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ULTOMIRIS (RAVULIZUMAB-CWVZ)
ULTOMIRIS (generic name: RAVULIZUMAB-CWVZ) is a drug developed by ALEXION PHARM. It is currently FDA-approved for Atypical hemolytic uremic syndrome (aHUS), Generalized myasthenia gravis, Myasthenia gravis.
ULTOMIRIS, also known as ravulizumab, is a medication used to treat conditions such as Paroxysmal Nocturnal Hemoglobinuria, COVID-19 severe pneumonia, and Acute Lung Injury, as well as Generalized Myasthenia Gravis. It works by inhibiting the complement system, a part of the immune system, as indicated by its listing in ChEMBL.
At a glance
| Generic name | RAVULIZUMAB-CWVZ |
|---|---|
| Sponsor | ALEXION PHARM |
| Target | Complement C5 |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
- Atypical hemolytic uremic syndrome (aHUS)
- Generalized myasthenia gravis
- Myasthenia gravis
- Paroxysmal nocturnal hemoglobinuria
Common side effects
- Upper respiratory tract infection
- Headache
- Diarrhea
- Nausea
- Vomiting
- Hypertension
- Pyrexia
- Back pain
- Arthralgia
- Urinary tract infection
- COVID-19
- Anemia
Serious adverse events
- Hypertension
- Pneumonia
- Abdominal pain
- Sepsis
- Intracranial hemorrhage
- Cerebral arterial thrombosis
- Hyperthermia
- Pyrexia
Key clinical trials
- A Phase 1, Randomized, Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered (Phase 1)
- A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic (Phase 3)
- A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Dermatomyositis (Phase 2)
- A Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in S (Phase 2)
- mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Repurposed Drugs (TACTIC-R) (Phase 4)
- A Randomized, Open-Label, Eculizumab and Ravulizumab Controlled Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglob (Phase 3)
- A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab (Phase 3)
- A Phase 1, Randomized, Blinded, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of ALXN1210 Administered I (Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ULTOMIRIS CI brief — competitive landscape report
- ULTOMIRIS updates RSS · CI watch RSS
- ALEXION PHARM portfolio CI
Frequently asked questions about ULTOMIRIS
What is ULTOMIRIS?
What is ULTOMIRIS used for?
Who makes ULTOMIRIS?
What is the generic name of ULTOMIRIS?
What development phase is ULTOMIRIS in?
What are the side effects of ULTOMIRIS?
What does ULTOMIRIS target?
Related
- Target: All drugs targeting Complement C5
- Manufacturer: ALEXION PHARM — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Atypical hemolytic uremic syndrome (aHUS)
- Indication: Drugs for Generalized myasthenia gravis
- Indication: Drugs for Myasthenia gravis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing