What Clexio Biosciences does

Clexio Biosciences Ltd. is a clinical-stage pharmaceutical company founded in Israel (Yokne'am headquarters with a secondary office in Petach Tikva) that designs novel small-molecule drugs based on validated mechanisms of action in neuropsychiatry. Its pipeline targets two indications with documented unmet need: Major Depressive Disorder (MDD) and Epilepsy. The lead asset, CLE-100, is an oral NMDA receptor antagonist tablet (esketamine-class mechanism) with high affinity to the PCP site of the NMDA receptor, being developed as an add-on treatment for MDD patients with inadequate response to standard antidepressants; it is currently in Phase 2 multicenter studies in the United States (SOLEO study, initiated April 2024, 50% enrolled by December 2024), following the earlier CLEO Phase 2 proof-of-concept study in 2023. The second asset, CLE-043, is a KV7.2/3 channel opener in preclinical development for Epilepsy and MDD, with a lead compound identified. CLE-100 is protected by three issued US method-of-use patents and three additional allowed US patents, and the program has been supported by patient-advocacy engagement (DBSA) and translational neuroscience partnerships (NeuroKaire).

The company is privately held, pre-revenue, and operates with an 11-50 person organization. Its commercial model will ultimately rely on pharmaceutical drug sales following regulatory approval, with the addressable patient population being adults with treatment-resistant MDD — a segment in which approximately one-third of patients do not achieve remission even after four antidepressant trials, according to the STAR*D data Clexio cites. The team is composed largely of former Teva Pharmaceuticals executives across R&D, clinical, regulatory, legal, and business development functions, complemented by senior leaders with FDA, Roche-Genentech, Merck, and Novo Nordisk backgrounds. The go-to-market is currently clinical-trial-driven: US-based Phase 2 site activation, ClinicalTrials.gov recruitment (NCT06340958), patient advocacy partnerships, and scientific conference presentations (ASCP 2023, CNS Summit 2024, Oxford Conference on Ketamine and Related Compounds). Clexio discloses no commercial customers, no licensing revenue, and no external funding rounds in the available data, making its economics entirely dependent on continued clinical progress and future capital formation.

Name

Clexio Biosciences

Legal name

Clexio Biosciences Ltd.

Website

https://clexio.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

11–50 employees

Short description

Clexio Biosciences is a clinical-stage Israeli pharmaceutical company developing CLE-100 (an oral NMDA receptor antagonist in Phase 2 trials) and CLE-043 (a KV7.2/3 channel opener in preclinical) for patients with treatment-resistant Major Depressive Disorder and Epilepsy.

Ownership category

akta.pro rank

Headquarters

HQ city

Jerusalem

HQ country

Israel

HQ region

Middle East

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Pharmaceutical Drug Sales: Pre-revenue clinical-stage pharmaceutical company. Revenue will be generated through commercialization of novel drugs following FDA and regulatory approval. The company is developing CLE-100 for Major Depressive Disorder and CLE-043 for Epilepsy and MDD.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Clexio Biosciences is a clinical-stage pharmaceutical company designing novel drug candidates based on validated Mechanisms of Action in Neuropsychiatry. Its lead asset CLE-100 is an NMDA receptor antagonist tablet in Phase 2 trials as an add-on therapy for patients with Major Depressive Disorder who have inadequate response to standard antidepressants. Its second asset CLE-043 is a KV7.2/3 channel opener in preclinical development for Epilepsy and MDD.

Product overview

Clexio is a multi-asset clinical-stage pharmaceutical company developing two novel drug candidates based on validated Mechanisms of Action in Neuropsychiatry. The lead product, CLE-100 (an NMDA antagonist tablet), is currently in Phase 2 multicenter studies in the United States for Major Depressive Disorder. The second candidate, CLE-043 (a KV7.2/3 channel opener), is in preclinical development for Epilepsy and MDD. Both products target unmet needs in patients who have not found effective solutions for their neuropsychiatric conditions.

Differentiator

Problem solved

Functional benefit

Products and services

• CLE-100 CLE-100 is an investigational NMDA receptor antagonist tablet developed as an add-on treatment for patients with Major Depressive Disorder who have inadequate response to standard antidepressant therapy, targeting a more rapid antidepressant effect than most current medications.
• CLE-043 CLE-043 is a KV7.2/3 channel opener being developed for the treatment of Epilepsy and Major Depressive Disorder; currently in preclinical development with lead compound identified.

Quantifiable outcome

• Phase 2 CLEO study showed good safety profile and promising efficacy in subgroup of subjects enrolled during post-acute Covid period
• +1 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Two partnerships are on record, tiered minor and core.

• NeuroKaireminorStrategic or Co-development Partner · 1 November 2024Collaboration on profiling drug response mechanisms and patient sub-populations through readouts from a biobank of patient-derived neurons. Collaboration presented at CNS Summit 2024.
• Depression Bipolar Support Alliance (DBSA)coreStrategic or Co-development Partner · 1 January 2024Clexio partnered with the Depression Bipolar Support Alliance (DBSA) to evaluate the readability of the Informed Consent Form (ICF) designed for their Phase 2 trial in patients with Major Depressive Disorder. The feedback from patients enabled modifications to better explain trial procedures and ensure clear, concise information.

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Janssen Pharmaceuticals (Johnson & Johnson): Markets Spravato (esketamine), an FDA-approved NMDA antagonist for treatment-resistant depression. Represents the dominant incumbent CLE-100 must differentiate against.

Emerging players

• COMPASS Pathways: Developing psilocybin-based therapy for treatment-resistant depression. Competes for the same TRD patient population with a novel mechanism rather than NMDA antagonism.
• atai Life Sciences: Clinical-stage mental health platform developing psychedelic and non-psychedelic therapies for depression and other neuropsychiatric indications. Competes for the same underserved MDD patient pool with novel mechanisms.

Direct peers

• Neumora Therapeutics: Clinical-stage neuroscience company developing precision therapeutics for brain diseases including depression. Comparable in stage, indication focus, and pipeline breadth.
• Axsome Therapeutics: Approved Auvelity (dextromethorphan/bupropion), an NMDA-receptor-targeting therapy for major depressive disorder. Closest mechanistic and indication-level peer to Clexio's CLE-100 program.
• Xenon Pharmaceuticals: Developing XEN1101, a KV7.2/3 channel opener for epilepsy and MDD — directly comparable mechanism to Clexio's CLE-043 asset and a benchmark for that program's clinical pathway.
• Sage Therapeutics: CNS-focused biopharma commercializing Zurzuvae (zuranolone) for postpartum depression and pursuing other neuropsychiatric indications. Comparable clinical-stage CNS pipeline and commercialization model.
• Biohaven Pharmaceutical: Neurology and psychiatry-focused biopharma with programs in depression and other CNS indications. Similar indication targeting and clinical-stage profile post its spin-out restructuring.
• Karuna Therapeutics (acquired by Bristol Myers Squibb): Developed xanomeline-trospium (Cobenfy) for schizophrenia and has CNS pipeline activity. Recent acquisition by BMS illustrates the strategic M&A appetite for differentiated CNS assets.
• Cerevel Therapeutics (acquired by AbbVie): Clinical-stage CNS biopharma with pipeline across depression, schizophrenia, and epilepsy; acquired by AbbVie for ~$8.7B. Highly comparable neuroscience pipeline orientation.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/clexio

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Clexio Biosciences