Dirucotide
Also known as: AAB‑001, Dirucotide, MBP 82-98, MBP8298, MBP83‑99
Source Dirucotide at Peptiology
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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
Goals & Uses
- Reduction of relapse rate in MSNeurological / AutoimmuneLow
- Slow progression of secondary progressive multiple sclerosisNeurological / AutoimmuneLow
- Multiple SclerosisAutoimmune DiseaseModerate
- Induction of antigen-specific immune toleranceImmunomodulationModerate
Contraindications
- Hypersensitivity to Dirucotide or excipientsAllergyModerate
- Known hypersensitivity to dirucotide or any excipientAllergy / HypersensitivityHigh
- Active systemic infectionInfectiousModerate
Adverse Effects
- Hypersensitivity reactionsImmunologicRare
- Flu-like symptomsSystemic/ImmunologicalUncommon
- Flu‑like symptomsSystemicUncommon
- Injection site painLocalCommonPain at the injection site
- Injection site / infusion reactionsLocal/SystemicUncommon
Drug Interactions
- Immunosuppressants (e.g., corticosteroids)Moderate
- Immunosuppressants (e.g., corticosteroids, mitoxantrone)Moderate
Population Constraints
- Pediatric patientsAgeRelative
- Pregnant or breastfeeding womenReproductiveRelative
- Pregnant womenReproductiveRelative
- Patients with severe immunodeficiencyImmune StatusRelative
Regulatory Status
- European UnionUnapprovedNo marketing authorization; clinical trials conducted under EU Clinical Trial Regulation.
- United StatesInvestigationalIND holder Asterias Biotherapeutics; no FDA approval.
- United KingdomUnapprovedNot licensed by MHRA; used only in research settings.
Investigational New Drug (IND) status in the US; no marketing authorization in EU or UK.
Evidence & Sources
- Journal ArticleLow2008-01-01T00:00:00.000000Z
- Journal ArticleLowDeraos G, et al.2018-01-01T00:00:00.000000Z
- Journal ArticleLowBoudesocque L, et al.2017-01-01T00:00:00.000000Z
Frequently Asked Questions
What is Dirucotide?
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.
What is Dirucotide used for?
Dirucotide is educationally associated with: Reduction of relapse rate in MS, Slow progression of secondary progressive multiple sclerosis, Multiple Sclerosis, Induction of antigen-specific immune tolerance. Educational only — not medical advice.
How is Dirucotide administered?
Recorded routes of administration: Intradermal, Intravenous, Subcutaneous.
What are the potential side effects of Dirucotide?
Reported adverse effects include: Hypersensitivity reactions, Flu-like symptoms, Flu‑like symptoms, Injection site pain, Injection site / infusion reactions. This list is not exhaustive — consult a qualified clinician.
Who should avoid Dirucotide?
Recorded contraindications: Hypersensitivity to Dirucotide or excipients, Known hypersensitivity to dirucotide or any excipient, Active systemic infection. Consult a qualified clinician before use.