Paroxysmal Nocturnal Hemoglobinuria (PNH) Treatments

Find Paroxysmal Nocturnal Hemoglobinuria (PNH) Treatments

Brand Name

Ultomiris

Generic Name
Ravulizumab
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FDA approval date: December 21, 2018
Classification: Complement Inhibitor
Form: Solution

What is Ultomiris (Ravulizumab)?

ULTOMIRIS is a complement inhibitor indicated for: the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria .

Approved To Treat

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Related Clinical Trials

A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation
A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation
Enrollment Status: Recruiting
Publish Date: April 16, 2026
Intervention Type: Drug
Study Phase: Phase 3

Summary: The primary objective of this study is to demonstrate the efficacy of ravulizumab vs placebo in reducing the severity of DGF as measured by time to freedom from dialysis in adult participants who are at high risk of DGF after undergoing transplant of deceased donor kidney.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Immunoglobulin A Nephropathy (IgAN)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Immunoglobulin A Nephropathy (IgAN)
Enrollment Status: Recruiting
Publish Date: April 16, 2026
Intervention Type: Drug
Study Phase: Phase 3

Summary: The primary objective of this study to evaluate efficacy of ravulizumab compared with placebo on proteinuria reduction and change in eGFR in adult participants with IgAN who are at risk of disease progression.

Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Enrollment Status: Recruiting
Publish Date: April 16, 2026
Intervention Type: Drug

Summary: The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk.

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Use of ravulizumab in a pregnant patient with PNH: case-based insights.
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