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Daratumumab

Alternative Names: daratumumab, jnj-54767414, dara, darzalex, jnj54767414, jnj 54767414
Latest Update: 2024-06-18
Latest Update Note: Clinical Trial Update

Product Description

Darzalex (daratumumab) is the first FDA-approved monoclonal antibody that targets the CD38 protein on the surface of myeloma cells.  (Sourced from: https://www.myeloma.org/darzalex-daratumumab)

Mechanisms of Action: CD38 Inhibitor

Novel Mechanism: No

Modality: Antibody

Route of Administration: Intravenous,Subcutaneous

FDA Designation: None *

Approval Status: Approved

Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Vietnam

Approved Indications: Multiple Myeloma | Stem Cell Transplant

Known Adverse Events: Anemia | Thrombocytopenia | Neutropenia | Cross Infection | Contraception | Dyspnea | Asthenia | Diarrhea | Edema

Company: Johnson & Johnson
Company Location: NEW BRUNSWICK NJ 08933
Company CEO: Joaquin Duato
Additonal Commercial Interests: Genmab

Clinical Description

Map of Global Clinical Trials for Daratumumab

Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States, Unknown Location

Active Clinical Trial Count: 147

Highest Development Phases

Phase 3: Amyloidosis|Multiple Myeloma

Phase 2: Acute Lymphoid Leukemia|Alzheimer Disease|Anemia, Sickle Cell|Antiphospholipid Syndrome|Arthritis, Rheumatoid|Blood Protein Disorders|Chronic Lymphoid Leukemia|Heart Transplant|Kidney Diseases|Kidney Transplant|Large-Cell Immunoblastic Lymphoma|Leukemia, Plasma Cell|Lupus Erythematosus, Systemic|Lymphocytic Chronic B-Cell Leukemia|Lymphoid Leukemia|Monoclonal Gammopathy of Undetermined Significance|Myelodysplastic Syndrome|POEMS Syndrome|Paraproteinemias|Peripheral Nervous System Diseases|Plasmablastic Lymphoma|Plasmacytoma|Polyneuropathies|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Stem Cell Transplant|T-Cell Leukemia|T-Cell Lymphoma|T-Cell Peripheral Lymphoma|Waldenstrom Macroglobulinemia

Phase 1: Acute Myeloid Leukemia|Anemia, Aplastic|Bladder Cancer|Chronic Myeloid Leukemia|Diffuse Large B-Cell Lymphoma|Kidney Cancer|Myelofibrosis|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Preleukemia|Renal Cell Carcinoma|Transitional Cell Carcinoma|Urologic Cancer

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

SUN-RAY

P2

Recruiting

Anemia, Sickle Cell

2044-09-01

jRCT2031240014

P3

Not yet recruiting

Multiple Myeloma

2033-10-28

OMC01/19

P3

Recruiting

Multiple Myeloma

2031-06-01

jRCT2051210043

P3

Recruiting

Multiple Myeloma

2031-02-15

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