Drugs / BI 836858
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03207191 | Dec 2016 → Mar 2020 | acute myeloid leukemia | Philogen S.p.A. | Completed | No outcome recorded |
| Phase 1 | NCT01690624 | Sep 2012 → May 2018 | acute myeloid leukemia | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02632721 | Jun 2016 → Jan 2023 | acute myeloid leukemia | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02240706 | Jan 2015 → Nov 2019 | myelodysplastic syndrome | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03013998 | Nov 2016 → Dec 2032 expected | acute myeloid leukemia | Beat AML, LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2017-03-09 | Boehringer Ingelheim | Regulatory FDA grants orphan drug designation to Boehringer Ingelheim's investigational anti-CD33 monoclonal antibody BI 836858 for treatment of myelodysplastic syndromes prnewswire.com ↗
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its anti-CD33 monoclonal antibody BI 836858 for the treatment of myelodysplastic syndromes (MDS). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2017-03-09 | Boehringer Ingelheim | FDA grants orphan drug designation to Boehringer Ingelheim's investigational anti-CD33 monoclonal antibody BI 836858 for treatment of myelodysplastic syndromes prnewswire.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BI 836858 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01690624 ↗ |
| Modality | Protein / enzyme biologic | “the Anti-CD33 Antibody BI 836858” NCT03207191 ↗ |
| Route | Intravenous | “administered as intravenous infusion” NCT01690624 ↗ |
| Target | CD33 | “the Anti-CD33 Antibody BI 836858” NCT03207191 ↗ |