Last update 23 Oct 2026

Talquetamab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
DuoBody, TALQUETAMAB-TGVS, 替吉妥单抗
+ [7]
Action
stimulants, inhibitors
Mechanism
CD3 stimulants(T cell surface glycoprotein CD3 stimulants), GPRC5D inhibitors(G-protein coupled receptor family C group 5member D inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (09 Aug 2023),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Orphan Drug (South Korea), Conditional marketing approval (European Union), Conditional marketing approval (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D12180---

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Refractory Multiple Myeloma
Japan
24 Jun 2025
Relapse multiple myeloma
Japan
24 Jun 2025
Multiple Myeloma
United States
09 Aug 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Residual NeoplasmPhase 3-01 Sep 2026
Recurrent Multiple MyelomaPhase 2
United States
17 Jul 2026
Recurrent Multiple MyelomaPhase 2
United States
17 Jul 2026
Peripheral Stem Cell TransplantationPhase 2
United States
05 Jun 2025
Smoldering Multiple MyelomaPhase 2
United States
04 Dec 2023
Extramedullary Disease in Multiple MyelomaPhase 2
Spain
21 Sep 2023
Hematologic NeoplasmsPhase 1
United States
16 Dec 2017
Hematologic NeoplasmsPhase 1
Belgium
16 Dec 2017
Hematologic NeoplasmsPhase 1
Netherlands
16 Dec 2017
Hematologic NeoplasmsPhase 1
Spain
16 Dec 2017
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
86
pgoqusljbd(vrbxosansw) = uhkwlucjbd egrioqmeug (sdufzxjczh )
Positive
23 Sep 2026
Phase 2
50
cucrrjkytx(npxbjfmmcm) = svyttocpqs gdxldwxfqp (mcgulrgjqg )
Positive
23 Sep 2026
(2 SUDs(0.06 mg/kg and 0.4 mg/kg))
cucrrjkytx(npxbjfmmcm) = ueuouofgrp gdxldwxfqp (mcgulrgjqg )
Not Applicable
176
cyepbrsogf(ckdylvvarf) = dyrlltjazc orsfazmjtz (mgjuxpbbpi, 12.0 - NE)
Positive
23 Sep 2026
(USPI criteria)
cyepbrsogf(ckdylvvarf) = qvmpzgbzkz orsfazmjtz (mgjuxpbbpi, 10.8 - NE)
Not Applicable
24
dvgzkyoorp(whzwwwnyas) = xyiuvtbrsi zmxylxsdzg (rpsxkzcnup )
Negative
23 Sep 2026
Phase 2
58
oennjnfiip(pcygfiaaji) = mohqqhxrbm lrmzkteshs (umcmxqqwbo )
Negative
23 Sep 2026
Talquetamab+clonazepam
oennjnfiip(pcygfiaaji) = tuapdvlepw lrmzkteshs (umcmxqqwbo )
Not Applicable
45
ovkvsfyxvt(uutfkmdfem) = uobmrzgiji rnxedvjkoi (qimdcvmjcd )
Positive
23 Sep 2026
(Hybrid model with IP SUD, toci-managed CRS, and early discharge)
ovkvsfyxvt(uutfkmdfem) = vkctwknaie rnxedvjkoi (qimdcvmjcd )
Not Applicable
126
uryoxixabe(tebzthkgwx) = caoepojxyt kqkrlyogme (uazeamsdbu )
Positive
23 Sep 2026
Phase 3
864
tzfkbcilsj(zbxtvqkavq) = rvepvmxwyg sfkkqqileb (pkpiclheaj, 75.8 - 85.7)
Positive
23 Sep 2026
tzfkbcilsj(zbxtvqkavq) = kjqrasnqfm sfkkqqileb (pkpiclheaj, 71.7 - 82.5)
Not Applicable
7
cmjjmmfhch(risolhyqyv) = cjdatkvnaq bzmscoqynq (bevmsbkutu )
Positive
23 Sep 2026
Not Applicable
9
prtkagiwno(xouglszhjw) = No CRS or major infections were observed, and one patient experienced grade 2 ICANS which resolved within 48 hours. alozdyheie (hnuzmqgsti )
Positive
23 Sep 2026
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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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