A CNS-Focused Precision
Medicine Company

Rich Pipelines of First-in- Class CNS Assets
Lead Program in Phase 3, Psychiatric Drug Liafensine



Validated Innovative Model of Reviving the Abandoned Medicines through Biomarkers Strategies

Denovo Neuroscience is revolutionizing psychiatric treatment by developing precision medicines for CNS diseases. It has four first-in-class CNS programs with the lead asset, liafensine, a biomarker guided antidepressant, in phase 3 development in treatment-resistant depression (TRD).


Liafensine is a first–in–class triple reuptake inhibitor that simultaneously targets the serotonin, norepinephrine and dopamine transporters. Through its proprietary, big-data–enabled DGM™ biomarker discovery platform, Denovo identified a novel genetic biomarker in the ANK3 gene that predicts liafensine's efficacy in patients with TRD. In a prospective, biomarker-guided global phase 2b study, liafensine demonstrated robust efficacies in treating ANK3 biomarker-positive patients with TRD - one of the toughest indications to treat.


This work represents the first successful demonstration of precision medicine in psychiatry and validates Denovo’s innovative strategy of rescuing and advancing previously discontinued medicines through biomarker-driven development.

DB104 (liafensine)

  • Having robust efficacy in ANK3+ patients with TRD in the first pivotal study, liafensine just needs a single phase 3 study to NDA filing and it may become the 1st precision medicine in psychiatry

    Rich Pipeline Addressing Major Unmet Needs in CNS Disorders

    Despite decades of research and significant industry investment, many central nervous system (CNS) conditions still lack effective treatment options. Precision, biomarker-guided therapies are expected to deliver better outcomes, and Denovo’s core strength lies in its proprietary biomarker discovery platform that identifies the patients most likely to benefit. Denovo is advancing a pipeline of first-in-class CNS therapeutics designed to meet these substantial unmet medical needs via the biomarker approach employed in liafensine’s success.


    Beyond liafensine, Denovo’s CNS portfolio includes:


    • DB103 – an mGluR2/3 agonist for schizophrenia paused at phase 3
    • DB105 – an α2C adrenoceptor antagonist for Alzheimer’s paused at phase 2b
    • DB109 – a serotonin receptor antagonist for Alzheimer’s paused at phase 3


    All three programs are first-in-class, orally administered therapeutics supported by extensive clinical data, reinforcing Denovo’s position as a leader in biomarker-guided CNS drug development.

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    News

    A Landmark Pivotal Study Applying Precision Medicine to Psychiatry with Denovo’s DB104 (liafensine) for Treatment-Resistant Depression Published in JAMA Psychiatry

    September 11, 2025
    Denovo to Participate in Upcoming Investor Events

    Aug 14 , 2025
    Denovo Enters into an Exclusive Out-License Agreement with Chuang Yi Global Asset Management Co., Ltd. for Biomarker-Guided DB104 (liafensine) in Patients with Treatment-Resistant Depression (TRD) in Taiwan

    Jun 23 , 2025
    Denovo Announces Formation of Neuroscience Scientific Advisory Board to Advance Precision Medicine in Depression

    Jun 06 , 2025
    Denovo Announces a Major Breakthrough in Treatment Resistant Depression with Precision Medicine

    Apr 03 , 2024