MedPath

Pegcetacoplan

Generic Name
Pegcetacoplan
Brand Names
Empaveli, Syfovre, Aspaveli
Drug Type
Biotech
CAS Number
2019171-69-6
Unique Ingredient Identifier
TO3JYR3BOU

Overview

Pegcetacoplan is a complement inhibitor indicated in the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Prior to its FDA approval, patients with PNH were typically treated with the C5 inhibiting monoclonal antibody eculizumab. Patients given eculizumab experienced less hemolysis caused by the membrane attack complex, but were still somewhat susceptible to hemolysis caused by C3b opsonization. Pegcetacoplan was developed out of a need for an inhibitor of complement mediated hemolysis further upstream of C5. Pegcetacoplan is a pegylated C3 inhibitor that can disrupt the processes leading to both forms of hemolysis that threaten patients with PNH. Pegcetacoplan for subcutaneous use was granted FDA approval on 14 May 2021. In February 2023, pegcetacoplan for intravitreal use was approved by the FDA for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration.

Indication

Pegcetacoplan is indicated to treat adults with paroxysmal nocturnal hemoglobinuria (PNH). It is also indicated to treat geographic atrophy (GA) secondary to age-related macular degeneration.

Associated Conditions

  • Geographic Atrophy Secondary to Age-related Macular Degeneration
  • Paroxysmal Nocturnal Haemoglobinuria (PNH)

Clinical Trials

View More Clinical Trials

Sign in to access the complete clinical trial database with detailed study information.

Title
Posted
Study ID
Phase
Status
Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Drug Approvals

View More FDA Approvals

Sign in to access additional FDA-approved drug information with detailed regulatory data.

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

View More EMA Approvals

Sign in to access additional EMA-approved drug information with detailed regulatory data.

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

View More HSA Approvals

Sign in to access additional HSA-approved drug information with detailed regulatory data.

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

View More NMPA Approvals

Sign in to access additional NMPA-approved drug information with detailed regulatory data.

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

View More PPB Approvals

Sign in to access additional PPB-approved drug information with detailed regulatory data.

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

View More TGA Approvals

Sign in to access additional TGA-approved drug information with detailed regulatory data.

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

© Copyright 2025. All Rights Reserved by MedPath