Drugs / Inotuzumab
Trials 2 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT06533748 | Jan 2025 → May 2028 expected | lymphoblastic lymphoma, precursor B-cell acute lymphoblastic leukemia | St. Jude Children's Research Hospital | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07443592 | Mar 2026 → Mar 2031 expected | acute lymphoblastic leukemia | PETHEMA Foundation | Not yet recruiting | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03628053 Comparator | Jun 2020 → Oct 2025 | acute lymphoblastic leukemia | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-08-17 | Pfizer | Pfizer Receives U.S. FDA Approval for BESPONSA® (inotuzumab ozogamicin) pfizer.com ↗ |
| 2017-04-21 | Pfizer | Pfizer Receives Positive CHMP Opinion for BESPONSA® (Inotuzumab Ozogamicin) for the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia pfizer.com ↗ |
| 2017-02-21 | Pfizer | Pfizer Announces Acceptance of Regulatory Submission for Inotuzumab Ozogamicin by the U.S. Food and Drug Administration pfizer.com ↗ |
| 2016-06-12 | Pfizer | Pfizer Announces Final Results from Inotuzumab Ozogamicin Pivotal Phase 3 Study in Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia pfizer.com ↗ |
| 2015-10-19 | Pfizer | Pfizer’s Inotuzumab Ozogamicin Receives FDA Breakthrough Therapy Designation for Acute Lymphoblastic Leukemia (ALL) pfizer.com ↗ |
| 2015-04-21 | Pfizer | Pfizer Phase 3 Study Of Inotuzumab Ozogamicin Meets Primary Endpoint In Adult Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia pfizer.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Inotuzumab | “Resistant participants will receive a second induction with inotuzumab for B-cell precursor ALL or with FLAG-Ida (fludarabine, cytarabine, idarubicin and granulocyte colony...” NCT07443592 ↗ |
| Known as | G5/44 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297558 ↗ |
| Modality | Other / unclassified | “CD22-directed antibody-drug conjugate” NCT03628053 ↗ |
| Route | Intravenous | “2 doses of inotuzumab IV on Days 2 and 8” NCT06533748 ↗ |
| Target | CD22 | “CD22 binding agent” CHEMBL4297558 ↗ |