Histamine Analogs Market: Competitive Landscape, Pipeline, and Market Analysis 2024

Histamine is an organic nitrogenous compound involved in local immune response communication, as well as regulating physiological functions in the gut and acting as a neurotransmitter for the brain, spinal cord, and uterus. Histamine is involved in the inflammatory response and has a central role as a mediator of itching. As part of an immune response to foreign pathogens, histamine is produced by basophils and by mast cells found in nearby connective tissues. Histamine increases the permeability of the capillaries to white blood cells and some proteins, to allow them to engage pathogens in the infected tissues. The histamine receptors are a class of G protein-coupled receptors that bind histamine as their primary endogenous ligand. There are four known histamine receptors; H1 receptor, H2 receptor, H3 receptor, and H4 receptor.

Antihistamines mechanism of action (MOA) is by blocking histamine at H1 receptors; inhibits smooth muscle constriction in blood vessels and the respiratory and GI tracts; and decreases capillary permeability, salivation, and tear formation. Antihistamines are used for the treatment of CNS disorder, asthma, respiratory tract diseases, digestive system diseases, acute myelogenous leukemia, autoimmune diseases, motion sickness, nausea, vomiting, insomnia, allergy symptoms such as hay fever, hives, conjunctivitis, and reactions to insect bites or stings. The launch of newer products by the market players significantly enhances the revenue of the Histamine Analogs market over the forecast years. For instance, Harmony Biosciences launched Wakix (Pitolisant) for the treatment of narcolepsy. Moreover, to address the difficulties in therapy, numerous market participants are developing innovative compounds. For instance, J&J’s Toreforant (JNJ-38518168) for the indication of asthma and arthritis is under the various stages of clinical studies.

Key Market Developments:

• In August 2019, Harmony Biosciences received FDA approval for Wakix (Pitolisant), for excessive daytime sleepiness in adults with narcolepsy.
• In October 2020, Harmony Biosciences received an FDA grant for an expanded indication of Wakix (Pitolisant) for cataplexy in adults with narcolepsy.
• February 2021, Ursapharm Arzneimittel and Cebina announce a partnership to repurpose the antihistamine azelastine to combat COVID-19.

Approved Drug Molecules for Histamine Analogs along with the Brand Names:

• Wakix (Pitolisant)
• Zerviate (Cetirizine Ophthalmic Solution 0.24%)
• Bepreve (Bepotastine Besilate Ophthalmic Solution) and others

Drugs under the Pipeline for Histamine Analogs:

• Bavisant (JNJ-31001074)
• Toreforant (JNJ-38518168)
• GSK239512
• AZD-5213
• Ceplene (Histamine)
• Futaden (Lafutidine)
• JNJ-39758979
• Diphenhydramine/Naproxen (BAY98-7111)
• Adriforant (ZPL 3893787)
• Montelukast
• JWP1601
• MK0249
• ABT-652
• Belion CR (Bepotastine Sustained-Release)
• S38093
• Samelisant (SUVN-G3031)
• ABT-288
• Aphthasol (Amlexanox)
• BP1.3656
• CU06
• Gastrocrom (Cromolyn)
• SCH-49707 and
• others

Clinical Activity and Developments of Histamine Analogs:

Up until July 2023, there will be about more than 30 companies with over 130 compounds that focus on various forms of allergic and CNS disorder. For these molecules, more than 100 of clinical trials are being conducted and majority are in phase-2, phase-3 clinical trials by the players across the globe. For instance,

• In December 2021, Immune Pharmaceuticals completed Phase 4, open-label, multicenter, effects of remission maintenance therapy with Ceplene, given in conjunction with low-dose interleukin-2, on immune response and minimal residual disease in adult patients with AML in first complete remission.
• In May 2020, Suven Life Sciences completed phase 1, single-center, double-blind, placebo-controlled, randomized study to evaluate the safety, tolerability, and pharmacokinetics of SUVN-G3031 after single ascending doses and multiple ascending doses in healthy male subjects.