Last reviewed 2026-06-02 · How we verify

Campath (ALEMTUZUMAB)

Campath (generic name: ALEMTUZUMAB) is a CD52-directed Cytolytic Antibody [EPC] Monoclonal antibody drug developed by Sanofi. It is currently FDA-approved (first approved 2001) for Conditioning treatment prior to allogeneic haematopoietic stem cell transplant, Recurrent chronic lymphocytic leukemia, Refractory chronic lymphocytic leukemia.

Campath works by binding to a specific protein on the surface of immune cells, marking them for destruction.

Campath, also known as Alemtuzumab, is an antibody that inhibits the CAMPATH-1 antigen. It is used in various clinical trials for conditions such as Severe Sickle Cell Disease, Bone Marrow Failure Syndromes, and Immunologic Disorders, often as part of a reduced intensity conditioning regimen or graft-versus-host disease prophylaxis.

At a glance

Mechanism of action

The precise mechanism by which alemtuzumab exerts its therapeutic effects in multiple sclerosis is unknown but is presumed to involve binding to CD52, cell surface antigen present on and lymphocytes, and on natural killer cells, monocytes, and macrophages. Following cell surface binding to and lymphocytes, alemtuzumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.

Approved indications

• Conditioning treatment prior to allogeneic haematopoietic stem cell transplant
• Recurrent chronic lymphocytic leukemia
• Refractory chronic lymphocytic leukemia
• Relapsing remitting multiple sclerosis

Boxed warnings

• WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS See full prescribing information for complete boxed warning. Serious, including fatal, cytopenias, infusion-related reactions, and infections can occur (5.1–5.3). Limit doses to 30 mg (single) and 90 mg (cumulative weekly); higher doses increase risk of pancytopenia. ( 2.1 ) Escalate dose gradually and monitor patients during infusion. Withhold therapy for Grade 3 or 4 infusion-related reactions. ( 5.2 ) Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections. ( 2.2 , 5.3 ) Cytopenias : Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving CAMPATH. Single doses of CAMPATH greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see Warnings and Precautions (5.1) ] . Infusion-Related Reactions : CAMPATH administration can result in serious, including fatal, infusion-related reactions. Carefully monitor patients during infusions and withhold CAMPATH for Grade 3 or 4 infusion-related reactions. Gradually escalate CAMPATH to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days [see Dosage and Administration (2.1) and Warnings and Precautions (5.2) ] . Immunosuppression/Infections : Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving CAMPATH. Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections [see Dosage and Administration (2.2) and Warnings and Precautions (5.3) ] .

Common side effects

• Neutropenia
• Cytopenias
• Infections
• Infusion-related reactions
• Nausea
• Emesis
• Diarrhea
• Insomnia
• Lymphopenia
• Immunosuppression/infections
• Anemia
• Thrombocytopenia

Key clinical trials

• Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita (PHASE2)
• Base Editing Hematopoietic Stem Cell and T Cell Gene Therapy for CD40L-HyperIgM Syndrome: Single Patient Study (PHASE1,PHASE2)
• Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease (CGD) With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) Antagonists (PHASE1,PHASE2)
• Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases (PHASE1,PHASE2)
• Haploidentical Transplant for People With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant Cyclophosphamide (EARLY_PHASE1)
• Addition of JSP191 (C-kit Antibody) to Nonmyeloablative Hematopoietic Cell Transplantation for Sickle Cell Disease and Beta-Thalassemia (PHASE1,PHASE2)
• Allo HSCT for High Risk Hemoglobinopathies (PHASE2)
• Minimizing Toxicity in HLA-identical Sibling Donor Transplantation for Children With Sickle Cell Disease (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Campath CI brief — competitive landscape report
• Campath updates RSS · CI watch RSS
• Sanofi portfolio CI

Frequently asked questions about Campath

Related

• Drug class: All CD52-directed Cytolytic Antibody [EPC] drugs
• Target: All drugs targeting CAMPATH-1 antigen
• Manufacturer: Sanofi — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Conditioning treatment prior to allogeneic haematopoietic stem cell transplant
• Indication: Drugs for Recurrent chronic lymphocytic leukemia
• Indication: Drugs for Refractory chronic lymphocytic leukemia

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing