Drugs / Nelarabine
Nelarabine
also known as
506U78 · 506U · Arranon · Atriance · Attriance · GW-506U78 · Nelarabina · Nelzarabine · +3 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ARRANON | — | 2019-07-31 | fda.gov ↗ |
| Approved | EU (EMA) | Atriance | — | 2007-08-22 | europa.eu ↗ |
| Approved | US (FDA) | ARRANON | — | 2005-10-28 | fda.gov ↗ |
Trials 21 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03328104 Background | Jul 2018 → Jun 2023 | T-lymphoblastic lymphoma | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT00406757 Comparator | Aug 2006 → Jul 2009 | T lymphoblastic leukemia/lymphoma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07294677 Background | Mar 2026 → Mar 2032 expected | leukemia, lymphoma | University of Chicago | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03808610 Background | Apr 2019 → May 2026 | B-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06390319 Background | Dec 2024 → Dec 2027 expected | T-cell acute lymphoblastic leukemia, T-cell non-Hodgkin lymphoma, mixed phenotype acute leukemia | St. Jude Children's Research Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06210750 Background | Aug 2024 → Sep 2026 | T-cell acute lymphoblastic leukemia, T-lymphoblastic lymphoma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07072585 Background | Aug 2026 → Sep 2035 expected | T-cell acute lymphoblastic leukemia, T-lymphoblastic lymphoma | Children's Oncology Group | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT03117751 Background | Mar 2017 → Sep 2026 expected | lymphoblastic leukemia, acute, with lymphomatous features | St. Jude Children's Research Hospital | Active not recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT03020030 Background | Mar 2017 → Nov 2026 expected | childhood acute lymphoblastic leukemia | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00408005 Comparator | Jan 2007 → Sep 2017 | T-cell acute lymphoblastic leukemia, T-lymphoblastic lymphoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 33 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nelarabine | “Mitoxantrone Nelarabine Nilotinib” NCT02551718 ↗29 |
| Known as | 506U | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | 506U78 | “Nelarabine (506U78) is a soluble pro-drug of 9-beta-D-arabinofuranosylguanine (ara-G), a deoxyguanosine derivative.” PMID 17344466 ↗ Mar 20072“Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma” NCT00406757 ↗ |
| Known as | Arranon | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | Atriance | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | Attriance | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | GW-506U78 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | Nelarabina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | Nelzarabine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | NSC #686673 | “Compound 506U78 (NSC #686673)” NCT00004239 ↗ |
| Known as | NSC-755985 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | NSC-759876 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Modality | Small molecule | “Nelarabine (506U78) is a soluble pro-drug of 9-beta-D-arabinofuranosylguanine (ara-G), a deoxyguanosine derivative.” PMID 17344466 ↗ Mar 2007 |
| Route | Intravenous | “Given IV” NCT00002970 ↗ |