Ukoniq FDA Approval History
FDA Approved: Yes (First approved February 5, 2021)
Brand name: Ukoniq
Generic name: umbralisib
Dosage form: Tablets
Company: TG Therapeutics, Inc.
Treatment for: Marginal Zone Lymphoma; Follicular Lymphoma
Ukoniq (umbralisib) is a dual inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon for the treatment of marginal zone lymphoma (MZL) and follicular Lymphoma (FL).
- Ukoniq is indicated for the treatment of adults with:
- Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen.
- Relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.
- Ukoniq tablets are taken once daily with food.
- Ukoniq may cause serious side effects including infections, neutropenia, diarrhea or non-infectious colitis, hepatotoxicity, severe cutaneous reactions, allergic reactions (due to the inactive ingredient tartrazine), and embryo-fetal toxicity.
- Common adverse reactions include increased creatinine, diarrhea-colitis, fatigue, nausea, neutropenia, transaminase elevation, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite, and rash.
Development Timeline for Ukoniq
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