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

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.