COMPANY
Vanda Pharmaceuticals
FDA-approved therapeutic company Clinical Phase 3
Timeline
- Trial start Phase 3: Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis source ↗
- Trial start Phase 3: A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use source ↗
- FDA FDA New drug/biologic (novel): BYSANTI (milsaperidone) — NDA220358, Feb 20, 2026. Applicant at approval: Vanda Pharmaceuticals, Inc. source ↗
- Trial start Phase 3: Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis source ↗
- FDA FDA New drug/biologic (novel): NEREUS (tradipitant) — NDA220152, Dec 30, 2025. Applicant at approval: Vanda Pharmaceuticals Inc. source ↗
- Partnership Partnership / licensing announced Oct 1, 2025. Source: SEC filing. source ↗
- Trial start Phase 2: An Eight-Week Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye source ↗
- Trial start Phase 3: Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder source ↗
- Trial start Phase 2: Evaluation of Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension source ↗
- Trial start Phase 3: Randomized Withdrawal Study in Patients With Schizophrenia source ↗
- Trial start Phase 1/Phase 2: Treatment of Charcot-Marie-Tooth Disease, Axonal, Type 2S (CMT2S) in an Individual Patient source ↗
- Trial start Phase 2: Safety, Tolerability and Efficacy of Trichostatin A in Patients With Mild to Severe Onychomycosis source ↗
- Trial start Phase 3: Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia source ↗
- Trial start Phase 3: Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder source ↗
- Trial start Phase 2: A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use source ↗
- Trial start D: Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant source ↗
- Trial start Phase 1: Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions source ↗
- Trial start Phase 3: Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis source ↗
- Trial start Phase 3: Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness source ↗
- Trial start Phase 4: Safety and Tolerability of Open-Labeled Iloperidone in Adolescents source ↗
- Trial start Phase 3: Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness source ↗
- Trial start Phase 1: Food Effect Study of VHX-896 in Healthy Volunteers source ↗
- Trial start Phase 2: A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis source ↗
- Trial start Phase 1: Bioequivalence Study Between Tasimelteon Capsule Formulation and Liquid Suspension Formulation in Healthy Volunteers source ↗
- Trial start Phase 3: Study to Evaluate the Long-Term Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Subjects With GPP source ↗
Upcoming milestones
- 2026-10 (ESTIMATED) · Phase 2 · Evaluation of Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension · NCT07090161
- 2026-12 (ESTIMATED) · Phase 3 · Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder · NCT07221578
- Dec 1, 2026 (ESTIMATED) · Phase 3 · A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use · NCT07446439
- 2027-03 (ESTIMATED) · Phase 1/Phase 2 · Treatment of Charcot-Marie-Tooth Disease, Axonal, Type 2S (CMT2S) in an Individual Patient · NCT07223632
- Sep 30, 2027 (ESTIMATED) · Phase 3 · Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness · NCT06138613
- 2027-11 (ESTIMATED) · Phase 3 · Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia · NCT06953869
- 2027-11 (ESTIMATED) · Phase 3 · Randomized Withdrawal Study in Patients With Schizophrenia · NCT06961968
- 2027-12 (ESTIMATED) · Phase 1 · Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies · NCT03838926
Funding
- Partnership / licensing announced Oct 1, 2025. Source: SEC filing. source ↗
Clinical trials (lead sponsor) Showing 50 of 82
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT04652882 | Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) | D | Completed | Dec 9, 2020 | Sep 4, 2026 (actual) |
| NCT00254202 | Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia | Phase 3 | Completed | Nov 18, 2005 | Sep 26, 2006 (actual) |
| NCT05648591 | Safety and Tolerability of Open-Labeled Iloperidone in Adolescents | Phase 4 | Recruiting | May 24, 2023 | Dec 31, 2028 (estimated) |
| NCT04028492 | Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis | Phase 3 | Completed | Aug 20, 2019 | Feb 21, 2025 (actual) |
| NCT06830044 | Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder | Phase 3 | Recruiting | Mar 3, 2025 | 2028-03 (estimated) |
| NCT07362017 | Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis | Phase 3 | Recruiting | Feb 17, 2026 | 2028-08 (estimated) |
| NCT07223632 | Treatment of Charcot-Marie-Tooth Disease, Axonal, Type 2S (CMT2S) in an Individual Patient | Phase 1/Phase 2 | Active, not recruiting | May 13, 2025 | 2027-03 (estimated) |
| NCT07686081 | Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis | Phase 3 | Recruiting | 2026-09 | 2029-04 (estimated) |
| NCT07221578 | Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder | Phase 3 | Active, not recruiting | Sep 22, 2025 | 2026-12 (estimated) |
| NCT06953869 | Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia | Phase 3 | Recruiting | Apr 21, 2025 | 2027-11 (estimated) |
| NCT07446439 | A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use | Phase 3 | Recruiting | Mar 27, 2026 | Dec 1, 2026 (estimated) |
| NCT06138613 | Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness | Phase 3 | Active, not recruiting | Feb 27, 2023 | Sep 30, 2027 (estimated) |
| NCT05366855 | Study to Evaluate the Long-Term Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Subjects With GPP | Phase 3 | Terminated | Apr 21, 2022 | Jul 12, 2024 (actual) |
| NCT05352893 | Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP | Phase 3 | Completed | Apr 14, 2022 | Aug 17, 2023 (actual) |
| NCT03838926 | Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies | Phase 1 | Recruiting | Sep 27, 2018 | 2027-12 (estimated) |
| NCT07090161 | Evaluation of Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension | Phase 2 | Recruiting | Sep 15, 2025 | 2026-10 (estimated) |
| NCT07065773 | Safety, Tolerability and Efficacy of Trichostatin A in Patients With Mild to Severe Onychomycosis | Phase 2 | Active, not recruiting | May 5, 2025 | 2026-09 (estimated) |
| NCT06961968 | Randomized Withdrawal Study in Patients With Schizophrenia | Phase 3 | Recruiting | May 14, 2025 | 2027-11 (estimated) |
| NCT06804603 | A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use | Phase 2 | Completed | Feb 25, 2025 | Oct 6, 2025 (actual) |
| NCT04697069 | A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash | Phase 2 | Terminated | May 4, 2021 | Dec 13, 2021 (actual) |
| NCT04856917 | A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris | Phase 2 | Completed | May 15, 2021 | Feb 1, 2022 (actual) |
| NCT04856930 | A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis Suppurativa | Phase 2 | Completed | Jul 7, 2021 | Jul 15, 2022 (actual) |
| NCT06494397 | Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions | Phase 1 | Completed | Jul 11, 2024 | Oct 24, 2024 (actual) |
| NCT07179055 | An Eight-Week Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye | Phase 2 | Recruiting | 2025-10 | 2026-09 (estimated) |
| NCT03619902 | A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis | Phase 2 | Completed | Jan 30, 2019 | Jan 20, 2021 (actual) |
| NCT04697056 | A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis | Phase 2 | Terminated | Jan 25, 2021 | Nov 19, 2021 (actual) |
| NCT03633396 | A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis | Phase 2 | Completed | May 20, 2019 | Apr 23, 2021 (actual) |
| NCT04622345 | Safety and Efficacy of VSJ-110 in the Treatment of Allergic Conjunctivitis in Adults With a History of Ocular Allergies | Phase 2 | Completed | Nov 21, 2020 | May 22, 2021 (actual) |
| NCT04474990 | Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis | Not listed | Available | Not listed | Not listed |
| NCT03772340 | Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness | Phase 2 | Completed | Dec 20, 2018 | Jun 6, 2019 (actual) |
| NCT05903924 | Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness | Phase 3 | Completed | Sep 9, 2023 | Apr 6, 2024 (actual) |
| NCT06836557 | Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis | Phase 3 | Recruiting | Jan 9, 2024 | 2025-12 (estimated) |
| NCT06803290 | Food Effect Study of VHX-896 in Healthy Volunteers | Phase 1 | Completed | Jun 21, 2022 | Dec 27, 2022 (actual) |
| NCT04327661 | Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness | Phase 3 | Completed | Nov 15, 2021 | Apr 1, 2023 (actual) |
| NCT06701396 | Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant | D | Recruiting | Oct 8, 2024 | Jun 30, 2025 (estimated) |
| NCT02970968 | Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis | Phase 2 | Completed | 2016-11 | 2018-11 (actual) |
| NCT02651714 | Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis | Phase 2 | Completed | Jan 19, 2016 | Aug 4, 2017 (actual) |
| NCT02004041 | Proof of Concept of VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic Dermatitis | Phase 2 | Completed | Dec 10, 2013 | Feb 19, 2015 (actual) |
| NCT04140695 | Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2) | Phase 3 | Terminated | Oct 21, 2019 | Oct 14, 2020 (actual) |
| NCT03568331 | Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE) | Phase 3 | Completed | Jul 9, 2018 | Dec 27, 2019 (actual) |
| NCT04819776 | Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder | Phase 3 | Completed | Mar 22, 2021 | Sep 7, 2022 (actual) |
| NCT04849559 | Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation, and Gastric Emptying in Healthy Volunteers | Phase 1/Phase 2 | Completed | Feb 1, 2021 | Sep 24, 2021 (actual) |
| NCT01218789 | Safety Study of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder in Blind Individuals With No Light Perception | Phase 3 | Unknown status (ClinicalTrials.gov) | Oct 28, 2010 | Dec 5, 2024 (estimated) |
| NCT04353401 | WGS Analysis of COVID-19 Positive Patients | Not listed | Completed | Aug 3, 2020 | Mar 9, 2022 (actual) |
| NCT05572281 | Bioequivalence Study Between Tasimelteon Capsule Formulation and Liquid Suspension Formulation in Healthy Volunteers | Phase 1 | Completed | May 18, 2022 | Jun 15, 2022 (actual) |
| NCT06323655 | Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects | Phase 1 | Completed | Jul 19, 2018 | Aug 28, 2018 (actual) |
| NCT05361707 | Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances | Phase 3 | Unknown status (ClinicalTrials.gov) | Jul 28, 2021 | 2025-07 (estimated) |
| NCT05344365 | A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis | Phase 2 | Withdrawn | 2022-06 | 2023-11 (estimated) |
| NCT02776215 | Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents | Phase 1 | Completed | Oct 4, 2016 | Dec 20, 2017 (actual) |
| NCT04800237 | Evaluating the Effects of VQW-765 vs. Placebo in Performance Anxiety | Phase 2 | Completed | Feb 23, 2021 | Aug 2, 2022 (actual) |
FDA records (last 2 years)
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