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drugsProductWithdrawn

Umbralisib

A PI3K inhibitor for marginal zone and follicular lymphoma approved in 2021 and withdrawn in 2022 after the UNITY-CLL trial suggested more deaths.

UNITY-NHL: response rates ~45-50% in relapsed MZL and FL (accelerated approval February 2021). UNITY-CLL (umbralisib-ublituximab) showed a possible overall-survival detriment; TG Therapeutics withdrew the drug in 2022 and the FDA revoked approval.

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Umbralisib
PubChem
Modality
Oral PI3Kδ / CK1ε inhibitor
Mechanism
PI3K delta inhibition with casein kinase 1 epsilon inhibition, intended to reduce immune-mediated toxicity of the class.
Brand / code
Ukoniq

Regulatory

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Approvals

RegionYearIndication
US2021Relapsed marginal zone lymphoma and follicular lymphomaWithdrawn 2022

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
24 studies0 recruiting23 Phase 23 Phase 3
Search “Umbralisib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Umbralisib
intervention: Umbralisib
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Umbralisib" OR ABSTRACT:"Umbralisib" OR TITLE:"Ukoniq" OR ABSTRACT:"Ukoniq") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Umbralisib, not a curated reading list.

Connected

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