Dapirolizumab pegol
Also known as: anti-CD40L Fab-PEG, CDP7657, Dapirolizumab pegol, DZS-SLE, RG786
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Summary
Dapirolizumab pegol is a PEGylated humanized Fab' fragment targeting CD40L, investigated for systemic lupus erythematosus and other autoimmune diseases.
Mechanism of Action
Binds CD40 ligand (CD154) and blocks CD40‑CD40L interaction, inhibiting T‑cell dependent B‑cell activation
Routes of Administration
Goals & Uses
- Reduction of lupus flaresAutoimmune/InflammatoryModerate
- Rheumatoid arthritisAutoimmune DiseaseLow
- Reduction of autoantibody titers (anti-dsDNA)Biomarker/SerologicalModerate
- Reduction of SLE disease activityAutoimmune/InflammatoryModerate
- Steroid-sparing effect in SLEAutoimmune/InflammatoryLow
- Systemic lupus erythematosusAutoimmune DiseaseModerate
- Treatment of lupus nephritisRenal/AutoimmuneLow
Contraindications
- Hypersensitivity to dapirolizumab pegol or PEGAllergyHigh
- Known hypersensitivity to dapirolizumab pegol or PEGImmunologicHigh
- Active serious infectionsInfectiousHigh
- Active tuberculosisInfectiousHigh
Adverse Effects
- NasopharyngitisInfectiousCommon
- HeadacheNeurologicCommonPain in the head or upper neck
- Thromboembolic eventsCardiovascularRare
- Infections (upper respiratory, urinary tract)InfectiousCommon
- Infusion‑related reactionsGeneralCommon
- Serious infectionsInfectiousUncommon
- InfectionsImmunologicUncommon
- Infusion-related reactionsHypersensitivityUncommon
Drug Interactions
- Live vaccinesHigh
- Other immunosuppressants (mycophenolate, azathioprine, cyclophosphamide)Moderate
- Immunosuppressive agentsModerate
- CorticosteroidsLow
Population Constraints
- PregnancyReproductive SafetyRelative
- Patients with history of recurrent serious infectionsInfectiousRelative
- Pediatric patientsAgeRelative
- Pregnant womenReproductiveRelative
- Renal impairment (severe)RenalRelative
Regulatory Status
- European UnionInvestigationalNot authorized by EMA.
- United StatesInvestigationalNo FDA approval; clinical trials ongoing or discontinued.
- United KingdomInvestigationalNot approved by MHRA.
Development halted after phase II due to safety concerns; not approved in any major jurisdiction.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Dapirolizumab pegol?
Dapirolizumab pegol is a PEGylated humanized Fab' fragment targeting CD40L, investigated for systemic lupus erythematosus and other autoimmune diseases.
What is Dapirolizumab pegol used for?
Dapirolizumab pegol is educationally associated with: Reduction of lupus flares, Rheumatoid arthritis, Reduction of autoantibody titers (anti-dsDNA), Reduction of SLE disease activity, Steroid-sparing effect in SLE, Systemic lupus erythematosus, Treatment of lupus nephritis. Educational only — not medical advice.
How is Dapirolizumab pegol administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of Dapirolizumab pegol?
Reported adverse effects include: Nasopharyngitis, Headache, Thromboembolic events, Infections (upper respiratory, urinary tract), Infusion‑related reactions, Serious infections, Infections, Infusion-related reactions. This list is not exhaustive — consult a qualified clinician.
Who should avoid Dapirolizumab pegol?
Recorded contraindications: Hypersensitivity to dapirolizumab pegol or PEG, Known hypersensitivity to dapirolizumab pegol or PEG, Active serious infections, Active tuberculosis. Consult a qualified clinician before use.