SOLIRIS (eculizumab)
SOLIRIS is indicated for the treatment of Paroxysmal nocturnal hemoglobinuria (PNH); Atypical hemolytic uremic syndrome (aHUS); Generalized myasthenia gravis (gMG); Neuromyelitis optica spectrum disorder (NMOSD).
How SOLIRIS Works
Eculizumab is a monoclonal antibody that binds to the complement protein C5, preventing its cleavage into C5a and C5b. This action inhibits the formation of the terminal complement complex C5b-9, which otherwise mediates cell destruction. In PNH and aHUS, this process prevents intravascular hemolysis and thrombotic microangiopathy. In patients with gMG and NMOSD, the therapeutic effect is presumed to involve the inhibition of C5b-9 deposition at the neuromuscular junction or other targeted tissues.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2007-03-16
- Patent Cliff
- 2027
- Routes
- IV (INFUSION)
- Dosage Forms
- INJECTABLE
SOLIRIS Approval History
What SOLIRIS Treats
4 indicationsSOLIRIS is approved for 4 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Atypical hemolytic uremic syndrome (aHUS)
- Generalized myasthenia gravis (gMG)
- Neuromyelitis optica spectrum disorder (NMOSD)
SOLIRIS Boxed Warning
SERIOUS MENINGOCOCCAL INFECTIONS SOLIRIS, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ] . Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 wee...
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS SOLIRIS, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ] . Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of SOLIRIS, unless the risks of delaying therapy with SOLIRIS outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria. Patients receiving SOLIRIS are at increased risk for invasive disease caused by Neisseria meningitidis , even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected. Because of the risk of serious meningococcal infections, SOLIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ULTOMIRIS and SOLIRIS REMS [see Warnings and Precautions (5.2) ] . WARNING: SERIOUS MENINGOCOCCAL INFECTIONS See full prescribing information for complete boxed warning SOLIRIS increases the risk of serious and life-threatening infections caused by Neisseria meningitidis . Complete or update meningococcal vaccination at least 2 weeks prior to the first dose of SOLIRIS, unless the risks of delaying SOLIRIS outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) re
SOLIRIS Biosimilars
2 FDA-approved1 can be substituted at the pharmacy without calling the prescriber. The other 1 require prescriber approval to switch.
What are biosimilars? Lower-cost alternatives to SOLIRIS with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
SOLIRIS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SOLIRIS
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
70 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02205541 ECULISHU | RC31/13/7052 PHRC 13-0060, 2014-001169-28 | Ph 3 | completed | Eculizumab in Shiga-toxin Related Hemolytic and Uremic Syndrome Pediatric Patients - ECULISHU |
| NCT05133531 ACCESS-1 | R3918-PNH-2021 2020-004486-40, 2023-509657-31-00 | Ph 3 | active not recruiting | 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 |
| NCT04935177 ConfIdeS | 20-HMedIdeS-17 | Ph 3 | completed | Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx |
| NCT04432584 COMMODORE 1 | BO42161 2020-000597-26, 2023-506526-37-00 | Ph 3 | active not recruiting | A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors |
| NCT04434092 COMMODORE 2 results posted | BO42162 2019-004931-21, 2023-506498-36-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors |
| NCT05646563 | NM8074-PNH-106 | Ph 2 | not yet recruiting | Study of NM8074 in Adult PNH Patients With Inadequate Response to Soliris |
| NCT06764160 ECU-MG-304 | D7411C00003 ECU-MG-304 | Ph 3 | completed | Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG |
| NCT06724809 ECU-NMO-304 | D7412C00002 | Ph 3 | active not recruiting | Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD |
| NCT05876351 Soliris results posted | D7413C00001 ECU-aHUS-302, 2025-000162-29 | Ph 3 | completed | Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China |
| NCT06513338 | C5mAb in anti-GBM disease | Ph 2 | completed | Complement C5 mAb in the Treatment of Anti-GBM Disease |
| NCT02113891 TAMARCIN | P101004 | Ph 1, Ph 2 | withdrawn | Eculizumab Therapy for Subclinical Antibody-mediated Rejection in Kidney Transplantation |
| NCT04752566 results posted | ECU-GBS-301 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome |
| NCT06987864 | BCD-148-EXT | Ph 3 | completed | An Extension Clinical Study of BCD-148 for the Treatment of Patients With PNH Previously Treated in Clinical Study No. BCD-148-2/NOCTURN |
| NCT05886244 Soliris | D7414C00001 | Ph 3 | completed | Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China |
| NCT04702568 results posted | BCX9930-201 2020-000501-93 | Ph 2 | terminated | A Long-Term Safety Study of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) |
| NCT05131204 ACCESS 2 results posted | R3918-PNH-2022 2020-002761-33 | Ph 3 | terminated | Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria |
| NCT03056040 results posted | ALXN1210-PNH-302 2016-002026-36 | Ph 3 | completed | ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab |
| NCT05116774 REDEEM-1 results posted | BCX9930-202 2020-004438-39 | Ph 2 | terminated | BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants With Inadequate Response to C5 Inhibitor Therapy |
| NCT03759366 results posted | ECU-MG-303 2016-001384-37 | Ph 3 | completed | A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG) |
| NCT04558918 APPLY-PNH results posted | CLNP023C12302 2019-004665-40 | Ph 3 | completed | Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment |
| NCT04155424 results posted | ECU-NMO-303 2019-001829-26 | Ph 2, Ph 3 | terminated | A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder |
| NCT04320602 results posted | ALXN1210-PNH-401 2019-003440-74 | Ph 4 | completed | Ravulizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With High-Dose Eculizumab |
| NCT06453135 | WestChina-ECU-KT | Ph 1, Ph 2 | not yet recruiting | Eculizumab for Prevention of Antibody-Mediated Rejection in ABO-Incompatible Living Donor Kidney Transplantation |
| NCT02946463 results posted | ALXN1210-PNH-301 2016-002025-11 | Ph 3 | completed | ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) |
| NCT03472885 PNH results posted | ACH471-101 2016-003526-16, U1111-1209-4655 | Ph 2 | completed | Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Response to Eculizumab |
| NCT04725812 CRUSH results posted | STUDY00000039 | Ph 2 | terminated | Complement Regulation to Undo Systemic Harm in Preeclampsia |
| NCT04103489 | IRB00193549 1K12HD085845-01 | Ph 1 | completed | The Use of Eculizumab in HELLP Syndrome |
| NCT03518203 results posted | 2018-7119C | Ph 2 | completed | Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome -Associated Multiple Organ Dysfunction Syndrome in Hematopoietic Stem Cell Transplant Recipients |
| NCT03818607 DAHLIA results posted | 20150168 | Ph 3 | completed | A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH |
| NCT02003144 results posted | ECU-NMO-302 2013-001151-12 | Ph 3 | completed | An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients |
| NCT03500549 results posted | APL2-302 | Ph 3 | completed | Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) |
| NCT02013037 DUET results posted | CSR 205237 Pro00028970 | Ph 3 | completed | The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation |
| NCT04060264 | BCD-148-2 | Ph 3 | completed | Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria |
| NCT01029587 results posted | NA_00029904 | Ph 2 | completed | Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome |
| NCT04027803 results posted | BCD-148-3 | Ph 1 | completed | Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris® |
| NCT02301624 results posted | ECU-MG-302 2013-002191-41 | Ph 3 | completed | Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis |
| NCT03722329 | SB12-1001 | Ph 1 | completed | Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects |
| NCT02574403 STOPECU | RC15_0061 | Ph 4 | completed | Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With aHUS |
| NCT00727194 results posted | C08-001 | Ph 2 | terminated | Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis |
| NCT01194804 results posted | E07-001 | Ph 2 | completed | E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients |
| NCT01327573 results posted | 100700716 | Ph 1 | completed | Eculizumab Therapy for Chronic Complement-Mediated Injury in Kidney Transplantation |
| NCT01997229 results posted | ECU-MG-301 2013-003589-15 | Ph 3 | completed | Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study) |
| NCT01892345 results posted | ECU-NMO-301 | Ph 3 | terminated | A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study) |
| NCT01403389 | HSM 10-1600 | Ph 2 | terminated | A Study of the Activity of Eculizumab for Prevention of Delayed Graft Function In Deceased Donor Kidney Transplant |
| NCT01567085 results posted | C10-002 2010-019631-35 | Ph 2 | completed | Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor |
| NCT01221181 results posted | AAAF2403 | Ph 1 | completed | Eculizumab Therapy for Dense Deposit Disease and C3 Nephropathy |
| NCT02298933 results posted | 150015 15-H-0015 | Ph 2 | completed | Complement Inhibition Using Eculizumab to Overcome Platelet Transfusion Refractoriness in Patients With Severe Thrombocytopenia |
| NCT02145182 results posted | ECU-DGF-201 2013-004650-25 | Ph 2, Ph 3 | completed | Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study) |
| NCT00867932 results posted | M07-005 2009-010402-11 | Ph 4 | completed | Eculizumab Pharmacokinetics/Pharmacodynamics Study in Pediatric/Adolescent Paroxysmal Nocturnal Hemoglobinuria (PNH) |
| NCT02727608 ICC | ICC version 2 2014-005421-12 | Ph 2 | completed | Complement Inhibitor Eculizumab in Clinical Islet Transplantation |
Showing 50 of 70 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SOLIRIS FDA Label Details
Indications & Usage
FDA Label (PDF)SOLIRIS is indicated for the treatment of Paroxysmal nocturnal hemoglobinuria (PNH); Atypical hemolytic uremic syndrome (aHUS); Generalized myasthenia gravis (gMG); Neuromyelitis optica spectrum disorder (NMOSD).
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS SOLIRIS, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ] . Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitor...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment