AMY-101

Complement Inhibitor (compstatin Analogue)Rx: InvestigationalCompound: Investigational

Also known as: AMY101, compstatin Cp40, Cp40

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

Summary

AMY-101 is a next-generation compstatin analogue developed by Amyndas Pharmaceuticals. It is a cyclic peptide inhibitor of complement component C3, offering potent, broad-spectrum complement inhibition. It has been investigated in clinical trials for conditions including periodontitis, COVID-19-associated ARDS, and other complement-mediated inflammatory diseases.

Mechanism of Action

Cyclic peptide that binds to complement component C3 and prevents its cleavage by C3 convertases, thereby blocking activation of all three complement pathways (classical, lectin, and alternative) at the central C3 node.

Routes of Administration

IntravenousSubcutaneous

Goals & Uses

  • Treatment of C3 glomerulopathyNephrologyLow
  • Complement inhibition in COVID-19 ARDSAnti Inflammatory / RespiratoryLow
  • Complement inhibition in periodontitisAnti InflammatoryModerate
  • Paroxysmal nocturnal hemoglobinuria (PNH)HematologyLow
  • Atypical hemolytic uremic syndrome (aHUS)Hematology / NephrologyLow

Contraindications

  • Active encapsulated bacterial infection (e.g., Neisseria meningitidis)Infectious DiseaseHigh
  • Known hypersensitivity to compstatin or its analoguesAllergyHigh
  • Uncontrolled systemic infectionInfectious DiseaseHigh

Adverse Effects

  • Increased susceptibility to encapsulated bacterial infectionsImmunologicalUncommon
  • Injection site reactionsLocalCommon
  • HeadacheNeurologicUncommonPain in the head or upper neck
  • Infusion-related reactionsHypersensitivityUncommon

Drug Interactions

  • Immunosuppressive agentsModerate
  • Eculizumab / Ravulizumab (C5 inhibitors)Moderate

Population Constraints

  • Pediatric patientsAgeRelative
  • Pregnant or lactating womenReproductiveRelative
  • Patients with renal impairmentOrgan ImpairmentRelative

Regulatory Status

  • European UnionInvestigationalClinical trials conducted in EU; no EMA marketing authorization granted.
  • United StatesInvestigationalIND-stage investigational compound; no FDA approval as of knowledge cutoff.
  • United KingdomInvestigationalNo MHRA approval; investigational status only.

AMY-101 has not received approval from the FDA, EMA, or any major regulatory authority. It has progressed through Phase I and Phase II clinical trials. Orphan Drug Designation and related designations may have been sought for specific indications.

Evidence & Sources

No sources recorded yet.

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