LEMTRADA (alemtuzumab)
LEMTRADA is indicated for the treatment of Multiple Sclerosis.
How LEMTRADA Works
Alemtuzumab binds to CD52, a cell surface antigen present on T and B lymphocytes, natural killer cells, monocytes, and macrophages. Although the precise therapeutic mechanism is unknown, binding to these lymphocytes results in antibody-dependent cellular cytolysis and complement-mediated lysis. These processes lead to the destruction of the targeted immune cells. This cytolytic action is presumed to be the basis for the drug's effect in treating multiple sclerosis.
Details
- Status
- Prescription
- First Approved
- 2001-05-07
- Patent Cliff
- 2008
- Revenue
- $18M (Q4-2022)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
LEMTRADA Approval History
What LEMTRADA Treats
1 indicationsLEMTRADA is approved for 1 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
LEMTRADA Boxed Warning
AUTOIMMUNITY, INFUSION REACTIONS, STROKE, AND MALIGNANCIES LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts before starting treatment and then at monthly intervals until 48 months after the last dose of LEMTRADA [see Warnings and Precautions (5.1) ] . LEMTRADA causes serious and life-threateni...
WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE, AND MALIGNANCIES LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts before starting treatment and then at monthly intervals until 48 months after the last dose of LEMTRADA [see Warnings and Precautions (5.1) ] . LEMTRADA causes serious and life-threatening infusion reactions. LEMTRADA must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Monitor patients for two hours after each infusion. Make patients aware that serious infusion reactions can also occur after the 2-hour monitoring period [see Warnings and Precautions (5.2) ] . Serious and life-threatening stroke (including ischemic and hemorrhagic stroke) has been reported within 3 days of LEMTRADA administration. Instruct patients to seek immediate medical attention if symptoms of stroke occur [see Warnings and Precautions (5.3) ]. LEMTRADA may cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders. Perform baseline and yearly skin exams [see Warnings and Precautions (5.4) ] . Because of the risk of autoimmunity, infusion reactions, and malignancies, LEMTRADA is available only through restricted distribution under a Risk Evaluation Mitigation Strategy (REMS) Program. Call 1-855-676-6326 to enroll in the LEMTRADA REMS program [see Warnings and Precautions (5.5) ] . WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE, AND MALIGNANCIES See full prescribing information for complete boxed warning. LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell co
LEMTRADA Competitive Set
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Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LEMTRADA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LEMTRADA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LEMTRADA
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Clinical Trial Registry
78 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02629120 | 160032 16-I-0032 | Ph 1, Ph 2 | active not recruiting | High Dose Peripheral Blood Stem Cell Transplantation With Post Transplant Cyclophosphamide for Patients With Chronic Granulomatous Disease |
| NCT05463133 | 10000977 000977-I | Ph 1, Ph 2 | recruiting | 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 |
| NCT03821610 ALL-RIC | RG_17-241 | Ph 2 | active not recruiting | A Comparison of Reduced Dose Total Body Irradiation (TBI) and Cyclophosphamide With Fludarabine and Melphalan Reduced Intensity Conditioning in Adults With Acute Lymphoblastic Leukaemia (ALL) in Complete Remission. (ALL-RIC) |
| NCT04339777 | 200070 20-C-0070 | Ph 2 | recruiting | Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity |
| NCT03214354 Sickle-AID | TRU-17-001 | Ph 2 | recruiting | Nonmyeloablative Stem Cell Transplant in Children With Sickle Cell Disease and a Major ABO-Incompatible Matched Sibling Donor |
| NCT00977691 results posted | 090225 09-H-0225 | Ph 1, Ph 2 | active not recruiting | Haploidentical PBMC Transplant for Severe Congenital Anemias |
| NCT03077542 results posted | 170069 17-H-0069 | Ph 1, Ph 2 | active not recruiting | Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease |
| NCT06084780 TRANSCAPE | CASE7Z23 | Ph 2 | not yet recruiting | Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE) |
| NCT02472054 C-HLH | P120109 2014-005585-30 | Ph 1, Ph 2 | completed | Treatment of Familiar Lymphohistiocytosis |
| NCT06959771 | 10002385 002385-I | Ph 1, Ph 2 | recruiting | Base Editing Hematopoietic Stem Cell and T Cell Gene Therapy for CD40L-HyperIgM Syndrome: Single Patient Study |
| NCT01659606 | 12-950 IRB-P00003466 | Ph 2 | active not recruiting | Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita |
| NCT05357482 | 10000539 000539-H | Ph 1, Ph 2 | active not recruiting | Addition of JSP191 (C-kit Antibody) to Nonmyeloablative Hematopoietic Cell Transplantation for Sickle Cell Disease and Beta-Thalassemia |
| NCT06872333 | 2024LS140 | Ph 2 | recruiting | Allo HSCT for High Risk Hemoglobinopathies |
| NCT03504241 TEACH | DAIT ITN062ST UM1AI109565, NIAID CRMS ID#: 20676 | Ph 1 | completed | Tolerance by Engaging Antigen During Cellular Homeostasis |
| NCT01625351 | RADIANT NCI-2012-00588 | Ph 1 | completed | A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas |
| NCT03579875 | 2016LS161 MT2017-17 | Ph 2 | recruiting | Alpha/Beta TCD HCT in Patients With Inherited BMF Disorders |
| NCT03500731 | STUDY19110120 | Ph 1, Ph 2 | recruiting | Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure |
| NCT05384756 | 20682 NCI-2022-03571, 20682 | Ph 1 | active not recruiting | TMLI and Alemtuzumab for Treatment of Sickle Cell Disease |
| NCT00692939 | STUDY19100005 | Ph 1, Ph 2 | recruiting | Autologous Stem Cell Transplantation for Crohn's Disease |
| NCT01962415 HSCT+RIC | STUDY19060337 | Ph 2 | recruiting | Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT |
| NCT04232085 | B19126 IRB00227401 | Ph 2 | recruiting | Regenerative Medicine to Restore Hematopoiesis and Immune Function in Immunodeficiencies and Inherited Bone Marrow Failures |
| NCT03630211 SSc | STUDY19050297 | Ph 2 | recruiting | Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis |
| NCT06358638 SUN-RAY | STUDY00000859 | Ph 2 | recruiting | Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell Antibody |
| NCT03653338 | STUDY19050050 | Ph 1, Ph 2 | recruiting | T-Cell Depleted Alternative Donor Bone Marrow Transplant for Sickle Cell Disease (SCD) and Other Anemias |
| NCT05501756 | 2022-0447 | Ph 2 | recruiting | Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation |
| NCT03477500 RAM-MS | 2017-001362-25 | Ph 3 | active not recruiting | Randomized Autologous heMatopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab for RRMS (RAM-MS) |
| NCT01361711 results posted | NU 10H06 NCI-2011-00514, STU00044115 | Ph 2 | active not recruiting | Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia |
| NCT02766465 STRIDE2 results posted | BMT CTN 1503 1U01HL128568-01 | Ph 2 | completed | Bone Marrow Transplantation vs Standard of Care in Patients With Severe Sickle Cell Disease (BMT CTN 1503) |
| NCT01499888 | 2011-0096 | Ph 1, Ph 2 | active not recruiting | Ph I/II Study of Allogeneic SCT for Clinically Aggressive Sickle Cell Disease (SCD) |
| NCT02105766 results posted | 140077 14-H-0077 | Ph 2 | active not recruiting | Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Beta-thalassemia in People With Higher Risk of Transplant Failure |
| NCT04018937 | IRB00093513 | Ph 2 | active not recruiting | Early Human Leukocyte Antigen (HLA) Matched Sibling Hematopoietic Stem Cell Transplantation |
| NCT03989466 | 2019-0054 NCI-2019-03203, 2019-0054 | Ph 1 | completed | Itacitinib and Alemtuzumab in Treating Patients With T-Cell Prolymphocytic Leukemia |
| NCT03182426 | Pro00053082 | Ph 1, Ph 2 | completed | Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM) |
| NCT02867800 | AAAQ2350 | Ph 1 | completed | Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease |
| NCT02061800 | AAAK8060 | Ph 1, Ph 2 | active not recruiting | CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant |
| NCT02385110 results posted | 2014-0989 NCI-2015-00526 | Ph 2 | completed | Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis |
| NCT01465334 results posted | 11-304 NCCN Protocol Number: NCCN-001, GSK Protocol Number: OFT115580 | Ph 2 | terminated | Ofatumumab With High Dose Methylprednisone Followed by Ofatumumab and Alemtuzumab in 17p CLL |
| NCT01013961 results posted | E1908 E1908, U10CA180794 | Ph 2 | terminated | Rituximab and Alemtuzumab in Treating Older Patients With Progressive Chronic Lymphocytic Leukemia |
| NCT01256398 results posted | NCI-2011-02621 NCI-2011-02621, CALGB 10701/CTSU C10701 | Ph 2 | completed | Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT01877837 results posted | Pro00001894 | Ph 3 | completed | Stem Cell Transplantation for Sickle Cell Anemia |
| NCT01982175 CLL004 | CMAB004 | Ph 2 | suspended | Phase II Clinical Trial of Alemtuzumab to Treat B-cell Chronic Lymphocytic Leukemia |
| NCT02689453 results posted | 160062 16-C-0062 | Ph 1 | completed | Subcutaneous Recombinant Human IL-15 (s.c. rhIL-15) and Alemtuzumab for People With Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL) |
| NCT04971005 COAST | inims-009 | Ph 2 | terminated | Ocrelizumab or Alemtuzumab Compared With Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis - a Phase-2 Randomised Controlled Trial |
| NCT00951457 | AGMT CLL-6 BendAlem | Ph 1, Ph 2 | completed | Bendamustine Combined With Alemtuzumab in Pretreated Chronic Lymphocytic Leukemia (CLL) |
| NCT03135249 SUPPRESS results posted | STU 112016-060 | Ph 4 | completed | Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis |
| NCT02678143 | 201602019 | Ph 1 | terminated | Nonmyeloablative Conditioning for Mismatched Hematopoietic Stem Cell Transplantation for Severe Sickle Cell Disease |
| NCT01186640 | T-PLL2 2008-001421-34 | Ph 2 | completed | Combined Immunochemotherapy in Patients With T-Prolymphocytic Leukemia (T-PLL) |
| NCT02419378 ALAIN01 | UKM12_0026 U1111-1156-6489 | Ph 4 | completed | Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential |
| NCT02497404 results posted | 1306014009 | Ph 2 | completed | Azacytidine Prior to in Vivo T-cell Depleted Allo Stem Cell Transplant for Patients With Myeloid Malignancies in CR |
| NCT01729494 results posted | BEST | Ph 4 | completed | Belatacept Early Steroid Withdrawal Trial |
Showing 50 of 78 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LEMTRADA FDA Label Details
Indications & Usage
FDA Label (PDF)LEMTRADA is indicated for the treatment of Multiple Sclerosis.
WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE, AND MALIGNANCIES LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis ...
Pro Intelligence Preview
Deep insights for LEMTRADA
Revenue Insights
- • Q4-2022: $18M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2008
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.