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Drugs in development · updated 30 October 2026

Monalizumab: clinical trials and development status

NLM verified identityNot approved in the USNo EMA authorisationEstimated launch Dec 2027 – Oct 2028 (Phuturdex estimate)

As of 30 October 2026 Monalizumab is in 9 active clinical trials (recruiting or ongoing, phases I–III) for 10 diseases. The most advanced phase is III.

9Active trials
IIIMost advanced phase
10Diseases studied

Summary updated every week · data as of 30 October 2026. In Phuturdex you can follow Monalizumab 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
Non-small-cell lung carcinomaIII3NCT05221840
Head and neck neoplasmsIII1NCT04590963
Head and neck squamous cell carcinomaIII1NCT04590963
Laryngeal diseaseIII1NCT04590963
Lung small cell carcinomaII2NCT05903092
Acute myeloid leukemiaII1NCT06892223
Lung neoplasmII1NCT05061550
MetastasisI–II1NCT02671435
Myeloproliferative disordersII1NCT06892223
Non-muscle invasive bladder neoplasmII1NCT06503614

Everything on Monalizumab

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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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