NBI-6024
Also known as: altered peptide ligand insulin B chain, Insulin B:9‑23 APL, Insulin B9-23 APL, NBI-6024, NBI‑6024
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Summary
NBI-6024 is an investigational altered peptide ligand (APL) derived from the insulin B‑chain (amino acids 9‑23). It is being studied as an immunomodulatory therapy for recent‑onset type 1 diabetes, with the aim of altering autoreactive T‑cell responses that destroy pancreatic beta‑cells.
Mechanism of Action
The peptide mimics the immunodominant B‑chain epitope recognized by pathogenic Th1 cells. When administered subcutaneously it binds T‑cell receptors and re‑educates the response toward a Th2 phenotype, increasing IL‑5, IL‑4 and IL‑10 while reducing IFN‑γ production. This shift is intended to suppress the autoimmune attack on beta‑cells.
What the Research Shows
Pre‑clinical work in NOD mice showed that subcutaneous NBI‑6024 delayed diabetes onset and reduced disease incidence, correlating with Th2‑type cytokine production. A phase I trial in recent‑onset patients reported dose‑dependent increases in IL‑5 and a reduction of Th1 responses after five bi‑weekly injections, indicating immunomodulation. However, a subsequent randomized, placebo‑controlled phase II trial (188 participants, up to 24 months of monthly dosing) found no preservation of C‑peptide secretion, no reduction in insulin requirements, and no changes in islet antibodies or T‑cell counts. The compound has progressed through several early‑phase studies but has not demonstrated clinical efficacy to date.
Reported Benefits
Evidence from animal models suggests NBI‑6024 can modulate the autoimmune response and delay disease onset. In humans, early phase I data indicated a measurable shift from Th1 to Th2 cytokine profiles, supporting its intended immunological mechanism.
Limitations of the Evidence
The pivotal phase II trial showed no improvement in beta‑cell function or insulin needs, indicating limited clinical benefit. Sample sizes remain modest, and long‑term outcomes are unknown. Safety data are sparse, and the peptide has not achieved regulatory approval for any indication.
Safety Considerations
Published trial reports did not highlight serious adverse events associated with NBI‑6024, but detailed safety assessments were not provided. Consequently, the safety profile remains incompletely characterized, and further monitoring would be required before broader use.
How It Is Administered
NBI‑6024 has been administered by subcutaneous injection. Early studies used five bi‑weekly doses, while later trials employed monthly injections over up to 24 months. Specific formulation details are not disclosed in the cited literature.
Routes of Administration
Goals & Uses
- Reduction of insulin-specific autoreactive T-cell activityImmunologicalModerate
- Immune tolerance induction in type 1 diabetesAutoimmune / ImmunomodulationModerate
- Preservation of beta-cell function (C-peptide)Metabolic / EndocrineLow
- Preserve beta‑cell functionDisease‑modifyingModerate
Contraindications
- Hypersensitivity to insulin peptide sequencesAllergy/HypersensitivityHigh
- Active severe infectionInfectiousModerate
- Active systemic infectionInfectiousModerate
- Concomitant immunosuppressive therapyDrug Interaction / ImmunologicalModerate
Adverse Effects
- Hypersensitivity reactionsImmunologicUncommon
- Flu-like symptomsSystemic/ImmunologicalUncommon
- Injection site reactionsLocalCommon
- Transient flu‑like symptomsSystemicUncommon
- Injection site erythemaLocalCommonRedness at the injection site
Drug Interactions
- Insulin (exogenous)Low
- Immunosuppressants (e.g., cyclosporine, corticosteroids)Moderate
- ImmunosuppressantsModeratePotential interaction with immune pathways or infection risk
Population Constraints
- HLA-DR4 negative individualsGenetic / ImmunologicalRelative
- Pregnant or breastfeeding womenReproductiveRelative
- Children <6 yearsAgeRelative
- Children under 18PediatricRelative
Regulatory Status
- European UnionInvestigationalClinical trial authorization only.
- United StatesInvestigationalIND held; no FDA approval.
- United KingdomUnknownNo MHRA approval identified.
Investigational new drug (IND) status in the US; never received marketing approval in any jurisdiction.
Evidence & Sources
- Journal ArticleModerateWalter M, et al.2009-01-01T00:00:00.000000Z
- Journal ArticleModerateAlleva DG, et al.2006-01-01T00:00:00.000000Z
- Journal ArticleLowBayés M, Rabasseda X, Prous JR2002-01-01T00:00:00.000000Z
- Journal ArticleLowAlleva DG, et al.2002-01-01T00:00:00.000000Z
- Journal ArticleLowGiannoukakis N2002-01-01T00:00:00.000000Z
Frequently Asked Questions
What is the intended therapeutic goal of NBI‑6024?
The peptide is designed to modulate the autoimmune T‑cell response in type 1 diabetes, shifting it from a destructive Th1 profile to a protective Th2 profile in order to preserve pancreatic beta‑cell function.
Has NBI‑6024 been shown to improve blood glucose control?
In a phase II trial, NBI‑6024 did not produce significant differences in C‑peptide levels, insulin requirements, or glycemic control compared with placebo, indicating no measurable clinical benefit in that study.
Are there any known side effects of NBI‑6024?
The published studies did not report serious adverse events, but comprehensive safety data are limited. Potential risks remain uncertain until larger, longer‑term trials are conducted.
How is NBI‑6024 given to patients?
The peptide is delivered by subcutaneous injection. Dosing regimens in trials have ranged from five bi‑weekly injections to monthly administrations for up to two years.
Is NBI‑6024 approved for use in diabetes?
No. NBI‑6024 remains an investigational compound in clinical research and has not received regulatory approval for any therapeutic indication.
What is NBI-6024 used for?
NBI-6024 is educationally associated with: Reduction of insulin-specific autoreactive T-cell activity, Immune tolerance induction in type 1 diabetes, Preservation of beta-cell function (C-peptide), Preserve beta‑cell function. Educational only — not medical advice.
How is NBI-6024 administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of NBI-6024?
Reported adverse effects include: Hypersensitivity reactions, Flu-like symptoms, Injection site reactions, Transient flu‑like symptoms, Injection site erythema. This list is not exhaustive — consult a qualified clinician.
Who should avoid NBI-6024?
Recorded contraindications: Hypersensitivity to insulin peptide sequences, Active severe infection, Active systemic infection, Concomitant immunosuppressive therapy. Consult a qualified clinician before use.