Drugs / Magrolimab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold acute megakaryoblastic leukemia in adult 1 milestone | |||||
| Clinical hold | US (FDA) | — | acute megakaryoblastic leukemia in adult | 2023-08-21 | “has placed a partial clinical hold on the initiation of new patients in U.S. studies evaluating magrolimab to treat acute myeloid leukemia (AML).” gilead.com ↗ |
| Clinical hold myelodysplastic syndrome 1 milestone | |||||
| Clinical hold | US (FDA) | — | myelodysplastic syndrome | 2022-01-25 | “the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine” gilead.com ↗ |
Trials 34
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 113 trials | ||||||
| Phase 1 | NCT05823480 | Oct 2024 → Feb 2026 | acute myeloid leukemia, myelodysplastic syndrome | City of Hope Medical Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT05807126 | Mar 2024 → Dec 2026 | castration-resistant prostate carcinoma, female breast carcinoma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05738161 | Jun 2023 → Feb 2024 | urothelial carcinoma | Insel Gruppe AG, University Hospital Bern | Withdrawn | No outcome recorded |
| Phase 1 | NCT05169944 | Apr 2022 → Sep 2024 | brain cancer | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1 | NCT04599634 | Dec 2021 → Mar 2024 | chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT04751383 | Aug 2021 → Sep 2024 | neuroblastoma, osteosarcoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT04403308 | Jul 2020 → Jan 2022 | cancer | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03922477 | Oct 2019 → Nov 2020 | acute myeloid leukemia | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1 | NCT03527147 | Jun 2018 → Mar 2021 | diffuse large B-cell lymphoma | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT03558139 | May 2018 → Dec 2020 | ovarian cancer | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT03248479 | Sep 2017 → Sep 2023 | hematopoietic and lymphoid cell neoplasm | Gilead Sciences | Terminated | No outcome recorded |
| Phase 1 | NCT02678338 | Nov 2015 → Nov 2018 | acute myeloid leukemia, myelodysplastic syndrome | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02216409 | Aug 2014 → Oct 2018 | cancer | Gilead Sciences | Completed | No outcome recorded |
| Phase 1/26 trials · 1 missed | ||||||
| Phase 1/2 | NCT05367401 | Dec 2024 → Oct 2029 | acute myeloid leukemia, myelodysplastic syndrome | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT04541017 | Apr 2021 → Oct 2024 | Sezary syndrome, mycosis fungoides | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1/2 | NCT04435691 | Jul 2020 → Mar 2025 | acute myeloid leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT03869190 | Jun 2019 → Oct 2025 | urinary bladder cancer, urothelial carcinoma | Hoffmann-La Roche | Completed | Missed primary |
| Phase 1/2 | NCT02953509 | Nov 2016 → Mar 2024 | non-Hodgkin lymphoma | Gilead Sciences | Terminated | No outcome recorded |
| Phase 1/2 | NCT02953782 | Nov 2016 → Feb 2020 | colorectal cancer | Gilead Sciences | Completed | No outcome recorded |
| Phase 211 trials · 3 missed | ||||||
| Phase 2 | NCT05829434 | Mar 2024 → Aug 2028 | acute myeloid leukemia, myelodysplastic syndrome | Uwe Platzbecker | Withdrawn | No outcome recorded |
| Phase 2 | NCT06046482 | Nov 2023 → Aug 2024 | head and neck squamous cell carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05929716 | Sep 2023 → Mar 2026 | B-cell non-Hodgkin lymphoma, large B-cell lymphoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT05835011 | Jun → Aug 2023 | myelodysplastic syndrome | Astex Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT05330429 | Jul 2022 → Jun 2024 | colorectal cancer | Gilead Sciences | Terminated | Missed primary Stop: Business |
| Phase 2 | NCT04788043 | Jun 2022 → Oct 2024 | classic Hodgkin lymphoma | Ranjana Advani | Terminated | No outcome recorded |
| Phase 2 | NCT04958785 | Dec 2021 → Oct 2024 | triple-negative breast carcinoma | Gilead Sciences | Terminated | Missed primary Stop: Business |
| Phase 2 | NCT04892446 | Nov 2021 → Apr 2024 | plasma cell myeloma | Gilead Sciences | Terminated | No outcome recorded |
| Phase 2 | NCT04827576 | Oct 2021 → Oct 2024 | neoplasm | Gilead Sciences | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04854499 | Sep 2021 → Oct 2024 | head and neck squamous cell carcinoma | Gilead Sciences | Terminated | Missed primary Stop: Business |
| Phase 2 | NCT04778410 | Jun 2021 → Mar 2024 | myeloid neoplasm | Gilead Sciences | Terminated | No outcome recorded Stop: Business |
| Phase 33 trials · 3 missed | ||||||
| Phase 3 | NCT05079230 | Jul 2022 → Apr 2024 | acute myeloid leukemia | Gilead Sciences | Terminated | Missed primary |
| Phase 3 | NCT04778397 | Jul 2021 → Mar 2024 | acute myeloid leukemia | Gilead Sciences | Terminated | Missed primary |
| Phase 3 | NCT04313881 | Sep 2020 → Sep 2023 | myelodysplastic syndrome | Gilead Sciences | Terminated | Missed primary |
| Phase not stated1 trial | ||||||
| — | NCT05627466 | — | acute myeloid leukemia | Gilead Sciences | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2023-08-22 | Ono Pharmaceutical Co., Ltd. | Regulatory Gilead Announces Partial Clinical Hold for Magrolimab Studies in AML ono-pharma.com ↗
the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the initiation of new patients in U.S. studies evaluating magrolimab to treat acute myeloid leukemia (AML). |
| 2023-08-21 | Gilead Sciences | Regulatory Gilead Announces Partial Clinical Hold for Magrolimab Studies in AML gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the initiation of new patients in U.S. studies evaluating magrolimab to treat acute myeloid leukemia (AML). |
| 2023-07-21 | Gilead Sciences | Results Gilead To Discontinue Phase 3 ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS gilead.com ↗
today announced that the Phase 3 ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been discontinued due to futility based on a planned analysis. |
| 2023-06-01 | Gilead Sciences | Results Gilead and Kite Oncology Demonstrate Growing Hematology Pipeline and Strength of Leading Cell Therapy Portfolio at EHA gilead.com ↗
Gilead will highlight data showing magrolimab’s potential effect on the tumor microenvironment to improve bone marrow function in patients with acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (HR-MDS). |
| 2022-04-13 | Ono Pharmaceutical Co., Ltd. | Regulatory FDA Lifts Partial Clinical Hold on MDS and AML Magrolimab Studies ono-pharma.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine. |
| 2022-04-11 | Gilead Sciences | Regulatory FDA Lifts Partial Clinical Hold on MDS and AML Magrolimab Studies gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine. |
| 2022-01-28 | Ono Pharmaceutical Co., Ltd. | Regulatory Gilead Announces Partial Clinical Hold for Studies Evaluating Magrolimab in Combination with Azacitidine ono-pharma.com ↗ |
| 2022-01-25 | Gilead Sciences | Regulatory Gilead Announces Partial Clinical Hold for Studies Evaluating Magrolimab in Combination With Azacitidine gilead.com ↗
Other magrolimab studies, or cohorts, that are not studying the combination of magrolimab plus azacitidine, will continue without any impact by the partial clinical hold. |
| 2020-12-06 | Gilead Sciences | Results Magrolimab Demonstrates Clinical Responses in Ongoing Phase 1b Trial of Previously Untreated Acute Myeloid Leukemia Patients gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced updated results from the magrolimab Phase 1b trial. |
| 2020-11-05 | Gilead Sciences | Results Gilead and Kite to Share Latest Scientific Advances in Hematologic Malignancies at ASH 2020 gilead.com ↗ |
| 2020-09-15 | Gilead Sciences | Regulatory Gilead’s Magrolimab, an Investigational Anti-CD47 Monoclonal Antibody, Receives FDA Breakthrough Therapy Designation for Treatment of Myelodysplastic Syndrome gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for magrolimab, a first-in-class, investigational anti-CD47 monoclonal antibody for the treatment of newly diagnosed myelodysplastic syndrome (MDS). |
| 2020-05-29 | Gilead Sciences | Results Investigational Magrolimab in Combination With Azacitidine Demonstrates Durable Activity in Previously-Untreated Myelodysplastic Syndrome and Acute Myeloid Leukemia gilead.com ↗ |
All press releases naming this drug 12 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Magrolimab | “Magrolimab (ONO-7913) is an anti-cluster of differentiation 47 (CD47) monoclonal antibody.” PMID 41888930 ↗ Mar 2026 |
| Known as | 5F9 | “PURPOSE: To evaluate the safety, pharmacokinetics, and pharmacodynamics of Hu5F9-G4 (5F9), a humanized IgG4 antibody that targets CD47 to enable phagocytosis.” PMID 30811285 ↗ Feb 2019 |
| Known as | Hu5F9-G4 | “Participants will receive atezolizumab and magrolimab (Hu5F9-G4) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated...” NCT03869190 ↗ |
| Known as | Mag | “magrolimab (Mag)” NCT04778410 ↗ |
| Known as | ONO-7913 | “Magrolimab (ONO-7913) is an anti-cluster of differentiation 47 (CD47) monoclonal antibody.” PMID 41888930 ↗ Mar 2026 |
| Action | Inhibit | “blocking monoclonal antibodies directed against CD47 enabled the phagocytosis” PMID 26390038 ↗ Sep 2015 |
| Modality | Monoclonal antibody | “a humanized IgG4 antibody” PMID 30811285 ↗ Feb 2019 |
| Route | Intravenous | “Hu5F9-G4 could be safely administered intravenously” PMID 26390038 ↗ Sep 2015 |
| Target | CD47 | “targets CD47” PMID 30811285 ↗ Feb 2019 |