Wednesday, June 10, 2026

Drug profile · INN

montelukast

montelukast (APX-MONTELUKAST) is a cysteinyl leukotriene receptor 1 antagonist. Associated with Alphapharm Pty Ltd.

TGA: approved NMPA: clinical trials
Patents linked 1
Pipeline programs 11
News articles 0
Drug details — montelukast

Quick answer

montelukast (APX-MONTELUKAST) is a cysteinyl leukotriene receptor 1 antagonist. Associated with Alphapharm Pty Ltd.

Key facts

INN montelukast
Brand APX-MONTELUKAST
Mechanism Cysteinyl leukotriene receptor 1 antagonist

Mechanism of action

Cysteinyl leukotriene receptor 1 antagonist

Approval history

Authority Status Date
TGA approved
NMPA clinical trials

Pipeline programs

  1. CPT for Allergic rhinoconjunctivitis to… Phase 3 · Anaxis Pharma · Allergic rhinoconjunctivitis to Dermatophagoides pteronyssin
  2. EFC14771 Phase 3 · Sanofi-Aventis U.S · Respiratory tract diseases - Wheezing, Asthma
  3. EFC15951 Phase 3 · Sanofi-Aventis U.S · Cancer - Plasma cell myeloma recurrent
  4. EFC15992 Phase 3 · Sanofi-Aventis U.S · Plasma cell myeloma
  5. 61186372NSC2005 Phase 2 · Janssen-Cilag International N.V · EGFR-mutated Advanced or Metastatic Non-small Cell Lung Canc
  6. ACT17453 Phase 2 · Sanofi-Aventis U.S · Cancer - Relapsed/refractory multiple myeloma
  7. ALL3024 Phase 2 · Telethon Foundation · Very High-Risk T-Lineage Acute Lymphoblastic Leukemia (ALL)
  8. LTS17704 Phase 2 · Sanofi-Aventis U.S · Cancer
  1. US 7812168

    Purification of montelukast

    Expires Mon Oct 07 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is montelukast?

montelukast (APX-MONTELUKAST) is a cysteinyl leukotriene receptor 1 antagonist. Associated with Alphapharm Pty Ltd.

What is the brand name for montelukast?

APX-MONTELUKAST is a marketed brand name for montelukast. Check FDA Drugs@FDA for the current US label holder and prescribing information.