MAVENCLAD (cladribine)
MAVENCLAD is indicated for the treatment of Multiple Sclerosis.
How MAVENCLAD Works
Mavenclad is thought to exert its therapeutic effects by inducing cytotoxic effects on B and T lymphocytes. As a purine antimetabolite, the drug impairs DNA synthesis within these specific white blood cells. This process results in the depletion of lymphocytes, which is the mechanism believed to manage the underlying pathology of relapsing forms of multiple sclerosis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-03-29
- Patent Cliff
- 2041
- Routes
- ORAL
- Dosage Forms
- TABLET
MAVENCLAD Approval History
What MAVENCLAD Treats
1 indicationsMAVENCLAD is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
MAVENCLAD Boxed Warning
MALIGNANCIES AND RISK OF TERATOGENICITY Malignancies Treatment with MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of MAVENCLAD on an individual patient basis. Follow standard cancer screening guidelines in patients treated with MAVENCLAD [see Contraindications (4) and Warnings and Precautions (5.1) ] . Risk of Terato...
WARNING: MALIGNANCIES AND RISK OF TERATOGENICITY Malignancies Treatment with MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of MAVENCLAD on an individual patient basis. Follow standard cancer screening guidelines in patients treated with MAVENCLAD [see Contraindications (4) and Warnings and Precautions (5.1) ] . Risk of Teratogenicity MAVENCLAD is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm. Malformations and embryolethality occurred in animals. Exclude pregnancy before the start of treatment with MAVENCLAD in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during MAVENCLAD dosing and for 6 months after the last dose in each treatment course. Stop MAVENCLAD if the patient becomes pregnant [see Contraindications (4) , Warnings and Precautions (5.2) , and Use in Specific Populations (8.1 , 8.3) ] . WARNING: MALIGNANCIES and RISK OF TERATOGENICITY See full prescribing information for complete boxed warning. Malignancies MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with current malignancy; evaluate the benefits and risks on an individual basis for patients with prior or increased risk of malignancy. ( 5.1 ) Risk of Teratogenicity MAVENCLAD is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the risk of fetal harm. ( 5.2 )
MAVENCLAD Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in MAVENCLAD's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications MAVENCLAD treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to MAVENCLAD
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
50 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06965114 | NCI-2025-03281 NCI-2025-03281, 10664 | Ph 1, Ph 2 | recruiting | Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia |
| NCT04797767 | RG1121403 NCI-2021-01379, 10793 | Ph 1, Ph 2 | recruiting | Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms |
| NCT03586609 | 2018-0020 NCI-2018-01318, 2018-0020 | Ph 2 | recruiting | Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia |
| NCT02250937 | 2014-0431 NCI-2014-02324, 2014-0431 | Ph 2 | active not recruiting | Venetoclax and Sequential Busulfan, Cladribine, and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome |
| NCT06561360 | 24-160 | Ph 2 | recruiting | A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL) |
| NCT06504459 | STUDY00026216 NCI-2024-05084, STUDY00026216 | Ph 2 | recruiting | Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML |
| NCT06021600 | 2023-0134 NCI-2023-06805 | Ph 1 | terminated | 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 |
| NCT04375631 | RG1006914 NCI-2020-02616, RG1006914 | Ph 1 | recruiting | CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia |
| NCT04708054 | 2020-0790 NCI-2020-13919, 2020-0790 | Ph 2, Ph 3 | recruiting | Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS |
| NCT01515527 | 2011-0987 NCI-2012-00145 | Ph 2 | recruiting | Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS) |
| NCT03926624 | D18-11141 | Ph 3 | terminated | Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage |
| NCT07311746 | 2025-1464 NCI-2025-09671 | Ph 1, Ph 2 | not yet recruiting | Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukemia |
| NCT05365035 | 2021-1116 NCI-2022-03803 | Ph 2 | recruiting | 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 |
| NCT06232655 | 23-0273.cc | Ph 2 | recruiting | Cladribine Venetoclax in Monocytic AML |
| NCT04047641 | 2017-0153 NCI-2019-04730, 2017-0153 | Ph 1, Ph 2 | recruiting | Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome |
| NCT04178005 | STU 2019-1618 | Ph 4 | active not recruiting | Cladribine Tablets After Treatment With Natalizumab (CLADRINA) |
| NCT03589729 | 2017-0937 NCI-2018-01108, 2017-0937 | Ph 2 | recruiting | Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers |
| NCT02115295 | 2012-0648 NCI-2014-01103, 2012-0648 | Ph 2 | recruiting | Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia |
| NCT04848974 results posted | 2020-0988 NCI-2021-02298, 2020-0988 | Ph 1, Ph 2 | completed | Uproleselan, Cladribine, and Low Dose Cytarabine for the Treatment of Patients With Treated Secondary Acute Myeloid Leukemia |
| NCT00923013 results posted | 090005 09-C-0005 | Ph 2 | active not recruiting | Cladribine With Simultaneous or Delayed Rituximab to Treat Hairy Cell Leukemia |
| NCT06474663 | 2024-0302 NCI-2024-05386 | Ph 1 | withdrawn | A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias |
| NCT04195945 results posted | RG1005577 NCI-2019-07640, 10330 | Ph 2 | active not recruiting | CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients |
| NCT03963375 CLOCK-MS | MS700568_0049-201906092 | Ph 4 | completed | Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis |
| NCT04861207 CLARA | 20-NIO-0001 | Ph 2 | active not recruiting | Total Body Irradiation and Cladribine Before Allogeneic Hematopoietic Cell Transplantation in Patients With AML (Acute Myeloid Leukemia) and Myelodysplastic Syndromes |
| NCT05766514 | UF-HEM-011 OCR43074, IRB202300983 | Ph 2 | withdrawn | 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 |
| NCT06763666 | NFEC-2024-639 | Ph 4 | not yet recruiting | CLAG+VEN vs CLAG in the Treatment of Relapsed/Refractory AML |
| NCT04121403 NOR-MS | 11383 | Ph 3 | completed | Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS) |
| NCT03441048 | PRO00031633 | Ph 1 | completed | Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia |
| NCT02096055 results posted | 2013-0843 NCI-2014-00981, 2013-0843 | Ph 2 | completed | Guadecitabine With or Without Idarubicin or Cladribine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia |
| NCT06007911 | PRO00050186 | Ph 1 | withdrawn | Venetoclax-Navitoclax With Cladribine-based Salvage Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia |
| NCT03745144 results posted | MS700568_0031 2018-001015-70 | Ph 1 | completed | Effects of Cladribine Tablets on the PK of Microgynon® |
| NCT04196010 | RG1005551 NCI-2019-07696, RG1005551 | Ph 1 | terminated | Continuous Infusion Chemotherapy (CI-CLAM) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms |
| NCT03531918 results posted | 10000 NCI-2018-00776, 10000 | Ph 1, Ph 2 | completed | Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untreated AML & High-Grade Myeloid Neoplasm |
| NCT02728050 results posted | 9510 NCI-2016-00286, 9510 | Ph 1, Ph 2 | completed | Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome |
| NCT05330377 | MCC-21-LEUK-18-PMC | Ph 1 | withdrawn | GM-CLAG in Relapsed/Refractory FLT3-mutated AML |
| NCT03012672 results posted | 9759 NCI-2016-02051, 9759 | Ph 2 | completed | Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm |
| NCT02756572 results posted | 9567 NCI-2016-00477, 9567 | Ph 2 | completed | Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms |
| NCT00725985 ORACLE MS results posted | 28821 | Ph 3 | completed | Oral Cladribine in Early Multiple Sclerosis (MS) |
| NCT00641537 results posted | 27820 2007-000381-20 | Ph 3 | completed | CLARITY Extension Study |
| NCT02921061 results posted | 9713 NCI-2016-01401, 9713 | Ph 1, Ph 2 | completed | Decitabine With GCLAM for Adults With Newly Diagnosed, Relapsed, or Refractory AML or High-Risk MDS |
| NCT02416908 results posted | 201505084 | Ph 1, Ph 2 | completed | Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia |
| NCT02044796 results posted | 2734.00 NCI-2013-02465, 2734.00 | Ph 1, Ph 2 | completed | Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes |
| NCT00980395 VCR results posted | 0800001071 P30CA023074, UARIZ-08-1071-04 | Ph 2 | completed | Bortezomib, Cladribine, and Rituximab in Treating Patients With Advanced Mantle Cell Lymphoma or Indolent Lymphoma |
| NCT03491579 ECC | ECC | Ph 1 | withdrawn | Epacadostat, Cladribine and Cytarabine (ECC) in AML |
| NCT00718549 results posted | ML21283 2008-001140-39 | Ph 3 | completed | A Study to Assess the Effect of Maintenance Treatment With Rituximab Versus No Treatment in Participants With Progressive B-Cell Chronic Lymphocytic Leukemia (CLL) |
| NCT01446900 | IEO S523/110 2010-018519-14 | Ph 2 | terminated | R-2cda and Prolongation of Therapy With Rituximab Alone in Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma |
| NCT00787969 | NCCTG-N078D NCI-2009-00669, CDR0000619329 | Ph 1 | completed | Rituximab, Cladribine, and Temsirolimus in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma |
| NCT00764517 results posted | IRB00004180 NCI-2011-03737, 4180 | Ph 2 | completed | Vorinostat, Cladribine, and Rituximab in Treating Patients With Mantle Cell Lymphoma, Relapsed Chronic Lymphocytic Leukemia, or Relapsed B Cell Non-Hodgkin's Lymphoma |
| NCT00938366 results posted | 27967 | Ph 1 | completed | Drug-Drug Interaction of Cladribine and Pantoprazole in Multiple Sclerosis Subjects |
| NCT01161550 CLAG ATRA AML | 10-1181 / 201108160 | Ph 1 | completed | Cladribine Based Induction Therapy With All-Trans Retinoic Acid and Midostaurin in Relapsed/Refractory AML |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MAVENCLAD FDA Label Details
Indications & Usage
FDA Label (PDF)MAVENCLAD is indicated for the treatment of Multiple Sclerosis.
WARNING: MALIGNANCIES AND RISK OF TERATOGENICITY Malignancies Treatment with MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the...
Pro Intelligence Preview
Deep insights for MAVENCLAD
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 3 active patents
Trial Analysis
- • 56 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment