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Clinical trials
catalyst calendar across sponsors →Studies where VNDA is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
76 interventional · 5 observational · 1 expanded access · 30 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Development of Clinical Database of Individuals With Smith-Magenis Syndrome and Sleep DisturbancesNCT03154697observationalNumber of individuals with Smith- Magenis syndrome | — | Recruiting | Other: Data collection of sleep disturbances in individuals with SMS | Sleep Disturbances in Smith-Magenis Syndrome | 1,000 | Dec 2030 | ≤ 1,594 d | 2024-03-20 |
| Patient Registry of Blind Subjects With Sleep-related ProblemsNCT01195558observationalNumber of blind participants | — | Recruiting | Other: Data collection on blindness and sleep problems | Sleep-wake Disorder in Blind Individuals | 10,000 | Apr 2030 | ≤ 1,349 d | 2020-06-24 |
| Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative ColitisNCT07686081Clinical Remission at Week 16Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Ponesimod, Placebo | Ulcerative Colitis (UC) | 150 | Apr 2029 | ≤ 984 d | 2026-08-18 |
| Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque PsoriasisNCT07362017Safety and tolerability of ponesimod as measured by reporting of adverse events (AEs)Open-label · Treatment | Phase 3 | Recruiting | Drug: Ponesimod | Moderate-to-severe Chronic Plaque Psoriasis | 300 | Aug 2028 | ≤ 742 d | 2026-06-11 |
| Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive DisorderNCT06830044Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Milsaperidone, Placebo | Major Depressive Disorder (MDD) | 500 | Mar 2028 | ≤ 589 d | 2026-02-27 |
| Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic MalignanciesNCT03838926Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs)Open-label · Treatment | Phase 1 | Recruiting | Drug: Trichostatin A | Relapsed or Refractory Hematologic Malignancies | 42 | Dec 2027 | ≤ 498 d | 2026-03-16 |
| Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric InsomniaNCT06953869Change in sleep latency, as measured by daily sleep diary.Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Tasimelteon Oral Suspension, Placebo | Insomnia Disorder | 420 | Nov 2027 | ≤ 467 d | 2026-06-05 |
| Randomized Withdrawal Study in Patients With SchizophreniaNCT06961968Time to exacerbation of symptomsRandomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: iloperidone, placebo | Schizophrenia | 400 | Nov 2027 | ≤ 467 d | 2026-01-12 |
| Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion SicknessNCT06138613Safety and tolerability of tradipitant as measured by reporting of adverse events (AEs).Randomized · Open-label · Treatment | Phase 3 | Active, not recruiting | Drug: Tradipitant | Motion Sickness | 705 | 2027-09-30 | in 406 d | 2026-04-16 |
| Treatment of Charcot-Marie-Tooth Disease, Axonal, Type 2S (CMT2S) in an Individual PatientNCT07223632Assessment of safety of therapy with VCA-894A when administered via intrathecal injection, as measured by the incidence of adverse events.Open-label · Treatment | Phase 1/2 | Active, not recruiting | Drug: VCA-894A | Charcot Marie Tooth Disease (CMT), Neuromuscular Diseases (NMD) | 1 | Mar 2027 | ≤ 223 d | 2026-08-19 |
| Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety DisorderNCT07221578Subjective Units of Distress Scale (SUDS)Randomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: VQW-765, Placebo | Social Anxiety Disorder (SAD) | 500 | Dec 2026 | ≤ 133 d | 2026-08-17 |
| A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist UseNCT07446439Proportion of participants with at least 1 vomiting episode per week in the tradipitant group compared to the placebo group as measured by a daily symptom diary.Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Tradipitant, Placebo | Nausea and Vomiting, Obesity | 280 | 2026-12-01 | in 103 d | 2026-04-20 |
| Evaluation of Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled HypertensionNCT07090161Change from baseline to treatment week 4 in SiSBPRandomized · Quadruple-masked · Treatment | Phase 2 | Recruiting | Drug: iloperidone, Placebo | Hypertension, Uncontrolled Hypertension | 240 | Oct 2026 | ≤ 72 d | 2026-02-27 |
| Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)NCT04652882Change in Sleep Onset over the treatment period, as measured by sleep diary.Randomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Tasimelteon, Placebo | Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders | 70 | Sep 2026 | ≤ 41 d | 2026-07-27 |
| Safety, Tolerability and Efficacy of Trichostatin A in Patients With Mild to Severe OnychomycosisNCT07065773Safety and TolerabilityOpen-label · Treatment | Phase 2 | Active, not recruiting | Drug: Trichostatin A | Onychomycosis of Toenail | 50 | Sep 2026 | ≤ 41 d | 2026-02-04 |
| An Eight-Week Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry EyeNCT07179055Corneal StainingRandomized · Quadruple-masked · Treatment | Phase 2 | Recruiting | Drug: VSJ-110, Placebo | Dry Eye | 160 | Sep 2026 | ≤ 41 d | 2025-09-17 |
| Safety and Tolerability of Open-Labeled Iloperidone in AdolescentsNCT05648591Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.Open-label · Treatment | Phase 4 | Recruiting | Drug: Iloperidone | Schizophrenia, Bipolar I Disorder | 100 | 2026-03-31 | — | 2025-03-04 |
| Open Label Safety Study of Tradipitant in Idiopathic and Diabetic GastroparesisNCT06836557Number of participants with adverse events (AEs), including suicidal ideation or behavior as measured by the C-SSRSOpen-label · Treatment | Phase 3 | Recruiting | Drug: Tradipitant | Idiopathic Gastroparesis, Diabetic Gastroparesis, Gastroparesis | 100 | Dec 2025 | — | 2025-02-20 |
| Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 VariantNCT06701396Latency to Persistent Sleep, as measured by polysomnography.Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Tasimelteon, Placebo | Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders, Gene Mutations and Other Alterations Nec | 60 | 2025-06-30 | — | 2024-11-22 |
| ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 InfectionNCT04326426Time to improvement on a 7-point ordinal scale as compared to baselineRandomized · Triple-masked · Treatment | Phase 3 | Enrolling by invitation | Drug: Tradipitant, Placebo | Coronavirus Infection | 300 | 2020-08-01 | — | 2020-04-20 |
| A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist UseNCT06804603Proportion of participants with at least 1 vomiting episode per week in the tradipitant group compared to the placebo group as measured by a daily symptom diary.Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Tradipitant, Placebo | Obesity | 124 | 2025-10-06actual | — | 2025-11-12 |
| Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep DisturbancesNCT05361707Change in sleep time over the treatment period, as measured by sleep diary.Open-label · Treatment | Phase 3 | Unknown status | Drug: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension | Autism Spectrum Disorder, Sleep Disorder, Neurological Disorder, Sleep Disturbance | 100 | Jul 2025 | — | 2024-03-21 |
| Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic GastroparesisNCT04028492Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Tradipitant, Placebo, Open Label Tradipitant | Idiopathic Gastroparesis, Diabetic Gastroparesis, Gastroparesis | 992 | 2025-02-21actual | — | 2025-07-24 |
| Safety Study of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder in Blind Individuals With No Light PerceptionNCT01218789Safety EvaluationsOpen-label · Treatment | Phase 3 | Unknown status | Drug: tasimelteon | Non 24 Hour Sleep Wake Disorder | 140 | 2024-12-05 | — | 2024-04-03 |
| Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State ConditionsNCT06494397Bioequivalence between VHX-896 tablets relative to iloperidone tabletsRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: VHX-896 and iloperidone, Iloperidone and VHX-896 | Schizophrenia, Bipolar I Disorder | 26 | 2024-10-24actual | — | 2025-09-19 |
| A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry EyeNCT06296966Schirmer's Tear TestRandomized · Quadruple-masked · Treatment | Phase 2 | Unknown status | Drug: VSJ-110, Placebo | Dry Eye | 40 | Jul 2024 | — | 2024-03-06 |
| Study to Evaluate the Long-Term Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Subjects With GPPNCT05366855results2026-03-27Incidence of Adverse EventsRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: AnaptysBio has concluded the GEMINI-2 trial, with all trial participants having been treated with imsidolimab for approximately six months and the furthest subject having been treated through 104 weeks. | Drug: Double-blind 200 mg imsidolimab, Open-label 200 mg imsidolimab, Imsidolimab 750 mg IV/200 mg SC · Other: Placebo, Standard of Care (SOC) | Generalized Pustular Psoriasis | 42 | 2024-07-12actual | — | 2026-03-27 |
| Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion SicknessNCT05903924results2025-04-04Prevention of Vomiting Measured by Vomiting Assessment (VA)Randomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Tradipitant, Placebo | Motion Sickness | 316 | 2024-04-06actual | — | 2025-04-04 |
| A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease PsychosisNCT05344365Assessment of safety and tolerability of iloperidone in patients with Parkinson's disease psychosis.Non-randomized · Open-label · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Study was terminated for business reasons; not due to safety or efficacy concerns. | Drug: Iloperidone | Parkinson Disease Psychosis | 0 | Nov 2023 | — | 2024-03-21 |
| Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPPNCT05352893results2026-03-17Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: 750 mg Imsidolimab, 300 mg Imsidolimab · Other: Placebo | Generalized Pustular Psoriasis | 45 | 2023-08-17actual | — | 2026-03-17 |
| Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion SicknessNCT04327661results2024-12-11Prevention of Vomiting Measured by Vomiting Assessment (VA)Randomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Tradipitant, Placebo | Motion Sickness | 366 | 2023-04-01actual | — | 2024-12-11 |
| Food Effect Study of VHX-896 in Healthy VolunteersNCT06803290Comparative bioavailability of VHX-tablets under fed versus fasted conditions.Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: VHX-896 | Healthy | 24 | 2022-12-27actual | — | 2025-01-31 |
| Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I DisorderNCT04819776results2024-04-16Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Iloperidone, Iloperidone Placebo | Bipolar I Disorder | 417 | 2022-09-07actual | — | 2024-04-18 |
| A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of SchizophreniaNCT04712734Pharmacokinetics of iloperidone and its metabolites following repeat-dosing of iloperidone given as a long-acting injection.Open-label · Treatment | Phase 1 | Completed | Drug: Iloperidone | Schizophrenia | 42 | 2022-08-30actual | — | 2023-06-29 |
| Evaluating the Effects of VQW-765 vs. Placebo in Performance AnxietyNCT04800237Subjective Units of Distress Scale (SUDS)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: VQW-765, Placebo | Performance Anxiety | 230 | 2022-08-02actual | — | 2024-03-20 |
| A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis SuppurativaNCT04856930results2025-09-22Change From Baseline in AN Count at Week 16: Placebo-Controlled PeriodRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Biological: Imsidolimab, Placebo | Hidradenitis Suppurativa | 149 | 2022-07-15actual | — | 2025-09-22 |
| Bioequivalence Study Between Tasimelteon Capsule Formulation and Liquid Suspension Formulation in Healthy VolunteersNCT05572281Bioequivalence between tasimelteon capsule formulation relative to tasimelteon liquid suspension formulationRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Tasimelteon Oral Capsule, Tasimelteon Oral Suspension | Healthy | 36 | 2022-06-15actual | — | 2024-03-21 |
| WGS Analysis of COVID-19 Positive PatientsNCT04353401observationalAssociations with severity and outcomes | — | Completed | — | Coronavirus Infection, COVID-19 | 79 | 2022-03-09actual | — | 2024-03-22 |
| A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne VulgarisNCT04856917results2023-06-15Change From Baseline in Facial Inflammatory Lesion Counts at Week 12Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Imsidolimab · Biological: Placebo | Acne Vulgaris | 123 | 2022-02-01actual | — | 2025-09-22 |
| A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform RashNCT04697069results2023-01-09Change From Baseline in Facial Inflammatory Lesion Count (Papules and Pustules) at Week 8Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Administrative Reason | Biological: Imsidolimab, Placebo | Acneiform Eruptions | 4 | 2021-12-13actual | — | 2025-09-22 |
| A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With IchthyosisNCT04697056results2023-03-02Change From Baseline in Ichthyosis Area Severity Index (IASI) Total Score at Week 16Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Administrative Reason | Drug: Imsidolimab · Biological: placebo | Ichthyosis | 5 | 2021-11-19actual | — | 2025-09-16 |
| Bioequivalence Study Between VHX-896 Tablets and Iloperidone Tablets in Healthy VolunteersNCT04969211Bioequivalence between VHX-896 tablets relative to iloperidone tabletsRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: VHX-896 and iloperidone, Iloperidone and VHX-896 | Healthy | 25 | 2021-10-13actual | — | 2022-07-11 |
| Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation, and Gastric Emptying in Healthy VolunteersNCT04849559results2024-04-16Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)Randomized · Quadruple-masked · Basic scienceStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: Tradipitant, Placebo | Healthy Volunteer | 27 | 2021-09-24actual | — | 2024-04-16 |
| Safety and Efficacy of VSJ-110 in the Treatment of Allergic Conjunctivitis in Adults With a History of Ocular AllergiesNCT04622345results2025-09-11Ocular Itching as Measured by Self-reported Numerical ScalesRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: VSJ-110, Placebo | Allergic Conjunctivitis | 47 | 2021-05-22actual | — | 2025-09-11 |
| A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar PustulosisNCT03633396results2022-05-31Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI)Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Biological: Imsidolimab · Drug: Placebo | Palmoplantar Pustulosis | 59 | 2021-04-23actual | — | 2025-09-15 |
| A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular PsoriasisNCT03619902results2022-03-29Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) ScaleOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Biological: Imsidolimab | Generalized Pustular Psoriasis | 8 | 2021-01-20actual | — | 2025-09-16 |
| Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2)NCT04140695results2024-05-14Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Business Decision | Drug: Tradipitant, Placebo | Atopic Dermatitis | 87 | 2020-10-14actual | — | 2024-05-14 |
| Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE)NCT03568331results2024-05-13Reduction of Worst Itch in Atopic DermatitisRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Tradipitant, Placebo | Atopic Dermatitis | 375 | 2019-12-27actual | — | 2024-05-13 |
| Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or SchizophreniaNCT04127058The frequency of treatment-emergent adverse events as measured by the number of eventsNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Iloperidone | Bipolar I Disorder, Schizophrenia | 12 | 2019-11-27actual | — | 2020-04-13 |
| Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion SicknessNCT03772340results2025-05-09The Most Severe Motion Sickness Severity During Vehicle TravelRandomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Tradipitant, Placebo | Motion Sickness | 126 | 2019-06-06actual | — | 2025-05-09 |
| Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of GastroparesisNCT02970968results2024-08-06Change From Baseline in Average Nausea SeverityRandomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: VLY-686 (Tradipitant) · Other: Placebo | Gastroparesis | 152 | Nov 2018actual | — | 2024-08-06 |
| Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMSNCT02231008To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parametersRandomized · Triple-masked · Treatment | Phase 2/3 | Completed | Drug: tasimelteon, placebo | Smith-Magenis Syndrome, Circadian | 49 | 2018-11-19actual | — | 2022-11-18 |
| Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy SubjectsNCT06323655Next-day effects on simulated driving performance as measured by changes in Standard Deviation of Lateral Position (SDLP)Randomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: Tasimelteon, Active Control Placebo, Tasimelteon Placebo, Active Control | Healthy Volunteers | 48 | 2018-08-28actual | — | 2024-03-21 |
| Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type InsomniaNCT03373201results2023-09-15Total Sleep Time in the First Two Thirds of the NightRandomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Tasimelteon, Placebo | Jet Lag Type Insomnia | 320 | 2018-03-05actual | — | 2023-09-15 |
| Study of the Pharmacokinetics and Safety of Tasimelteon in Children and AdolescentsNCT02776215Area under the curver (AUC) of tasimelteon and its metabolitesOpen-label · Treatment | Phase 1 | Completed | Drug: tasimelteon | Circadian Rhythm Sleep Disorders, Non-24 Hour Sleep-Wake Disorder, Autism Spectrum Disorder, Smith-Magenis Syndrome | 24 | 2017-12-20actual | — | 2024-03-21 |
| A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag DisorderNCT03291041results2021-11-03Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be DisruptedRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Tasimelteon, Placebo | Jet Lag Disorder | 25 | Nov 2017actual | — | 2021-11-03 |
| An Observational Study to Investigate the Effects of Rapid Transmeridian TravelNCT02560103observationalEffects of transmeridian travel on nighttime sleep after transmeridian travel measured by Polysomnography (PSG) | — | Completed | Other: Transmeridian travel across multiple time zones | Jet Lag Disorder | 119 | Oct 2017actual | — | 2018-06-26 |
| Tradipitant in Treatment-resistant Pruritus Associated With Atopic DermatitisNCT02651714results2024-06-13Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Tradipitant, Placebo | Atopic Dermatitis | 168 | 2017-08-04actual | — | 2024-06-13 |
| Observational Study to Investigate the Melatonin and Cortisol Circadian Rhythms of Individuals With Smith-Magenis Syndrome (SMS)NCT02180451observationalCircadian melatonin rhythm as measured by plasma melatonin | — | Unknown status | — | Smith Magenis Syndrome | 8 | Jan 2017 | — | 2016-03-25 |
| Study to Assess the Effect of Multiple Doses of Tradipitant on CYP3A4 Using Midazolam as a Substrate in Healthy SubjectsNCT02621385Midazolam Area Under the Curve (AUC)Open-label · Treatment | Phase 1 | Completed | Drug: tradipitant, Midazolam | Healthy Volunteers | 24 | Feb 2016actual | — | 2016-04-27 |
| Tolerability and Pharmacokinetics of Iloperidone in Adolescent PatientsNCT01495169Pharmacokinetics of iloperidone at different dose levels based on AUC (area under the plasma concentration time curve during a dosage interval) Cmax ss (maximum plasma concentration at steady state), Tmax ss (time to Cmax at steady state).Open-label · Treatment | Phase 1 | Completed | Drug: iloperidone (oral tablet) | Safety and Tolerability of Iloperidone | 33 | Feb 2015actual | — | 2016-06-13 |
| Proof of Concept of VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic DermatitisNCT02004041results2024-06-11Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity.Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: VLY-686, Placebo | Treatment-resistant Pruritus Associated With Atopic Dermatitis | 69 | 2015-02-19actual | — | 2024-06-11 |
| Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light PerceptionNCT01429116Number of participants with Treatment-Emergent Adverse Events (AEs)Open-label · Treatment | Phase 3 | Completed | Drug: tasimelteon | Non-24-Hour Sleep-Wake Disorder | 200 | Jan 2015actual | — | 2015-04-21 |
| Open Label Study to Assess the Absolute Bioavailability of Tasimelteon (HETLIOZ™)NCT02130999results2016-07-22Absolute Bioavailability After a Single Oral Dose of Hetlioz™(Tasimelteon) 20mgRandomized · Open-label · Basic science | Phase 4 | Completed | Drug: tasimelteon 20 mg capsule, tasimelteon 2 mg I.V. | Non-24-Hour-Sleep-Wake Disorder | 14 | May 2014actual | — | 2016-08-22 |
| Relapse Prevention Study in Patients With SchizophreniaNCT01291511results2023-07-17Time to Relapse or Impending RelapseRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Iloperidone, Placebo | Schizophrenia | 635 | Mar 2014actual | — | 2023-07-17 |
| Study of Itch Control by VLY-686 in Healthy Volunteers After Intradermal Injections of Substance PNCT01919944Itch severity score on the Verbal Rating ScaleRandomized · Quadruple-masked · Prevention | Phase 1 | Completed | Drug: VLY-686, Placebo | Pruritus | 12 | Nov 2013actual | — | 2015-06-03 |
| Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive DisorderNCT01428661results2015-06-19Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D)Randomized · Quadruple-masked · Treatment | Phase 2/3 | Completed | Drug: tasimelteon, placebo | Major Depressive Disorder | 507 | Jan 2013actual | — | 2015-06-19 |
| Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake DisorderNCT01430754results2014-10-10Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: tasimelteon, Placebo | Non-24-Hour Sleep-Wake Disorder | 20 | Dec 2012actual | — | 2014-10-10 |
| Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake DisorderNCT01163032results2014-10-16Proportion of Patients Entrained as Assessed by Urinary aMT6Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: tasimelteon, Placebo | Non-24-Hour Sleep-Wake Disorder | 136 | Nov 2012actual | — | 2014-10-16 |
| Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin.NCT01637636Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of tasimelteon and tasimelteon's metabolites with and without the CYP3A4 inhibitor ketoconazole.Non-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: tasimelteon, tasimelteon, Rifampin, Ketoconazole | Healthy | 48 | Aug 2012actual | — | 2014-02-17 |
| Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment and Matched Control Subjects With Relatively Normal Renal FunctionNCT01526746Tasimelteon pharmacokinetic parameters (AUC, Cmax, Tmax)Non-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: Tasimelteon, Tasimelteon | Renal Impairment | 32 | Jun 2012actual | — | 2014-02-17 |
| Evaluation of the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and EthanolNCT01578057Pharmacodynamic parameters (Digit Vigilance, Digit Symbol Substitution Task, Hopkins Verbal Learning Test Revised , Divided Attention Test, Balance Platform Test, Choice Reaction Time, Visual Analog Scale) as measured by peak change from baselineRandomized · Double-masked · Basic science | Phase 1 | Completed | Drug: tasimelteon, Ethanol, Placebo ethanol · Other: Placebo tasimelteon | Pharmacodyamics and Pharmacokinetics of Tasimelteon Alone and in Combination With Ethanol | 28 | Jun 2012actual | — | 2014-02-17 |
| Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, FluvoxamineNCT01540500Tasimelteon pharmacokinetic parameters (AUC, Cmax, Tmax)Open-label · Basic science | Phase 1 | Completed | Drug: Tasimelteon, Fluvoxamine | Healthy Volunteers | 24 | Mar 2012actual | — | 2014-02-17 |
| Effects of Smoking, Age and Body Size on Pharmacokinetics, Safety and Tolerability on Tasimelteon in Healthy SubjectsNCT01477619Tasimelteon plasma concentrations and pharmacokinetics in smokers versus non-smokersNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: Tasimelteon | Healthy Volunteers | 60 | Jan 2012actual | — | 2014-02-17 |
| Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic ImpairmentNCT01271387Plasma concentrations and PK of tasimelteonNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: tasimelteon | Hepatic Impairment | 29 | Aug 2011actual | — | 2014-02-17 |
| A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy SubjectsNCT01402076CYP3A4 PharmacokineticsNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: Tasimelteon, Rosiglitazone, Midazolam | Healthy Volunteers | 24 | Aug 2011actual | — | 2014-02-17 |
| VEC-162 Study in Adult Patients With Primary InsomniaNCT00548340results2014-10-15Average Change From Baseline - Latency to Persistent Sleep (LPS)Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: VEC-162 20 mg, Placebo, VEC-162 50 mg | Primary Insomnia | 322 | Feb 2008actual | — | 2014-10-15 |
| Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute SchizophreniaNCT00254202results2024-12-13Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) ScoreRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Iloperidone, Ziprasidone, Placebo | Schizophrenia | 593 | 2006-09-26actual | — | 2024-12-13 |
| VEC-162 Study in Healthy Adult Volunteers in a Model of InsomniaNCT00291187results2014-10-15Average Improvement of Latency to Persistent Sleep (LPS)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: 20 mg VEC-162, 50 mg VEC-162, 100 mg VEC-162, Placebo | Insomnia | 411 | Aug 2006actual | — | 2014-10-15 |
| Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult VolunteersNCT00490945results2014-08-26Circadian Phase ShiftRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: VEC-162 | Circadian Rhythm Sleep Disorders | 45 | Mar 2005actual | — | 2014-08-26 |
| VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive SleepinessNCT00467441Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: VSF-173 | Excessive Somnolence | 60 | — | — | 2007-11-02 |
| Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With GastroparesisNCT04474990expanded access | — | Available | Drug: Tradipitant | Gastroparesis, Diabetic Gastroparesis | — | — | — | 2025-08-24 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19