AMY-101
Also known as: AMY‑101, AMY101, Compstatin analog 40, compstatin Cp40, Cp40
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Summary
AMY-101 (also known as Cp40) is a second‑generation compstatin analog, a cyclic 13‑mer peptide that potently inhibits complement C3. It is being evaluated in early‑phase clinical trials for inflammatory and immune‑mediated diseases such as severe COVID‑19, age‑related macular degeneration, and transplant‑related complement activation.
Mechanism of Action
High‑affinity binding to complement component C3, blocking its cleavage and preventing downstream activation of the complement cascade.
Routes of Administration
Goals & Uses
- Age‑related macular degenerationOphthalmologyModerate
- Treatment of C3 glomerulopathyNephrologyLow
- Complement inhibition in COVID-19 ARDSAnti Inflammatory / RespiratoryLow
- Solid organ transplantationTransplantLow
- Complement inhibition in periodontitisAnti InflammatoryModerate
- Paroxysmal nocturnal hemoglobinuria (PNH)HematologyLow
- Atypical hemolytic uremic syndrome (aHUS)Hematology / NephrologyLow
- Paroxysmal nocturnal hemoglobinuriaHematologyLow
- Severe COVID‑19Viral InfectionModerate
Contraindications
- Active encapsulated bacterial infection (e.g., Neisseria meningitidis)Infectious DiseaseHigh
- Known hypersensitivity to compstatin or its analoguesAllergyHigh
- Uncontrolled systemic infectionInfectious DiseaseHigh
- Known hypersensitivity to AMY‑101 or any excipientAllergyHigh
Adverse Effects
- Increased susceptibility to encapsulated bacterial infectionsImmunologicalUncommon
- Injection site reactionsLocalCommon
- HeadacheNeurologicCommonPain in the head or upper neck
- Infusion‑related reactionsGeneralCommon
- InfectionsImmunologicUncommon
- Infusion-related reactionsHypersensitivityUncommon
Drug Interactions
- Immunosuppressive agentsModerate
- Eculizumab / Ravulizumab (C5 inhibitors)Moderate
- Immunosuppressants (e.g., tacrolimus)Moderate
- Broad‑spectrum antibioticsModerate
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patientsAgeRelative
- Pregnant or lactating womenReproductiveRelative
- Patients with renal impairmentOrgan ImpairmentRelative
Regulatory Status
- European UnionInvestigationalClinical trial applications submitted; no marketing authorization.
- United StatesInvestigationalIND filed; Phase I/II trials ongoing.
- United KingdomInvestigationalUnder MHRA review for early‑phase studies.
Not approved in any jurisdiction; currently in Phase I/II clinical studies. Developed by Amylyx Pharmaceuticals (formerly by Apellis/Compstatin).
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is AMY-101?
AMY-101 (also known as Cp40) is a second‑generation compstatin analog, a cyclic 13‑mer peptide that potently inhibits complement C3. It is being evaluated in early‑phase clinical trials for inflammatory and immune‑mediated diseases such as severe COVID‑19, age‑related macular degeneration, and transplant‑related complement activation.
What is AMY-101 used for?
AMY-101 is educationally associated with: Age‑related macular degeneration, Treatment of C3 glomerulopathy, Complement inhibition in COVID-19 ARDS, Solid organ transplantation, Complement inhibition in periodontitis, Paroxysmal nocturnal hemoglobinuria (PNH), Atypical hemolytic uremic syndrome (aHUS), Paroxysmal nocturnal hemoglobinuria, Severe COVID‑19. Educational only — not medical advice.
How is AMY-101 administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of AMY-101?
Reported adverse effects include: Increased susceptibility to encapsulated bacterial infections, Injection site reactions, Headache, Infusion‑related reactions, Infections, Infusion-related reactions. This list is not exhaustive — consult a qualified clinician.
Who should avoid AMY-101?
Recorded contraindications: Active encapsulated bacterial infection (e.g., Neisseria meningitidis), Known hypersensitivity to compstatin or its analogues, Uncontrolled systemic infection, Known hypersensitivity to AMY‑101 or any excipient. Consult a qualified clinician before use.