Phuturdex › Drugs › Ruxoprubart
Drugs in development · updated 11 November 2026
Ruxoprubart: clinical trials and development status
Other names and codes: NM8074
As of 11 November 2026 Ruxoprubart is in 8 active clinical trials (recruiting or ongoing, phases I–III) for 5 diseases. The most advanced phase is II.
Authorisation
- EU no (EMA)
- Italy not in the AIFA register
- Germany not available
- US no (FDA)
Sources: EMA, AIFA register (open data), FDA. For Germany only the EU centralised authorisation is shown: the national BfArM register is not one of our sources.
Map of sites in Europe with recruitment status, every trial and an email when something changes. Full access free until 31 March 2027, no card needed.
What it is
A humanized monoclonal antibody directed against complement factor Bb (FBb; Bb) that can be used to treat various alternate pathway (AP)-mediated diseases. Upon administration, ruxoprubart selectively targets, binds to and neutralizes Bb. This prevents the binding of Bb to C3 and prevents the formation of protease C3 convertase (C3Bb). This prevents the conversion of C3 into the fragments C3a and C3b, thereby preventing C3b deposition and C3b-mediated extravascular hemolysis. Also, by preventing the formation of C3Bb, C3Bb is unable to bind to C3b to form the protease C5 convertase (C3BbC3b). As C5 convertase is responsible for the conversion of C5 to C5a/C5b and initiation of membrane attack complex (MAC), ruxoprubart is able to prevent MAC-mediated tissue damage. Altogether, ruxoprubart inhibits the activation of the alternative complement pathway (ACP). Overactivation of AP plays a key role in the initiation and propagation of C3b deposition, inflammation and tissue destruction.
Diseases studied
For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.
| Disease | Most advanced phase | Active trials | Reference trial |
|---|---|---|---|
| Paroxysmal nocturnal hemoglobinuria | II | 3 | NCT05646563 |
| Anti-neutrophil cytoplasmic antibody-associated vasculitis | II | 1 | NCT06226662 |
| Atypical hemolytic uremic syndrome | II | 1 | NCT05684159 |
| Dermatomyositis | II | 1 | NCT06887738 |
| IgA glomerulonephritis | II | 1 | NCT06454110 |
Everything on Ruxoprubart
In Phuturdex you get every trial with sponsors, countries and dates, development events, FDA and EMA approvals, patents and exclusivities, orphan designations and safety alerts, with PDF and Excel export. Free until 31 March 2027.
Open in Phuturdex →Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 11 November 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, refers to the United States and is a Phuturdex calculation described on the Method page, not official data: the drug may already be marketed in other countries.