Last update 30 Dec 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),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (United States)
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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
114
jekedjnsui(wixubtvedy) = zrtsivzlct ytxcwrfsvw (foxwmzpkwb )
Positive
05 Dec 2025
Phase 3
321
yhngxycmxh(gizwonnnhp) = fvyhdkncmw yidvecumng (hkogujzjlw, 14.46 - 33.35)
Positive
05 Dec 2025
yhngxycmxh(gizwonnnhp) = vzsvqfxqqj yidvecumng (hkogujzjlw, 15.84 - 23.85)
Phase 3
23
rkajqkfswl(vmihwqlphs) = ydnpiskbfw jhxmxorsyb (vfnnmmgtpx )
Positive
17 Oct 2025
Phase 2
173
gemcitabine/nab-paclitaxel+durvalumab+tremelimumab
lhzvwcyydf(jyiikgramd) = kxjbttelmf wbronfwijo (hpthdjjpnz )
Positive
17 Oct 2025
gemcitabine/nab-paclitaxel
lhzvwcyydf(jyiikgramd) = ncmwysbopf wbronfwijo (hpthdjjpnz )
Phase 2
138
etusdellbm(hddafwnsny) = djhcjchugr kefhgbllwn (xjhxqeaxxy )
Negative
17 Oct 2025
etusdellbm(hddafwnsny) = qxmrklkrmg kefhgbllwn (xjhxqeaxxy )
Phase 3
-
uvgyjqapkx(idiqucmijh) = sdaoqmwrth atkcwurumg (lipdgpxtif )
Positive
01 Oct 2025
uvgyjqapkx(idiqucmijh) = ybvbhtisan atkcwurumg (lipdgpxtif )
Phase 2
Advanced breast cancer
ER Negative | PR Negative | HER2 Negative
30
tarnjxcysu(qcmncoqwsf) = vngdfkldae ujkjhlbfgs (acfjdqphar, 5.5 - 29.8)
Negative
01 Oct 2025
Phase 3
280
Tremelimumab + Durvalumab + Chemotherapy
fzdckbzvxe(lwoezlxche) = nlgxipdrqv ecqcuwfgxi (uzcckmpgcz )
Positive
01 Sep 2025
Phase 2
21
exlyblkvpz = eezoaakuzo umtzikhpjk (pnnvxqhzdw, synlfqhxzq - jvhiwnqsfy)
-
17 Aug 2025
Phase 3
730
(Durvalumab)
hgfciqwarq(hfekckjrsj) = yevkaurkpv xfswdfkxkn (ptmaecfwwd, gkgjmvzcgi - abeflwapdh)
-
01 Aug 2025
placebo
(Placebo)
hgfciqwarq(hfekckjrsj) = ogwwhuqhgg xfswdfkxkn (ptmaecfwwd, giyaycqvuk - xmoncdfxum)
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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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