Edratide

Summary

Edratide (also known as hCDR1) is an investigational immunomodulatory peptide derived from the CDR1 region of a human anti-DNA monoclonal antibody. It was primarily developed for the treatment of systemic lupus erythematosus (SLE). Clinical trials demonstrated some immunological activity but the compound did not meet primary endpoints in Phase II/III studies.

Mechanism of Action

Edratide is a synthetic peptide that modulates T-cell activity by competing with DNA for binding to anti-DNA antibodies and by inducing regulatory T cells, thereby downregulating pathogenic autoimmune responses in systemic lupus erythematosus (SLE). It is derived from the complementarity-determining region (CDR) of a human anti-DNA antibody.

Routes of Administration

Goals & Uses

• Reduction of anti-dsDNA antibody titersImmunological Biomarker ModulationModerate
• Reduction of lupus nephritisOrgan ProtectionLow
• Reduction of SLE disease activityAutoimmune/InflammatoryModerate
• Induction of regulatory T cellsImmunomodulationModerate

Contraindications

• Active serious infectionsInfectiousModerate
• Hypersensitivity to edratide or any excipientsAllergyHigh

Adverse Effects

• Flu-like symptomsSystemic/ImmunologicalUncommon
• Injection site reactionsLocalCommon
• HeadacheNeurologicUncommonPain in the head or upper neck

Drug Interactions

• Immunosuppressants (e.g., mycophenolate mofetil, azathioprine)Moderate
• CorticosteroidsLow

Population Constraints

• Pediatric patientsAgeRelative
• Pregnant womenReproductiveRelative
• Patients with severe renal impairmentOrgan ImpairmentRelative

Regulatory Status

• European UnionInvestigationalClinical trials conducted in Europe; no EMA approval granted.
• United StatesInvestigationalEvaluated in clinical trials under IND; never received FDA approval. Development discontinued.

Edratide has not received regulatory approval in any major jurisdiction. It was evaluated in Phase II clinical trials for SLE primarily by Teva Pharmaceutical Industries. Development appears to have been discontinued following failure to meet primary clinical endpoints.

Evidence & Sources

No sources recorded yet.