Cladribine
How it works: Resetting the immune system →
Mavenclad
EU: Approved in the EU since 2017US: FDA approved 2019
- Molecule type
- Small molecule
- Mechanism (ChEMBL)
- DNA inhibitor
- Targets
- DNA
- Availability
- Authorised in all EU and EEA countries. Reimbursement is decided by each country.
Approvals
Other regulatory events
- Application withdrawn · Movectro8 February 2011 Source
Safety communications
- EMA safety letter (DHPC) · 14 February 2022
Mavenclad: Adverse event Source
Most-reported side effects (FDA reports)
Reports to the FDA's adverse event system (FAERS) show what people and doctors reported while taking the medicine. They do not prove the medicine caused it, and they are not rates.
10,028 reports in total, 7,499 marked serious.
- Fatigue849
- Headache715
- Lymphocyte count decreased507
- Multiple sclerosis relapse495
- Nausea439
- Pneumonia419
- White blood cell count decreased376
- Off label use344
- Drug ineffective310
- Pyrexia298
Trials
Key trials
Large trials with a reported result on their main goal.
- Oral Cladribine in Early Multiple Sclerosis (MS)
Completed · Phase 3 · Early (CIS/RIS) · Met its main goal
- A Safety and Efficacy Study of Oral Cladribine in Subjects With Relaps
Completed · Phase 3 · Relapsing MS · Met its main goal
Running now
- The HIt HArd and hiT Early in Multiple Sclerosis Trial
Recruiting · Phase 2 · Relapsing MS · Still running
- Effects of CLADribine tablets on the Immune Synapse, in Relapsing Mult
Not yet recruiting · Phase 4 · Relapsing MS · Still running
- Cladribine Tablets Level of Response Predictors in Clinical Practice (
Running, not recruiting · Relapsing MS · Still running
- Cladribine vs Placebo for Non-active Progressive Multiple Sclerosis (C
Recruiting · Phase 2 / Phase 3 · Relapsing and progressive · Still running
- ChariotMS - Cladribine to Halt Deterioration in People With Advanced M
Running, not recruiting · Phase 2 / Phase 3 · Progressive MS · Still running
- Cladribine Tablets After Treatment With Natalizumab (CLADRINA)
Running, not recruiting · Phase 4 · Relapsing and progressive · Still running
Other trials (25)
Completed small trials, dose-finding studies and trials in other diseases.
- Cladribine Tablets as an Exit Therapy Strategy
Completed · Relapsing and progressive · No results found
- Therapeutic Monitoring of Drugs Used in the Treatment of Multiple Scle
Status unknown · Phase 4 · MS (type not specified) · No results found
- A phase IV, unicentric, open label clinical trial to evaluate the defa
Withdrawn · Phase 4 · MS (type not specified) · Stopped
- Effects of Oral Cladribine on Remyelination and Inflammation in Multip
Status unknown · Phase 4 · Relapsing MS · No results found
- Extension to the MAGNIFY MS Trial on Mavenclad® (Magnify MS Extension)
Completed · Phase 4 · Relapsing MS · Results posted, not judged
- Cognition and HRQoL in Adults With Highly-active RMS in Year 3 and 4 A
Completed · Phase 4 · Relapsing MS · Results posted, not judged
- Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy
Status unknown · Relapsing MS · No results found
- Relationship Between Oral DMT Burden and Adherence in MS
Status unknown · MS (type not specified) · No results found
- A Prospective Biomarker Study in Active SPMS Subjects Treated With Cla
Status unknown · Phase 4 · Progressive MS · No results found
- Effect of Cladribine Treatment on Microglial Activation in the CNS
Status unknown · Phase 4 · Relapsing MS · Paper found, not read
For information only, not medical advice. Talk to your neurologist before changing treatment.
Hypotheses involving this medicine
Loading hypotheses…
Loading reviews and guidelines…
Lab studies
Lab studies in animals or cells. Results in animals often do not hold in people, and these studies never change the status of an idea.
Loading lab studies…