NBI-6024

Altered Peptide Ligand (APL) / Tolerogenic PeptideRx: InvestigationalCompound: Investigational

Also known as: altered peptide ligand insulin B chain, Insulin B9-23 APL, NBI-6024

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

NBI-6024 is a synthetic altered peptide ligand designed to induce antigen-specific immune tolerance in type 1 diabetes mellitus (T1DM). By mimicking but altering key residues of the insulin B9-23 epitope, it aims to tolerize autoreactive T cells targeting pancreatic beta cells without generalized immunosuppression. Clinical trials (Phase I and II) were conducted in new-onset T1DM patients, with mixed efficacy results.

Mechanism of Action

NBI-6024 is an altered peptide ligand derived from the immunodominant insulin B-chain epitope (B9-23). It binds to HLA-DR4 and related MHC class II molecules and engages autoreactive T-cell receptors, inducing partial agonism or anergy in insulin-reactive CD4+ T cells, thereby promoting immune tolerance and reducing autoimmune destruction of pancreatic beta cells.

Routes of Administration

Subcutaneous

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

Contraindications

  • Hypersensitivity to insulin peptide sequencesAllergy/HypersensitivityHigh
  • Active systemic infectionInfectiousModerate
  • Concomitant immunosuppressive therapyDrug Interaction / ImmunologicalModerate

Adverse Effects

  • Hypersensitivity reactionsImmunologicUncommon
  • Flu-like symptomsSystemic/ImmunologicalUncommon
  • Injection site reactionsLocalCommon

Drug Interactions

  • Insulin (exogenous)Low
  • Immunosuppressants (e.g., cyclosporine, corticosteroids)Moderate

Population Constraints

  • HLA-DR4 negative individualsGenetic / ImmunologicalRelative
  • Pregnant or breastfeeding womenReproductiveRelative
  • Children under 18PediatricRelative

Regulatory Status

  • European UnionUnknownNo EMA approval or active registration identified.
  • United StatesInvestigationalCompleted Phase I and Phase II trials under IND; not approved by FDA. Development by Neurocrine Biosciences appears discontinued.
  • United KingdomUnknownNo MHRA approval identified.

NBI-6024 was investigated by Neurocrine Biosciences. Phase II clinical trials in new-onset type 1 diabetes were completed, but the compound has not received regulatory approval in any jurisdiction. Development appears to have been discontinued.

Evidence & Sources

No sources recorded yet.

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