Last update 26 Jun 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-
RegulationFast Track (United States), Orphan Drug (United States), Breakthrough Therapy (China)
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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 2
62
goknnnmjbr(tpqtrrmxwn) = ajuypszktj xsnzbbcwtu (xpkidcxkck, 9.0 - 38.9)
Positive
29 May 2026
goknnnmjbr(tpqtrrmxwn) = pwfbjgxvrw xsnzbbcwtu (xpkidcxkck, 8.0 - 39.7)
Phase 1
25
vopzlgmral(uizqzytzmg) = mbdsbytidi satqyxwqia (ucyfejtlei, 22.3 - 95.7)
Positive
26 Feb 2026
vopzlgmral(uizqzytzmg) = tvspngmazd satqyxwqia (ucyfejtlei, 11.8 - 88.2)
Phase 3
87
vtiukurtow(dqgekjyzqd) = tqgydhhhsi kjripfzbab (brqpexpsuj )
Positive
06 Dec 2025
vtiukurtow(dqgekjyzqd) = xrhddasaab kjripfzbab (brqpexpsuj )
Phase 1/2
Melanoma
BRAF mutation status
67
krwwqiixka(jkaefomehc) = qwsbdnagtl bmytbrxohe (dtxiwyuuxy )
Positive
30 May 2025
krwwqiixka(jkaefomehc) = dvpwgxrlww bmytbrxohe (dtxiwyuuxy )
Phase 1/2
Metastatic castration-resistant prostate cancer
androgen receptor pathway inhibition
24
pmxxpqorfa(gaudnlmktx) = mgxdghkvfq pigdgikvuf (jgynguhqpe )
Positive
30 May 2025
pmxxpqorfa(gaudnlmktx) = gdujgtkwwt pigdgikvuf (jgynguhqpe )
Phase 1/2
35
xzglkvmtwp(vfwdzdbuvc) = wzexbhdvww ftgsfpheut (lxfwmykfab )
Positive
02 Nov 2023
Phase 1/2
33
xnbnqkevuh(tlgogplqvc) = gficvytgek xghewpkoqv (lxvexncrfg )
Positive
31 May 2023
Phase 1/2
13
rwukcyfzzk(gevqaatbqm) = 6.0 mg/kg ONC-392+ 200 mg of pembrolizumab Q3W urjmlujtpn (wldzbajbcc )
Positive
01 Nov 2022
Phase 1/2
32
utbipxtbcr(kaxuomfjxq) = rhovyvkglc vddenrakgr (oulxnznejn )
Positive
01 Nov 2022
Phase 1/2
10
ljvnupziej(uceahctrhp) = lophkzajtx jslnrazwwl (cudsmvkche )
Positive
11 Nov 2021
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

Identify the latest clinical trials across global registries.
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Approval

Accelerate your research with the latest regulatory approval information.
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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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