azacitidine
azacitidine: developed by 1 company · 85 clinical trials tracked · 1 FDA decision.
azacitidine evidence translation
What we can confirm
1 FDA record · 85 tracked trials
What it means
What to watch
Prepared research question
How could azacitidine → RDY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 21 study sponsors
Related indications
Development Pipeline (1)
| Company | Phase |
|---|---|
| DR REDDYS LABORATORIES LTD (RDY) | Approved |
Clinical Trials (85)showing 10 most recent
Phase 1 Investigation of Belinostat-Based Combinations in Relapsed/Refractory T-Cell Lymphoma
Primary endpoint: Occurrence of dose-limiting toxicities (DLT) (Arm A)
A Phase 1b Dose Escalation and Dose Expansion Study of CLN 049 in Combination With Azacitidine and Venetoclax for the Treatment of Adult Patients With Newly Diagnosed, Acute Myeloid Leukemia
Primary endpoint: Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs) [safety and tolerability] of CLN-049 combined with azacitidine and venetoclax
A Phase 1/2a, Open-Label, Dose Finding and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sonrotoclax (BGB-11417) in Combination With Other Agents in Pediatric Patients Aged 6 Months to 17 Years, With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Primary endpoint: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
A Phase 1/2 Study of Pacritinib in Combination With Azacitidine for the Treatment of IPSS-M Moderate Low to Very High Risk Myelodysplastic Syndrome
Primary endpoint: Optimal Dose of Pacritinib in Combination with Azacitidine - Phase 1
Pilot Single Arm Phase 2 Study of Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax
Primary endpoint: Composite complete remission rate
A Randomized Phase 2/3 Study Evaluating the Safety and Efficacy of Pivekimab Sunirine (PVEK) in Combination With Venetoclax and Azacitidine in Adult Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible to Receive Intensive Chemotherapy
Primary endpoint: Phase 2: Complete remission (CR)
Clinical Study of Sonrotoclax Combined With Azacitidine Plus Individualized Targeted Drugs in the Treatment of Newly Diagnosed Adult Acute Myeloid Leukemia
Primary endpoint: Composite Complete Remission
A Phase I Study to Evaluate the Safety of Ruxolitinib in Combination With Azacitidine Maintenance in Patients Undergoing Reduced Intensity Allogeneic Transplant for Acute Myeloid Leukemia (AML)
Primary endpoint: Incidence of dose limiting toxicities (DLTs)
Single-Arm Phase 2 Study of Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Who Are Eligible for Intensive Induction Chemotherapy
Primary endpoint: Number of Participants Experiencing Excessive Toxicity
A Pilot Study of Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Overlap Neoplasms and Chronic Neutrophilic Leukemia (M-HArbOr)
Primary endpoint: Number of participants who achieve a complete response
FDA Decisions1 records
Frequently asked questions
Who is developing azacitidine?
azacitidine is being developed by DR REDDYS LABORATORIES LTD.
How many clinical trials involve azacitidine?
BioSniper tracks 85 clinical trials involving azacitidine.
What is azacitidine's latest FDA decision?
The most recent tracked FDA decision for azacitidine is Approval for 1 INDICATIONS AND USAGE Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (C, dated September 16, 2013.