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Drugs in development · updated 30 October 2026

Fianlimab: clinical trials and development status

Other names and codes: REGN3767

FDA substance registryNot approved in the USNo EMA authorisationEstimated launch Dec 2027 – Oct 2028 (Phuturdex estimate)

As of 30 October 2026 Fianlimab is in 34 active clinical trials (recruiting or ongoing, phases I–III) for 30 diseases. The most advanced phase is III.

34Active trials
IIIMost advanced phase
30Diseases studied

Summary updated every week · data as of 30 October 2026. In Phuturdex you can follow Fianlimab 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
MelanomaIII8NCT06246916
Non-small-cell lung carcinomaII–III3NCT05800015
Skin neoplasmIII3NCT05608291
Lung neoplasmII–III2NCT05800015
MetastasisIII1NCT05352672
Renal cell carcinomaII3NCT07188896
AdenocarcinomaII2NCT07281768
CarcinomaII2NCT07281768
Colonic neoplasmII2NCT07058012
Colorectal neoplasmII2NCT07281768
Fallopian tube neoplasmII2NCT06787612
Ovarian neoplasmII2NCT06787612
Basal-cell carcinoma of the skinII1NCT07808515
Bladder neoplasmII1NCT06571708
Brain NeoplasmsII1NCT06887088
Breast neoplasmII1NCT01042379
Endometrial neoplasmI–II1NCT04590326
Head and neck neoplasmsII1NCT07179315
Head and neck squamous cell carcinomaII1NCT03916627
HemangiosarcomaII1NCT01042379
Hepatocellular carcinomaII1NCT03916627
Malignant mesotheliomaII1NCT07234058
NeoplasmII1NCT01042379
Prostatic NeoplasmsI–II1NCT04989946
Rectal neoplasmII1NCT07281768
Squamous cell carcinomaII1NCT07346196
Triple-negative breast neoplasmII1NCT01042379
Multiple myelomaI1NCT05137054
Nasopharyngeal CarcinomaI1NCT07650266
Nasopharyngeal neoplasmI1NCT07650266

Everything on Fianlimab

In Phuturdex you get every trial with sponsors, countries and dates, development events, FDA and EMA approvals, patents and exclusivities, orphan designations and safety alerts, with PDF and Excel export. Free until 31 March 2027.

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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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