Wednesday, July 8, 2026

Drug profile · INN

vortioxetine

vortioxetine (BRINTELLIX) is a serotonin 3a (5-ht3a) receptor antagonist. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Nervous system (N06) N06AX26
US status approved
Patents linked 1
Pipeline programs 29
News articles 0
Drug details — vortioxetine
US status
approved
Class
Nervous system (N06)
Route
ORAL
Patents
1
Programs
29
Data quality
0.84

Quick answer

vortioxetine (BRINTELLIX) is a serotonin 3a (5-ht3a) receptor antagonist. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN vortioxetine
Brand BRINTELLIX
Mechanism Serotonin 3a (5-HT3a) receptor antagonist
Therapeutic class Nervous system (N06)
Route ORAL
Formulation TABLET:FILM COATED
ATC code N06AX26

Mechanism of action

Serotonin 3a (5-HT3a) receptor antagonist

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. INTENSIFY MDD Phase 3 · Disc Medicine · Major depressive disorder
  2. Vortioxetine Phase 3 · Takeda · TBI
  3. Vortioxetine Phase 3 · Takeda · Major Depressive Disorder
  4. Vortioxetine Phase 3 · Takeda · Generalized Anxiety Disorder
  5. Vortioxetine Phase 3 · Takeda · Depressive Disorder, Major
  6. Vortioxetine Phase 3 · University of Hong · Cannabis Use Disorder
  7. Vortioxetine Phase 3 · Takeda · Treatment Outcome
  8. Vortioxetine Phase 3 · Cognition Therapeutics · Major Depressive Disorder

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)

Related patents

  1. US 9278096

    Therapeutic uses of compounds having combined SERT, 5-HT3 and 5-HT1A activity

    Expires 2036-03-03T00:00:00.000Z

    granted

Frequently asked questions

What is vortioxetine?

vortioxetine (BRINTELLIX) is a serotonin 3a (5-ht3a) receptor antagonist. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for vortioxetine?

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

What is the US approval status of vortioxetine?

vortioxetine 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.