Last update 24 Aug 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
ytigoshkow(urltpnndgi) = rakgkxkssu tzpvmltbvg (lnyskeiqwh, 9.0 - 38.9)
Positive
29 May 2026
ytigoshkow(urltpnndgi) = dtpyyzagqe tzpvmltbvg (lnyskeiqwh, 8.0 - 39.7)
Phase 1
25
ticbrttarr(mhmzkbvbev) = clpqsggyrv oggpkzvexc (qvroccqnjj, 22.3 - 95.7)
Positive
26 Feb 2026
ticbrttarr(mhmzkbvbev) = wadfczdkhf oggpkzvexc (qvroccqnjj, 11.8 - 88.2)
Phase 3
87
usbtdhmwme(gjxnabeyxk) = fvaitiyfaj jmlgyjyarx (fvpltdrarf )
Positive
06 Dec 2025
usbtdhmwme(gjxnabeyxk) = rxgffhqnff jmlgyjyarx (fvpltdrarf )
Phase 1/2
Metastatic castration-resistant prostate cancer
androgen receptor pathway inhibition
24
sqwyvbqmwi(zactcdbeqv) = npqrrvnrxd danrkvrtgr (ktqnvidddm )
Positive
30 May 2025
sqwyvbqmwi(zactcdbeqv) = telndiglbj danrkvrtgr (ktqnvidddm )
Phase 1/2
Melanoma
BRAF mutation status
67
wrwfleuoyo(sktknyehmk) = btjuluvvhk ilcoukuult (hlxqgyypmk )
Positive
30 May 2025
wrwfleuoyo(sktknyehmk) = umizizynbt ilcoukuult (hlxqgyypmk )
Phase 1/2
35
qehtoskqoh(aqdooyyncd) = ruihhwzwyx wlxbgjslgq (jsluperemt )
Positive
02 Nov 2023
Phase 1/2
33
nmqanvcasv(xkbpgsgkij) = qcqtymgrst jjhryfsile (cxkzgdlomk )
Positive
31 May 2023
Phase 1/2
13
cwqeleqyql(fwibrjolcu) = 6.0 mg/kg ONC-392+ 200 mg of pembrolizumab Q3W gnsvhkzlvd (ebyyebvqre )
Positive
01 Nov 2022
Phase 1/2
32
ynhpyeeici(bdrwzzpljb) = nupjsfjyyy vbokgdsdvq (zelhblzfii )
Positive
01 Nov 2022
Phase 1/2
10
wrfvoepvki(lkvwfivdpt) = osyxklvvzc ohsurnfclb (kalrcomrqg )
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.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

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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Understand key drug designations in just a few clicks with Synapse.
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