Wednesday, July 8, 2026

Drug profile · INN

eculizumab

eculizumab (SOLIRIS) is a complement c5 inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: iv (infusion). Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved Antineoplastic and immunomodulating agents (L04) L04AA25
US status approved
Patents linked 0
Pipeline programs 11
News articles 0
Drug details — eculizumab
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
IV (INFUSION)
Patents
0
Programs
11
Data quality
0.84

Quick answer

eculizumab (SOLIRIS) is a complement c5 inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: iv (infusion). Current US regulatory status: approved.

Key facts

INN eculizumab
Brand SOLIRIS
Mechanism Complement C5 inhibitor
Target Complement C5
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route IV (INFUSION)
Formulation INJECTABLE
ATC code L04AA25

Mechanism of action

Complement C5 inhibitor

Primary target: Complement C5

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved

Pipeline programs

  1. ALXN2040-PNH-303 Phase 3 · Alexion Europe SAS · Patients with Paroxysmal Nocturnal Hemoglobinuria
  2. BO42161 Phase 3 · HOFFMANN-LA ROCHE · Paroxysmal Nocturnal Hemoglobinuria (PNH)
  3. BO42162 Phase 3 · HOFFMANN-LA ROCHE · Paroxysmal Nocturnal Hemoglobinuria (PNH)
  4. C3391003 Phase 3 · First Biotech (Australia) · DUCHENNE MUSCULAR DYSTROPHY (DMD)
  5. ECULIZUMAB , ECULIZUMAB Phase 3 · PARItec · Adult patients with aHUS associated with HE and severe kidne
  6. Eculizumab Phase 3 · Alexion Europe SAS · Neuromyelitis Optica
  7. KYV101-006 Phase 3 · Kyverna Therapeutics · Generalized myasthenia gravis
  8. R3918-PNH-2021 Phase 3 · Anaxis Pharma · Paroxysmal nocturnal haemoglobinuria (PNH)

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)

Frequently asked questions

What is eculizumab?

eculizumab (SOLIRIS) is a complement c5 inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: iv (infusion). Current US regulatory status: approved.

What is the brand name for eculizumab?

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

What is the US approval status of eculizumab?

eculizumab 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.