Eculizumab

Generic Name: Eculizumab

Brand Names: Soliris, Epysqli, Bekemv

Drug Type: Biotech

CAS Number: 219685-50-4

Unique Ingredient Identifier: A3ULP0F556

Background: Eculizumab is a monoclonal antibody that targets complement protein C5. Binding to this protein prevents the activation of a complement terminal complex, which is used to treat a number of autoimmune conditions.

Eculizumab was granted FDA approval on 16 March 2007. In Q1 2023, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of two formulations of eculizumab indicated for the treatment of paroxysmal nocturnal hemoglobinuria.

Indication: Eculizumab is indicated in the US to treat paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy, and neuromyelitis optica spectrum disorder (NMOSD). It is also indicated in EU to treat PNH in both adult and pediatric patients.

Associated Conditions: Generalized Myasthenia Gravis, Neuromyelitis Optica Spectrum Disorders, Paroxysmal Nocturnal Haemoglobinuria (PNH), Thrombotic Microangiopathies

Clinical Trials

Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy

Phase 3

Recruiting

Conditions: Paroxysmal Nocturnal Haemoglobinuria (PNH)

Interventions: Drug: MY008211A tablets
Drug: Eculizumab Injection

First Posted Date: 2025-04-17

Last Posted Date: 2025-05-09

Lead Sponsor: Wuhan Createrna Science and Technology Co., Ltd

Target Recruit Count: 66

Registration Number: NCT06932744

Locations: 🇨🇳
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
🇨🇳
Chinese Academy of Medical Sciences Hematology Hospital, Tianjin, Tianjin, China

BLAZE-Limiting Approach in NMOSD

Completed

Conditions: Neuromyelitis Optica Spectrum Disorders (NMOSD)

Interventions: Drug: Eculizumab administration

First Posted Date: 2025-03-21

Last Posted Date: 2025-03-21

Lead Sponsor: Huashan Hospital

Target Recruit Count: 9

Registration Number: NCT06888622

Locations: 🇨🇳
Huashan Hospital, Shanghai, Shanghai, China

A Phase III Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy

Phase 3

Recruiting

Conditions: PNH

Interventions: Drug: HSK39297 tablets
Drug: Eculizumab Injection

First Posted Date: 2025-01-29

Last Posted Date: 2025-01-29

Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Target Recruit Count: 66

Registration Number: NCT06799546

Locations: 🇨🇳
The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
🇨🇳
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China

Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG

Phase 3

Recruiting

Conditions: Generalized Myasthenia Gravis (gMG)
Refractory gMG

Interventions: Drug: Eculizumab

First Posted Date: 2025-01-08

Last Posted Date: 2025-01-17

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Target Recruit Count: 15

Registration Number: NCT06764160

Locations: 🇨🇳
Research Site, Wuhan, China

Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD

Phase 3

Recruiting

Conditions: NMOSD
Neuromyelitis Optica Spectrum Disorders

Interventions: Drug: eculizumab

First Posted Date: 2024-12-09

Last Posted Date: 2025-05-07

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Target Recruit Count: 21

Registration Number: NCT06724809

Locations: 🇨🇳
Research Site, Wuhan, China
🇨🇳
Research Site, Zhengzhou, China

A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy

Phase 3

Active, not recruiting

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Interventions: Drug: Eculizumab Injection
Drug: HRS-5965 capsule

First Posted Date: 2024-09-19

Last Posted Date: 2025-02-26

Lead Sponsor: Chengdu Suncadia Medicine Co., Ltd.

Target Recruit Count: 76

Registration Number: NCT06593938

Locations: 🇨🇳
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
🇨🇳
The Blood Disease Hospital of the Chinese Academy of Medical Sciences, Tianjin, Tianjin, China