Drugs / BAX 888
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT03370172 | Feb 2018 → Jul 2024 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2017-10-25 | Takeda | Regulatory Shire Receives Orphan Drug Designation for Gene Therapy Candidate SHP654 (BAX 888) for the Treatment of Hemophilia A takeda.com ↗
today announced the U.S. Food and Drug Administration (FDA) awarded Orphan Drug Designation to Shire’s gene therapy candidate SHP654 (also designated as BAX 888), an investigational factor VIII (FVIII) gene therapy for the treatment of hemophilia A. |
| 2017-07-06 | Takeda | Regulatory Shire submits investigational New Drug Application to FDA for Gene Therapy candidate SHP654 for treatment of Hemophilia A takeda.com ↗
The IND filing for SHP654 represents the latest step forward for Shire’s gene therapy program, which shows promise for both hemophilia A and B populations. |
All press releases naming this drug 2 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BAX 888 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03370172 ↗ |
| Modality | Gene therapy (AAV / viral vector) | “Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing B-Domain Deleted Factor VIII (BDD-FVIII)” NCT03370172 ↗ |
| Route | Intravenous | “single peripheral intravenous (IV) infusion of BAX 888” NCT03370172 ↗ |