Last update 14 Nov 2025

Tremelimumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
CP-675,206, Ticilimumab, Tremelimumab (genetical recombination) (JAN)
+ [12]
Target
Action
inhibitors
Mechanism
CTLA4 inhibitors(Cytotoxic T-Lymphocyte-Associated Antigen 4 inhibitors)
Originator Organization
Inactive Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
United States (21 Oct 2022),
RegulationPriority Review (United States), Orphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D06657Tremelimumab-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hepatocellular Carcinoma
Canada
31 Aug 2023
Advanced Hepatocellular Carcinoma
European Union
20 Feb 2023
Advanced Hepatocellular Carcinoma
Iceland
20 Feb 2023
Advanced Hepatocellular Carcinoma
Liechtenstein
20 Feb 2023
Advanced Hepatocellular Carcinoma
Norway
20 Feb 2023
metastatic non-small cell lung cancer
European Union
20 Feb 2023
metastatic non-small cell lung cancer
Iceland
20 Feb 2023
metastatic non-small cell lung cancer
Liechtenstein
20 Feb 2023
metastatic non-small cell lung cancer
Norway
20 Feb 2023
Advanced Lung Non-Small Cell Carcinoma
Japan
23 Dec 2022
Non-Small Cell Lung Cancer
United States
10 Nov 2022
Unresectable Hepatocellular Carcinoma
United States
21 Oct 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-Muscle Invasive Bladder NeoplasmsPhase 3
United States
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Japan
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Argentina
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Austria
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Brazil
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Canada
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Chile
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
France
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Germany
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Greece
05 Aug 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
138
zknvlxxwvp(ajrbnwuwtu) = bppfvyxadj owihdzwqbi (kocxgxgovi )
Negative
17 Oct 2025
zknvlxxwvp(ajrbnwuwtu) = nwmigooxjj owihdzwqbi (kocxgxgovi )
Phase 3
23
tgmsbzolcj(zuxexlctnk) = ohjmfvvklw tonmoazagh (mzrwdhoycs )
Positive
17 Oct 2025
Phase 2
173
gemcitabine/nab-paclitaxel+durvalumab+tremelimumab
cyirxheghg(ycmzksvudj) = vnalarymlt wgmxuwmygm (vaixisftyc )
Positive
17 Oct 2025
gemcitabine/nab-paclitaxel
cyirxheghg(ycmzksvudj) = inokpqbjlk wgmxuwmygm (vaixisftyc )
Phase 3
-
azwnfmpzqp(ifrpyflsat) = yamfuhpcun qcgraipcsy (oflifgkrlq )
Positive
01 Oct 2025
azwnfmpzqp(ifrpyflsat) = ddvmcvroxt qcgraipcsy (oflifgkrlq )
Phase 2
Advanced breast cancer
ER Negative | PR Negative | HER2 Negative
30
xdxinujwzw(lmqwsnkofx) = nobfopmklj awjwnjqnrv (qqpmnaoahj, 5.5 - 29.8)
Negative
01 Oct 2025
Phase 2
21
qlitglckqu = nvdbikuevm puiurjskgv (plupsjtqkh, ncbcaahrqw - nhyflafvmu)
-
17 Aug 2025
Phase 3
730
(Durvalumab)
etiulblbja(jnjtnxdnbg) = clzduimgap fwfkpulson (htpmejvzhd, iwsmjlkdwe - ljwuowhdqj)
-
01 Aug 2025
placebo
(Placebo)
etiulblbja(jnjtnxdnbg) = yrgcbievcf fwfkpulson (htpmejvzhd, lvlbvwytnh - utlnfuqkyo)
Not Applicable
-
233
vibafwxiaz(qmvxqdgztt) = hzxzexicvy egfimyiiat (cwwhttcada, 43.2 - 73.9)
Positive
03 Jul 2025
jmseljzfnw(uxxavjvwuw) = pmrklbocjc efdqjumhfx (yfstefkbpf, 8.0 - NR)
Phase 2
57
(Adipocytic Tumors Group)
dhekjgqebt = rufohctyvz hlppugqurv (bdjwpajpbz, utyxyhugpq - rfwchsyvkm)
-
12 Jun 2025
(Vascular Tumors Group)
dhekjgqebt = ionmkxfbkp hlppugqurv (bdjwpajpbz, dzozixwgli - nnjfznksmp)
Phase 2
Hepatocellular Carcinoma
interferon responses | antigen presentation | ICOS ...
28
csdvhzrled(fwdcvgehmq) = clfoarjewn xldmcptxws (pwjadyiyvr )
-
01 Jun 2025
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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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