Ravulizumab

also known as ALXN1210 · Ravulizumab cwvz · Ultomiris

Monoclonal antibody targets C5 via inhibition

Developed for: paroxysmal nocturnal hemoglobinuria · thrombotic microangiopathy · atypical hemolytic-uremic syndrome · COVID-19 · generalized myasthenia gravis · IgA glomerulonephritis · neuromyelitis optica spectrum disorder with anti-AQP4 antibodies · acute kidney injury
+10 more
· acute lung injury · adult acute respiratory distress syndrome · amyotrophic lateral sclerosis · chronic kidney disease · dermatomyositis · immunoglobulin A vasculitis · lupus nephritis · neuromyelitis optica · preeclampsia · viral pneumonia
Investigated by: Alexion Pharmaceuticals, Inc. · Regeneron Pharmaceuticals · Brigham and Women's Hospital · Cambridge University Hospitals NHS Foundation Trust · Charite University, Berlin, Germany · Massachusetts General Hospital
+3 more
· Mayo Clinic · Patient-Centered Outcomes Research Institute · The Sumaira Foundation

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	EU (EMA)	Ultomiris	—	2019-07-02	europa.eu ↗

Trials 39 · a red edge is where a trial was stopped

today

EU approved 2019

NCT06333652 · Ph 2 NCT07557420 · Ph 3 NCT07010302 · Ph 4 NCT07596784 · Ph 3 NCT07308574 · Ph 4 NCT07024563 · Ph 3 NCT06830798 · Ph 3 NCT06578949 · Ph 3 NCT06291376 · Ph 3 NCT05644561 · Ph 3 NCT05746559 · Ph 3 NCT05131204 · Ph 3 NCT05133531 · Ph 3 NCT05346354 · Ph 2/3 NCT04999020 · Ph 2/3 NCT04743804 · Ph 3 NCT04320602 · Ph 4 NCT04564339 · Ph 2 NCT04570397 · Ph 3 NCT04543591 · Ph 3 NCT04557735 · Ph 3 NCT04369469 · Ph 3 NCT04390464 · Ph 4 NCT04248465 · Ph 3 NCT04201262 · Ph 3 NCT03920293 · Ph 3 NCT03748823 · Ph 3 NCT05396742 · Ph 1 NCT03406507 · Ph 3 NCT03131219 · Ph 3 NCT03056040 · Ph 3 NCT02949128 · Ph 3 NCT02946463 · Ph 3 NCT05288829 · Ph 1 NCT05288816 · Ph 1 NCT02605993 · Ph 2 NCT02598583 · Ph 1/2 NCT05288673 · Ph 1 NCT05288660 · Ph 1

2015201620172018201920202021202220232024202520262027202820292030

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 15 trials
Phase 1	NCT05396742	Aug 2018 → May 2019	—	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1	NCT05288829	Aug 2016 → Jul 2017	—	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1	NCT05288816	Apr 2016 → Jul 2017	—	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1	NCT05288673	Jul 2015 → Sep 2016	—	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1	NCT05288660	Aug 2014 → Mar 2015	—	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT02598583	Nov 2015 → Jul 2016	paroxysmal nocturnal hemoglobinuria	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 23 trials
Phase 2	NCT06333652	Sep 2026 → Dec 2028 expected	preeclampsia	Mayo Clinic	Recruiting	No outcome recorded
Phase 2	NCT04564339	Jan 2021 → Mar 2025	IgA glomerulonephritis, lupus nephritis	Alexion Pharmaceuticals, Inc.	Terminated	No outcome recorded
Phase 2	NCT02605993	Jan 2016 → Feb 2017	paroxysmal nocturnal hemoglobinuria	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 2/32 trials
Phase 2/3	NCT05346354	Jun 2022 → Jun 2026 overdue	neuromyelitis optica spectrum disorder with anti-AQP4 antibodies	Alexion Pharmaceuticals, Inc.	Active not recruiting	No outcome recorded
Phase 2/3	NCT04999020	Nov 2021 → Oct 2023	dermatomyositis	Alexion Pharmaceuticals, Inc.	Terminated	No outcome recorded
Phase 324 trials
Phase 3	NCT07557420	Aug 2026 → Oct 2028 expected	neuromyelitis optica spectrum disorder with anti-AQP4 antibodies	Alexion Pharmaceuticals, Inc.	Not yet recruiting	No outcome recorded
Phase 3	NCT07596784	Jul 2026 → Aug 2027 expected	generalized myasthenia gravis	Alexion Pharmaceuticals, Inc.	Not yet recruiting	No outcome recorded
Phase 3	NCT07024563	Jun 2025 → Jul 2028 expected	IgA glomerulonephritis, immunoglobulin A vasculitis	Alexion Pharmaceuticals, Inc.	Recruiting	No outcome recorded
Phase 3	NCT06830798	May 2025 → Nov 2027 expected	—	Alexion Pharmaceuticals, Inc.	Recruiting	No outcome recorded
Phase 3	NCT06578949	Oct 2024 → May 2025	paroxysmal nocturnal hemoglobinuria	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT06291376	Mar 2024 → Jan 2026 overdue	IgA glomerulonephritis	Alexion Pharmaceuticals, Inc.	Active not recruiting	No outcome recorded
Phase 3	NCT05644561	Jun 2023 → Jul 2026 overdue	generalized myasthenia gravis	Alexion Pharmaceuticals, Inc.	Active not recruiting	No outcome recorded
Phase 3	NCT05746559	Apr 2023 → Oct 2025	chronic kidney disease, heart disorder	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT05131204	Oct 2022 → Jul 2023	paroxysmal nocturnal hemoglobinuria	Regeneron Pharmaceuticals	Terminated	No outcome recorded
Phase 3	NCT05133531	Aug 2022 → Oct 2026 expected	paroxysmal nocturnal hemoglobinuria	Regeneron Pharmaceuticals	Active not recruiting	No outcome recorded
Phase 3	NCT04743804	Jun 2021 → Dec 2022	thrombotic microangiopathy	Alexion Pharmaceuticals, Inc.	Terminated	No outcome recorded
Phase 3	NCT04570397	Dec 2020 → May 2023	COVID-19, acute kidney injury, thrombotic microangiopathy	Brigham and Women's Hospital	Unknown	No outcome recorded
Phase 3	NCT04543591	Dec 2020 → Sep 2025	thrombotic microangiopathy	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT04557735	Dec 2020 → Nov 2024	thrombotic microangiopathy	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT04369469	May 2020 → Feb 2021	COVID-19, acute lung injury, adult acute respiratory distress syndrome, viral pneumonia	Alexion Pharmaceuticals, Inc.	Terminated	No outcome recorded
Phase 3	NCT04248465	Mar 2020 → Oct 2021	amyotrophic lateral sclerosis	Alexion Pharmaceuticals, Inc.	Terminated	No outcome recorded
Phase 3	NCT04201262	Dec 2019 → Mar 2022	neuromyelitis optica	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT03920293	Mar 2019 → May 2021	generalized myasthenia gravis	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT03748823	Feb 2019 → Feb 2021	paroxysmal nocturnal hemoglobinuria	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT03406507	Feb 2018 → Mar 2020	paroxysmal nocturnal hemoglobinuria	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT03131219	Aug 2017 → Dec 2022	atypical hemolytic-uremic syndrome	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT03056040	May 2017 → Feb 2022	paroxysmal nocturnal hemoglobinuria	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT02949128	Jan 2017 → Jan 2023	atypical hemolytic-uremic syndrome	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT02946463	Dec 2016 → Feb 2023	paroxysmal nocturnal hemoglobinuria	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded

Phase 44 trials
Phase 4	NCT07010302	Aug 2026 → Jan 2030 expected	neuromyelitis optica spectrum disorder with anti-AQP4 antibodies	Massachusetts General Hospital	Not yet recruiting	No outcome recorded
Phase 4	NCT07308574	Dec 2025 → Jun 2027 expected	atypical hemolytic-uremic syndrome	Alexion Pharmaceuticals, Inc.	Recruiting	No outcome recorded
Phase 4	NCT04320602	Apr 2021 → Dec 2022	paroxysmal nocturnal hemoglobinuria	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 4	NCT04390464	May 2020 → May 2021	COVID-19	Cambridge University Hospitals NHS Foundation Trust	Unknown	No outcome recorded

Also used as a comparator or background therapy in 5 trials

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 22 trials
Phase 2	NCT05116774 Comparator	Dec 2021 → Sep 2023	paroxysmal nocturnal hemoglobinuria	BioCryst Pharmaceuticals	Terminated	No outcome recorded
Phase 2	NCT04702568 Background	Dec 2020 → Oct 2023	paroxysmal nocturnal hemoglobinuria	BioCryst Pharmaceuticals	Terminated	No outcome recorded
Phase 32 trials
Phase 3	NCT04558918 Comparator	Jan 2021 → Sep 2022	paroxysmal nocturnal hemoglobinuria	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT04469465 Background	Dec 2020 → Jun 2022	paroxysmal nocturnal hemoglobinuria	Alexion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 41 trial
Phase 4	NCT07221838 Background	Mar 2026 → Aug 2027 expected	generalized myasthenia gravis	Alexion Pharmaceuticals, Inc.	Recruiting	No outcome recorded

Press releases naming this drug 12 releases

Date	Issuer	Release
2026-07-27	AstraZeneca	Update on Phase III trial of Ultomiris in adults and adolescents with thrombotic microangiopathy after haematopoietic stem cell transplant astrazeneca.com ↗
2026-06-15	AstraZeneca	Ultomiris granted Priority Review in the US as treatment for adults with immunoglobulin A nephropathy astrazeneca.com ↗
2026-06-06	AstraZeneca	Ultomiris demonstrated 43.4% reduction in proteinuria vs placebo in adults with immunoglobulin A nephropathy at 34 weeks in I CAN Phase III trial astrazeneca.com ↗
2026-04-21	AstraZeneca	Ultomiris demonstrated statistically significant and clinically meaningful reduction of proteinuria in adults with immunoglobulin A nephropathy in I CAN Phase III trial astrazeneca.com ↗
2025-09-19	AstraZeneca	Alexion data presented at ECTRIMS 2025 reinforces Ultomiris leadership in transforming care for patients with NMOSD astrazeneca.com ↗
2024-12-07	Regeneron Pharmaceuticals	Novel Combination of Pozelimab and Cemdisiran (Poze-Cemdi) Achieved Greater Control of Intravascular Hemolysis in Patients with Paroxysmal Nocturnal Hemoglobinuria Compared to Ravulizumab regeneron.com ↗
2024-04-23	AstraZeneca	Voydeya approved in the EU as add-on treatment to ravulizumab or eculizumab for adults with the rare disease PNH who have residual haemolytic anaemia astrazeneca.com ↗
2024-04-08	AstraZeneca	Alexion data at AAN 2024 demonstrate how Ultomiris and Soliris can transform outcomes for rare neurological diseases astrazeneca.com ↗
2024-04-01	AstraZeneca	Voydeya approved in the US as add-on therapy to ravulizumab or eculizumab for treatment of extravascular haemolysis in adults with the rare disease PNH astrazeneca.com ↗
2024-03-25	AstraZeneca	Ultomiris approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD) astrazeneca.com ↗
2024-02-26	AstraZeneca	Voydeya recommended for approval in the EU by CHMP as add-on treatment to ravulizumab or eculizumab for adults with PNH who have residual haemolytic anaemia astrazeneca.com ↗
2023-12-11	AstraZeneca	Long-term ALPHA Phase III trial data showed danicopan as add-on to Ultomiris or Soliris sustained clinical improvements in subset of patients with PNH experiencing clinically significant extravascular haemolysis astrazeneca.com ↗

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 46 sources stand behind the page.

Field	Value	Cited text
Known as	Ravulizumab	“Participants will continue to receive their ongoing C5 inhibitor (eculizumab or ravulizumab) therapy according to their usual dose and schedule.” NCT04469465 ↗ 38 NCT03056040 ↗ NCT05396742 ↗ NCT06578949 ↗ NCT03406507 ↗ NCT03748823 ↗ NCT04702568 ↗ NCT04369469 ↗ NCT07024563 ↗ NCT04543591 ↗ NCT02949128 ↗ NCT04558918 ↗ NCT04248465 ↗ NCT03920293 ↗ NCT04570397 ↗ NCT07596784 ↗ NCT06333652 ↗ NCT05116774 ↗ NCT06830798 ↗ NCT04999020 ↗ NCT04557735 ↗ NCT02946463 ↗ NCT05346354 ↗ NCT07221838 ↗ NCT06291376 ↗ NCT05644561 ↗ NCT03131219 ↗ NCT05131204 ↗ NCT07010302 ↗ NCT04320602 ↗ NCT04743804 ↗ NCT04201262 ↗ NCT05133531 ↗ NCT04390464 ↗ NCT04564339 ↗ NCT07557420 ↗ NCT07308574 ↗ NCT05746559 ↗ NCT02605993 ↗
Known as	ALXN1210	“ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)” NCT02946463 ↗ 5 NCT05288829 ↗ NCT05288816 ↗ NCT05288673 ↗ NCT05288660 ↗ NCT02598583 ↗
Known as	Ravulizumab cwvz	ChEMBL registry synonym — accepted as the source's own label CHEMBL3989986 ↗
Known as	Ultomiris	“Ultomiris (Ravulizumab), is a monoclonal antibody that specifically targets terminal complement products” NCT04570397 ↗
Action	Inhibit	“complement inhibitor” NCT02598583 ↗
Modality	Monoclonal antibody	“a humanized monoclonal antibody to complement component C5” PMID 30171081 ↗ Sep 2018
Route	Intravenous	“All treatments were given as IV infusions.” NCT02605993 ↗
Target	C5	“complement component C5” PMID 30171081 ↗ Sep 2018