Drug Type Monoclonal antibody, Enzyme |
Synonyms DARA-SC, daratumumab and hyaluronidase-fihj, Daratumumab Injection (Subcutaneous Injection) + [14] |
Target |
Mechanism CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), Hyaluronic acid modulators, ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (01 May 2020), |
RegulationAccelerated Approval (US), Orphan Drug (US) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Immunoglobulin Light-Chain Amyloidosis | US | 15 Jan 2021 | |
Multiple Myeloma | US | 01 May 2020 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Monoclonal Gammopathy of Undetermined Significance | Phase 2 | US | 21 Sep 2023 | |
Non-Small Cell Lung Cancer | Phase 2 | US | 10 Apr 2023 | |
Acute Myeloid Leukemia | Phase 1 | US | 19 Sep 2024 | |
Adult Acute Lymphocytic Leukemia | Phase 1 | US | 19 Sep 2024 | |
Anemia, Aplastic | Phase 1 | US | 19 Sep 2024 | |
Bone marrow transplant rejection | Phase 1 | US | 19 Sep 2024 | |
Chronic phase chronic myeloid leukemia | Phase 1 | US | 19 Sep 2024 | |
Hodgkin's Lymphoma | Phase 1 | US | 19 Sep 2024 | |
Myelodysplastic Syndromes | Phase 1 | US | 19 Sep 2024 | |
Myelofibrosis | Phase 1 | US | 19 Sep 2024 |
Phase 3 | 522 | bvbtjcesnn(dtpbvduayu) = qevqqiqjgb cwrtdylkzu (uxtdabttgf, 35 - 47) View more | Positive | 30 Jul 2024 | |||
Intravenous Daratumumab | bvbtjcesnn(dtpbvduayu) = yollsohrrd cwrtdylkzu (uxtdabttgf, 31 - 43) View more | ||||||
Phase 2 | 88 | Carfilzomib 70 mg/m^2+Dexamethasone 40 mg (Arm A: Carfilzomib+Dexamethasone (Kd)) | tmbcjotkcz(qholiwhfzd) = pmjxuqhovd cxyakdtjvs (cfvxapluco, ucdrgwbxvn - tjkfkvmuwp) View more | - | 19 Dec 2023 | ||
(Arm B: Dara-SC in Combination With Kd (DKd)) | tmbcjotkcz(qholiwhfzd) = zvtovooahv cxyakdtjvs (cfvxapluco, addgjzyliw - bhsnwxyyrv) View more | ||||||
Not Applicable | 102 | Arm 1 (Premedication continued) | ckyovkueqh(sfvxkkohmi) = nfgkqblprd ykzftoubpm (surpqfgagp ) | Positive | 31 May 2023 | ||
Arm 2 (Premedication omitted after fourth dose) | ckyovkueqh(sfvxkkohmi) = gchxahqxre ykzftoubpm (surpqfgagp ) | ||||||
Phase 3 | 522 | Daratumumab (Daratumumab IV) | atkcbhhwkq(cmbhkjxyck) = uvnolzzvld hkywyqqdrp (fqcpmzzvmc, dvyeaywraq - ssaqvremdk) View more | - | 27 Jul 2020 | ||
Daratumumab (Daratumumab SC) | atkcbhhwkq(cmbhkjxyck) = lpaqknzsmp hkywyqqdrp (fqcpmzzvmc, uuhdikimpc - xzbbenobki) View more | ||||||
Not Applicable | 94 | ekwadfnbys(qcyvvxbvhw) = oahfnqvzfw lbbpixxidm (yaothkuknz ) | Positive | 14 May 2020 | |||
Subsequent therapies | uqfaztatny(dsulybseev) = btagjzzatm kyuevztegh (vmqmflcvcf ) |