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Drugs in development · updated 30 October 2026

Balstilimab: clinical trials and development status

Other names and codes: AGEN2034

NLM verified identityNot approved in the USNo EMA authorisationEstimated launch Jul 2029 – May 2030 (Phuturdex estimate)

As of 30 October 2026 Balstilimab is in 33 active clinical trials (recruiting or ongoing, phases I–III) for 26 diseases. The most advanced phase is III.

33Active trials
IIIMost advanced phase
26Diseases studied

Summary updated every week · data as of 30 October 2026. In Phuturdex you can follow Balstilimab and get an email at every change or safety alert.

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Diseases studied

For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.

DiseaseMost advanced phaseActive trialsReference trial
Stomach neoplasmIII3NCT06346197
MetastasisIII2NCT06346197
Colorectal neoplasmII13NCT07551596
Pancreatic neoplasmII6NCT06843551
Rectal neoplasmII5NCT07595874
Colonic neoplasmII3NCT07595874
NeoplasmII2NCT06322108
Non-small-cell lung carcinomaII2NCT06322108
Prostatic NeoplasmsI–II2NCT06782555
AdenocarcinomaI–II1NCT06782932
CarcinomaI–II1NCT06782932
Esophageal neoplasmII1NCT06251973
Esophagus adenocarcinomaII1NCT06251973
GlioblastomaII1NCT05864534
GliosarcomaII1NCT05864534
Head and neck squamous cell carcinomaI–II1NCT06782555
LymphomaII1NCT05891821
Renal cell carcinomaII1NCT07516366
SarcomaII1NCT04028063
Triple-negative breast neoplasmI–II1NCT05318469
Diffuse Intrinsic Pontine GliomaI1NCT04943848
Endometrial neoplasmI1NCT03860272
Fibrolamellar hepatocellular carcinomaI1NCT03860272
GliomaI1NCT04943848
HemangiosarcomaI1NCT03860272
Ovarian neoplasmI1NCT03860272

Everything on Balstilimab

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Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 30 October 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, is a Phuturdex calculation described on the Method page, not official data.

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