Update: Diasome Presents OPTI-2 Phase 2b Data at the ADA 86th Scientific Sessions
Demonstrates HDV™-Insulin Lispro Maintains Glycemic Control While Reducing Hypoglycemia in Adults with Type 1 Diabetes

Advancing Therapies Where Metabolism Begins

Our HDV™ platform supports a growing pipeline of therapies designed to overcome limitations in today’s most-used metabolic treatments—addressing unmet patient needs in diabetes, obesity, and other cardiometabolic diseases by targeting the portal-hepatic region.

Scientist holding vials in a lab

Our Pipeline

Diasome’s hepatocyte-directed vesicle (HDV™) pipeline is focused on advancing therapies across three key areas:

  • HDV-Insulin Program

    Type 1 Diabetes
    Type 2 Diabetes
    S.C. Injectable

    HDV-Insulin

    HDV-Insulin

    Preclinical
    Phase 2
    PHase 2B
    Phase 3

    Potentially powerful new insulin

    By increasing insulin delivery to the liver, HDV is designed to restore physiologic glucose regulation at mealtime. This approach has been shown to reduce hypoglycemia, improves post-prandial predictability and expand the therapeutic window of rapid-acting insulin.

    Next anticipated milestone: Phase 3 study initiation

    OPTI-2 Phase 2b results presented at ADA 86th Scientific Sessions 2026 showed glycemic control was maintained while also reducing hypoglycemia, supporting Phase 3 advancement and clinical validation of the HDV platform.

    HDV-Insulin OPTI-2 phase 2b trial results: Equivalent glycemic control with less hypoglycemia

    • A1C non-inferiority maintained
    • Statistically significant reductions in hypoglycemia
    • Dramatic reduction in severe hypoglycemic events with HDV-insulin
    • New insight into hypoglycemia burden
    View the Clinical Trial
    See the latest data

  • HDV-GLP-1 and GLP-1/GIP Program

    Type 2 Diabetes
    S.C. Injectable

    HDV-GLP-1

    HDV-GLP-1

    Preclinical
    Phase 2
    PHase 2B
    Phase 3

    Using HDV targeted incretins to access the Gut-Liver-Brain axis

    Intestinal-derived GLP-1 plays an important role in several metabolic processes including brain-mediated satiety signaling and appetite regulation. By targeting GLP-1 to the portal vein we expect to improve efficacy in fat, glucose and weight endpoints, while mitigating off-target side effects.

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    Next anticipated milestone: IND filing

    View the Clinical Trial

  • HDV-Serotonin Program

    Type 2 Diabetes
    ORAL

    HDV-
    Serotonin

    HDV-Serotonin

    Preclinical
    Phase 2
    PHase 2B
    Phase 3

    Addressing insulin resistance in Type 2 Diabetes

    A novel, first-in-class oral therapy designed to replace declining or deficient portal-hepatic serotonin levels, enabling hepatic utilization of insulin.

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    Next anticipated milestone: Tox study completion

    View the Clinical Trial