5-HT2 Agonist - Pipeline Insight, 2025

This “5-HT2 Agonist - Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 22+ pipeline drugs in 5-HT2 Agonist pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

5-HT2 Agonist: Understanding

5-HT2 Agonist: Overview

5-HT2 (5-hydroxytryptamine 2) agonists are a class of drugs that specifically target and activate the 5-HT2 receptors, which are a subtype of serotonin receptors found in the central nervous system. Serotonin, also known as 5-hydroxytryptamine (5-HT), is a neurotransmitter involved in various physiological processes, including mood regulation, cognition, and sensory perception. The 5-HT2 receptor subfamily consists of three main subtypes: 5-HT2A, 5-HT2B, and 5-HT2C.

5-HT2 agonists bind to and activate the 5-HT2 receptors, leading to a cascade of intracellular signaling events. These receptors are G protein-coupled receptors (GPCRs), and their activation can modulate the activity of various downstream signaling pathways, including phospholipase C (PLC), protein kinase C (PKC), and mitogen-activated protein kinase (MAPK) pathways.

5-HT2 receptors are integral membrane proteins with seven transmembrane domains that mediate the effects of serotonin and other ligands. Their structure enables ligand binding, G protein coupling, and activation of intracellular signaling pathways, leading to diverse physiological and pharmacological responses. Understanding the structure and function of 5-HT2 receptors is essential for the development of therapeutic agents targeting these receptors and for elucidating their roles in health and disease.

Targeting 5-HT2 receptors with agonists has emerged as a promising therapeutic approach across various medical domains due to the receptors' pivotal roles in modulating physiological processes. One notable application lies in psychiatry, where 5-HT2A agonists have shown potential as antidepressants and anxiolytics. Compounds like psilocybin, found in psychedelic mushrooms, and lysergic acid diethylamide (LSD) have demonstrated efficacy in treating mood disorders and anxiety when administered under controlled settings. Additionally, 5-HT2C agonists are being explored for their potential in managing obesity and related metabolic disorders by regulating appetite and energy balance. In the realm of neurology, 5-HT2B and 5-HT2C agonists are investigated for their role in migraine management due to their vasoconstrictive properties. Moreover, 5-HT2B agonists are being researched for their potential cardioprotective effects in conditions like heart failure. Despite their therapeutic promise, the clinical utility of 5-HT2 agonists necessitates careful consideration of their psychotropic effects and potential adverse reactions, underscoring the importance of rigorous research and controlled administration in optimizing their therapeutic benefits.

“5-HT2 Agonist - Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the mechanism of action. A detailed picture of the 5-HT2 Agonist pipeline landscape is provided which includes the disease overview and 5-HT2 Agonist treatment guidelines. The assessment part of the report embraces, in depth 5-HT2 Agonist commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, 5-HT2 Agonist collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence 5-HT2 Agonist R&D. The therapies under development are focused on novel approaches to treat/improve 5-HT2 Agonist.

5-HT2 Agonist Emerging Drugs Chapters

This segment of the 5-HT2 Agonist report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

5-HT2 Agonist Emerging Drugs

CYB003: Cybin

CYB003 is a proprietary deuterated molecule related to psilocybin, which is part of a family of molecules called indolamines that includes more common neurotransmitters like serotonin. CYB003 is a new chemical entity (NCE) and has been granted FDA Breakthrough Therapy Designation for the adjunctive treatment of Major Depressive Disorder (MDD). Currently, the drug is in the Phase II stage of its development for the treatment of MDD. The company is planning to initiate a Phase III pivotal multinational trial of CYB003 in MDD by mid-2024.

RE104: Reunion Neuroscience

RE104 is a potential best-in-class, short duration, patented prodrug of 4-OH-DiPT, a psilocybin-like compound. RE104 targets the serotonin 2A receptor (5HT2AR), which is the recognized target for the antidepressant effects of psychedelic compounds. RE104 is protected under U.S. Patent No. 11,292,765 issued on April 5, 2022 (priority June 30, 2020), with claims for composition of matter, methods of manufacturing, formulations, and methods of use for a genus of hemiester tryptamines, including RE104, which could provide protection up to June 30, 2041. Currently, the drug is in the Phase II stage of its development for the treatment of Postpartum Depression.

BETR-001: BetterLife Pharma

BETR-001 is BetterLife’s proprietary 2-bromo-LSD, a non-hallucinogenic derivative of lysergic acid diethylamide (LSD). . Recent milestones include the completion of IND-enabling cardio-pulmonary GLP studies, with metabolism and genotoxicity GLP studies set to commence shortly. To bolster these efforts, the company secured a substantial USD 1.168 million convertible debenture financing. Furthermore, they've expedited the US patent process for BETR-001 and other LSD derivatives to streamline regulatory pathways. BETR-001 is currently undergoing non-clinical studies aimed at achieving Investigational New Drug (IND) status, targeting conditions like treatment-resistant depression, post-traumatic stress disorder, and cluster headaches, where effective treatments are lacking.

5-HT2 Agonist: Therapeutic Assessment

This segment of the report provides insights about the different 5-HT2 Agonist drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in 5-HT2 Agonist

There are approx. 20+ key companies which are developing the therapies for 5-HT2 Agonist. The companies which have their 5-HT2 Agonist drug candidates in the most advanced stage, i.e. Phase II include, Cybins.

Phases

The report covers around 22+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

5-HT2 Agonist pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

5-HT2 Agonist: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses 5-HT2 Agonist therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging 5-HT2 Agonist drugs.

5-HT2 Agonist Report Insights

• 5-HT2 Agonist Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

5-HT2 Agonist Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing 5-HT2 Agonist drugs?
• How many 5-HT2 Agonist drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of 5-HT2 Agonist?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the 5-HT2 Agonist therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for 5-HT2 Agonist and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Cybin
• Reunion Neuroscience
• BetterLife Pharma
• Gilgamesh Pharmaceuticals
• Epygenix
• Mindmed

Key Products

• CYB003
• RE104
• BETR-001
• GM2505
• EPX-100
• MM120

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