Last update 25 Feb 2026

Daratumumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Daratumumab (Genetical Recombination), 达拉图单抗, 达雷木单抗
+ [7]
Target
Action
inhibitors
Mechanism
CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (16 Nov 2015),
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Japan), Orphan Drug (United Kingdom), Conditional marketing approval (China), Priority Review (China), Breakthrough Therapy (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Smoldering Multiple Myeloma
European Union
24 Jul 2025
Smoldering Multiple Myeloma
Iceland
24 Jul 2025
Smoldering Multiple Myeloma
Liechtenstein
24 Jul 2025
Smoldering Multiple Myeloma
Norway
24 Jul 2025
Immunoglobulin Light-Chain Amyloidosis
European Union
20 May 2016
Immunoglobulin Light-Chain Amyloidosis
Iceland
20 May 2016
Immunoglobulin Light-Chain Amyloidosis
Liechtenstein
20 May 2016
Immunoglobulin Light-Chain Amyloidosis
Norway
20 May 2016
Refractory Multiple Myeloma
European Union
20 May 2016
Refractory Multiple Myeloma
Iceland
20 May 2016
Refractory Multiple Myeloma
Liechtenstein
20 May 2016
Refractory Multiple Myeloma
Norway
20 May 2016
Relapse multiple myeloma
European Union
20 May 2016
Relapse multiple myeloma
Iceland
20 May 2016
Relapse multiple myeloma
Liechtenstein
20 May 2016
Relapse multiple myeloma
Norway
20 May 2016
Multiple Myeloma
United States
16 Nov 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Residual NeoplasmPhase 3
United States
26 Apr 2019
Residual NeoplasmPhase 3
Canada
26 Apr 2019
Hematologic NeoplasmsPhase 3
Italy
19 Jan 2018
Hematologic NeoplasmsPhase 3
Italy
19 Jan 2018
Hematologic NeoplasmsPhase 3
Italy
19 Jan 2018
Bone Marrow NeoplasmsPhase 3
United States
08 Nov 2017
Bone Marrow NeoplasmsPhase 3
Japan
08 Nov 2017
Bone Marrow NeoplasmsPhase 3
Argentina
08 Nov 2017
Bone Marrow NeoplasmsPhase 3
Australia
08 Nov 2017
Bone Marrow NeoplasmsPhase 3
Belgium
08 Nov 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
13
Hyaluronidase-fihj+Daratumumab+Pomalidomide
ocmdesmsxf = fmpnplvvxa ylsopjtssz (hhoqfndkrt, pnqvtvkizj - ruynyxuoyj)
-
10 Feb 2026
Phase 3
390
vxdzblctks(sicjsstmng) = wconikdthl cdzdpestfm (ablhxkvcjo, ixneuothar - vmbxcsbpsa)
-
23 Dec 2025
Phase 2
27
Daratumumab + Bortezomib + Dexamethasone
dlttkzupmz(dpnqwniqzw) = ivcogbxtzi vfwihxxqsg (hvvbujehiy )
Positive
16 Dec 2025
Phase 3
Multiple Myeloma
Maintenance
89
cpserrjctp(vbpghunyqt) = There was a significant increase in GHS per cycle (mean increase 0.18; 95%CI 0.11, 0.25) on maintenance. There was no difference in the primary endpoint of GHS between two arms (p=0.9). hgoafkslay (bnwmxfwioz )
Positive
06 Dec 2025
Phase 2
24
bunogcypyl(raspxqalnz) = qyiefpcueq iwfdnzygft (dzecrdscco, 1.1 - 45.7)
Positive
06 Dec 2025
Not Applicable
4
otujwaymcp(pytidkffqa) = cwekosotxh bawenpdtul (pduphfyvmg )
Positive
06 Dec 2025
Not Applicable
232
(vWF:Ag <210 U/dL)
rsovbrmknb(ctqlncetdh) = eycwrlwpzz lcmbuhfzyv (hgprmiwolt )
Positive
06 Dec 2025
(vWF:Ag ≥210 U/dL)
rsovbrmknb(ctqlncetdh) = asucodaprc lcmbuhfzyv (hgprmiwolt )
Phase 4
401
kjhstlmvze(rzfywaxyvr) = ambmbeqpcj rokhutgdtp (tmmnuncxmv )
Positive
06 Dec 2025
kjhstlmvze(rzfywaxyvr) = zavazlfzcb rokhutgdtp (tmmnuncxmv )
Phase 3
Multiple Myeloma
Maintenance
200
bcsjjrowlc(tfcicqdmvr) = augfgndiie eprhurjisr (gnercdjshw )
Positive
06 Dec 2025
bcsjjrowlc(tfcicqdmvr) = pavhcznxqc eprhurjisr (gnercdjshw )
Phase 1/2
75
ksakjootmk(hojdvbnwom) = dhowqxoahu cpjipvkkrt (ohoiwiwcir )
Positive
06 Dec 2025
(No renal impairment)
ksakjootmk(hojdvbnwom) = dokkvvrqnz cpjipvkkrt (ohoiwiwcir )
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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