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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.
    These indications are approved under accelerated approval based on overall response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • 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

DateArticle
Feb  5, 2021Approval  FDA Approves Ukoniq (umbralisib) for Marginal Zone Lymphoma and Follicular Lymphoma
Dec  1, 2020TG Therapeutics Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration for Ublituximab in Combination with Umbralisib as a Treatment for Patients with Chronic Lymphocytic Leukemia
Aug 13, 2020TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma and Follicular Lymphoma
May  5, 2020TG Therapeutics Announces Positive Topline Results from the UNITY-CLL Phase 3 Study Evaluating the Combination of Umbralisib and Ublituximab (U2) for the Treatment of Patients with Chronic Lymphocytic Leukemia
Mar  5, 2020TG Therapeutics Receives Orphan Drug Designation for Umbralisib from the U.S. Food and Drug Administration for the Treatment of Follicular Lymphoma
Jan 16, 2020TG Therapeutics Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma or Follicular Lymphoma
Oct 28, 2019TG Therapeutics Announces Positive Results from the UNITY-NHL Phase 2b Pivotal Trial Evaluating Umbralisib Monotherapy in Patients with Relapsed/Refractory Follicular Lymphoma
Jun 11, 2019TG Therapeutics Confirms Registration Path for Umbralisib in Marginal Zone Lymphoma Following FDA Meeting
Apr 15, 2019TG Therapeutics Receives Orphan Drug Designation for Umbralisib from the U.S. Food and Drug Administration for the Treatment of Marginal Zone Lymphoma

Further information

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