Wednesday, July 8, 2026

Drug profile · INN

pegcetacoplan

pegcetacoplan (EMPAVELI) is a complement c3 inhibitor. Associated with Swedish Orphan Biovitrum Pty Ltd. Route of administration: subcutaneous. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L04) L04AJ03
US status approved
Patents linked 12
Pipeline programs 17
News articles 1
Drug details — pegcetacoplan
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
SUBCUTANEOUS
Patents
12
Programs
17
Data quality
0.89

Quick answer

pegcetacoplan (EMPAVELI) is a complement c3 inhibitor. Associated with Swedish Orphan Biovitrum Pty Ltd. Route of administration: subcutaneous. Current US regulatory status: approved.

Key facts

INN pegcetacoplan
Brand EMPAVELI
Mechanism Complement C3 inhibitor
Target Complement C3
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route SUBCUTANEOUS
Formulation SOLUTION
ATC code L04AJ03

Mechanism of action

Complement C3 inhibitor

Primary target: Complement C3

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Recent coverage

Pipeline programs

  1. APL-2, Pegcetacoplan Phase 3 · Genzyme Europe · Geographic Atrophy Secondary to Age-related Macular Degenera
  2. APL2-C3G-310 Phase 3 · Anaxis Pharma · complement 3 glomerulopathy (C3G)/immune complex membranopr
  3. PEGCETACOPLAN (APL-2) Phase 3 · Genzyme Europe · Geographic Atrophy Secondary to Age-related Macular Degenera
  4. Pegcetacoplan Phase 3 · Genzyme Europe · C3G
  5. Pegcetacoplan Phase 3 · Genzyme Europe · Delayed Graft Function
  6. Pegcetacoplan Phase 3 · Genzyme Europe · Paroxysmal Nocturnal Hemoglobinuria
  7. Pegcetacoplan Phase 3 · Genzyme Europe · PNH
  8. APL-3007, pegcetacoplan (APL-2) Phase 2 · Genzyme Europe · Geographic Atrophy Secondary to Age-related Macular Degenera

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. US 12290566

    Dosing regimens and related compositions and methods

    Expires Mon May 01 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12251395

    RNAS for complement inhibition

    Expires Mon Mar 13 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11903994

    Dosing regimens

    Expires Mon Feb 15 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11844841

    Dosing regimens and related compositions and methods

    Expires Mon Dec 14 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11661441

    Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof

    Expires Mon May 25 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11510939

    RNAs for complement inhibition

    Expires Mon Nov 24 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11291407

    Detection of high risk drusen

    Expires Mon Mar 31 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 11292815

    Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods

    Expires Mon Mar 31 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 11040107

    Dosing regimens and related compositions and methods

    Expires Mon Jun 17 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 10875893

    Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods

    Expires Mon Dec 24 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 10125171

    Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof

    Expires Mon Nov 08 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 10035822

    Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods

    Expires Mon Jul 26 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is pegcetacoplan?

pegcetacoplan (EMPAVELI) is a complement c3 inhibitor. Associated with Swedish Orphan Biovitrum Pty Ltd. Route of administration: subcutaneous. Current US regulatory status: approved.

What is the brand name for pegcetacoplan?

EMPAVELI is a marketed brand name for pegcetacoplan. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of pegcetacoplan?

pegcetacoplan has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.