Dirucotide

Myelin Basic Protein (MBP) Fragment / Immunomodulatory PeptideRx: ResearchCompound: Investigational

Also known as: Dirucotide, MBP 82-98, MBP8298

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

Summary

Dirucotide (MBP8298) is a synthetic myelin basic protein peptide fragment investigated as a disease-modifying agent for secondary progressive multiple sclerosis (SPMS). It aimed to induce immune tolerance against myelin antigens. Phase III trials (MAESTRO-03) failed to meet primary endpoints, halting further development.

Mechanism of Action

Dirucotide is a synthetic peptide corresponding to residues 82–98 of human myelin basic protein (MBP82-98). It induces antigen-specific T-cell tolerance by promoting anergy or apoptosis of autoreactive T-cells that target myelin, thereby reducing inflammatory demyelination in multiple sclerosis.

Routes of Administration

Intravenous

Goals & Uses

  • Reduction of relapse rate in MSNeurological / AutoimmuneLow
  • Slow progression of secondary progressive multiple sclerosisNeurological / AutoimmuneLow
  • Induction of antigen-specific immune toleranceImmunomodulationModerate

Contraindications

  • Known hypersensitivity to dirucotide or any excipientAllergy / HypersensitivityHigh
  • Active systemic infectionInfectiousModerate

Adverse Effects

  • Hypersensitivity reactionsImmunologicRare
  • Flu-like symptomsSystemic/ImmunologicalUncommon
  • Injection site / infusion reactionsLocal/SystemicUncommon

Drug Interactions

  • Immunosuppressants (e.g., corticosteroids, mitoxantrone)Moderate

Population Constraints

  • Pediatric patientsAgeRelative
  • Pregnant or breastfeeding womenReproductiveRelative
  • Patients with severe immunodeficiencyImmune StatusRelative

Regulatory Status

  • European UnionInvestigationalNever received EMA approval; development halted after Phase III failure.
  • United StatesInvestigationalPhase III development discontinued; no NDA filed or approved.
  • United KingdomInvestigationalNo MHRA approval; clinical programme discontinued.

Dirucotide was never approved by any regulatory agency. Phase III clinical development was discontinued after failure to demonstrate efficacy in SPMS in the pivotal MAESTRO-03 trial (results reported ~2011). No approved indications exist in the US, EU, or UK.

Evidence & Sources

No sources recorded yet.

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