Forigerimod

Immunomodulatory Peptide / Toll Like Receptor InhibitorRx: InvestigationalCompound: Investigational

Also known as: IPP-201101, Lupuzor, P140, P140 peptide

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

Summary

Forigerimod (P140 peptide, IPP-201101) is an investigational phosphopeptide being developed primarily for the treatment of systemic lupus erythematosus (SLE). It selectively targets overactivated immune cells without broadly suppressing the immune system. Phase II and Phase III clinical trials have been conducted, showing signals of efficacy in SLE patients, particularly in reducing disease activity scores.

Mechanism of Action

Forigerimod (P140 peptide) is a phosphopeptide derived from the U1-70K snRNP protein. It binds to HSC70 (heat shock cognate protein 70) and inhibits aberrant MHC class II-mediated autophagy-driven antigen presentation, thereby downregulating overactivated T and B lymphocyte responses characteristic of systemic lupus erythematosus (SLE). It modulates innate immune signaling by interfering with TLR7/TLR9 pathways.

Routes of Administration

Subcutaneous

Goals & Uses

  • Immune modulation without broad immunosuppressionTargeted ImmunotherapyModerate
  • Reduction of anti-dsDNA antibodiesBiomarker ModulationModerate
  • Steroid-sparing effectCorticosteroid ReductionLow
  • Reduction of SLE disease activityAutoimmune/InflammatoryModerate

Contraindications

  • Hypersensitivity to forigerimod or excipientsAllergy / HypersensitivityHigh
  • PregnancyPopulationModeratePotential fetal risk or insufficient safety data
  • Active severe infectionInfectiousHigh

Adverse Effects

  • Hypersensitivity reactionsImmunologicRare
  • Injection site reactionsLocalCommon
  • HeadacheNeurologicUncommonPain in the head or upper neck
  • NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
  • FatigueGeneralUncommonLow energy or tiredness

Drug Interactions

  • HydroxychloroquineLow
  • CorticosteroidsLow
  • Mycophenolate mofetilLow

Population Constraints

  • Pediatric patientsAgeRelative
  • Severe renal impairment / lupus nephritisOrgan ImpairmentRelative
  • Pregnancy and lactationReproductiveRelative

Regulatory Status

  • European UnionInvestigationalNot EMA approved. Clinical trials conducted in EU member states. Orphan designation explored.
  • United StatesInvestigationalNot FDA approved. Studied under IND in Phase II/III trials for SLE (LUPUZOR, ARISE programs).
  • United KingdomInvestigationalNot approved by MHRA. Status mirrors EU investigational classification.

Not approved by FDA, EMA, or other major regulatory agencies as of 2024. Studied under IND/clinical trial frameworks in the US and Europe. Orphan Drug Designation has been explored. Phase IIIARES trial results were mixed.

Evidence & Sources

No sources recorded yet.

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