Serotonin Receptor Agonist Market: Competitive Landscape, Pipeline, and Market Analysis 2024

5-HT receptors, 5-hydroxytryptamine receptors, or serotonin receptors, are a group of G protein-coupled receptor and ligand-gated ion channels found in the central and peripheral nervous systems. They mediate both excitatory and inhibitory neurotransmission. The serotonin receptors are activated by the neurotransmitter serotonin, which acts as their natural ligand. The serotonin receptors modulate the release of many neurotransmitters, including glutamate, GABA, dopamine, epinephrine/norepinephrine, and acetylcholine, as well as many hormones like oxytocin, prolactin, vasopressin, cortisol. Serotonin receptors influence various biological and neurological processes such as aggression, anxiety, appetite, cognition, learning, memory, mood, nausea, sleep, and thermoregulation. The mechanism of action (MOA) of serotonin receptor agonists that target the 5-HT1 receptor subtypes primarily act by binding to and activating these receptors. The 5-HT1 receptor family includes subtypes such as 5-HT1A, 5-HT1B, 5-HT1D, and so on. Activation of 5-HT1 receptors generally leads to inhibitory effects on neuronal activity and neurotransmitter release and 5-HT2 receptor subtypes mainly act by activating these receptors. Serotonin Receptor Agonists are used to treat CNS disorders, movement disorders, schizophrenia, metabolic disorders, diabetes mellitus, digestive system diseases, stress disorders, dementia, and neurotoxicity syndrome to name a few. Increased prevalence of neurological disorders and changing lifestyles are the key drivers for the Serotonin Receptor Agonist market. For instance, according to the World Health Organization 2023, an estimated 3.8% of the population experience depression, including 5% of adults (4% among men and 6% among women) and 5.7% of adults older than 60 years. approximately 280 million people in the world have depression. Depression is about 50% more common among women than among men. The launch of newer products by the market players could seek opportunities that influence extensive research and development in Serotonin Receptor Agonist. For instance, Zogenix launched Fintepla (Fenfluramine) to treat seizures. Moreover, the development of novel molecules by many market players is coming up to overcome challenges in therapy. For instance, Resilience’s PRX-03140 for the treatment of Alzheimer's disease is under the various stages of clinical studies.

Key Market Developments:

• In January 2019, Upsher-Smith Laboratories received FDA approval for its Tosymra (Sumatriptan) Nasal Spray for the treatment of acute migraine in adults.
• In June 2020, Zogenix received FDA approval for its Fintepla (Fenfluramine) for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.

 Approved Drug Molecules and Brand Names for Serotonin Receptor Agonist:

  Fintepla (Fenfluramine)

 Tosymra (Sumatriptan) Nasal Spray

 Motegrity (Prucalopride)

Drugs under the Pipeline for Serotonin Receptor Agonist:

Midomafetamine (MDMA)

 5-Methoxy-Dimethyltryptamine Inhalation (GH001)

 PRX-03140

 Velusetrag (TD-5108)

 5-Methoxy-Dimethyltryptamine Dry-Powder Intranasal (BPL-003)

 Xaprila (Xaliproden)

 Naronapride (ATI-7505)

 ML-004

 5-Methoxy-Dimethyltryptamine Injection (GH002)

 ATHX-105

 LY2590443

 N, N-Dimethyltryptamine (AP-188)

 Dihydroergotamine Mesylate

Clinical Activity and Developments of Serotonin Receptor Agonist:

Till July 2023, more than 15 companies have approximately 16 molecules targetting the many CNS disorders. For these molecules, more than 60 clinical trials are being conducted; most are in phase-2 and phase-3 clinical trials by players across the globe. For instance,

• In March 2020, Zogenix received an FDA grant for an expanded indication of its Fintepla (Fenfluramine) based on the global, randomized, placebo-controlled Phase 3 clinical trial in 263 patients with LGS (age 2-35 years) data for the treatment of seizures.
• In October 2022, MAPS completed phase 3, a randomized, double-blind, placebo-controlled, multi-site study of the efficacy and safety of manualized MDMA (Midomafetamine) Assisted psychotherapy for the treatment of severe posttraumatic stress disorder.