Disease × agent evidence record

Alemtuzumab for Multiple Sclerosis: evidence, trials and status

Alemtuzumab has both completed registered trials and synthesis-level publications linked to Multiple Sclerosis. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit.

8 registered trials 0 recruiting 20 publications Evidence tier A · Strong Score 73.0
Research Tracker › Pairs › Multiple Sclerosis › Alemtuzumab
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Alemtuzumab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Multiple Sclerosis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Multiple Sclerosis. ClinicalTrials.gov lists 8 registered trials linking Alemtuzumab to Multiple Sclerosis: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03135249). The largest enrolment is 1314 participants (NCT00930553). Registration activity spans 2009 to 2022. The literature layer holds 20 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 2 systematic reviews, 4 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2019 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.

The RepurpOS disease-intelligence file for Multiple Sclerosis ranks 371 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Untreated relapsing MS: ~1 relapse/year; disability accumulates over time in ~85% who convert to secondary progressive MS; spontaneous remission from MS is not possible.

Open in Repurposing ExplorerMultiple Sclerosis hubMultiple Sclerosis biomarkers & interventions

Evidence table

Evidence tierA · Strong
Evidence score73.0 (trials 23.0, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other
Linked publications20 (5 Cochrane reviews, 5 clinical trial publications, 4 meta-analyses, 4 randomised controlled trial publications, 2 systematic reviews)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classantibody; antibody; inhibitor
Data sourcesDGIdb
Linked via biomarker / targetCD52
How the evidence score is calculated
  • Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
  • Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
  • The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
  • Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
  • The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.

Registered clinical trials

NCT IDTitleStatusPhaseEnrolment
NCT03135249Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis
2018
completedPhase 49
NCT00930553An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
2009
completedPhase 31,314
NCT02583594A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis
2015
completedPhase 124
NCT06310343ADAs to Alemtuzumab
2022
completedNot applicable15
NCT04633967Observational Study of a Novel Peri Infusion Regimen on the Infusion Associated Reactions With Alemtuzumab Infusion in Patients With Multiple Sclerosis in a Canadian Clinical Setting.
2016
completedNot applicable30
NCT01020370Exploratory Study to Investigate the Reparative and Regenerative Potential of Alemtuzumab in Relapsing-Remitting Multiple Sclerosis Patients Participating in the CARE MS I and MS II StudiescompletedNot applicable—
NCT04821596Study of the Mechanisms of Action of Cladribine in Multiple Sclerosis
2020
completedNot applicable77
NCT02529839Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation (BMT) in Patients With Multiple Sclerosis (MS)
2015
status unknownNot applicable20

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Published literature

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Mechanism and notes

Recorded mechanism or class: antibody; antibody; inhibitor.

OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CD52. The tier describes how well the drug-disease link is documented, not how well the drug works.

Frequently asked questions

Is Alemtuzumab approved for Multiple Sclerosis?

Alemtuzumab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Multiple Sclerosis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Multiple Sclerosis. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.

Is Alemtuzumab in clinical trials for Multiple Sclerosis?

ClinicalTrials.gov lists 8 registered trials linking Alemtuzumab to Multiple Sclerosis: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03135249). The largest enrolment is 1314 participants (NCT00930553). Registration activity spans 2009 to 2022.

What does the evidence show for Alemtuzumab in Multiple Sclerosis?

Alemtuzumab has both completed registered trials and synthesis-level publications linked to Multiple Sclerosis. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CD52. The tier describes how well the drug-disease link is documented, not how well the drug works.

Cite this page

Open Source Medicine Foundation. Alemtuzumab for Multiple Sclerosis: evidence, trials and status. OSMF Research Tracker. Updated 2026-07-05. https://research.opensourcemed.info/pairs/multiple-sclerosis/alemtuzumab.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.

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This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.