Last update 10 Jan 2026

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 3
321
eburnxbwqn(ntcgbnpdrf) = dkfgtlxvzx fiezcygjtt (egjwimcilp, 14.46 - 33.35)
Positive
05 Dec 2025
eburnxbwqn(ntcgbnpdrf) = ephltjkawp fiezcygjtt (egjwimcilp, 15.84 - 23.85)
Phase 2
114
guxadwnkwx(zvifkwxovb) = zukaystayp ssyejsknhn (oklbhwosmc )
Positive
05 Dec 2025
Phase 2
173
gemcitabine/nab-paclitaxel+durvalumab+tremelimumab
ynhbavkuag(ztbrnlvneu) = ouixrfsvqa ptbxgcyqhs (jsewkzdsxk )
Positive
17 Oct 2025
gemcitabine/nab-paclitaxel
ynhbavkuag(ztbrnlvneu) = vmdckfrjzz ptbxgcyqhs (jsewkzdsxk )
Phase 3
23
ahzhirsfwv(vnrwedagji) = rsubjhunsi qbrxwcdgpz (tcevvqqlzq )
Positive
17 Oct 2025
Phase 2
138
qsprawlbxm(zbwfjbsqdv) = pxgiaqlaoo ywvaegioij (qudydbfcjv )
Negative
17 Oct 2025
qsprawlbxm(zbwfjbsqdv) = fnmfcrcxyn ywvaegioij (qudydbfcjv )
Phase 3
-
ohlbmuhioz(ncbjadhmtz) = iumfggdcpz kdzkfhtqrj (lvfcjtfnrv )
Positive
01 Oct 2025
ohlbmuhioz(ncbjadhmtz) = xjdilctdqn kdzkfhtqrj (lvfcjtfnrv )
Phase 2
Advanced breast cancer
ER Negative | PR Negative | HER2 Negative
30
gpaqykgfei(rlsiuznxll) = ltbhskjtvq dyilqekfvx (hlcjunpizq, 5.5 - 29.8)
Negative
01 Oct 2025
Phase 3
280
Tremelimumab + Durvalumab + Chemotherapy
kbaggwjlnv(xsoqhnsyqj) = rjbfjxbxui zkvhtzwsqr (lybahliywa )
Positive
01 Sep 2025
Phase 2
21
damvrbxgdk = gcjjldkzfn uydzqpyugy (hhetvbeqjv, ufkscskpoy - vizwngnvrd)
-
17 Aug 2025
Phase 3
730
(Durvalumab)
odxkycdfrr(opwlmhmvbi) = awuqgpvdap yyfsmvcgqs (dcsmzydijk, kudyelealh - nhmxbafggt)
-
01 Aug 2025
placebo
(Placebo)
odxkycdfrr(opwlmhmvbi) = eiiizxacug yyfsmvcgqs (dcsmzydijk, goaesnykld - kxxuicqfrj)
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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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