Drugs / Wilate
Wilate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | wilate | von Willebrand disease (hereditary or acquired) | 2023-02-21 | “Octapharma USA has submitted a Biologics License Application Supplement (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approval of wilate®” octapharma.com ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT03095287 | Jan 2018 → Sep 2020 | hemophilia A | Grifols Therapeutics LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00717626 | Jul 2008 → Apr 2011 | hemophilia A | The Hospital for Sick Children | Completed | No outcome recorded |
| Phase 36 trials · 2 met primary | ||||||
| Phase 3 | NCT06205095 | Oct 2024 → Sep 2026 overdue | von Willebrand disease (hereditary or acquired) | Unity Health Toronto | Recruiting | No outcome recorded |
| Phase 3 | NCT04953884 | Sep 2021 → Dec 2024 | von Willebrand disease (hereditary or acquired) | Octapharma | Completed | No outcome recorded |
| Phase 3 | NCT04052698 | Jun 2020 → Apr 2022 | von Willebrand disease (hereditary or acquired) | Octapharma | Completed | Met primary |
| Phase 3 | NCT03376516 | Nov 2017 → Nov 2018 | severe hemophilia A | Octapharma | Completed | No outcome recorded |
| Phase 3 | NCT02954575 | Dec 2016 → Mar 2018 | severe hemophilia A | Octapharma | Completed | Met primary |
| Phase 3 | NCT01365546 | Jun 2011 → Feb 2014 | — | Octapharma | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT04555785 | Apr 2022 → Nov 2027 expected | hemorrhagic disease | University Hospital, Basel, Switzerland | Recruiting | No outcome recorded |
| Phase 4 | NCT03204539 | Jun 2017 → Jul 2019 | hemophilia A | University of California, Davis | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT00555555 | Jul 2008 → Feb 2012 | von Willebrand disease 3 | Grifols Biologicals, LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00168090 | Oct 2001 → May 2006 | blood platelet disease, von Willebrand disease (hereditary or acquired) | CSL Behring | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01051076 | Nov 2009 → Oct 2020 | severe hemophilia A | City of Hope Medical Center | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT02250508 Comparator | Dec 2004 → Jun 2005 | von Willebrand disease (hereditary or acquired) | Bio Products Laboratory | Completed | No outcome recorded |
| — | NCT01051544 Comparator | Sep 2009 → Jun 2020 | severe hemophilia A | City of Hope Medical Center | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-07-10 | Octapharma | Regulatory Octapharma USA Announces Expanded FDA Approval of wilate® for von Willebrand Disease Prophylaxis in Children Younger Than 6 Years octapharma.com ↗
This approval expands access to the first von Willebrand Factor (VWF) concentrate indicated for prophylactic treatment across all ages and forms of VWD, the most common inherited bleeding disorder. |
| 2024-04-29 | Octapharma | Regulatory Octapharma USA: FDA Grants Orphan Drug Exclusivity to wilate®, the First VWF Concentrate for Prophylaxis in All Types of VWD octapharma.com ↗ |
| 2024-01-22 | Octapharma | Results Publication of data from WIL-31 study marks a milestone in improving long-term care for patients with severe von Willebrand disease (VWD) octapharma.com ↗ |
| 2024-01-17 | Octapharma | Results Octapharma to present clinical and scientific data at the 17th Annual Congress of the European Association for Haemophilia and Allied Disorders octapharma.com ↗
The study shows that wilate ® prophylaxis is highly effective at reducing bleeding rates in children and adults with all types of VWD and across examined bleeding sites. |
| 2023-12-07 | Octapharma | Regulatory Octapharma USA: FDA Grants Expanded Approval to wilate® as the First VWF Concentrate for Prophylaxis in All Types of VWD octapharma.com ↗
Octapharma USA announced the expansion of the U.S. Food and Drug Administration (FDA) approval for wilate ® , von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection. |
| 2023-11-27 | Octapharma | Results Octapharma to present new clinical and scientific data at ASH 2023 from ongoing research initiatives aimed at advancing care for people living with bleeding disorders octapharma.com ↗
The results of the study showed that wilate ® prophylaxis is highly effective at reducing the number of bleeds in children and adults and provides compelling evidence to support the use of regular prophylaxis in patients with severe VWD. |
| 2023-02-21 | Octapharma | Regulatory Octapharma USA Requests FDA Approval for wilate® VWD Prophylaxis Supplement octapharma.com ↗ |
| 2022-12-05 | Octapharma | Results Octapharma to present new clinical data and studies at ASH 2022 to demonstrate its continued mission to meet the challenges faced by people with bleeding disorders octapharma.com ↗
Prophylaxis with wilate® significantly reduced bleeding rates in children and adults with any type of von Willebrand disease (VWD) in the phase 3 WIL-31 study. |
All press releases naming this drug 9 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Wilate | “Wilate® is a plasma-derived, highly purified concentrate administered through intravenous injection.” NCT06205095 ↗9“Human Factor VWF/FVIII Concentrate (Wilate)” NCT01365546 ↗ “Wilate” NCT01051076 ↗ “Wilate” NCT01051544 ↗ |
| Known as | Alphanate | “Alphanate” NCT01051544 ↗ |
| Known as | Alphanate Factor VIII/VWF concentrate (Human) | “Alphanate® Factor VIII/VWF concentrate (Human)” NCT00555555 ↗ |
| Known as | Alphanate SD/HT | “Anti-Hemophilic/von Willebrand Factor VIII (Human) Alphanate SD/HT” NCT00555555 ↗ |
| Known as | Anti-Hemophilic/von Willebrand Factor VIII (Human) | “Anti-Hemophilic/von Willebrand Factor VIII (Human) Alphanate SD/HT” NCT00555555 ↗ |
| Known as | Antihemophilic Factor/Von Willebrand Factor Complex | “Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects With Von...” NCT00168090 ↗ |
| Known as | FVIII/VWF Complex (Human) | “To assess the efficacy of FVIII/VWF Complex (Human), Alphanate® as replacement therapy in preventing excessive bleeding in subjects with congenital Type 3 von Willebrand...” NCT00555555 ↗ |
| Known as | Haemate P | “Haemate P” NCT01051076 ↗ |
| Known as | Human Factor VWF/FVIII Concentrate | “Human Factor VWF/FVIII Concentrate (Wilate)” NCT01365546 ↗ |
| Known as | Humate-P | “Humate P” NCT01051076 ↗ |
| Known as | Octanate | “Octanate” NCT01051076 ↗1“Octanate” NCT01051544 ↗ |
| Action | Restore | “To assess the efficacy of FVIII/VWF Complex (Human), Alphanate® as replacement therapy in preventing excessive bleeding in subjects with congenital Type 3 von Willebrand...” NCT00555555 ↗ |
| Modality | Protein / enzyme biologic | “Blood coagulation Factor VIII and vWF, human” NCT00168090 ↗ |
| Route | Intravenous | “intravenous infusion” NCT01365546 ↗ |