Thursday, July 9, 2026

Drug profile · INN

asenapine

asenapine (SAPHRIS) is a serotonin 2a (5-ht2a) receptor antagonist. Associated with Organon Pharma Pty Ltd. Route of administration: transdermal. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Nervous system (N05) N05AH05
US status approved
Patents linked 1
Pipeline programs 40
News articles 0
Drug details — asenapine
US status
approved
Class
Nervous system (N05)
Route
TRANSDERMAL
Patents
1
Programs
40
Data quality
0.84

Quick answer

asenapine (SAPHRIS) is a serotonin 2a (5-ht2a) receptor antagonist. Associated with Organon Pharma Pty Ltd. Route of administration: transdermal. Current US regulatory status: approved.

Key facts

INN asenapine
Brand SAPHRIS
Mechanism Serotonin 2a (5-HT2a) receptor antagonist
Therapeutic class Nervous system (N05)
Route TRANSDERMAL
Formulation SYSTEM
ATC code N05AH05

Mechanism of action

Serotonin 2a (5-HT2a) receptor antagonist

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. - Phase 3 · Disc Medicine · Resectable colorectal rectal metastases without extrahepatic
  2. 220735 Phase 3 · GSK Glaxo Smith · Asthma
  3. Asenapine Sublingual Tablets 10 mg Phase 3 · Amneal Pharma Europe · Schizophrenia
  4. DM199-2021-001 Phase 3 · DiaMedica Therapeutics · Acute Ischemic Stroke
  5. LIOTHYRONINE for Hypothyroidism Triiodothyronine… Phase 3 · Disc Medicine · Hypothyroidism Triiodothyronine Quality of Life Persistant c
  6. Mosunetuzumab, Mosunetuzumab Phase 3 · HOFFMANN-LA ROCHE · NA
  7. Oxycodone Naltrexone (a) Phase 3 · ELITE PHARMACEUTICALS INC · Pain
  8. (+)-α-DIHYDROTETRABENAZINE Phase 2 · Anaxis Pharma · Tardive dyskinesia

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)
  1. US 11819554

    Compositions and methods for modulating FMR1 expression

    Expires Mon Nov 16 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is asenapine?

asenapine (SAPHRIS) is a serotonin 2a (5-ht2a) receptor antagonist. Associated with Organon Pharma Pty Ltd. Route of administration: transdermal. Current US regulatory status: approved.

What is the brand name for asenapine?

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

What is the US approval status of asenapine?

asenapine 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.