYSSEY Study Comparing Tradipitant And Placebo In Hospitalized COVID-19 Pneumonia Patients vandapharma.com ↗
Enrollment was closed because the study met the pre-defined futility criteria, indicating that the study was unlikely to succeed in its pre-specified primary endpoint. |
| 2020-08-31 | Vanda Pharmaceuticals | Results Vanda Pharmaceuticals Provides Update on Tradipitant Development Program vandapharma.com ↗
Interim analysis from ODYSSEY study shows tradipitant may accelerate clinical improvement in patients with COVID-19 pneumonia |
| 2020-08-18 | Vanda Pharmaceuticals | Results Vanda Pharmaceuticals' Interim Analysis from ODYSSEY Study Shows Tradipitant may Accelerate Clinical Improvement in Patients with COVID-19 Pneumonia vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today reported that interim analysis showed tradipitant may accelerate clinical improvement in SARS-CoV-2 (COVID-19) pneumonia in the ODYSSEY study. |
| 2020-07-13 | Vanda Pharmaceuticals | Regulatory FDA grants authorization for Individual Patient Expanded Access Protocol for the use of tradipitant for gastroparesis vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) announced today that the U.S. Food and Drug Administration (FDA) has authorized a single patient in an Individual Patient Expanded Access protocol (VP-VLY-686-3303). |
| 2020-04-02 | Vanda Pharmaceuticals | Regulatory Vanda Pharmaceuticals Announces the Initiation of ODYSSEY, an FDA Approved Clinical Study of Tradipitant in Hospitalized Patients with Severe COVID-19 Pneumonia vandapharma.com ↗
Vanda has received FDA permission to proceed with the study for the treatment and prevention of pneumonia associated with COVID-19. |
| 2020-02-25 | Vanda Pharmaceuticals | Results Vanda Reports results from the EPIONE study of Tradipitant in the treatment of Pruritus in Atopic Dermatitis vandapharma.com ↗
The EPIONE study did not meet its primary endpoint in reduction of pruritus across the overall study population. |
| 2020-02-25 | Vanda Pharmaceuticals | Results Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Financial Results vandapharma.com ↗
Results from the EPIONE study of tradipitant in the treatment of pruritus in atopic dermatitis were reported today. |
| 2019-07-16 | Vanda Pharmaceuticals | Results Tradipitant Effective in Preventing Motion Sickness vandapharma.com ↗
In the overall population, a significantly higher percentage of participants experienced vomiting in the placebo arm as compared to the tradipitant arm, 39.7% versus 17.5% respectively, p value = 0.0039. |
| 2018-12-03 | Vanda Pharmaceuticals | Results Vanda Announces Positive Phase II Study Results for Tradipitant in Patients with Gastroparesis vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:VNDA) today announced that tradipitant met the primary endpoint in VLY686-2301, a Phase II clinical study in patients with idiopathic and diabetic gastroparesis. |
| 2017-09-13 | Vanda Pharmaceuticals | Results Vanda´s Tradipitant Improves Itch and Disease Severity in Patients with Atopic Dermatitis vandapharma.com ↗
Tradipitant was shown to improve the intensity of the worst itch patients experienced, as well as atopic dermatitis disease severity. |
| 2015-03-04 | Vanda Pharmaceuticals | Results Vanda Pharmaceuticals Announces Tradipitant Phase II Proof of Concept Study Results for Chronic Pruritus in Atopic Dermatitis vandapharma.com ↗
However, subsequent analysis of population PK samples across all patients in the study revealed significant and clinically meaningful responses across multiple outcomes evaluated in individuals with higher levels of tradipitant exposure at the time of their pruritus assessments. |
All press releases naming this drug 29 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tradipitant | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03772340 ↗ |
| Known as | LY686017 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00310427 ↗ |
| Known as | VLY-686 | “VLY-686 (Tradipitant) oral capsule for 4 weeks.” NCT02970968 ↗ |
| Action | Inhibit | “LY686017 blocks Substance P from acting at the NK1 receptors.” NCT00310427 ↗1“Neurokinin 1 receptor antagonist” CHEMBL3544984 ↗ |
| Modality | Small molecule | — CHEMBL3544984 ↗ |
| Route | Oral | “50 mg administered orally on a daily basis” NCT00310427 ↗ |
| Target | TACR1 | “Neurokinin 1 receptor antagonist” CHEMBL3544984 ↗ |