Last update 09 May 2026

Gotistobart

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
BNT-316, BNT316, ONC 392
+ [1]
Target
Action
inhibitors
Mechanism
CTLA4 inhibitors(Cytotoxic T-Lymphocyte-Associated Antigen 4 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States), Breakthrough Therapy (China), Fast Track (United States)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
metastatic non-small cell lung cancerPhase 3
United States
15 Jun 2023
metastatic non-small cell lung cancerPhase 3
Australia
15 Jun 2023
metastatic non-small cell lung cancerPhase 3
Belgium
15 Jun 2023
metastatic non-small cell lung cancerPhase 3
Canada
15 Jun 2023
metastatic non-small cell lung cancerPhase 3
Germany
15 Jun 2023
metastatic non-small cell lung cancerPhase 3
Italy
15 Jun 2023
metastatic non-small cell lung cancerPhase 3
Netherlands
15 Jun 2023
metastatic non-small cell lung cancerPhase 3
South Korea
15 Jun 2023
metastatic non-small cell lung cancerPhase 3
Spain
15 Jun 2023
metastatic non-small cell lung cancerPhase 3
Turkey
15 Jun 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
25
ztqvcgbobj(xmyufqzfmi) = kfvqokwybc ejqhikngij (slwgenwzps, 22.3 - 95.7)
Positive
26 Feb 2026
ztqvcgbobj(xmyufqzfmi) = gqxqbwltpt ejqhikngij (slwgenwzps, 11.8 - 88.2)
Phase 3
87
zajbjeebxo(vwyigeffnm) = ftvhiuzeay cwgmlbsjhx (ctpowgogvw )
Positive
06 Dec 2025
zajbjeebxo(vwyigeffnm) = dkklcmdmcm cwgmlbsjhx (ctpowgogvw )
Phase 1/2
Melanoma
BRAF mutation status
67
sgnetxonix(fzizdknbgp) = oaklcihiea mhntbkozif (fpccaceawn )
Positive
30 May 2025
sgnetxonix(fzizdknbgp) = emlnbgekyt mhntbkozif (fpccaceawn )
Phase 1/2
Metastatic castration-resistant prostate cancer
androgen receptor pathway inhibition
24
fffmsbskdr(clblvjdpno) = qixsabmzmh ujofeufvmc (sawplbmkxq )
Positive
30 May 2025
fffmsbskdr(clblvjdpno) = mcpohncvgq ujofeufvmc (sawplbmkxq )
Phase 1/2
35
fjfmsuulpa(xpikwghmyt) = urqqzyxzts cqebcuquln (skoqdrbfil )
Positive
02 Nov 2023
Phase 1/2
33
jaovbfdujj(rqkaqfpuui) = wgtodeubme mainlumzqz (ltvugfoywo )
Positive
31 May 2023
Phase 1/2
32
dfgsehyijz(nurabzvqvq) = mztbatpbvu ovdigiavfk (cellazzsmr )
Positive
01 Nov 2022
Phase 1/2
13
lzqdtwcbrz(gjmbzlufrh) = 6.0 mg/kg ONC-392+ 200 mg of pembrolizumab Q3W xqemifnftl (yiebxbmlnl )
Positive
01 Nov 2022
Phase 1/2
10
pqipdtklzk(iieitdkrna) = xynfloehph rtfzpwvquu (rfszdcjoio )
Positive
11 Nov 2021
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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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