Drugs / Crovalimab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Piasky | — | 2024-08-22 | europa.eu ↗ |
Trials 10 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04912869 | Mar 2022 → Dec 2024 | sickle cell disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03157635 | Nov 2016 → Sep 2026 expected | paroxysmal nocturnal hemoglobinuria | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07172022 | Mar 2026 → Mar 2030 | antiphospholipid syndrome | Hoffmann-La Roche | Withdrawn | No outcome recorded |
| Phase 2 | NCT05075824 | Mar 2022 → Jun 2025 | sickle cell disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT05494619 | Nov 2022 → Mar 2026 | Guillain-Barre syndrome | Hoffmann-La Roche | Withdrawn | No outcome recorded |
| Phase 3 | NCT04958265 | Nov 2021 → Jul 2025 overdue | atypical hemolytic-uremic syndrome | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04861259 | Oct 2021 → Oct 2025 overdue | atypical hemolytic-uremic syndrome | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04654468 | Mar 2021 → Feb 2022 overdue | paroxysmal nocturnal hemoglobinuria | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04434092 | Oct 2020 → Nov 2022 overdue | paroxysmal nocturnal hemoglobinuria | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04432584 | Sep 2020 → Sep 2027 expected | paroxysmal nocturnal hemoglobinuria | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-08-27 | Roche Global Development | Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH roche.com ↗ |
| 2024-06-28 | Roche Global Development | CHMP recommends EU approval of Roche’s PiaSky for people with PNH, a rare, life-threatening blood condition roche.com ↗ |
| 2023-06-09 | Roche Global Development | New data show Roche’s subcutaneously administered crovalimab achieved disease control and was well-tolerated in people with paroxysmal nocturnal haemoglobinuria (PNH) roche.com ↗ |
| 2023-02-07 | Roche Global Development | Roche announces positive data from global phase III programme for crovalimab in PNH, a rare life-threatening blood condition roche.com ↗ |
| 2022-12-11 | Roche Global Development | Roche’s subcutaneous crovalimab given every four weeks achieves disease control in people with PNH, a life-threatening blood condition roche.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Crovalimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04432584 ↗ |
| Known as | Crovalimab-akkz | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594316 ↗ |
| Known as | Piasky | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594316 ↗ |
| Known as | RG-6107 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594316 ↗ |
| Known as | RO-7112689 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594316 ↗ |
| Known as | SKY-59 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594316 ↗ |
| Action | Inhibit | “Crovalimab, a novel C5 inhibitor” PMID 38924124 ↗ Jun 2024 |
| Modality | Monoclonal antibody | “Crovalimab, a sequential monoclonal antibody recycling technology antibody” PMID 31978221 ↗ Mar 2020 |
| Route | Intravenous | “intravenous (IV) infusion” NCT03157635 ↗ |
| Target | C5 | “complement C5 inhibitor crovalimab” PMID 31978221 ↗ Mar 2020 |