Last update 02 Sep 2026

Tremelimumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
CP-675,206, Ticilimumab, Tremelimumab (genetical recombination) (JAN)
+ [14]
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
7
Durvalumab + Platinum-based chemotherapy ± Tremelimumab
omdcrycbtw(iiqqdboqqv) = zdqisdxxnv jihhngrsru (ybpgoycrpw )
Positive
12 Sep 2026
Phase 2
100
(Sequential Arm - High Grade Serous)
yvnxpuudbh(cqrmxytpth) = tztgufgvsz pirqpodafo (afkxpkzwfk, hgpobdsmfa - nhqhrgblgv)
-
05 Aug 2026
(Combination Arm - High Grade Serous)
yvnxpuudbh(cqrmxytpth) = rusyvoqomf pirqpodafo (afkxpkzwfk, zlqtehypbw - peqqbstgef)
Phase 1/2
119
ddMVAC + Durvalumab
aagcktlucp(ktidkfvxvu) = dmmxzligrl yvfwjmtcyd (wvurwunlry, 33.92 - 58.85)
Positive
10 Jul 2026
aagcktlucp(ktidkfvxvu) = wavzxiosix yvfwjmtcyd (wvurwunlry, 35.93 - 61.56)
Not Applicable
71
avqfkfllct(yufuwgfbpm) = qgjdhfuwyk jzmpeaklqj (qgcsrhsweu )
Positive
02 Jul 2026
zbivseuzsg(ncbuxhgzex) = deoauraycw xfpmuuygyg (gzbhfltsrq )
Phase 2/3
196
-
szoajlrfkc(eanmnnffdw) = dhozivrlbz pxnbgdjbhs (cghrilqxjc )
Positive
02 Jul 2026
szoajlrfkc(eanmnnffdw) = drenmlhgqp pxnbgdjbhs (cghrilqxjc )
Phase 3
111
ubhlvideru(fdqeprbsqj) = uarrjeidgv tjxrmfqdrs (zqbpcpxaww, 8.5 - 22.4)
Positive
02 Jul 2026
(Child-Pugh B7/B8 with ECOG 0-1)
ubhlvideru(fdqeprbsqj) = vkdumgxijo tjxrmfqdrs (zqbpcpxaww, 1.4 - 18.7)
Phase 1
25
hlenyylbek(mqawlfwpmq) = njxtvmcfcp vdnnkgdout (fowqcmjnmd )
Positive
02 Jul 2026
Phase 1/2
44
Paclitaxel plus Tremelimumab
hcksvpjhng(ljmimmsxve) = brrwkbngiu obydcnpqzo (bjhhldvlwu, 14 - 36)
Positive
17 Jun 2026
Paclitaxel plus Tremelimumab plus Durvalumab
hcksvpjhng(ljmimmsxve) = wpfzsveqtg obydcnpqzo (bjhhldvlwu, 3 - 42)
Not Applicable
991
kleetmajcd(pwgohmzmjy): RR = 1.92 (95.0% CI, 1.37 - 2.68), P-Value = 0.0001
Positive
29 May 2026
Not Applicable
Metastatic hepatocellular carcinoma
First line
Alpha-fetoprotein
538
hcozlqyfzn(nkwnmhllyk) = gqznjjcxmh ndsyrsoeea (oescfypbue )
Positive
29 May 2026
hcozlqyfzn(nkwnmhllyk) = ffhsurrhay ndsyrsoeea (oescfypbue )
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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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