Wednesday, July 8, 2026

Drug profile · INN

milsaperidone

milsaperidone (BYSANTI) is an FDA-listed pharmaceutical active ingredient. Associated with Vanda Pharmaceuticals Netherlands B.V.. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 20
Pipeline programs 2
News articles 0
Drug details — milsaperidone
US status
approved
Class
Route
ORAL
Patents
20
Programs
2
Data quality
0.89

Quick answer

milsaperidone (BYSANTI) is an FDA-listed pharmaceutical active ingredient. Associated with Vanda Pharmaceuticals Netherlands B.V.. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN milsaperidone
Brand BYSANTI
Route ORAL
Formulation TABLET

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Milsaperidone Phase 3 · Vanda Pharmaceuticals Netherlands · Major Depressive Disorder (MDD)
  2. VP-VHX-896-3201 Phase 3 · Vanda Pharmaceuticals Netherlands · Major Depressive Disorder
  1. US 12427132

    Method of improving sleep

    Expires Mon Sep 25 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12419869

    Methods of treating multiple sclerosis

    Expires Mon Sep 18 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 12403134

    Method for improving or enhancing cognition

    Expires Mon Aug 28 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 12357616

    Methods of treating multiple sclerosis

    Expires Mon Jul 10 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11845990

    Prediction of sleep parameter and response to sleep-inducing compound based on PER3 VNTR genotype

    Expires Mon Dec 14 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11458116

    Method of improving sleep

    Expires Mon Sep 29 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11433057

    Method for improving or enhancing cognition

    Expires Mon Sep 01 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 11060144

    Prediction of sleep parameter and response to sleep-inducing compound based on PER3 VNTR genotype

    Expires Mon Jul 08 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 10570453

    Method of predicting a predisposition to QT prolongation

    Expires Mon Feb 20 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 10570452

    Method of predicting a predisposition to QT prolongation

    Expires Mon Feb 20 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 10563259

    Method of treatment based on polymorphisms of the KCNQ1 gene

    Expires Mon Feb 13 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 10563260

    Method of predicting a predisposition to QT prolongation

    Expires Mon Feb 13 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 10563261

    Method of predicting a predisposition to QT prolongation

    Expires Mon Feb 13 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 10272075

    Method and composition for treating an alpha adrenoceptor-mediated condition

    Expires Mon Apr 25 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 9987264

    Method and composition for treating a serotonin receptor-mediated condition

    Expires Mon May 31 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 9708291

    Intermediate and process useful in the preparation of {2-[1-(3,5-bis-trifluoromethyl-benzyl)-5-pyridin-4-yl-1H-[1,2,3]triazol-4-yl]-pyridin-3-yl)-(2-chlorophenyl)-methanone

    Expires Mon Jul 13 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 9446038

    Method and composition for treating a serotonin receptor-mediated condition

    Expires Mon Sep 15 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 9157121

    Method of treatment based on polymorphisms of the KCNQ1 gene

    Expires Mon Oct 08 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 9072742

    Method of predicting a predisposition to QT prolongation

    Expires Mon Jul 02 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 9074256

    Method of predicting a predisposition to QT prolongation

    Expires Mon Jul 02 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is milsaperidone?

milsaperidone (BYSANTI) is an FDA-listed pharmaceutical active ingredient. Associated with Vanda Pharmaceuticals Netherlands B.V.. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for milsaperidone?

BYSANTI is a marketed brand name for milsaperidone. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of milsaperidone?

milsaperidone has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.