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eculizumab

Generic: eculizumab·Brand: Bkemv, Epysqli, Soliris

eculizumab: developed by 1 company · 3 clinical trials tracked · 1 FDA decision.

eculizumab evidence translation

What we can confirm

1 FDA record · 3 tracked trials

What it means

Source-backed records connect eculizumab to AMGN; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could eculizumab → AMGN affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 3 study sponsors
Development Pipeline (1)
CompanyPhase
AMGEN INC (AMGN)Approved
Clinical Trials (3)

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

NCT07010302·Phase 4·ENTA
Not yet recruiting

Primary endpoint: Time to adjudicated safety or tolerability failure

InterventionalRandomizeddouble160 targetStarted 2026-05Completion 2030-053 sites · Germany, United StatesMassachusetts General Hospital

Open-Label, Multicenter Study to Assess the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Complement Inhibitor Treatment Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China

NCT05886244·Phase 3·ALXN
Completed

Primary endpoint: Percentage Change From Baseline in LDH at Week 12

Interventionalopen25 enrolledStarted 2023-07Completion 2025-047 sites · ChinaAlexion Pharmaceuticals, Inc.

An Open-label, Controlled, Randomized Phase 3 Trial Evaluating 12-month Kidney Function in Highly Sensitized (cPRA ≥99.9%) Kidney Tx Patients With Positive XM Against a Deceased Donor, Comparing Desensitization Using Imlifidase With SoC

NCT04935177·Phase 3·PNT
Completed

Primary endpoint: Mean estimated glomerular filtration rate (eGFR) at 12 months

InterventionalRandomizedopen64 enrolledStarted 2021-10Completion 2025-0625 sites · United StatesHansa Biopharma AB
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE BKEMV is a complement inhibitor indicated for: The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. ( 1.1 ) The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. ( 1.2 ) Limitation of Use BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). The treatment of generalized myasthenia gravi(AMGN)FDA ↗
BLA761333Type 2 - New Active IngredientStandardOtherInjectable

Frequently asked questions

Who is developing eculizumab?

eculizumab is being developed by AMGEN INC.

How many clinical trials involve eculizumab?

BioSniper tracks 3 clinical trials involving eculizumab.

What is eculizumab's latest FDA decision?

The most recent tracked FDA decision for eculizumab is Approval for 1 INDICATIONS AND USAGE BKEMV is a complement inhibitor indicated for: The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. ( 1.1 ) The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. ( 1.2 ) Limitation of Use BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). The treatment of generalized myasthenia gravi, dated May 28, 2024.