Soliris

(Eculizumab)

ApprovedMonoclonal antibody

Eculizumab 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 8 indications[4].[1]

Soliris is one of 153 biologic programs targeting Atypical Hemolytic-Uremic Syndrome. It is currently in Approved.

Indications

Total Trials

Active Trials

152

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Atypical Hemolytic-Uremic SyndromeCompleted

Kidney TransplantTerminated

Thrombotic MicroangiopathyCompleted

Neuromyelitis OpticaRecruiting

Paroxysmal Nocturnal HemoglobinuriaCompleted

EfficacyActive, not recruiting

NMOSDNot yet recruiting

Age-Related Macular DegenerationUnknown

Atypical Hemolytic-Uremic SyndromeApproved

Completed

Kidney TransplantPhase 2

Terminated

Thrombotic MicroangiopathyPhase 3

Completed

Neuromyelitis OpticaApproved

Recruiting

Paroxysmal Nocturnal HemoglobinuriaApproved

Completed

EfficacyPhase 3

Active, not recruiting

NMOSDApproved

Not yet recruiting

Unknown

Competition

Competitive Landscape

139 competitors in Efficacy

#DrugCompanyPhaseTrials

Soliris

AstraZeneca

Approved

1 2

Biaxin

AbbVie

Phase 3

4 3

Rogaine

Pfizer

Phase 3

1 4

Rayos

RRoxane Laboratories

Phase 3

5 5

Paraplatin

AAvyxa

Phase 3

4 6

Lesinurad

EEsperion Therapeutics, Inc.

Phase 3

2 7

Levocept

SSebela Women's Health Inc.

Phase 3

1 8

Aralen

Sanofi

Preclinical

2 9

Primaquine

Sanofi

Preclinical

2 10

Proamatine

Takeda

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Efficacy

NCT06724809

Q1 2027

Phase 3Recruiting

Paroxysmal Nocturnal Hemoglobinuria

NCT05133531

Q2 2027

Phase 3Active, not recruiting

Paroxysmal Nocturnal Hemoglobinuria

NCT04434092

Phase 3Active, not recruiting

Paroxysmal Nocturnal Hemoglobinuria

NCT04432584

Post-ApprovalRecruiting

Neuromyelitis Optica

NCT07420296

Q3 2028

Phase 2Recruiting

Thrombotic Microangiopathy

NCT07707687

Clinical

Trials by Indication[1]

Paroxysmal Nocturnal Hemoglobinuria25 trials

Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00122304·85 enrolled

Eculizumab Pharmacokinetics/Pharmacodynamics Study in Pediatric/Adolescent Paroxysmal Nocturnal Hemoglobinuria (PNH)

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00867932·7 enrolled

Safety and Efficacy Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01192399·29 enrolled

Show 22 more trials

ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT02946463·272 enrolled

Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT05886244·25 enrolled

The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol

Approved for marketing· AstraZeneca logo

AstraZeneca··NCT00438789

A Long-Term Safety Study of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Terminated·BBioCryst Pharmaceuticals·Phase 2·NCT04702568·19 enrolled

ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT03056040·202 enrolled

E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01194804·27 enrolled

BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants With Inadequate Response to C5 Inhibitor Therapy

Terminated·BBioCryst Pharmaceuticals·Phase 2·NCT05116774·12 enrolled

Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00122330·75 enrolled

A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment

Recruiting· Regeneron logo

Regeneron·Phase 3·NCT05133531·190 enrolled

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

Recruiting·WWuhan Createrna Science and Technology Co., Ltd·Phase 3·NCT06932744·66 enrolled

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

Completed· Haisco Pharmaceutical Group Co., Ltd. logo

Haisco Pharmaceutical Group Co., Ltd.·Phase 3·NCT06799546·73 enrolled

A Phase III Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients

Not yet recruiting·NNanjing Chia-tai Tianqing Pharmaceutical·Phase 3·NCT07177859·78 enrolled

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

Completed·CChengdu Suncadia Medicine Co., Ltd.·Phase 3·NCT06593938·76 enrolled

Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00122317·187 enrolled

Eculizumab in Treating Patients With Paroxysmal Nocturnal Hemoglobinuria

Completed·JJonsson Comprehensive Cancer Center·Phase 3·NCT00112983

Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria

Terminated· Regeneron logo

Regeneron·Phase 3·NCT05131204·3 enrolled

Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00098280·75 enrolled

Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00130000·87 enrolled

Ravulizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With High-Dose Eculizumab

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT04320602·18 enrolled

Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Response to Eculizumab

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT03472885·12 enrolled

A Phase III, Randomized, Open-label, Active-controlled, Multicenter Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04434092·210 enrolled

A Phase III, Randomized, Open-label, Active-controlled, Multicenter Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamic and Efficacy of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04432584·190 enrolled

Kidney Transplant10 trials

A Study of the Activity of Eculizumab for Prevention of Delayed Graft Function In Deceased Donor Kidney Transplant

Terminated·—·Phase 2·NCT01403389·8 enrolled

Eculizumab for Prevention of Antibody-Mediated Rejection in ABO-Incompatible Living Donor Kidney Transplantation

Not yet recruiting·TTao Lin·Phase 1/2·NCT06453135·30 enrolled

Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Cross Match Living Donor Kidney Transplant

Completed·MMark Stegall·Phase 1/2·NCT00670774·31 enrolled

Show 7 more trials

Eculizumab Therapy for Subclinical Antibody-mediated Rejection in Kidney Transplantation

Withdrawn·AAssistance Publique - Hôpitaux de Paris·Phase 1/2·NCT02113891

Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01567085·80 enrolled

Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Crossmatch Deceased Donor Kidney Transplant

Terminated·MMayo Clinic·Phase 1/2·NCT01106027·2 enrolled

Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization

Terminated· AstraZeneca logo

AstraZeneca·Phase 2·NCT01399593·102 enrolled

Eculizumab to Prevent Antibody-mediated Rejection in ABO Blood Group Incompatible Living Donor Kidney Transplantation

Terminated·MMayo Clinic·Phase 1/2·NCT01095887·6 enrolled

Eculizumab for Prevention of Delayed Graft Function (DGF) in Kidney Transplantation

Terminated·—·Phase 2·NCT01919346·21 enrolled

Eculizumab Therapy for Chronic Complement-Mediated Injury in Kidney Transplantation

Completed·SSanjay Kulkarni·Phase 1·NCT01327573·16 enrolled

Atypical Hemolytic-Uremic Syndrome6 trials

Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-sensitive Atypical Hemolytic Uremic Syndrome (aHUS)

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00838513·15 enrolled

Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT05876351·25 enrolled

An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01194973·44 enrolled

Show 3 more trials

An Open-Label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients With Atypical Hemolytic-Uremic Syndrome

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01193348·22 enrolled

The Safety and Efficacy of Eculizumab in Japanese Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01757431·2 enrolled

Multicentric, Prospective Open-label Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With Atypical Hemolytic Uremic Syndrome (aHUS)

Completed·NNantes University Hospital·Approved·NCT02574403·58 enrolled

COVID-194 trials

SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19

No longer available· AstraZeneca logo

AstraZeneca··NCT04355494

CORIMUNO19-ECU: Trial Evaluating Efficacy and Safety of Eculizumab (Soliris) in Patients With COVID-19 Infection, Nested in the CORIMUNO-19 Cohort

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT04346797·120 enrolled

Eculizumab (Soliris) in Covid-19 Infected Patients

Available·HHudson Medical··NCT04288713

Show 1 more trial

COVID-19 Soliris Expanded Access Protocol

No longer available· AstraZeneca logo

AstraZeneca··NCT04802083

Myasthenia Gravis4 trials

Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT02301624·117 enrolled

Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01997229·125 enrolled

Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis

Terminated· AstraZeneca logo

AstraZeneca·Phase 2·NCT00727194·14 enrolled

Show 1 more trial

A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT03759366·12 enrolled

37 more indications

Neuromyelitis Optica3 trials

Modified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder

Recruiting·TTianjin Medical University General Hospital·Phase 4·NCT07420296·198 enrolled

An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica

Completed·MMayo Clinic·Phase 1/2·NCT00904826·14 enrolled

A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder

Terminated· AstraZeneca logo

AstraZeneca·Phase 2/3·NCT04155424·5 enrolled

Immunogenicity3 trials

Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects

Completed·SSamsung Bioepis Co., Ltd.·Phase 1·NCT03722329·240 enrolled

A Safety and Immunogenicity Study in Long-term Treatment of Eculizumab (JSC "GENERIUM", Russian Federation)

Completed·AAO GENERIUM·Phase 3·NCT04679103·50 enrolled

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

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT06764160·15 enrolled

NMOSD2 trials

BLAZE-Limiting Approach in NMOSD

Completed·HHuashan Hospital··NCT06888622·9 enrolled

A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder

Recruiting·MMassachusetts General Hospital·Approved·NCT07010302·540 enrolled

Trial2 trials

JET-GBS - Japanese Eculizumab Trial for GBS

Completed·—·Phase 2·NCT02493725·34 enrolled

An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT02003144·119 enrolled

Adolescent2 trials

Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive aHUS

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00844428·5 enrolled

Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant aHUS

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00844844·1 enrolled

Efficacy and Safety2 trials

A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH

Completed· Amgen logo

Amgen·Phase 3·NCT03818607·42 enrolled

A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT04752566·57 enrolled

Treatment2 trials

An Extension Clinical Study of BCD-148 for the Treatment of Patients With PNH Previously Treated in Clinical Study No. BCD-148-2/NOCTURN

Completed·BBiocad·Phase 3·NCT06987864·24 enrolled

Complement C5 mAb in the Treatment of Anti-GBM Disease

Completed·PPeking University First Hospital·Phase 2·NCT06513338·16 enrolled

Thrombotic Microangiopathy2 trials

Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome -Associated Multiple Organ Dysfunction Syndrome in Hematopoietic Stem Cell Transplant Recipients

Completed·—·Phase 2·NCT03518203·23 enrolled

The Safety and Efficacy of Eculizumab for High-risk Transplant-associated Thrombotic Microangiopathy.

Recruiting·FFirst Affiliated Hospital of Zhejiang University·Phase 2·NCT07707687·24 enrolled

Injury1 trial

Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

Completed·RRussian Academy of Medical Sciences·Phase 2·NCT01756508·57 enrolled

HELLP Syndrome1 trial

The Use of Eculizumab in HELLP Syndrome

Completed·JJohns Hopkins University·Phase 1·NCT04103489·3 enrolled

Thrombocytopenia1 trial

Complement Inhibition Using Eculizumab to Overcome Platelet Transfusion Refractoriness in Patients With Severe Thrombocytopenia

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT02298933·10 enrolled

Real-world Study1 trial

Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study

Recruiting·—·Phase 4·NCT07410039·200 enrolled

Preeclampsia1 trial

Complement Regulation to Undo Systemic Harm in Preeclampsia

Terminated·—·Phase 2·NCT04725812·2 enrolled

Stem Cell Transplant1 trial

Identification and Treatment of Thrombotic Microangiopathies in Allogeneic Stem Cell Transplants

Completed·WWeill Medical College of Cornell University··NCT02604420·200 enrolled

Desensitization1 trial

Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx

Completed·HHansa Biopharma AB·Phase 3·NCT04935177·64 enrolled

Cold Agglutinin Disease1 trial

Therapy of Chronic Cold Agglutinin Disease With Eculizumab

Completed·UUniversity Hospital, Essen·Phase 2·NCT01303952·13 enrolled

Delayed Graft Function1 trial

Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)

Completed· AstraZeneca logo

AstraZeneca·Phase 2/3·NCT02145182·288 enrolled

Anemia1 trial

Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment

Completed· Novartis logo

Novartis·Phase 3·NCT04558918·97 enrolled

Dense Deposit Disease1 trial

Eculizumab Therapy for Dense Deposit Disease and C3 Nephropathy

Completed·—·Phase 1·NCT01221181·6 enrolled

Macular Degeneration1 trial

Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD)

Completed·—·Phase 2·NCT00935883·60 enrolled

Randomized Controlled Trial1 trial

A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)

Terminated· AstraZeneca logo

AstraZeneca·Phase 3·NCT01892345·143 enrolled

Vasculitis1 trial

Targeting Complement Activation in Antineutrophil Cytoplasmic Autoantibodies (ANCA)-Vasculitis - Eculizumab

Withdrawn·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT01275287

APL1 trial

Transcriptome and Metabolic Analyses of CHAPLE Disease

Unknown status·MMarmara University··NCT03950804·60 enrolled

Hemolytic-Uremic Syndrome1 trial

Safety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)

Completed· AstraZeneca logo

AstraZeneca·Phase 2/3·NCT01410916·198 enrolled

Guillain-Barre syndrome1 trial

Inhibition of Complement Activation (Eculizumab) in Guillain-Barre Syndrome Study

Unknown status·NNHS Greater Glasgow and Clyde·Phase 2·NCT02029378·30 enrolled

Gemcitabine1 trial

Multicenter, Uncontrolled Pilot Study Evaluating the Efficacy of Eculizumab in the Treatment of Gemcitabine-induced Thrombotic Microangiopathies

Unknown status·UUniversity Hospital, Rouen·Phase 3·NCT05702996·10 enrolled

Adult1 trial

Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant aHUS

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00844545·16 enrolled

Liver Transplant1 trial

Pilot Trial of Eculizumab Therapy to Reduce Preservation Injury in Human Macrosteatotic Liver Transplantation

Withdrawn·YYale University·Phase 1·NCT03468140

Allergic Asthma1 trial

Safety and Efficacy Study of Eculizumab in Patients With Mild Allergic Asthma

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00485576·21 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

Renal Transplantation1 trial

Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome

Completed·JJohns Hopkins University·Phase 2·NCT01029587·1 enrolled

Efficacy1 trial

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

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06724809·21 enrolled

Islet Transplantation1 trial

Complement Inhibitor Eculizumab in Clinical Islet Transplantation

Completed·UUppsala University·Phase 2·NCT02727608·3 enrolled

Pediatric Patients1 trial

Eculizumab in Shiga-toxin Related Hemolytic and Uremic Syndrome Pediatric Patients - ECULISHU

Completed·UUniversity Hospital, Toulouse·Phase 3·NCT02205541·100 enrolled

Cardiac Transplant1 trial

The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation

Completed·—·Phase 3·NCT02013037·36 enrolled

PNH1 trial

A Multicenter, Randomized, Open-Label, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of VSA012 Injection in Participants With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy

Not yet recruiting·BBisirna Therapeutics (Suzhou) Co., Ltd.·Phase 3·NCT07816237·70 enrolled

Unspecified2 trials

An Open Label Study of the Effects of Eculizumab in CD59 Deficiency

Unknown status·HHadassah Medical Organization·Phase 1/2·NCT01579838·5 enrolled

Eculizumab in Primary MPGN

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 2·NCT02093533·10 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 16, 2007

SOLIRIS

BLA BLA125166

Mar 16, 2007

SOLIRIS

NDA BLA125166

Jun 30, 2009

SOLIRIS

NDA BLA125166

Jun 4, 2010

SOLIRIS

NDA BLA125166

Sep 23, 2011

SOLIRIS

NDA BLA125166

Dec 21, 2012

SOLIRIS

NDA BLA125166

Apr 30, 2014

SOLIRIS

NDA BLA125166

Apr 30, 2014

SOLIRIS

NDA BLA125166

Oct 10, 2014

SOLIRIS

NDA BLA125166

Dec 3, 2015

SOLIRIS

NDA BLA125166

Dec 3, 2015

SOLIRIS

NDA BLA125166

Apr 13, 2016

SOLIRIS

NDA BLA125166

Jan 13, 2017

SOLIRIS

NDA BLA125166

Oct 23, 2017

SOLIRIS

NDA BLA125166

Feb 28, 2018

SOLIRIS

NDA BLA125166

Jul 25, 2018

SOLIRIS

NDA BLA125166

Jul 25, 2018

SOLIRIS

NDA BLA125166

Jun 27, 2019

SOLIRIS

NDA BLA125166

Apr 7, 2020

SOLIRIS

NDA BLA125166

Nov 20, 2020

SOLIRIS

NDA BLA125166

Feb 8, 2024

SOLIRIS

NDA BLA125166

Mar 22, 2024

SOLIRIS

NDA BLA125166

Jun 28, 2024

SOLIRIS

NDA BLA125166

Sep 19, 2024

SOLIRIS

NDA BLA125166

Feb 28, 2025

SOLIRIS

NDA BLA125166

Jun 27, 2025

SOLIRIS

NDA BLA125166

Jun 1, 2026

SOLIRIS

NDA BLA125166

Jun 30, 2026

SOLIRIS

NDA BLA125166

Sources

References

[1]
ClinicalTrials.gov — 97 trial records for Eculizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Soliris drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Eculizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Eculizumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA125166). U.S. Food & Drug Administration.
[6]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Complement C5 Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: AstraZeneca

Soliris

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2028

Trials by Indication[1]

Paroxysmal Nocturnal Hemoglobinuria25 trials

Kidney Transplant10 trials

Atypical Hemolytic-Uremic Syndrome6 trials

COVID-194 trials

Myasthenia Gravis4 trials

Neuromyelitis Optica3 trials

Immunogenicity3 trials

NMOSD2 trials

Trial2 trials

Adolescent2 trials

Efficacy and Safety2 trials

Treatment2 trials

Thrombotic Microangiopathy2 trials

Injury1 trial

HELLP Syndrome1 trial

Thrombocytopenia1 trial

Real-world Study1 trial

Preeclampsia1 trial

Stem Cell Transplant1 trial

Desensitization1 trial

Cold Agglutinin Disease1 trial

Delayed Graft Function1 trial

Anemia1 trial

Dense Deposit Disease1 trial

Macular Degeneration1 trial

Randomized Controlled Trial1 trial

Vasculitis1 trial

APL1 trial

Hemolytic-Uremic Syndrome1 trial

Guillain-Barre syndrome1 trial

Gemcitabine1 trial

Adult1 trial

Liver Transplant1 trial

Allergic Asthma1 trial

Antibody-mediated Rejection1 trial

Renal Transplantation1 trial

Efficacy1 trial

Islet Transplantation1 trial

Pediatric Patients1 trial

Cardiac Transplant1 trial

PNH1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News