Drugs / DZD8586
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07454863 | Mar 2026 | non-Hodgkin lymphoma | Dizal Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05824585 | May 2023 → Jun 2025 | non-Hodgkin lymphoma | Dizal Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05176873 | Dec 2021 → May 2022 | non-Hodgkin lymphoma | Dizal Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07059650 | Aug 2025 → Oct 2030 expected | diffuse large B-cell lymphoma | Dizal Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05844956 | Jun 2022 → Feb 2024 | B-cell non-Hodgkin lymphoma | Dizal Pharmaceuticals | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07294365 | Jan 2026 → Jul 2027 expected | autoimmune thrombocytopenia | Dizal Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT07154264 | Sep 2025 → Dec 2029 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Dizal Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT06539182 | Apr 2024 → Sep 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Dizal Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT06539195 | Mar 2024 → Dec 2026 expected | diffuse large B-cell lymphoma | Dizal Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07712588 | Sep 2027 → Jan 2031 expected | diffuse large B-cell lymphoma | Dizal Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07139873 | Sep 2025 → Jan 2029 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Dizal Pharmaceuticals | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-05-13 | Dizal Pharmaceuticals | Results Dizal to Present Nine Abstracts Across Its Hematology Portfolio at EHA 2026 dizalpharma.com ↗
The new data to be presented at EHA 2026 further demonstrate birelentinib’s durable activity across molecular subtypes, supporting its potential as a differentiated treatment option for patients with DLBCL. |
| 2025-08-06 | Dizal Pharmaceuticals | Regulatory The U.S. FDA Granted Fast Track Designation to Dizal’s Birelentinib for Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma dizalpharma.com ↗ |
| 2025-05-23 | Dizal Pharmaceuticals | Results Dizal to Highlight its Portfolio Advances in Hematologic Malignancies and Lung Cancer at ASCO 2025 dizalpharma.com ↗
An objective response rate (ORR) of 84.2% was achieved. |
| 2024-12-09 | Dizal Pharmaceuticals | Results Dizal Presents Latest Data of DZD8586, a LYN/BTK Dual Inhibitor, in B-cell Non-Hodgkin Lymphoma at the 2024 ASH Annual Meeting dizalpharma.com ↗
In chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL), the overall response rate (ORR) was 57.9% (≥ 50 mg) by data cutoff. |
All press releases naming this drug 7 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DZD8586 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07294365 ↗ |
| Known as | Birelentinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07712588 ↗ |
| Route | Oral | “Daily oral dose of DZD8586 at 25 mg.” NCT06539182 ↗ |