Drugs / Azacitadine
last change Jun 2025 re-read 3 minutes ago

Azacitadine

also known as AZA · Azacitidine · azacytidine · Vidaza
Developed for
acute myeloid leukemia · peripheral T-cell lymphoma, not otherwise specified
Investigated by
AbbVie · Dynamic Solutions · Genentech, Inc. · PETHEMA Foundation · Ruijin Hospital

Trials 3

2015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT02265731 Sep 2014 → Mar 2021 acute myeloid leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, plasma cell myeloma AbbVie Completed No outcome recorded
Phase 21 trial · 1 met primary
Phase 2 NCT04480099 Jul 2020 → Apr 2023 peripheral T-cell lymphoma, not otherwise specified Ruijin Hospital Unknown Met primary
Phase 31 trial
Phase 3 NCT02319135 Oct 2014 → Oct 2018 acute myeloid leukemia PETHEMA Foundation Completed No outcome recorded
Comparator or background therapy1 trial
Phase 1 NCT06651229 Background Mar 2025 → Aug 2027 expected acute myeloid leukemia, myelodysplastic syndrome Janssen Research & Development, LLC Recruiting No outcome recorded

Press releases naming this drug 17 releases

DateIssuerRelease
2025-06-12 Janssen Research & Development, LLC New results for Johnson & Johnson’s bleximenib demonstrate promising antileukemic activity in combination with venetoclax and azacitidine for acute myeloid leukemia jnj.com ↗
2025-06-12 Janssen Research & Development, LLC New results for Johnson & Johnson's bleximenib demonstrate promising antileukemic activity in combination with venetoclax and azacitidine for acute myeloid leukemia jnj.com ↗
2023-12-10 AbbVie ImmunoGen Presents Findings from Newly Diagnosed Acute Myeloid Leukemia Cohorts in Phase 1b/2 Study of Pivekimab Sunirine in Combination with Azacitidine and Venetoclax at ASH abbvie.com ↗
2023-01-01 OncoVerity, Inc. Results from a phase I/II trial of cusatuzumab combined with azacitidine in patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy oncoverity.com ↗
2022-12-10 AbbVie ImmunoGen Presents Findings from Expansion Cohorts in Phase 1b/2 Study of Pivekimab Sunirine with Vidaza® and Venclexta® in Acute Myeloid Leukemia at ASH abbvie.com ↗
2021-12-12 AbbVie ImmunoGen Presents Initial Findings From the Phase 1b/2 Study of IMGN632 in Combination With Vidaza® and Venclexta® in Relapsed/Refractory Acute Myeloid Leukemia at ASH abbvie.com ↗
2021-11-04 AbbVie ImmunoGen to Present Initial Data Combining IMGN632 with Vidaza® and Venclexta® in Relapsed/Refractory Acute Myeloid Leukemia at ASH abbvie.com ↗
2021-07-21 Hoffmann-La Roche FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes roche.com ↗
2021-07-20 Genentech, Inc. FDA Grants Breakthrough Therapy Designation for Venclexta in Combination With Azacitidine for the Treatment of Patients With Myelodysplastic Syndromes gene.com ↗
2021-01-05 Samyang Biopharmaceuticals Corporation Samyang Biopharmaceuticals Corporation successfully launched its anti-cancer treatment drug Azacitidine Injection in the EU for the first time as a Korean company samyang.com ↗
2020-06-13 AbbVie VENCLEXTA®/VENCLYXTO® (venetoclax) Plus Azacitidine Demonstrates Statistically Significant Overall Survival Benefit and Improved Remission Rates in Treatment-Naïve Acute Myeloid Leukemia Patients abbvie.com ↗
2020-03-23 AbbVie AbbVie Announces Positive Topline Results from Phase 3 Trial of VENCLEXTA® (venetoclax) in Combination with Azacitidine in Patients with Acute Myeloid Leukemia (AML) abbvie.com ↗

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as azacitadine “Azacitadine 100mg/day ivgtt D-7 to -1 if with TET2/KMT2D gene mutation.” NCT04480099 ↗
3

NCT02265731 ↗

NCT02319135 ↗

NCT06651229 ↗

Known as AZA “Azacitadine (AZA)” NCT06651229 ↗
Known as Azacitidine “Subcutaneous Azacitidine 75 mg/m2/day, days 1 to 7.” NCT02319135 ↗
Known as azacytidine “comparing azacytidine (AZA) with fludarabine plus low-dose cytarabine (FLUGA).” PMID 34070172 ↗ May 2021
Known as Vidaza “Azacytidine (Vidaza®) Versus Fludarabine and Cytarabine” NCT02319135 ↗
Route Intravenous “by IV infusion” NCT02265731 ↗