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Arranon

(nelarabine)

ApprovedSmall molecule

Nelarabine is a chemotherapy medication used to treat certain types of blood cancers, specifically leukemia and lymphoma that have not responded to other treatments or have returned after previous therapy. It works by destroying cancer cells.[2] Arranon is currently approved and in use across 13 indications[4].[1]

Arranon is one of 256 small molecule programs targeting Precursor T-Cell Lymphoblastic Leukemia-Lymphoma. It is currently in Approved.

13

Indications

31

Total Trials

8

Active Trials

255

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Precursor T-Cell Lymphoblastic Leukemia-LymphomaActive, not recruiting

T-Cell Acute Lymphoblastic LeukemiaActive, not recruiting

Lymphoblastic LymphomaActive, not recruiting

LymphomaActive, not recruiting

Cutaneous T-Cell LymphomaActive, not recruiting

LeukemiaActive, not recruiting

Mycosis FungoidesApproved

Sezary's DiseaseApproved

Lymphoid LeukemiaApproved

Childhood LeukemiaActive, not recruiting

Precursor T-Cell Lymphoblastic Leukemia-LymphomaApproved

Active, not recruiting

T-Cell Acute Lymphoblastic LeukemiaPhase 3

Active, not recruiting

Lymphoblastic LymphomaPhase 3

Active, not recruiting

LymphomaPhase 2

Active, not recruiting

Cutaneous T-Cell LymphomaPhase 2

Active, not recruiting

LeukemiaPhase 2

Active, not recruiting

Mycosis FungoidesApproved

Approved

Sezary's DiseaseApproved

Approved

Lymphoid LeukemiaApproved

Approved

Childhood LeukemiaApproved

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Arranon

Blenoxane

SSequus Pharmaceuticals

Velban

EEastern Cooperative Oncology Group

Norvir

Wellcovorin

GGlaxo Dba Glaxosmithkline

Nuvigil

NNuvo Research GmbH

Kenalog

BBausch Health Americas, Inc.

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

PEG-Intron

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

T-Cell Acute Lymphoblastic Leukemia

NCT00501826

Phase 1/2Active, not recruiting

T-Cell Acute Lymphoblastic Leukemia

NCT03808610

Q3 2028

Phase 2/3Active, not recruiting

Acute Lymphoblastic Leukemia

NCT03117751

Q1 2032

Phase 1/2Recruiting

Chemotherapy

NCT07294677

Q4 2033

Phase 2Recruiting

T-Cell Acute Lymphoblastic Leukemia

NCT06390319

Clinical

Trials by Indication[1]

Acute Lymphoblastic Leukemia8 trials

506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)

Completed·GGoethe University·Phase 2·NCT00684619·120 enrolled

Standard Chemotherapy with or Without Nelarabine or Rituximab in Treating Patients with Newly Diagnosed Acute Lymphoblastic Leukemia

Completed·UUniversity College, London··NCT01085617

506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00003545·35 enrolled

Show 5 more trials

Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment

Completed·GGoethe University·Phase 3·NCT02881086·1,023 enrolled

Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Completed·NNational Cancer Institute (NCI)·N/A·NCT00016302·100 enrolled

Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

Active, not recruiting·—·Phase 3·NCT03020030·560 enrolled

BL-8040 and Nelarabine for Relapsed or Refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma

Terminated·WWashington University School of Medicine·Phase 2·NCT02763384·12 enrolled

Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2/3·NCT03117751·790 enrolled

T-cell acute lymphoblastic leukemia6 trials

Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LBL)

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT06210750

506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Completed·NNational Cancer Institute (NCI)·N/A·NCT00003837·25 enrolled

Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)

Recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT06390319·100 enrolled

Show 3 more trials

Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma

Terminated·SSt. Jude Children's Research Hospital·Phase 2·NCT02518750·3 enrolled

Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT03808610·50 enrolled

Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT00501826·160 enrolled

Leukemia3 trials

Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma

Completed· GSK logo

GSK·Phase 1·NCT00406757·13 enrolled

S0010 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia

Completed·SSWOG Cancer Research Network·Phase 2·NCT00006020·35 enrolled

Everolimus in Combination With Nelarabine, Cyclophosphamide and Etoposide in Lymphoblastic Leukemia/Lymphoma

Completed·EEmory University·Phase 1·NCT03328104·8 enrolled

Lymphoma2 trials

506U78 in Treating Patients With Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00005080·74 enrolled

506U78 in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or T-cell Lymphoma

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT00005950·111 enrolled

Lymphoblastic Lymphoma2 trials

Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)

Not yet recruiting·CChildren's Oncology Group·Phase 2/3·NCT07072585·1,708 enrolled

The Efficacy and Safety of Nelarabine Injection in Patients With T-lymphoblastic Leukemia and T-lymphoblastic Lymphoma

Not yet recruiting· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 3·NCT06434467·83 enrolled

10 more indications

Lymphoid Malignancies1 trial

Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Nelarabine in Patients With Relapsed/Refractory Lymphoid Malignancies

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01094860·29 enrolled

Observational Study1 trial

Observational Study of Nelarabine in Children and Young Adults

Completed· GSK logo

GSK··NCT00866671·28 enrolled

Relapse1 trial

Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL

Terminated·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 1/2·NCT00981799·23 enrolled

Cutaneous T-cell lymphoma1 trial

506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT00005982·35 enrolled

Drug1 trial

Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg

Completed· Novartis logo

Novartis··NCT01376115·343 enrolled

Chronic Lymphocytic Leukemia1 trial

506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents

Completed· GSK logo

GSK·Phase 2·NCT00003635

Chemotherapy1 trial

CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL

Recruiting·UUniversity of Chicago·Phase 1/2·NCT07294677·104 enrolled

Hematologic Cancer1 trial

506U78 in Treating Patients With Refractory Hematologic Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00002970·148 enrolled

Treatment1 trial

Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old)

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT02619630·275 enrolled

T Acute Lymphoblastic Leukemia1 trial

Intensified Methotrexate, Nelarabine (Compound 506U78) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00408005·1,895 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 28, 2005

ARRANON

NDA NDA021877

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for nelarabine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Arranon drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — nelarabine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for nelarabine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021877). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

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