Leukotriene Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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Leukotrienes are a family of eicosanoid inflammatory mediators produced in leukocytes by the oxidation of arachidonic acid (AA) and the essential fatty acid eicosapentaenoic acid (EPA) by the enzyme arachidonate 5-lipoxygenase. The production of leukotrienes is usually accompanied by the production of histamine and prostaglandins, which also act as inflammatory mediators. One of their roles (specifically, leukotriene D4) is to trigger contractions in the smooth muscles lining the bronchioles; their overproduction is a major cause of inflammation in asthma and allergic rhinitis. Leukotriene antagonists are used to treat these disorders by inhibiting the production or activity of leukotrienes. The mechanism of action (MOA) of the leukotriene receptor antagonists is to block the activity of cysteinyl leukotrienes at their receptors (CysLT1) on bronchial smooth muscle, while the leukotriene synthesis inhibitors block the synthesis of all leukotrienes by interrupting the 5-lipoxygenase pathway. Leukotriene antagonists are used in the treatment of asthma, respiratory hypersensitivity, bronchial diseases, lung diseases, nose diseases, allergic rhinitis, brain diseases, common cold, conjunctival diseases, and enteritis. Increased prevalence of respiratory tract infections and allergic rhinitis are the key drivers for the Leukotriene market. For instance, according to the Centers for Disease Control and Prevention 2021, around there were 4.6% of adults who have ever been diagnosed with COPD, emphysema, or chronic bronchitis. The introduction of newer products by market players may look for opportunities that have a big impact on comprehensive research and development in Leukotriene antagonists. For instance, Viatris Gastrocrom (Cromolyn) launch for the treatment of mastocytosis.  Moreover, to address the difficulties in therapy, numerous market participants are developing innovative compounds. For instance, Akari Therapeutics Coversin SC (Nomacopan SC) for the indication of myelogenous leukemia is under the various stages of clinical studies.

Key Market Developments:

  • In May 2022, Cambridge University study find that Leukotriene inhibitors with dexamethasone show promise in the prevention of death in COVID-19 patients with low oxygen saturations.
  • In February 2023, IntelGenx enters into a research collaboration with Renowned Neurologist to evaluate Montelukast VersaFilm for the treatment of Parkinson’s disease.

Approved Drug Molecules and Brand Names for Leukotriene:

  •    Gastrocrom (Cromolyn)
  •    Accolate (Zafirlukast)
  •    Singulair (Montelukast Sodium)
  •    Zyflo (Zileuton)
  •    Visudyne (Verteporfin For Injection)

Drugs under the Pipeline for Leukotriene:

  • Coversin SC (Nomacopan SC)
  • Acebilustat (CTX-4430)
  • Montelukast/ levocetirizine (HCP1102)
  • LYS006
  • Gemilukast (ONO-6950)
  • Tipelukast (MN-001)
  • Aphthasol (Amlexanox)
  • Gastrocrom (Cromolyn)
  • Onon Dry Syrup (Pranlukast)
  • Q301
  • AZD9898
  • Coversin Topical (Nomacopan Topical)
  • JNJ-40929837
  • LY2300559
  • TA-270
  • Masilukast (MCC-847)
  • Montelukast Versafilm (INT0043)

Clinical Activity and Developments of Leukotriene:

As of June 2023, there will be about 17 companies with over 35 compounds that focus on various forms of respiratory and hypersensitivity disorders. For these molecules, more than 325 of clinical trials are being conducted and majority are in phase-, and phase-3 clinical trials. For instance,

  • In May 2018, Ono Pharmaceutical completed phase 2a, a multicenter, double-blind, randomized parallel-group trial of Gemilukast (ONO-6950) in patients with asthma.
  • In March 2023, Celtaxsys has completed phase 2, a pragmatic multi-arm, adaptive, blinded, randomized placebo-controlled platform trial of Acebilustat (CTX-4430) to evaluate the efficacy of different investigational therapeutics in reducing time to disease resolution or viral load cessation, as compared to standard supportive care in outpatients with COVID-19.

Molecule Name

Number of Studies

Coversin SC (Nomacopan SC)


Acebilustat (CTX-4430)


Montelukast/ levocetirizine (HCP1102)




Gemilukast (ONO-6950)


Target Indication Analysis of Leukotriene

The molecules such as Gastrocrom (Cromolyn) developed by Viatris for the line of treatment for the symptoms of mastocytosis. Mastocytosis is a rare condition caused by too many mast cells in the body. These mast cells release substances that cause the symptoms of the disease, such as abdominal pain, nausea, vomiting, diarrhea, headache, flushing or itching of skin, or hives. Bausch in global collaboration with Lomb’s Visudyne (Verteporfin For Injection) for the treatment of subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis.

Leukotriene Market Segmentation

By Geography
  • USA
  • Germany
  • France
  • United Kingdom
  • Spain
  • Italy
  • Japan
  • Rest of World

Frequently Asked Questions

Gastrocrom (Cromolyn), Accolate (Zafirlukast), and Singulair (Montelukast Sodium) are the few FDA-approved Leukotriene.

Viatris, Merck, Akari Therapeutics, Celtaxsys, and Novartis are a few leading market players in Leukotriene Market.

Asthma, respiratory hypersensitivity, bronchial diseases, lung diseases, nose diseases, allergic rhinitis, brain diseases, common cold, conjunctivitis diseases, and enteritis are the major indication of Leukotriene antagonists.

There are a total of 17 molecules that are in Phase-1, Phase-2, and Phase-3 clinical development.

Key Features of the Reports

  • The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
  • Viatris
  •  Akari Therap
  •  Celtaxsys
  •  Novartis
  •  Ono Pharma
  •  MediciNova
  •  Abeona Therapeutics
  •  Ono Pharma
  •  Qurient
  •  AstraZeneca
  •  Akari Therapeutics
  •  J&J
  •  Eli Lilly
  •  Mariposa Health
  •  Mitsubishi Tanabe
  •  IntelGenx

Adjacent Markets