Advancements in precision medicine and pharmacogenomics are shaping this market by enabling selective targeting of serotonin receptor subtypes such as 5-HT2A and 5-HT2C. These innovations not only reduce side effects but also significantly improve patient safety and treatment efficacy. Personalized approaches that identify patients most likely to respond are accelerating clinical adoption and drug development.
DelveInsight, a leading healthcare business consulting and market research firm, has released its latest report, “5-HT2 Agonist Pipeline Insight 2025.” The comprehensive study highlights the remarkable progress being made in the 5-HT2 agonist clinical trial landscape, where over 20 pharmaceutical and biotech companies are actively advancing more than 22 drug candidates across multiple stages of development.
Download a sample of DelveInsight’s 5-HT2 Agonist Pipeline Insight 2025 report to explore in-depth pipeline analysis, company profiles, and emerging therapies shaping the future of psychiatry and neurology. @ 5-HT2 Agonist Pipeline Report
5-HT2 agonist Therpeutic and Competitive Landscape
According to DelveInsight’s analysis, the 5-HT2 agonist pipeline space is expanding at a rapid pace, with more than 20 active players driving innovation in psychiatric, neurological, and metabolic disorders.
Some of the most prominent 5-HT2 agonist companies in this segment include:
- Cybin
- Reunion Neuroscience
- BetterLife Pharma
- Gilgamesh Pharmaceuticals
- Harmony Biosciences
- MindMed
- ATAI Life Sciences N.V.
- Reviva Pharmaceuticals
- Beckley Psytech
- MindBio Therapeutics
These companies are spearheading efforts to design safer, more selective, and highly effective 5-HT2 agonists.
Promising pipeline assets include CYB003, RE104, BETR-001, GM2505, EPX-100, MM120, EMP 01, Brilaroxazine, Psilocybin infusion, and MB-22001, among others. Each of these candidates targets key indications ranging from major depressive disorder (MDD) and generalized anxiety disorder (GAD) to drug-resistant epilepsy, metabolic diseases, and cluster headaches.
Gain exclusive access to the complete competitive landscape of 5-HT2 agonists – request the full report today and stay ahead in pipeline intelligence. @ 5-HT2 Agonist Therapeutics
Recent Key Developments in 5-HT2 agonist
The report highlights several major breakthroughs in the past year that reinforce the growth trajectory of this pipeline:
- August 2025 - Bright Minds Biosciences, Inc. (“Bright Minds,” “BMB” or the “Company”) (NASDAQ: DRUG), a pioneering company focused on developing highly selective 5-HT2 agonists for the treatment of drug-resistant epilepsy, depression, and other central nervous system (CNS) disorders, announced that the Company will present at the upcoming conferences.
- August 2025 - AbbVie (NYSE: ABBV) and Gilgamesh Pharmaceuticals Inc. ("Gilgamesh") today announced a definitive agreement under which AbbVie will acquire Gilgamesh's lead investigational candidate, currently in clinical development for the treatment of patients with moderate-to-severe major depressive disorder (MDD). Psychedelic compounds, including 5-HT2A receptor agonists, have gained recognition as potential treatments for mental health disorders, such as MDD, because of their demonstrated rapid, robust and durable antidepressant effects. However, existing agents in this class are hampered by their long duration of psychoactive experience.
- May 2025 - Gilgamesh Pharmaceuticals, a clinical-stage neuroscience company developing innovative, best-in-class new chemical entities (NCEs) that transform the treatment paradigm for psychiatric diseases, today announced Phase 2a results for GM-2505, a novel, rapid-acting 5-HT2A receptor agonist and 5-HT releaser in development for the treatment of patients with moderate-to-severe MDD.
- December 2024 – Mind Medicine announced that MM120 ODT, a pharmaceutically optimized form of LSD, had been granted an Innovation Passport under ILAP by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for its potential in treating GAD.
- October 2024 – Lundbeck A/S and Longboard Pharmaceuticals, Inc. signed a landmark acquisition deal worth USD 60.00 per share, strengthening Lundbeck’s CNS drug portfolio.
- October 2024 – Bright Minds Biosciences Inc. reported positive preclinical data for BMB-201, a highly selective 5-HT2 agonist for epilepsy, depression, and other CNS disorders, in collaboration with the U.S. National Institute of Health.
- March 2024 – Mind Medicine secured FDA Breakthrough Therapy Designation for MM120 (lysergide d-tartrate) in the treatment of GAD. Results from its Phase 2b trial showed statistically significant durability of effect over 12 weeks, positioning MM120 as a strong late-stage contender.
Don’t miss critical pipeline updates from companies like Cybin, MindMed, Reunion Neuroscience, and others. Connect with our analysts to learn how these advancements could impact your business decisions @ 5-HT2 Agonist Clinical Trials
Understanding 5-HT2 Agonists
5-HT2 agonists are a class of drugs that selectively bind to and activate the 5-HT2 receptors, a subgroup of serotonin receptors critical in regulating mood, cognition, appetite, and sensory processing. The receptor family is composed of three primary subtypes: 5-HT2A, 5-HT2B, and 5-HT2C.
By triggering intracellular pathways such as phospholipase C (PLC), protein kinase C (PKC), and mitogen-activated protein kinase (MAPK), 5-HT2 agonists influence diverse physiological functions. Their therapeutic promise spans psychiatry, neurology, cardiology, and metabolic health.
- Psychiatry: 5-HT2A agonists, including psilocybin and LSD, have shown clinical potential in treating depression and anxiety.
- Neurology: 5-HT2B and 5-HT2C agonists are under investigation for migraine management and epilepsy.
- Metabolic Disorders: 5-HT2C agonists demonstrate appetite-suppressing properties, positioning them as candidates for obesity management.
- Cardiology: 5-HT2B agonists are being studied for cardioprotective benefits in heart failure.
However, these therapies require careful dosing and monitoring due to potential psychotropic effects and safety concerns, underlining the need for rigorous clinical trials.
5-HT2 agonist Pipeline Snapshot
A closer look at late- and mid-stage clinical assets reveals exciting progress:
CYB003 – Cybin (Phase III, Major Depressive Disorder, Oral) CYB003 is an investigational oral therapy being developed by Cybin for the treatment of major depressive disorder (MDD). As a Phase III candidate, it has reached an advanced stage of clinical testing, demonstrating both safety and potential efficacy in earlier trials. The oral route of administration makes it convenient for patients, which is particularly important in chronic conditions like depression. CYB003 aims to provide an alternative to existing antidepressants by targeting serotonin receptors in a more selective and potentially more effective manner, addressing the unmet need for faster-acting and better-tolerated treatments in MDD.
MM120 – MindMed / University of Basel (Phase III, Anxiety Disorders, Oral) MM120, developed by MindMed in collaboration with the University Hospital of Basel, is currently in Phase III trials for the treatment of anxiety disorders. The drug is an optimized form of lysergide d-tartrate (LSD) designed for pharmaceutical use. Importantly, MM120 has already received FDA Breakthrough Therapy Designation for generalized anxiety disorder (GAD), highlighting its therapeutic potential. Administered orally, MM120 has shown promising results in maintaining efficacy over extended periods, giving hope to patients with anxiety disorders who often face limitations with conventional therapies.
RE104 – Reunion Neuroscience (Phase II, Postnatal Depression, Subcutaneous) RE104, a drug from Reunion Neuroscience, is being evaluated in Phase II clinical trials for postnatal depression, a serious condition affecting new mothers and their families. Administered via a subcutaneous injection, RE104 is designed to provide rapid relief by targeting serotonin receptors in the brain. The use of psychedelics or serotonin-based therapies in postnatal depression is a novel approach, and early studies suggest that RE104 could significantly reduce depressive symptoms and improve overall maternal well-being. Its development reflects a growing interest in specialized mental health treatments tailored to specific populations.
GM2505 – Gilgamesh Pharmaceuticals (Phase II, Major Depressive Disorder, Intravenous) GM2505, developed by Gilgamesh Pharmaceuticals, is an intravenous therapy currently in Phase II clinical trials for major depressive disorder (MDD). Unlike oral or subcutaneous options, IV administration allows for controlled and rapid delivery of the drug, which may be beneficial for acute treatment scenarios. GM2505 is part of a wave of next-generation psychedelic-inspired compounds aimed at improving both efficacy and safety compared to traditional antidepressants. If successful, GM2505 could offer an alternative for patients with treatment-resistant depression, providing quicker symptom relief and potentially fewer side effects.
EPX-100 – Epygenix Therapeutics / UCSF (Phase II, Dravet & Lennox-Gastaut Syndromes, Oral) EPX-100, being developed by Epygenix Therapeutics in collaboration with the University of California, San Francisco (UCSF), is in Phase II clinical development for Dravet syndrome and Lennox-Gastaut syndrome, two severe forms of childhood epilepsy. The drug is delivered orally, making it more practical for pediatric use. By targeting serotonin receptors, EPX-100 represents a unique therapeutic approach for these difficult-to-treat epileptic conditions. Early clinical results suggest the potential to reduce seizure frequency and improve quality of life for patients and caregivers who currently have limited treatment options.
BETR-001 – BetterLife Pharma (Preclinical, MDD, PTSD, Neuropathic Pain, Cluster Headache) BETR-001 is a preclinical candidate from BetterLife Pharma, being investigated for a broad range of indications including major depressive disorder (MDD), post-traumatic stress disorder (PTSD), neuropathic pain, and cluster headaches. Although still in early development and not yet tested in humans, BETR-001 is designed to harness the benefits of 5-HT2 receptor modulation while minimizing psychedelic side effects. If successful, it could represent a versatile therapy applicable across multiple psychiatric and neurological disorders. Its preclinical status means much of its potential is yet to be proven, but it reflects the broad interest in 5-HT2 agonists for diverse unmet medical needs.
Explore detailed drug profiles, clinical trial insights, and future growth prospects. Schedule a demo with our experts and uncover strategic opportunities in the 5-HT2 agonist space. @ 5-HT2 Agonist Drugs and Therapies
5-HT2 agonist Report Scope and Insights
DelveInsight’s 5-HT2 Agonist Pipeline Insight 2025 offers a global coverage of the therapeutic domain. The report delivers:
- Pipeline Coverage by Stage: Discovery, Preclinical, Phase I–III, Pre-registration
- Therapeutic Assessment: Mono, Combination, and Hybrid therapies
- Route of Administration: Oral, Subcutaneous, Intravenous, Intraocular, Topical, Transdermal, and more
- Molecule Type: Small molecules, peptides, and oligonucleotides
- Competitive Landscape: Active vs. dormant pipeline assets, collaborations, licensing deals, and M&A activities
5-HT2 agonist Market Outlook and Growth Potential
The demand for safer, effective treatments for psychiatric, neurological, and metabolic disorders is fueling investment into the 5-HT2 agonist pipeline. Precision medicine, AI-driven drug discovery, and advanced trial methodologies are accelerating development timelines.
However, challenges such as regulatory scrutiny, psychotropic side effects, and ethical considerations around psychedelics remain key hurdles. Companies that successfully navigate these complexities stand to capture significant market share in the next decade.
Transform your market strategy with DelveInsight’s expertise. Contact us today to access tailored competitive intelligence on the evolving 5-HT2 agonist pipeline. @ 5-HT2 Agonist Competitive Landscape
Analyst Commentary
"The 5-HT2 agonist clinical pipeline represents one of the most promising frontiers in neuroscience and psychiatric drug development. With over 20 companies actively pursuing diverse therapeutic avenues, the field is advancing at an unprecedented pace. If ongoing trials deliver positive outcomes, 5-HT2 agonists could transform the treatment landscape for mental health, epilepsy, and beyond." — DelveInsight Analyst Team
About DelveInsight
DelveInsight is a leading Business Consulting and Market Research firm focused exclusively on the life sciences sector. With deep expertise in competitive intelligence, market research, and pipeline analysis, the company provides actionable insights to pharmaceutical, biotech, and medical device clients worldwide.
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