Developer · VNDA · United States

Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals is a Washington, D.C.-based biopharmaceutical company focused on the development and commercialization of therapies for high unmet medical needs, with a CNS pipeline that includes iloperidone (Fanapt) formulations, milsaperidone (Bysanti), and VQW-765.

vandapharma.com ↗

3compounds
4programs
4indications
Approvedlead asset

Phase distribution

  • Approved1
  • Phase 33

Modality

  • Small molecule 3

Mechanism focus

Pipeline (3)

Deals & partnerships

  • Dec 31, 2014Licensing dealVanda in-licenses VQW-765 (AQW051) alpha-7 nicotinic agonist from NovartisAs part of the December 2014 Novartis settlement, Vanda received an exclusive worldwide license under certain Novartis patents and intellectual property to develop and commercialize VQW-765 (a Phase II alpha-7 nicotinic acetylcholine receptor partial agonist, the former Novartis candidate AQW051), effective December 31, 2014. Vanda is responsible for all development costs with no milestone obligations; Novartis is eligible for tiered royalties on net sales up to the mid-teens percent.VQW-765source ↗
  • Dec 31, 2014Licensing dealVanda regains worldwide Fanapt (iloperidone) rights from Novartis in settlementUnder a December 2014 settlement of their iloperidone licensing dispute, Novartis transferred all U.S. and Canadian commercial rights for the Fanapt (iloperidone) franchise back to Vanda effective December 31, 2014, consolidating worldwide rights to develop and commercialize iloperidone (including long-acting injectable formulations) in Vanda. Vanda had originally licensed worldwide rights to iloperidone from Novartis Pharma AG in June 2004. Novartis also made a $25 million equity investment in Vanda as part of the settlement.Iloperidone LAIsource ↗

Catalysts · 3 upcoming · 2 reported

Recently reported

Recent activity

  • Feb 20, 2026Phase changeMilsaperidone (VHX-896)·Major depressive disorderPhase 3On FDA approval of Bysanti for bipolar I and schizophrenia, Vanda restated that Bysanti remains in an ongoing Phase 3 study as a once-daily adjunctive treatment in treatment-resistant MDD, expected to complete by end of 2026. MDD remains investigational (Phase 3).source ↗
  • Feb 20, 2026ReadoutMilsaperidone (VHX-896)·Bipolar disordermetFDA approves Bysanti (milsaperidone) for the acute treatment of manic or mixed episodes associated with bipolar I disorder (co-approved with schizophrenia).source ↗
  • Feb 11, 2026Phase changeIloperidone LAI·SchizophreniaPhase 3Vanda's Q4/full-year 2025 financial results (PR 11 Feb 2026) confirmed the Phase 3 LAI iloperidone schizophrenia relapse-prevention study remains actively enrolling patients; no topline-data timing was guided.source ↗
  • Sep 22, 2025Phase changeVQW-765·Social anxiety disorderPhase 3Phase 3 social anxiety disorder study (NCT07221578) initiated; first study start date on ClinicalTrials.gov.source ↗
  • May 14, 2025Phase changeIloperidone LAI·SchizophreniaPhase 3Pivotal Phase 3 randomized-withdrawal/relapse-prevention study of iloperidone LAI vs placebo injection in schizophrenia (NCT06961968; VP-VYV-683-3102; est. n=400; primary completion Nov 2027) started and began enrolling patients.source ↗
  • May 7, 2025Phase changeMilsaperidone (VHX-896)·Major depressive disorderPhase 3Vanda (Q1 2025 results, SEC Form 8-K) confirmed the Bysanti Phase 3 once-daily adjunctive MDD study is ongoing with results expected in 2026; same filing reported the Bysanti NDA (bipolar I / schizophrenia, not MDD) accepted for filing with a 21 Feb 2026 PDUFA date.source ↗
  • Apr 21, 2025Phase changeMilsaperidone (VHX-896)·Bipolar disorderFiled (NDA)Vanda's Bysanti (milsaperidone) NDA 220358, covering both schizophrenia and acute manic/mixed episodes of bipolar I disorder, was submitted to FDA (FDA received the application 21 Feb 2025; the May 2025 8-K reported acceptance for filing with a 21 Feb 2026 PDUFA date). Bipolar I efficacy bridged from iloperidone studies.source ↗
  • Mar 3, 2025Phase changeMilsaperidone (VHX-896)·Major depressive disorderPhase 3Phase 3 adjunctive MDD study NCT06830044 (milsaperidone vs placebo as add-on to ongoing antidepressant; primary MADRS at week 6; target n=500) initiated; program first announced by Vanda as initiated in Q4 2024 with results expected in 2026.source ↗
  • Dec 2, 2022ReadoutVQW-765·Social anxiety disordermissedPhase 2 VQW-765 performance-anxiety study missed primary endpoint overall; significant in femalessource ↗
  • Sep 7, 2022Phase changeMilsaperidone (VHX-896)·Bipolar disorderPhase 3Pivotal Phase 3 acute bipolar I mania trial NCT04819776 (iloperidone, 4-week, n=417 enrolled / 414 dosed) reached primary completion; primary endpoint (YMRS change from baseline to Week 4) was met (LS-mean difference vs placebo -4.0, 95% CI -5.70 to -2.25, adjusted p=0.000008). This iloperidone trial became the registration basis for milsaperidone's bipolar I claim via the documented in-vivo interconversion/bioequivalence bridge.source ↗
  • Aug 30, 2022Phase changeIloperidone LAI·SchizophreniaPhase 1Open-label, adaptive, repeat-dose Phase 1 study of iloperidone LAI safety/tolerability/PK in schizophrenia patients (NCT04712734, n=42) reached completion, establishing the depot formulation's pharmacokinetics ahead of the Phase 3 program.source ↗
  • Aug 2, 2022Phase changeVQW-765·Social anxiety disorderPhase 2Phase 2 performance-anxiety study (NCT04800237) completed; primary SUDS endpoint missed in overall ITT population (P=0.1443) but significant in the female subgroup (P=0.034).source ↗

Trials recruiting · 5 recruiting of 21 sponsored

  • Phase 4Iloperidonen=1009 sites · United States

    Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

    SchizophreniaBipolar I DisorderNCT05648591 ↗

  • Phase 3VQW-765n=50030 sites · United States

    A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Acute Anxiety in Patients With Social Anxiety Disorder

    Social Anxiety DisorderNCT07221578 ↗

  • Phase 3Iloperidone LAIn=40022 sites · United States

    A Multicenter, Double-Blind, Randomized Withdrawal Study in Patients With Schizophrenia Receiving Either Iloperidone Long-Acting Injection (LAI) or Placebo Injection

    SchizophreniaNCT06961968 ↗

  • Phase 3Tasimelteon Oral Suspension, Placebon=42035 sites · United States, United Kingdom, Poland

    Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia

    Insomnia DisorderNCT06953869 ↗

  • Phase 3Milsaperidone (VHX-896)n=50038 sites · United States, Poland, Czechia

    A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Milsaperidone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

    Major Depressive DisorderNCT06830044 ↗

Competitive landscape

Other companies developing against Vanda Pharmaceuticals Inc.'s targets or indications.

Leadership & advisors (13)