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TG THERAPEUTICS

TG THERAPEUTICS logo
🇺🇸United States
Ownership
Public
Established
1993-01-01
Employees
264
Market Cap
$3.5B
Website
http://www.tgtherapeutics.com

Clinical Trials

58

Active:24
Completed:15

Trial Phases

4 Phases

Phase 1:37
Phase 2:10
Phase 3:7
+1 more phases

Drug Approvals

1

FDA:1

Drug Approvals

BRIUMVI

Approval Date
Jan 19, 2023
FDA

Clinical Trials

Distribution across different clinical trial phases (55 trials with phase data)• Click on a phase to view related trials

Phase 1
37 (67.3%)
Phase 2
10 (18.2%)
Phase 3
7 (12.7%)
Not Applicable
1 (1.8%)

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)

Not Applicable
Recruiting
Conditions
Relapsing Multiple Sclerosis
Interventions
First Posted Date
2025-10-08
Last Posted Date
2025-10-08
Lead Sponsor
TG Therapeutics, Inc.
Target Recruit Count
360
Registration Number
NCT07211633
Locations
🇺🇦

TG Therapeutics Investigational Trial Site, Vinnytsia, Ukraine

A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders

Phase 1
Recruiting
Conditions
B-cell Mediated Autoimmune Disorders
Interventions
Drug: Azercabtagene zapreleucel (azer-cel)
First Posted Date
2024-11-08
Last Posted Date
2025-09-10
Lead Sponsor
TG Therapeutics, Inc.
Target Recruit Count
32
Registration Number
NCT06680037
Locations
🇺🇸

TG Therapeutics Investigational Trial Site, Cleveland, Ohio, United States

A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)

Recruiting
Conditions
Multiple Sclerosis
First Posted Date
2024-05-30
Last Posted Date
2025-10-01
Lead Sponsor
TG Therapeutics, Inc.
Target Recruit Count
728
Registration Number
NCT06433765
Locations
🇺🇸

BRIUMVI® Pregnancy Registry Virtual Research Coordination Center, Wilmington, North Carolina, United States

A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)

Recruiting
Conditions
Relapsing Multiple Sclerosis
Multiple Sclerosis
First Posted Date
2024-05-30
Last Posted Date
2025-10-06
Lead Sponsor
TG Therapeutics, Inc.
Target Recruit Count
500
Registration Number
NCT06433752
Locations
🇵🇷

TG Therapeutics Investigational Trial Site, Guaynabo, Puerto Rico

A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk

Recruiting
Conditions
Relapsing Multiple Sclerosis
First Posted Date
2023-11-22
Last Posted Date
2025-10-06
Lead Sponsor
TG Therapeutics, Inc.
Target Recruit Count
16
Registration Number
NCT06143514
Locations
🇺🇸

PROVIDE Virtual Research Coordination Center, Wilmington, North Carolina, United States

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News

TG Therapeutics to Present Six-Year BRIUMVI Data at ECTRIMS 2025, Showcasing Long-Term Multiple Sclerosis Treatment Outcomes

TG Therapeutics will present six years of long-term efficacy and safety data for BRIUMVI (ublituximab-xiiy) from the ULTIMATE I and II open-label extension studies at the 2025 ECTRIMS meeting in Barcelona.

TG Therapeutics Reports 91% Revenue Surge Driven by BRIUMVI Multiple Sclerosis Treatment

TG Therapeutics reported a remarkable 91% year-over-year revenue increase in Q2 2025, primarily driven by strong sales of its multiple sclerosis treatment BRIUMVI.

TG Therapeutics Initiates Phase 3 Trial for Subcutaneous BRIUMVI in Multiple Sclerosis

TG Therapeutics has commenced enrollment in a Phase 3 trial evaluating subcutaneous BRIUMVI (ublituximab-xiiy) for relapsing forms of multiple sclerosis, marking a significant milestone in the company's subcutaneous development program.

Roche's High-Dose Ocrevus Fails Phase 3 Trial for Multiple Sclerosis, Boosting TG Therapeutics

Roche announced that its Phase 3 MUSETTE trial testing a high-dose version of Ocrevus (ocrelizumab) failed to show additional benefit in slowing disability progression in relapsing multiple sclerosis patients.

TG Therapeutics to Present New BRIUMVI Data in Multiple Sclerosis at ACTRIMS 2025 Forum

TG Therapeutics will showcase data from ULTIMATE I & II Phase 3 trials and ENHANCE Phase 3b trial evaluating BRIUMVI in relapsing multiple sclerosis at the upcoming ACTRIMS forum in Florida.

TG Therapeutics Partners with MaxCyte to Advance Novel CAR T-Cell Therapy for Progressive MS

• TG Therapeutics has secured access to MaxCyte's flow electroporation technology to develop azercabtagene zapreleucel, an off-the-shelf CAR T-cell therapy for progressive multiple sclerosis. • The Phase 1 clinical trial will evaluate azer-cel in up to 32 patients with progressive MS forms, focusing on determining optimal dosing and safety profiles. • This innovative therapy targets CD19-expressing B-cells using donor-derived T-cells, potentially reducing MS-driving autoantibodies while avoiding graft-versus-host disease complications.

TG Therapeutics' Briumvi Exceeds Expectations, Eyes Subcutaneous Formulation and Azer-Cel Trial in MS

TG Therapeutics announced that Briumvi's 2024 sales reached $310 million, surpassing initial expectations, driven by strong adoption in relapsing forms of multiple sclerosis (RMS).

Multiple Sclerosis Pipeline Shows Promise with Novel Therapies in Development

The multiple sclerosis (MS) therapeutic landscape is expanding, with over 80 active pipeline therapies currently in development by more than 75 companies.

FDA's Accelerated Approval Pathway Faces Scrutiny as Some Drugs are Withdrawn

Several drugs approved under the FDA's accelerated approval pathway have been withdrawn from the market due to safety concerns or failure to confirm clinical benefit.

BRIUMVI Rapid Infusion Shows Promise in Multiple Sclerosis Treatment

Phase 3b ENHANCE study reveals that 30-minute infusions of BRIUMVI (ublituximab-xiiy) are well-tolerated in patients with relapsing forms of multiple sclerosis (RMS).

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