Drugs / Cladribine
Cladribine
also known as
2-CdA · Mavenclad · 2-chlorodeoxyadenosine · CdA · CLAD · CladT · 2-chloro-2-deoxyadenosine · Cladribine (Leustatin) · +3 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Litak | — | 2004-04-14 | europa.eu ↗ |
| Approved | US (FDA) | LEUSTATIN | — | 1993-02-26 | fda.gov ↗ |
Trials 97 · started per year
today
US approved 1993
EU approved 2004
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News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2025-11-24 | EMD Serono Research & Development Institute, Inc. | Regulatory EMD Serono Takes Patient-Directed Approach to Bring Innovation to the Treatment of Rare Neuromuscular Disorder, Generalized Myasthenia Gravis emdserono.com ↗
Cladribine capsules has received Fast Track designation and Orphan Drug Designation by the US FDA |
| 2025-11-24 | Merck KGaA, Darmstadt, Germany | Regulatory Merck KGaA, Darmstadt, Germany Takes Patient-Directed Approach to Bring Innovation to the Treatment of Rare Neuromuscular Disorder, Generalized Myasthenia Gravis emdgroup.com ↗
The company today announced the FDA has granted Fast Track designation for cladribine capsules for the treatment of gMG. |
| 2025-09-17 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono to Present New Data Highlighting Durable Effects of MAVENCLAD® in RMS at ECTRIMS emdserono.com ↗
New four-year data from two large Phase 4 studies highlight the long-term efficacy, favorable disability outcomes and durable impact of MAVENCLAD® (cladribine) tablets in people living with relapsing multiple sclerosis (RMS). |
| 2025-09-17 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany to Present New Data Highlighting Durable Effects of MAVENCLAD® in RMS at ECTRIMS emdgroup.com ↗
New four-year data from two large Phase 4 studies highlight the long-term efficacy, favorable disability outcomes and durable impact of MAVENCLAD® (cladribine) tablets in people living with relapsing multiple sclerosis (RMS). |
| 2024-09-12 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Unveils New MAVENCLAD® Four-Year Data Highlighting Benefits of Early Treatment and Sustained Efficacy Across Multiple Measures of Disease Activity emdserono.com ↗
Phase IV studies demonstrate the consistent safety and high efficacy of MAVENCLAD on NEDA-3, MRI and cognition outcomes over four years |
| 2024-09-12 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany Unveils New MAVENCLAD® Four-Year Data Highlighting Benefits of Early Treatment and Sustained Efficacy Across Multiple Measures of Disease Activity emdgroup.com ↗
New data on blood and CSF biomarkers show the impact of MAVENCLAD to promote immune cell reconstitution, while clinical data confirmed 93.7% of patients free from PIRA |
| 2024-02-29 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Presents New MAVENCLAD ® Data Supporting Cognitive Function Benefits emdserono.com ↗
The post-hoc analysis from 270 patients showed a clinically meaningful benefit in cognitive processing speed in patients treated with MAVENCLAD. |
| 2023-10-10 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Presents New MAVENCLAD ® (Cladribine) Tablets Data Highlighting Sustained Reduction in NfLs and Benefit of Early Initiation emdserono.com ↗
New data showed sustained reduction in neurofilament light chain (NfL) levels over two years of treatment with MAVENCLAD® (cladribine) tablets in patients with relapsing multiple sclerosis (RMS) |
| 2023-02-23 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Highlights New Four-Year Efficacy and Safety Data for Investigational BTK Inhibitor, Evobrutinib, in RMS emdserono.com ↗
Participants maintained their employment status over the two years of the study, which included the COVID-19 pandemic, with 43.4% (n=209) of patients employed full-time at month 24, compared to 47.5% (n=229) at baseline. |
| 2022-10-26 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Showcases Depth of MS Portfolio at ECTRIMS Supporting Commitment to Advancing MS Care emdserono.com ↗
Phase IV study highlights improvement in measures of Quality of Life in people living with RMS after two years of treatment with MAVENCLAD® (cladribine) tablets |
| 2022-03-31 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Shares Advances in MS Portfolio with Key Efficacy and Safety Data at AAN 2022 emdserono.com ↗ |
| 2022-02-24 | EMD Serono Research & Development Institute, Inc. | Results New MAVENCLAD® Data at ACTRIMS Forum 2022 Show Favorable Efficacy Outcomes Versus Other Oral DMTs and Lower Occurrence of Further Relapses or Disability Progression emdserono.com ↗
New real-world data show MAVENCLAD® (cladribine) tablets had lower annualized relapse rates and longer time to first relapse and time to switch than fingolimod, dimethyl fumarate and teriflunomide in relapsing multiple sclerosis patients |
| 2021-10-13 | EMD Serono Research & Development Institute, Inc. | Results New Real-World MAVENCLAD® Data Show Sustained Effectiveness and Benefit on Quality-of-Life Measures in RMS Patients emdserono.com ↗
After completing half the recommended cumulative dose of MAVENCLAD over two years, improvements from baseline were observed for physical and mental health composite scores (nominal p<0.0001) as measured by the Quality of Life-54 questionnaire. |
| 2021-10-04 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Completes Enrollment of Evobrutinib Phase III Clinical Trials Ahead of ECTRIMS 2021 emdserono.com ↗
New independent data being presented found that patients treated with MAVENCLAD® (cladribine) tablets had increased antibody IgG titer levels similar to that of the general population after a complete course of an mRNA COVID-19 vaccine |
| 2021-04-23 | EMD Serono Research & Development Institute, Inc. | Results New Data Strengthening Evidence for Continued Safe and Effective MAVENCLAD® Use During the COVID-19 Pandemic emdserono.com ↗
New analysis indicates a specific immune repopulation pattern in people treated with MAVENCLAD, which may contribute to their ability to fight infections and develop protective antibodies from vaccines |
| 2021-02-25 | EMD Serono Research & Development Institute, Inc. | Results New Data Presented at ACTRIMS Forum 2021 Indicate MAVENCLAD®-treated RMS Patients Mount Protective Antibody Response to Common Vaccines emdserono.com ↗
The data indicate that RMS patients receiving MAVENCLAD are able to mount a response to seasonal influenza and varicella zoster vaccination. |
| 2018-10-10 | Merck KGaA, Darmstadt, Germany | Results Up to 10-Years of Follow-up Data Reaffirm Safety Profile of Investigational Cladribine Tablets prnewswire.com ↗
As part of this analysis, an overview of the post-approval safety data from EU approval on August 2017 to July 2018 also showed no new safety or tolerability signals for cladribine tablets. |
| 2018-06-18 | Merck KGaA, Darmstadt, Germany | Results Data Provide Further Insight Into the Consistent Efficacy Benefits of Mavenclad in Relapsing MS prnewswire.com ↗
The results highlight the improvements observed in annualized relapse rate (ARR) and MRI outcomes versus placebo in both subgroups of RRMS patients, ≤50 and >50 years; MAVENCLAD ® reduced relapse risk compared to placebo by 59% and 52%, respectively. |
All press releases naming this drug 21 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 140 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cladribine | “For the patients in Non-CR group, the conditioning regimens include: IAC（IDA 12mg/m2 d1-3，Ara-C 200 mg/m2 d1-7， Cladribine 5mg/m2 d1-5) or HD Ara-C(high-dose Ara-c 3g/m2 q12h d1-3).” NCT02676856 ↗128“Intensive chemotherapy Cladribine-cytarabine-etoposide -venetoclax sequential with fludarabine, busulfan and melphalan or fludarabine and total marrow irradiation” NCT05870995 ↗ “A Study of Cladribine, Low Dose Cytarabine, and Venetoclax in Treatment of Relapsed/Refractory or Secondary Acute Myeloid Leukemia” NCT07423104 ↗ “using MCBC as conditioning regimen, Mel 60mg/ m2 -9\~-8d, Cladribine 5 mg/m2 -9\~-5d, Bu3.2mg/kg -5\~-3d； Cy 30mg/kg -2\~-1 d” NCT06133556 ↗ “Cladribine: 5mg/m2 administered through a 2 hour intravenous infusion daily for 5 consecutive days starting on Day 2” NCT00594555 ↗ “Cladribine 5 mg/m2/day , cytarabine 20mg q12h, venetoclax 100mg d1, 200 d2, 400 mg/day from day 3 to day 21.” NCT05657639 ↗ “chemotherapy consisting of Cladribine (5mg/m2), cytarabine (1.5g/m2) and mitoxantrone （10mg/m2）for 5 days” NCT02910752 ↗ “Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response,” NCT00117598 ↗ “Cladribine combined with cytarabine and VP16 sequential with Fludarabine combined with busulifan” NCT03882203 ↗ “Cladribine, 5 mg/m\^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2” NCT00955916 ↗ “including Cladribine 5mg/msq/d (d1-5), Ara-C 100mg/msq/d(d1-7) and IDA 8mg/msq/d (d1-3)” NCT02323022 ↗ |
| Known as | 2-CdA | “Phase I will use 3 dose levels Level 1: caldribine (2-CdA) 3mg/m2 days 1-5; Level 2 caldribine 4mg/m2 days 1-5; Level 3: cladribine 5mg/m2 days 1-5” NCT01439750 ↗8“Patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) daily for 5 days every 4 weeks for a maximum of 6 courses” NCT00002879 ↗ “another purine analog, cladribine (2-CdA), is also able” NCT03257241 ↗ “cladribine (2-chlorodeoxyadenosine; 2-CdA)” NCT00004762 ↗ “the nucleoside analog cladribine (2CdA)” NCT00656812 ↗ |
| Known as | 2-chloro-2-deoxyadenosine | “For patients of the high-risk group, the administration of 2-chloro-2-deoxyadenosine (2-CDA) will be integrated in the first phase of consolidation to achieve an even higher...” NCT00111345 ↗ |
| Known as | 2-chlorodeoxyadenosine | “Patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) daily for 5 days every 4 weeks for a maximum of 6 courses” NCT00002879 ↗3“2-Chlorodeoxyadenosine (2-CdA) and Cytarabine (Ara-C) in Idiopathic Hypereosinophilic Syndrome (HES)” NCT00483067 ↗ “cladribine (2-chlorodeoxyadenosine; 2-CdA)” NCT00004762 ↗ “2-CdA [Cladribine, 2-Chlorodeoxyadenosine]” NCT02072811 ↗ |
| Known as | CdA | “the concentration-time course of cladribine (CdA) and its main metabolite 2-chloroadenine (CAde)” PMID 28255849 ↗ Oct 20171“Hairy cell leukemia (HCL) is highly responsive to but not curable by cladribine (CdA).” NCT00923013 ↗ |
| Known as | CLAD | “Drug: Cladribine (CLAD)” NCT07032727 ↗1“Cladribine (CLAD)” NCT06561152 ↗ |
| Known as | Cladribine (Leustatin) | “Cladribine (Leustatin)” NCT01513603 ↗ |
| Known as | cladribine (Mavenclad) | “cladribine (Mavenclad®)” NCT04047628 ↗ |
| Known as | Cladribine, Syn 2CdA, (LITAK) 0.14 mg/kg | “Cladribine, Syn 2CdA, (LITAK®) 0.14 mg/kg” NCT02157181 ↗ |
| Known as | CladT | “BACKGROUND AND OBJECTIVES: Cladribine tablets (CladT) represent an effective immune reconstitution therapy, administered in short treatment courses over two consecutive years.” PMID 39963134 ↗ Feb 20251“Cladribine tablets (CladT) preferentially reduce B and T lymphocyte levels.” PMID 35003076 ↗ Dec 2021 |
| Known as | Mavenclad | “INTRODUCTION: Cladribine Tablets (MAVENCLAD®) selectively reduce absolute lymphocyte counts (ALCs) in patients with multiple sclerosis.” PMID 29992396 ↗ Mar 20196“Cladribine (MAVENCLAD®) 3.5mg/kg, administered as weight-adjusted 10mg tablets” NCT04695080 ↗ “Mavenclad oral cladribine tablets” NCT04121403 ↗ |
| Known as | Mavenclad (cladribine) | “Mavenclad (cladribine)” NCT03535298 ↗ |
| Action | Inhibit | “anti-adenosine deaminase” NCT04254640 ↗ |
| Modality | Small molecule | “The purine nucleoside analogue cladribine (2-chlorodeoxyadenosine, 2-CdA)” NCT00126321 ↗ |
| Route | Intravenous | “cladribine IV continuously” NCT00003174 ↗ |