Drug Profile

Umbralisib - TG Therapeutics

Alternative Names: RP 5307; RP-5264; TGR-1202; UKONIQ

Latest Information Update: 12 Feb 2025

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At a glance

Originator Incozen Therapeutics; Rhizen Pharmaceuticals
Developer TG Therapeutics Inc; Vanderbilt-Ingram Cancer Center
Class Amines; Antineoplastics; Benzopyrans; Fluorinated hydrocarbons; Ketones; Pyrazoles; Pyrimidines; Small molecules
Mechanism of Action Casein kinase 1 epsilon inhibitors; Phosphatidylinositol 3 kinase delta inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Diffuse large B cell lymphoma; Chronic lymphocytic leukaemia; Marginal zone B-cell lymphoma; Follicular lymphoma
New Molecular Entity Yes

Phase III Chronic lymphocytic leukaemia
Phase II/III Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma
Phase II Hodgkin's disease; Waldenstrom's macroglobulinaemia
Phase I/II Non-Hodgkin's lymphoma
No development reported Multiple sclerosis; Myelofibrosis; Polycythaemia vera; Richter's syndrome; Solid tumours

12 Feb 2025 Efficacy and adverse events data from the phase II trial in Mantle cell lymphoma presented at the 66^th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2024)
28 Jul 2024 No recent reports of development identified for phase-I development in Polycythaemia-vera(Combination therapy) in USA (PO)
03 Jul 2024 TG Therapeutics terminates phase II trial in Chronic lymphocytic leukaemia (Monotherapy, Second-line therapy or greater) in USA (PO) due to strategic/business decision (NCT02742090)

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