Friday, July 10, 2026

Drug profile · INN

asenapine maleate

asenapine maleate (ASENAPINE MALEATE) is a dopamine d2 receptor antagonist. Route of administration: sublingual. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 3
Pipeline programs 5
News articles 0
Drug details — asenapine maleate
US status
approved
Class
Route
SUBLINGUAL
Patents
3
Programs
5
Data quality
0.84

Quick answer

asenapine maleate (ASENAPINE MALEATE) is a dopamine d2 receptor antagonist. Route of administration: sublingual. Current US regulatory status: approved.

Key facts

INN asenapine maleate
Brand ASENAPINE MALEATE
Mechanism Dopamine D2 receptor antagonist
Target D(2) dopamine receptor
Route SUBLINGUAL
Formulation TABLET

Mechanism of action

Dopamine D2 receptor antagonist

Primary target: D(2) dopamine receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. 12916 Phase 2 · Bayer · "Patients with interstitial lung disease associated pulmonar
  2. DIABECELL(R) Phase 2 · Otsuka Beijing Research · Type 1 Diabetes
  3. Osteosheet(r) Phase 2 · Hospital Authority · Orbital Trauma
  4. BO42203 Phase 1 · HOFFMANN-LA ROCHE · Diffuse large B-cell lymphoma (DLBCL), Grade 3B follicular l
  5. G060-A5 Phase 1 · Vertex Pharmaceuticals (Australia) · Hepatitis C

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. cabergoline Dopamine D2 receptor agonist
  4. clozapine Serotonin 2a (5-HT2a) receptor antagonist
  5. fluphenazine decanoate Dopamine D2 receptor antagonist
  6. fluphenazine hydrochloride Dopamine D2 receptor antagonist

Related patents

  1. WO 2025146482

    FINÉRÉNONE DESTINÉE À ÊTRE UTILISÉE DANS UN PROCÉDÉ DE PRÉVENTION OU DE TRAITEMENT D'UNE INSUFFISANCE CARDIAQUE CHEZ UN PATIENT RECEVANT UN INHIBITEUR DE CYP3A4 OU UN INDUCTEUR DE CYP3A4

    Expires Wed Jul 05 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. EP 4567715

    ERZEUGUNG SYNTHETISCHER DARSTELLUNGEN

    Expires Tue Jun 06 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. EP 4567716

    ERZEUGUNG SYNTHETISCHER DARSTELLUNGEN

    Expires Tue Jun 06 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is asenapine maleate?

asenapine maleate (ASENAPINE MALEATE) is a dopamine d2 receptor antagonist. Route of administration: sublingual. Current US regulatory status: approved.

What is the brand name for asenapine maleate?

ASENAPINE MALEATE is a marketed brand name for asenapine maleate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of asenapine maleate?

asenapine maleate 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.