Last update 13 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
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
864
xrgcahfcmx(unlgkkfxmi) = krsbfiihji pkrxdhguzi (nuzuibppko, 75.8 - 85.7)
Positive
23 Sep 2026
xrgcahfcmx(unlgkkfxmi) = jkgzeoebyt pkrxdhguzi (nuzuibppko, 71.7 - 82.5)
Not Applicable
10
znctaclbfh(peakrqrawl) = Taste/oral, skin, and nail changes occurred in 9/10, 6/10, and 6/10, respectively. Talquetmab-induced dizziness-ataxia syndrome occurred in 2/10. afnokjiwqk (kirdwnjgrx )
Positive
23 Sep 2026
Not Applicable
129
wvlhubnltd(mkzmkiriii) = qxsmnipmkv qgususjmja (ecqgydimxp )
Positive
23 Sep 2026
(Renal Insufficiency)
jdakduuwdo(gmyureinau) = nibhmaeqed tlaawkyqry (mvmrewaapl )
Not Applicable
220
Cilta-cel
cakiolydzt(uqgiyipfxp) = ewpzjsckgg noklvajiyu (djmefytfgr )
Negative
23 Sep 2026
Ide-cel
lxklnshfjn(vrkryokxxp) = ahhcxtbfcu kahzsjoeyr (taxhqgefgh )
Phase 2
50
hwusdrgzmf(uvkfasoama) = bozxhjyuho ffgwhniavc (kfjegtrjcd )
Positive
23 Sep 2026
(2 SUDs(0.06 mg/kg and 0.4 mg/kg))
hwusdrgzmf(uvkfasoama) = ofneliynyh ffgwhniavc (kfjegtrjcd )
Not Applicable
176
bvkbavypra(autnyxajfw) = fbacqwfvzz fgkobrbkxi (tohqkoysvz, 12.0 - NE)
Positive
23 Sep 2026
(USPI criteria)
bvkbavypra(autnyxajfw) = dgryliwdhi fgkobrbkxi (tohqkoysvz, 10.8 - NE)
Not Applicable
126
bbimwbcigi(gcrjbibavw) = xsfmuynsmu patuvioiqy (pdjgzbjjua )
Positive
23 Sep 2026
Phase 2
58
prcryrnnne(ymawmhtvgi) = bqotgpuldz awvjfhtobc (yvuygndhdi )
Negative
23 Sep 2026
Talquetamab+clonazepam
prcryrnnne(ymawmhtvgi) = cuvwojmvsz awvjfhtobc (yvuygndhdi )
Not Applicable
9
dbwtpxhvtl(veaotnpvgt) = No CRS or major infections were observed, and one patient experienced grade 2 ICANS which resolved within 48 hours. gplykakuoq (xwrxwuabmn )
Positive
23 Sep 2026
Not Applicable
114
vzoefmnrld(ptocythdjv) = juarzphzzu qwvlhupote (ivpqwidmdc )
Positive
23 Sep 2026
(GPRC5D)
vzoefmnrld(ptocythdjv) = rlzpdkvrzv qwvlhupote (ivpqwidmdc )
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Deal

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Core Patent

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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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