Vanda Pharmaceuticals Inc.VNDA
MetabolicPsychiatry42 cited findings · profile updated 2026-08-26
5.33 USDnot live — refreshed daily
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is developing therapies for metabolic and psychiatry indications. The company's drug, Hetlioz (tasimelteon), a melatonin receptor agonist, received approval for nighttime sleep disturbances in Smith-Magenis Syndrome (SNOMED term 401315004). This approval followed a resubmission of its New Drug Application and Efficacy Supplement, with a PDUFA goal date of 12/1/2020 and a review completion date of 11/30/2020. Hetlioz is available in 20 mg capsules and a 4 mg/mL suspension.
Clinical trials for Hetlioz included Study 2401, a Double-Blind, Randomized, Two-Period Crossover Study, which enrolled 26 patients. In this study, tasimelteon showed a mean difference of 18.5 minutes in total sleep time (DDTST50) versus placebo and a mean difference of 21.1 minutes in total sleep duration (DDTST) versus placebo across all nights. Additionally, 70% of patients in Study 2401 showed positive improvement in sleep quality (DDSQ), with a 0.4 points LS mean difference in DDSQ50 versus placebo. The NEREUS (tradipitant) program is in Phase III development.
Compiled from the cited findings below — figures are as stated in each company's published technical reports and filings.
Key figures — cited
| Approval | Approval | Vanda Pharmaceuticals Inc. — Hetlioz FDA Review (NDA214517, ORIG 1, 20, p.2 |
| DDTST50 (total sleep time) mean difference vs placebo | 18.5 minutes | Vanda Pharmaceuticals Inc. — Hetlioz FDA Review (NDA214517, ORIG 1, 20, p.18 |
| DDSQ (sleep quality) positive improvement (difference >0) | 70 % | Vanda Pharmaceuticals Inc. — Hetlioz FDA Review (NDA214517, ORIG 1, 20, p.18 |
| DDSQ50 (sleep quality) LS mean difference vs placebo | 0.4 points | Vanda Pharmaceuticals Inc. — Hetlioz FDA Review (NDA214517, ORIG 1, 20, p.21 |
| DDTST (total sleep time) improvement of >1 hour | 15 % | Vanda Pharmaceuticals Inc. — Hetlioz FDA Review (NDA214517, ORIG 1, 20, p.21 |
| Patients with infections and infestations (pooled data) | 21.3 % | Vanda Pharmaceuticals Inc. — Hetlioz FDA Review (NDA214517, ORIG 1, 20, p.20 |
Key projects
- Hetlioz (nighttime sleep disturbances in Smith-Magenis Syndrome)
Hetlioz (tasimelteon) received approval for nighttime sleep disturbances in Smith-Magenis Syndrome.
- NEREUS (tradipitant)
NEREUS (tradipitant) is in Phase III development.
Every figure cites its source document. Prices refresh daily, not live. Informational only — not investment advice. Explore the Psychiatry research library →