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- Application withdrawn · Movectro2011-02-08 Source
Safety communications
- EMA safety letter (DHPC) · 2022-02-14
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.
9,616 reports in total, 7,191 marked serious.
- Fatigue815
- Headache683
- Lymphocyte count decreased488
- Multiple sclerosis relapse475
- Nausea425
- Pneumonia407
- White blood cell count decreased363
- Off label use335
- Drug ineffective292
- Pyrexia291
Trials
Key trials
Large trials with a reported result on their main goal.
- ORACLE MS
Completed · Phase 3 · Early (CIS/RIS) · Main goal met
- CLARITY
Completed · Phase 3 · Relapsing MS · Main goal met
Running now
- HiHat
Recruiting · Phase 2 · Relapsing MS · ongoing
- Cladribine, phase 4
Not yet recruiting · Phase 4 · Relapsing MS · ongoing
- Cladribine
Running, not recruiting · Relapsing MS · ongoing
- CLASP-MS
Recruiting · Phase 2 / Phase 3 · Relapsing and progressive · ongoing
- ChariotMS
Running, not recruiting · Phase 2 / Phase 3 · Progressive MS · ongoing
- Cladribine, phase 4
Running, not recruiting · Phase 4 · Relapsing and progressive · ongoing
- CLADPET
Running, not recruiting · Phase 4 · Relapsing MS · ongoing
Other trials (24)
Completed small trials, dose-finding studies and trials in other diseases.
- CLADREXIT
Completed · Relapsing and progressive · no_result_found
- TDM-MS
Status unknown · Phase 4 · MS (type not specified) · no_result_found
- CLADRI_NET
Withdrawn · Phase 4 · MS (type not specified) · stopped_other
- CLAREMI
Status unknown · Phase 4 · Relapsing MS · no_result_found
- Cladribine, phase 4
Completed · Phase 4 · Relapsing MS · results_posted_no_test
- Cladribine, phase 4
Completed · Phase 4 · Relapsing MS · results_posted_no_test
- Cladribine
Status unknown · Relapsing MS · no_result_found
- STATURE
Status unknown · MS (type not specified) · no_result_found
- Cladribine, phase 4
Status unknown · Phase 4 · Progressive MS · no_result_found
- Cladribine
Completed · Relapsing MS · results_posted_no_test
For information only, not medical advice. Talk to your neurologist before changing treatment.
Hypotheses involving this medicine
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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.
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