Soliris
(Eculizumab)ApprovedMonoclonal antibody
AstraZenecaEculizumab is used to treat rare blood disorders and certain autoimmune diseases by reducing the activity of the immune system. It works by blocking a protein in the blood that causes inflammation and damage to healthy cells.[2] Soliris is currently approved and in use across 33 indications[4].[1]
Soliris is one of 622 biologic programs targeting Liver Transplant. It is currently in Approved.
33
Indications
95
Total Trials
10
Active Trials
621
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 32 indications
Competition
Competitive Landscape
1931 competitors in COVID-19
#DrugCompanyPhaseTrials
1Soliris
AstraZenecaApproved
Aldactone
PfizerPreclinical
Calciferol
Alnylam PharmaceuticalsPreclinical
Activella
Eli LillyPreclinical
Aprotinin
BayerPreclinical
Antithrombin-III
OctapharmaPreclinical
Conventional
PPopulation Health Research Institute
Preclinical
Exoflo
DDirect Biologics, LLC
Preclinical
Moderna COVID-19 Vaccine
ModernaPreclinical
COVID-19 Vaccines
UUniversity of British Columbia
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Paroxysmal Nocturnal Hemoglobinuria25 trials
Show 22 more trials
Kidney Transplant10 trials
Eculizumab for Prevention of Delayed Graft Function (DGF) in Kidney Transplantation
Terminated·—·Phase 2·NCT01919346·21 enrolled
A Study of the Activity of Eculizumab for Prevention of Delayed Graft Function In Deceased Donor Kidney Transplant
Terminated·—·Phase 2·NCT01403389·8 enrolled
Show 7 more trials
Atypical Hemolytic-Uremic Syndrome5 trials
COVID-194 trials
Myasthenia Gravis4 trials
37 more indications
Neuromyelitis Optica3 trials
Immunogenicity3 trials
NMOSD2 trials
Adolescent2 trials
Efficacy and Safety2 trials
Trial2 trials
JET-GBS - Japanese Eculizumab Trial for GBS
Completed·—·Phase 2·NCT02493725·34 enrolled
Treatment2 trials
Real-world Study1 trial
Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study
Recruiting·—·Phase 4·NCT07410039·200 enrolled
Gemcitabine1 trial
Stem Cell Transplant1 trial
Desensitization1 trial
Renal Transplantation1 trial
Pediatric Patients1 trial
Thrombotic Microangiopathy1 trial
Thrombocytopenia1 trial
Anemia1 trial
Hemolytic-Uremic Syndrome1 trial
Cardiac Transplant1 trial
The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation
Completed·—·Phase 3·NCT02013037·36 enrolled
Randomized Controlled Trial1 trial
Vasculitis1 trial
Guillain-Barre syndrome1 trial
Macular Degeneration1 trial
Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD)
Completed·—·Phase 2·NCT00935883·60 enrolled
Antibody-mediated Rejection1 trial
Efficacy and Safety of Eculizumab for Treatment of Antibody-mediated Rejection Following Renal Transplantation
Terminated·—·Phase 2·NCT01895127·11 enrolled
Preeclampsia1 trial
Complement Regulation to Undo Systemic Harm in Preeclampsia
Terminated·—·Phase 2·NCT04725812·2 enrolled
Children1 trial
Delayed Graft Function1 trial
Dense Deposit Disease1 trial
Eculizumab Therapy for Dense Deposit Disease and C3 Nephropathy
Completed·—·Phase 1·NCT01221181·6 enrolled
Adult1 trial
Liver Transplant1 trial
Regulatory
FDA Approval Timeline[5]
Mar 16, 2007
SOLIRIS
BLA BLA125166
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Soliris drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Eculizumab. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Complement C5 Inhibitor[3]
- Modality
- Monoclonal antibody[3]
- Highest Phase
- Approved[1]
- Company