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TG Therapeutics (TGTX)
NASDAQ:TGTX
Ublituximab, Fingolimod
Relapsing Multiple Sclerosis
Phase II/III
Not Yet Recruiting
Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
Oct 22, 2025
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Ublituximab
Relapsing Multiple Sclerosis
Phase III
Recruiting
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
Oct 01, 2025
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Azercabtagene Zapreleucel (Azer-Cel)
B-Cell Mediated Autoimmune Disorders
Phase I
Recruiting
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
Nov 01, 2024
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Ublituximab
Relapsing Multiple Sclerosis
Phase III
Recruiting
Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
May 18, 2023
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Ublituximab
Relapsing Multiple Sclerosis (Rms)
Phase III
Active Not Recruiting
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Oct 16, 2019
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Obinutuzumab, Chlorambucil, Ublituximab, Tgr-1202
Chronic Lymphocytic Leukemia
Phase III
Terminated
Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia
Nov 18, 2015
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does TG Therapeutics (TGTX) have in its pipeline
TGTX is currently developing the following drugs: Ublituximab, Fingolimod, Ublituximab, Azercabtagene Zapreleucel (Azer-Cel). These drug candidates are in various stages of clinical development as the company works toward FDA approval.