Drugs / Caplacizumab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Cablivi | — | 2018-08-30 | europa.eu ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03172208 | Jun → Oct 2017 | — | Ablynx, a Sanofi company | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT04720261 | Apr 2021 → May 2023 | acquired thrombotic thrombocytopenic purpura | University Hospital, Rouen | Terminated | No outcome recorded |
| Phase 2 | NCT01151423 | Jan 2011 → Mar 2014 | acquired thrombotic thrombocytopenic purpura | Ablynx, a Sanofi company | Completed | Met primary |
| Phase 2 | NCT01020383 | Sep 2009 → Apr 2011 | intermediate coronary syndrome, myocardial infarction | Ablynx, a Sanofi company | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04074187 | Oct 2019 → May 2021 | thrombotic thrombocytopenic purpura | Sanofi | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT05468320 | Nov 2022 → Dec 2024 | thrombotic thrombocytopenic purpura | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02878603 | Oct 2016 → Oct 2020 | acquired thrombotic thrombocytopenic purpura | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02553317 | Nov 2015 → Aug 2017 | acquired thrombotic thrombocytopenic purpura | Ablynx, a Sanofi company | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-12-11 | Sanofi | Regulatory Press Release: Sanofi’s Qfitlia and Cablivi approved in China, expanding care for rare diseases sanofi.com ↗
The National Medical Products Administration (NMPA) in China has approved two innovative Sanofi medicines for rare hematologic diseases: Qfitlia (fitusiran) for hemophilia and Cablivi (caplacizumab) for acquired thrombotic thrombocytopenic purpura. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2025-12-11 | Sanofi | Press Release: Sanofi’s Qfitlia and Cablivi approved in China, expanding care for rare diseases sanofi.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Caplacizumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04720261 ↗ |
| Known as | ALX-0081 | “Caplacizumab (ALX-0081)” NCT04074187 ↗ |
| Known as | Cablivi | ChEMBL registry synonym — accepted as the source's own label CHEMBL2109624 ↗ |
| Known as | Caplacizumab yhdp | ChEMBL registry synonym — accepted as the source's own label CHEMBL2109624 ↗ |
| Action | Inhibit | “inhibits the interaction between ultralarge von Willebrand factor multimers and platelets” PMID 26863353 ↗ Feb 2016 |
| Modality | Protein / enzyme biologic | “Caplacizumab, an anti-von Willebrand factor humanized, bivalent variable-domain-only immunoglobulin fragment, inhibits interaction between von Willebrand factor multimers and platelets.” PMID 30625070 ↗ Jan 2019 |
| Route | Intravenous | “4 i.v. bolus injections, once every 6 hours” NCT01020383 ↗ |
| Target | VWF | “Anti-VWF therapy with caplacizumab” PMID 41348038 ↗ Dec 2025 |