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Leustatin

(Cladribine)

ApprovedSmall molecule

Cladribine is used to treat certain types of blood cancers and leukemias, and also to treat multiple sclerosis by helping to suppress the overactive immune system that damages nerve cells.[2] Leustatin is currently approved and in use across 24 indications[4].[1]

Leustatin is one of 425 small molecule programs targeting Hairy Cell Leukemia. It is currently in Approved.

24

Indications

95

Total Trials

28

Active Trials

424

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

3

Patents

Pipeline

Status by Indication[4][1]

Indication

Hairy Cell LeukemiaActive, not recruiting

Myelodysplastic SyndromesActive, not recruiting

LeukemiaRecruiting

Myelodysplastic SyndromeRecruiting

Acute Myeloid LeukemiaRecruiting

Lymphoblastic LymphomaActive, not recruiting

Immune System DiseaseActive, not recruiting

AnemiaActive, not recruiting

Precursor T-Cell Lymphoblastic Leukemia-LymphomaActive, not recruiting

Chronic Progressive Multiple SclerosisApproved

Hairy Cell LeukemiaPhase 2

Active, not recruiting

Myelodysplastic SyndromesPhase 2

Active, not recruiting

LeukemiaPhase 2

Recruiting

Myelodysplastic SyndromePhase 2

Recruiting

Acute Myeloid LeukemiaPhase 2

Recruiting

Lymphoblastic LymphomaApproved

Active, not recruiting

Immune System DiseaseApproved

Active, not recruiting

AnemiaApproved

Active, not recruiting

Precursor T-Cell Lymphoblastic Leukemia-LymphomaPreclinical

Active, not recruiting

Chronic Progressive Multiple SclerosisApproved

Approved

Showing 10 of 24 indications

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Leustatin

Novantrone

Xospata

Cerubidine

EEastern Cooperative Oncology Group

Vepesid

Vanflyta

Cerubidine

HHikma Pharmaceuticals LLC

Nexavar

Cellcept

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalActive, not recruiting

Treatment

NCT04178005

Q1 2027

Phase 1Recruiting

Recurrent Acute Myeloid Leukemia

NCT04375631

Q2 2027

Phase 2Recruiting

Acute Myeloid Leukemia

NCT03586609

Phase 2Recruiting

Hairy Cell Leukemia

NCT00412594

Q3 2027

Phase 2Recruiting

Hairy Cell Leukemia

NCT06561360

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia15 trials

Uproleselan, Cladribine, and Low Dose Cytarabine for the Treatment of Patients With Treated Secondary Acute Myeloid Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT04848974·37 enrolled

Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm

Completed·UUniversity of Washington·Phase 2·NCT03012672·50 enrolled

Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia

Completed·WWashington University School of Medicine·Phase 1/2·NCT02416908·40 enrolled

Show 12 more trials

Cladribine in Combination With CAG in Patients With Refractory/Relapsed Acute Myeloid Leukemia

Unknown status·SSun Yat-sen University·Phase 2·NCT03181815·48 enrolled

Continuous Infusion Chemotherapy (CI-CLAM) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms

Terminated·UUniversity of Washington·Phase 1·NCT04196010·13 enrolled

Guadecitabine With or Without Idarubicin or Cladribine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02096055·44 enrolled

Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia

Completed·CChildren's Oncology Group·Phase 2·NCT00003178·120 enrolled

Study of Chidamide Combined With Cladribine in Refractory/Relapsed Acute Myeloid Leukemia

Unknown status·GGe Zheng·Phase 2·NCT05330364·31 enrolled

Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03586609·145 enrolled

Venetoclax-Navitoclax With Cladribine-based Salvage Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Withdrawn·MMedical College of Wisconsin·Phase 1·NCT06007911

Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms

Recruiting·UUniversity of Washington·Phase 1/2·NCT04797767·62 enrolled

Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia

Completed·MMedical College of Wisconsin·Phase 1·NCT03441048·26 enrolled

Study of Cladribine+Venetoclax After Failure of Venetoclax+Hypomethylating Agent in Monocytic AML

Active, not recruiting·UUniversity of Colorado, Denver·Phase 2·NCT06232655·10 enrolled

Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT04708054·324 enrolled

Randomized Phase 2 Trial of CPX-351 (Vyxeos) vs. CLAG-M (Cladribine, Cytarabine, G-CSF, and Mitoxantrone) in Medically Less-Fit Adults With Acute Myeloid Leukemia (AML) or Other High-Grade Myeloid Neoplasm

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT04195945·60 enrolled

Multiple Sclerosis8 trials

A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD)

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 2·NCT00436826·172 enrolled

Oral Cladribine in Early Multiple Sclerosis (MS)

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 3·NCT00725985·617 enrolled

Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)

Completed· Merck & Co. logo

Merck & Co.··NCT04934800·256 enrolled

Show 5 more trials

Drug-Drug Interaction of Cladribine and Pantoprazole in Multiple Sclerosis Subjects

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00938366·18 enrolled

Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)

Completed·OOslo University Hospital·Phase 3·NCT04121403·267 enrolled

Effects of Oral Cladribine on Remyelination and Inflammation in Multiple Sclerosis Patients

Unknown status·PPontificia Universidade Católica do Rio Grande do Sul·Phase 4·NCT05902429·10 enrolled

Cladribine vs Placebo for Non-active Progressive Multiple Sclerosis (CLASP-MS).

Recruiting·IInstitute of Psychiatry and Neurology, Warsaw·Phase 2/3·NCT05961644·188 enrolled

Cladribine Tablets: Collaborative Study to Evaluate the Impact On Central Nervous System Biomarkers in Multiple Sclerosis

Completed·WWashington University School of Medicine·Approved·NCT03963375·47 enrolled

Lymphoma5 trials

Chidamide Combined With Clad/Gem/Bu With AutoSCT in R/R Diffuse Large B Cell Lymphoma

Unknown status·SSichuan University·Phase 2·NCT03151876·93 enrolled

Chidamide Combined With Clad/Gem/Bu With AutoSCT in High Risk Hodgkin & Non-Hodgkin Lymphoma

Unknown status·SSichuan University·Phase 2·NCT03602131·30 enrolled

R-2cda and Prolongation of Therapy With Rituximab Alone in Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma

Terminated·EEuropean Institute of Oncology·Phase 2·NCT01446900·25 enrolled

Show 2 more trials

ChiCGB vs BEAM in High-risk or R/R Lymphomas

Unknown status·SSichuan University·Phase 3·NCT05466318·306 enrolled

Rituximab and Cladribine in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00053027·30 enrolled

Myelodysplastic Syndrome5 trials

Venetoclax and Sequential Busulfan, Cladribine, and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02250937·116 enrolled

Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04047641·80 enrolled

Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Completed·UUniversity of Washington·Phase 1/2·NCT02728050·84 enrolled

Show 2 more trials

Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02115295·508 enrolled

Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed·CChildren's Oncology Group·Phase 2·NCT00002805·115 enrolled

Mantle Cell Lymphoma4 trials

Bortezomib (VELCADE), Cladribine and Rituximab (VCR) in Mantle Cell Lymphoma (PSHCI 10-011)

Unknown status·MMilton S. Hershey Medical Center·Phase 1·NCT01439750·13 enrolled

Bortezomib, Cladribine, and Rituximab in Treating Patients With Advanced Mantle Cell Lymphoma or Indolent Lymphoma

Completed·UUniversity of Arizona·Phase 2·NCT00980395·24 enrolled

Rituximab, Cladribine, and Temsirolimus in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

Completed·AAlliance for Clinical Trials in Oncology·Phase 1·NCT00787969·74 enrolled

Show 1 more trial

Cladribine in Patients With Mantle Cell Lymphoma

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00002879·51 enrolled

40 more indications

Hairy Cell Leukemia4 trials

Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT00412594·150 enrolled

A Randomized, Multi-Center, Phase II Study of Vemurafenib Plus Obinutuzumab vs. Cladribine Plus Rituximab in Patients With Previously Untreated Hairy Cell Leukemia (HCL)

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06561360·86 enrolled

Randomized Trial of Cladribine (CdA) With Simultaneous or Delayed Rituximab to Eliminate Hairy Cell Leukemia Minimal Residual Disease

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT00923013·175 enrolled

Show 1 more trial

A Phase 1 Study of Combination Tovorafenib (DAY101) and Rituximab Treatment in Relapsed or Refractory Classical Hairy Cell Leukemia and Phase 2 Randomized Study Comparing Tovorafenib (DAY101) and Rituximab With Cladribine and Rituximab for Front-Line Treatment of Classical Hairy Cell Leukemia

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT06965114·84 enrolled

Leukemia3 trials

Cladribine, Cytarabine and Idarubicin in Patients With Relapsed Acute Myelocytic Leukemia (AML)

Unknown status·UUniversity Hospital, Bonn·Phase 2·NCT00126321·50 enrolled

A Phase 1, Open-Label, Sequential Cross-over, Bioavailability/Bioequivalence Study to Compare the Pharmacokinetics of Oral Cladribine With the Reference Listed Drug, Intravenous Cladribine

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT06021600·3 enrolled

Phase II Study of Cladribine Plus Low Dose Cytarabine (LDAC) Induction Followed By Consolidation With Cladribine Plus LDAC Alternating With Decitabine in Patients With Untreated Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT01515527·160 enrolled

Chronic Lymphocytic Leukemia3 trials

Vorinostat, Cladribine, and Rituximab in Treating Patients With Mantle Cell Lymphoma, Relapsed Chronic Lymphocytic Leukemia, or Relapsed B Cell Non-Hodgkin's Lymphoma

Completed·OOHSU Knight Cancer Institute·Phase 2·NCT00764517·57 enrolled

A Study to Assess the Effect of Maintenance Treatment With Rituximab Versus No Treatment in Participants With Progressive B-Cell Chronic Lymphocytic Leukemia (CLL)

Completed· Roche logo

Roche·Phase 3·NCT00718549·128 enrolled

Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

Completed·BBarbara Ann Karmanos Cancer Institute·Phase 1·NCT00003174·80 enrolled

Acute Lymphoblastic Leukemia2 trials

Cladribine in Combination With GAP in Patients With Refractory/Relapsed Acute Lymphoblastic Leukemia

Unknown status·SSun Yat-sen University·Phase 2·NCT03318419·50 enrolled

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)

Completed·GGoethe University·Phase 4·NCT00198991·1,883 enrolled

Myeloid Neoplasm2 trials

Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms

Completed·UUniversity of Washington·Phase 2·NCT02756572·30 enrolled

Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untreated AML & High-Grade Myeloid Neoplasm

Completed·FFred Hutchinson Cancer Center·Phase 1/2·NCT03531918·66 enrolled

Treatment2 trials

Cladribine Combined With G-CSF and Cytarabine as a Salvage Treatment in R/R ALL

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 2/3·NCT05578378·32 enrolled

Cladribine Tablets After Treatment With Natalizumab (CLADRINA)

Active, not recruiting·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT04178005·40 enrolled

Refractory AML2 trials

CBA Versus FBA Conditioning Followed by Haploidentical Allogeneic HSCT in Treatment of High Risk and Refractory AML

Unknown status·SShanghai General Hospital, Shanghai Jiao Tong University School of Medicine·Phase 3·NCT03384225·120 enrolled

CBA Versus FBA Conditioning Followed by Allogeneic HSCT in Treatment of High Risk and Refractory AML

Unknown status·SShanghai General Hospital, Shanghai Jiao Tong University School of Medicine·Phase 3·NCT03384212·120 enrolled

Myelodysplastic Syndromes2 trials

Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

Completed·FFred Hutchinson Cancer Center·Phase 1/2·NCT02044796·199 enrolled

Total Body Irradiation and Cladribine Before Allogeneic Hematopoietic Cell Transplantation in Patients With AML (Acute Myeloid Leukemia) and Myelodysplastic Syndromes

Active, not recruiting·MMaria Sklodowska-Curie National Research Institute of Oncology·Phase 2·NCT04861207·40 enrolled

Chronic Myelogenous Leukemia2 trials

Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00002833·53 enrolled

Cladribine, Cytarabine, and Imatinib Mesylate in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Blastic Phase Chronic Myelogenous Leukemia

Completed·UUniversity of Rochester·Phase 1·NCT00258271·18 enrolled

Efficacy and Safety2 trials

the Efficacy and Safety of CLAE in R/R T-ALL/LBL

Unknown status·PPeking University Third Hospital··NCT04679506·50 enrolled

Efficacy and Safety of Cladribine in Combination With CAG in Newly Diagnosed Unfit Patients With AML

Unknown status·SSun Yat-sen University·Phase 2·NCT04254640·34 enrolled

Relapsed/Refractory AML2 trials

CLAG+VEN vs CLAG in the Treatment of Relapsed/Refractory AML

Not yet recruiting·NNanfang Hospital, Southern Medical University·Phase 4·NCT06763666·172 enrolled

Cladribine Based Induction Therapy With All-Trans Retinoic Acid and Midostaurin in Relapsed/Refractory AML

Completed·WWashington University School of Medicine·Phase 1·NCT01161550·11 enrolled

Acute Monocytic Leukemia2 trials

Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2/3·NCT05313958·43 enrolled

A Phase II Study of Venetoclax (ABT-199) in Combination With Cladribine and Low-Dose Cytarabine Alternating With Azacitidine Plus Venetoclax in Newly Diagnosed Monocytic AML and Active-Signaling Mutated AML

Recruiting·OOHSU Knight Cancer Institute·Phase 2·NCT06504459·40 enrolled

Trial1 trial

Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage

Terminated·DDelta-Fly Pharma, Inc.·Phase 3·NCT03926624·167 enrolled

Elderly Patients1 trial

Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML

Unknown status·LLanZhou University·N/A·NCT05053425·30 enrolled

Acute Leukemia1 trial

A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT06474663

Relapsed/Refractory1 trial

GM-CLAG in Relapsed/Refractory FLT3-mutated AML

Withdrawn·AAyman H Qasrawi·Phase 1·NCT05330377

AML1 trial

Epacadostat, Cladribine and Cytarabine (ECC) in AML

Withdrawn·IInsel Gruppe AG, University Hospital Bern·Phase 1·NCT03491579

Effects of Chemotherapy1 trial

Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03589729·100 enrolled

Newly Diagnosed1 trial

Decitabine With GCLAM for Adults With Newly Diagnosed, Relapsed, or Refractory AML or High-Risk MDS

Completed·FFred Hutchinson Cancer Center·Phase 1/2·NCT02921061·28 enrolled

Prospective1 trial

A Prospective Biomarker Study in Active SPMS Subjects Treated With Cladribine Tablets

Unknown status·—·Phase 4·NCT04550455·30 enrolled

T-cell acute lymphoblastic leukemia1 trial

Treatment of Relapsed T-cell Acute Lymphoblastic Leukemia or T-lymphoblastic Lymphoma With MabCampath

Completed·GGoethe University·Phase 2·NCT00199030·8 enrolled

Chronic Myelomonocytic Leukemia1 trial

A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05365035·60 enrolled

Sclerosing Cholangitis1 trial

Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004762·5 enrolled

MDS1 trial

A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.··NCT03933215·100 enrolled

Stem Cell Transplantation1 trial

Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Completed·NNorthwestern University·Phase 1·NCT00004904

Langerhans Cell Histiocytosis1 trial

Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Pulmonary Langerhans Cell Histiocytosis

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT01473797·10 enrolled

Induction Therapy1 trial

Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With CLL

Completed·SSwiss Cancer Institute·Phase 2·NCT00072007·43 enrolled

Oral1 trial

Relationship Between Oral DMT Burden and Adherence in MS

Enrolling by invitation·MMonash University··NCT04676204·323 enrolled

Frontline1 trial

Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction

Withdrawn·UUniversity of Florida·Phase 2·NCT05766514

Infusion1 trial

A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.··NCT03933202·291 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy

Unknown status·CClaudio Gobbi··NCT04640818·45 enrolled

Relapsed or Refractory1 trial

Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML

Recruiting·SStanford University·Phase 1/2·NCT06561152·20 enrolled

Malignant Glioma1 trial

Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00019071

Lymphoblastic Lymphoma1 trial

German Multicenter Trial for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults

Completed·JJohann Wolfgang Goethe University Hospital·Phase 4·NCT00199017·75 enrolled

Recurrent Acute Myeloid Leukemia1 trial

CLAG-M or FLAG-Ida Chemotherapy Followed Immediately by Related/Unrelated Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1 Study

Recruiting·FFred Hutchinson Cancer Center·Phase 1·NCT04375631·120 enrolled

Targeted Therapy1 trial

Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07032727·68 enrolled

Advanced Multiple Sclerosis1 trial

ChariotMS - A National (UK) Phase IIb, Multi-centre, Randomised, Double-blind, Placebo Controlled (1:1) Efficacy Trial With Cost-utility Analysis of Cladribine Tablets (3.5mg/kg Over Two Years) in People With Advanced Multiple Sclerosis. Is Cladribine Superior to Placebo in Protecting Upper Limb Function?

Active, not recruiting·QQueen Mary University of London·Preclinical·NCT04695080·204 enrolled

Acute Myeloid Leukemia (AML)1 trial

A Phase 1 Open-Label, Dose-Ranging Safety and Pharmacokinetics Study of Oral Cladribine in Patients With Acute Myeloid Leukemia (AML)

Not yet recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT07053020·58 enrolled

T-Cell Prolymphocytic Leukemia1 trial

Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukemia

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT07311746·36 enrolled

Unspecified3 trials

CLARITY Extension Study

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 3·NCT00641537·867 enrolled

Cladribine Tablets as an Exit Therapy Strategy

Not yet recruiting·UUniversity Hospital, Strasbourg, France··NCT06887426·450 enrolled

Effects of Cladribine Tablets on the PK of Microgynon®

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT03745144·28 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 26, 1993

LEUSTATIN

NDA NDA020229

Mar 29, 2019

MAVENCLAD

NDA NDA022561

Sources

References

[1]
ClinicalTrials.gov — 95 trial records for Cladribine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Leustatin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Cladribine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Cladribine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022561). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Leustatin. U.S. Food & Drug Administration.
[7]
SEC EDGAR — EMD Serono company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

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

Patent Landscape[6]

Patent Cliff

Nov 23, 2038

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10849919Nov 23, 2038

12533408Sep 10, 2041

12539329Sep 10, 2041

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