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

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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.

Molecule Name

Number of Studies

Bavisant (JNJ-31001074)


Toreforant (JNJ-38518168)






Ceplene (Histamine)


Target Indication Analysis of Histamine Analogs

The molecules such as Wakix (Pitolisant) developed by Harmony Biosciences is specifically indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy and the treatment of cataplexy in adult patients with narcolepsy. Wakix (Pitolisant) is a histamine-3 (H3) receptor antagonist/inverse agonist. Wakix is supplied as a tablet for oral administration. Moreover, Zerviate (Cetirizine Ophthalmic Solution 0.24%) developed by Eyevance Pharmaceuticals specifically indicated for the treatment of ocular itching associated with allergic conjunctivitis. Zerviate is supplied as a solution for topical administration. The recommended dose is one drop in each affected eye twice daily (approximately 8 hours apart).

Frequently Asked Questions

Wakix (Pitolisant), Zerviate (Cetirizine Ophthalmic Solution 0.24%) are the few FDA- approved histamine analogs.

Total sales for Wakix (Pitolisant) by Harmony Biosciences were US$ 437.9 million for the full year FY2022 with a 41% YOY increase in net revenue.

Harmony Bioscience, GSK, Boehringer Ingelheim, AbbVie, etc are few leading market players in histamine analog market.

CNS disorder, asthma, respiratory tract diseases, digestive system diseases, acute myelogenous leukemia, autoimmune diseases, motion sickness, nausea, etc are the major indication of histamine analogs.

There are more than 120 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
  •  Harmony Bioscience
  •  GSK
  •  Boehringer Ingelheim
  •  AbbVie
  •  Bausch Health
  •  J&J
  •  BenevolentAI
  •  Nicox
  •  Santen
  •  AstraZeneca
  •  Immune Pharma
  •  Emcure
  •  Novartis
  •  LEO Pharma
  •  Merck (MSD)

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