Ukoniq

(Umbralisib)

ApprovedSmall molecule

Umbralisib is used to treat certain types of blood cancers, specifically marginal zone lymphoma and chronic lymphocytic leukemia. It works by blocking proteins that help cancer cells grow and survive.[2] Ukoniq is currently approved and in use across 6 indications[4].[1]

Ukoniq is one of 114 small molecule programs targeting Diffuse Large B-Cell Lymphoma. It is currently in Approved.

Indications

Total Trials

Active Trials

113

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Diffuse Large B-Cell LymphomaApproved

Hodgkins LymphomaApproved

Marginal Zone B-Cell LymphomaActive, not recruiting

Mantle Cell LymphomaTerminated

Grade 1 Follicular LymphomaActive, not recruiting

RelapseActive, not recruiting

Diffuse Large B-Cell LymphomaApproved

Approved

Hodgkins LymphomaApproved

Approved

Marginal Zone B-Cell LymphomaApproved

Active, not recruiting

Mantle Cell LymphomaPhase 2

Terminated

Grade 1 Follicular LymphomaPhase 2

Active, not recruiting

RelapsePhase 2

Active, not recruiting

Competition

Competitive Landscape

109 competitors in Diffuse Large B-Cell Lymphoma

#DrugCompanyPhaseTrials

Ukoniq

TTG Therapeutics, Inc.

Approved

21 2

Adriamycin

Pfizer

Phase 3

38 3

Rituxan

Oncovin

33 5

Polivy

Roche

Phase 3

20 6

Gemzar

Johnson & Johnson

Phase 3

18 7

Adriamycin

Pfizer

Phase 3

18 8

Gazyva

Roche

Phase 3

18 9

Oncovin

Eli Lilly

Phase 3

18 10

Cytoxan

BBaxter Healthcare Corporation

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Grade 1 Follicular Lymphoma

NCT03269669

Q1 2028

Phase 2Active, not recruiting

Relapse

NCT04624633

Clinical

Trials by Indication[1]

Chronic Lymphocytic Leukemia3 trials

TGR-1202 (Umbralisib) in Treatment Naïve Patients With Chronic Lymphocytic Leukemia (CLL)

Terminated·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT04163718·12 enrolled

Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax

Terminated·TTG Therapeutics, Inc.·Phase 2·NCT04016805·41 enrolled

Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy

Terminated·TTG Therapeutics, Inc.·Phase 2·NCT02742090·51 enrolled

Lymphoma3 trials

Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma

Completed·UUniversity of Colorado, Denver·Phase 2·NCT04508647·4 enrolled

Umbralisib and Pembrolizumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Terminated·UUniversity of Washington·Phase 2·NCT03776864·6 enrolled

Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma

Completed·TTG Therapeutics, Inc.·Phase 2·NCT03364231·21 enrolled

Follicular Lymphoma3 trials

Tazemetostat in Combination With Umbralisib and Ublituximab for the Treatment Relapsed or Refractory Follicular Lymphoma

Withdrawn·—·Phase 1/2·NCT05152459

Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma

Terminated·TTG Therapeutics, Inc.·Phase 2·NCT03828448·34 enrolled

Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma

Terminated·MMassachusetts General Hospital·Phase 2·NCT03919175·18 enrolled

Mantle Cell Lymphoma3 trials

Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma

Withdrawn·YYazeed Sawalha·Phase 1·NCT04635683

Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL)

Terminated·UUniversity of Alabama at Birmingham·Phase 1/2·NCT04692155·1 enrolled

A Phase II Study of BTK Inhibitor Acalabrutinib and PI3Kδ Inhibitor Umbralisib in Combination With Ublituximab (AU2) in Patients With Previously Untreated Mantle Cell Lymphoma (MCL)

Active, not recruiting·CCity of Hope Medical Center·Phase 2·NCT04783415·12 enrolled

Efficacy and Safety1 trial

Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)

Terminated·TTG Therapeutics, Inc.·Phase 2/3·NCT03801525·277 enrolled

8 more indications

Tyrosine Kinase Inhibitor1 trial

Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies

Terminated·TTG Therapeutics, Inc.·Phase 1·NCT03671590·172 enrolled

Non-Hodgkins Lymphoma1 trial

Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma

Terminated·TTG Therapeutics, Inc.·Phase 2/3·NCT02793583·710 enrolled

Relapsed or Refractory1 trial

Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL

Terminated·TTG Therapeutics, Inc.·Phase 1/2·NCT03379051·78 enrolled

Richter's Transformation1 trial

Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

Completed·TTG Therapeutics, Inc.·Phase 1·NCT02535286·27 enrolled

CLL1 trial

Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy

Terminated·WWeill Medical College of Cornell University·Phase 2·NCT04149821·1 enrolled

Relapse1 trial

Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL

Active, not recruiting·—·Phase 2·NCT04624633·29 enrolled

Safety and Efficacy1 trial

A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304

Terminated·TTG Therapeutics, Inc.·Phase 2·NCT02656303·116 enrolled

Grade 1 Follicular Lymphoma1 trial

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03269669·73 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 5, 2021

UKONIQ

NDA NDA213176

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Umbralisib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ukoniq drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Umbralisib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Umbralisib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA213176). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Ukoniq. U.S. Food & Drug Administration.
[7]
SEC EDGAR — TG Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Casein Kinase I Epsilon Inhibitor; PI3-Kinase P110-Delta Subunit Inhibitor; Tyrosine-Protein Kinase ABL Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: TTG Therapeutics, Inc.

Patent Landscape[6]

Patent Cliff

Jul 2, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9150579Jul 2, 2033

9669033Jul 2, 2033

10981919Jul 2, 2033

10072013Jul 2, 2033

10570142Jul 2, 2033

3 more patents

9969740May 26, 2035

10947244May 26, 2035

10414773May 26, 2035

Ukoniq

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q1 2028

Trials by Indication[1]

Chronic Lymphocytic Leukemia3 trials

Lymphoma3 trials

Follicular Lymphoma3 trials

Mantle Cell Lymphoma3 trials

Efficacy and Safety1 trial

Tyrosine Kinase Inhibitor1 trial

Non-Hodgkins Lymphoma1 trial

Relapsed or Refractory1 trial

Richter's Transformation1 trial

CLL1 trial

Relapse1 trial

Safety and Efficacy1 trial

Grade 1 Follicular Lymphoma1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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