Wednesday, July 8, 2026

Drug profile · INN

brexpiprazole

brexpiprazole (REXULTI) is a serotonin 2a (5-ht2a) receptor antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved Nervous system (N05) N05AX16
US status approved
Patents linked 0
Pipeline programs 1
News articles 1
Drug details — brexpiprazole

Quick answer

brexpiprazole (REXULTI) is a serotonin 2a (5-ht2a) receptor antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN brexpiprazole
Brand REXULTI
Mechanism Serotonin 2a (5-HT2a) receptor antagonist
Target D(2) dopamine receptor
Therapeutic class Nervous system (N05)
Route ORAL
Formulation TABLET
ATC code N05AX16

Mechanism of action

Serotonin 2a (5-HT2a) receptor antagonist

Primary target: D(2) dopamine receptor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved

Recent coverage

Pipeline programs

  1. INTENSIFY SZ Approved · Disc Medicine · schizophrenia, schizoaffective disorder, schizophrenifom dis

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brivaracetam Nervous system (N03)
  3. bupivacaine Nervous system (N01)
  4. buprenorphine Nervous system (N07)
  5. cabergoline Dopamine D2 receptor agonist
  6. caffeine citrate Nervous system (N06)

Frequently asked questions

What is brexpiprazole?

brexpiprazole (REXULTI) is a serotonin 2a (5-ht2a) receptor antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for brexpiprazole?

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

What is the US approval status of brexpiprazole?

brexpiprazole 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.