Zero ad trackers.We never sell your data.

TG Therapeutics

TG Therapeutics works on 4 rare diseases tracked on Trial Friend, including Gastrointestinal Stromal Tumor, Hodgkin Lymphoma, Multiple Sclerosis and 1 more, with 12 active clinical trials (9 recruiting) and 1 FDA-approved rare disease drug.

TG Therapeutics is a biotechnology company built around a single antibody, ublituximab, that it has been developing since 2012. The company took shape when a small private startup holding a license to the antibody merged into a public shell, Manhattan Pharmaceuticals, and took the TG Therapeutics name that year under founder and CEO Michael Weiss. For most of its first decade TG was a cancer company, and that chapter ended badly: in 2022 it withdrew its approved lymphoma pill Ukoniq (umbralisib) from the market and pulled a pending application in chronic lymphocytic leukemia after a large trial showed a survival imbalance. TG then bet everything on multiple sclerosis, moved its headquarters from New York to Morrisville, North Carolina, and today trades on Nasdaq under the ticker TGTX.

The bet paid off. BRIUMVI (ublituximab-xiiy) was approved by the FDA on December 28, 2022 for relapsing forms of multiple sclerosis. It works by depleting B cells, the immune cells that drive much of the inflammation in MS, through a marker on their surface called CD20, and its main practical advantage over older B cell therapies is speed: after the first two starter doses, maintenance treatment is a one-hour infusion every six months. Sales have grown quickly, reaching $594 million in the U.S. in 2025, and TG expects roughly $890 to $905 million in 2026. Neuraxpharm sells the drug in Europe, where it was approved in June 2023. In May 2026 the Phase 3 ENHANCE study showed that a single 600 mg infusion on day one delivers the same drug exposure as the current two-step start, and a Phase 3 trial of a subcutaneous injection version, designed for dosing every two or three months, is fully enrolled with results expected around the end of 2026 or early 2027. A Phase 2/3 study in children ages 10 to 17 with relapsing MS began in July 2026.

For the rare disease community, the program to watch is myasthenia gravis. In June 2026 TG reported that 9 of 11 patients with anti-AChR antibody-positive myasthenia gravis in an early study of subcutaneous BRIUMVI reached a clinically meaningful improvement in daily-living symptoms at 24 weeks, and in July 2026 it started a randomized, placebo-controlled Phase 2 trial (NCT07673744) that the company describes as potentially registration-directed. The design is unusual: every patient first receives a round of efgartigimod, an approved FcRn blocker that lowers antibody levels quickly, and those who respond are then randomized to BRIUMVI or placebo to see which group stays well longer. Results are expected in 2028. TG is also testing BRIUMVI in treatment-resistant schizophrenia and, through a license with Precision BioSciences, an off-the-shelf CD19 CAR-T cell therapy called azer-cel in progressive multiple sclerosis and other B cell autoimmune diseases, with the first data expected in the second half of 2026.

Type
Diversified Pharma
Ticker
TGTX
Headquarters
Morrisville, United States
Founded
2012
12
Active Rare Disease Trials
1
Approved Rare Disease Drugs
4
Rare Diseases in Portfolio
14
Years Active

TG Therapeutics Drug Pipeline

TG Therapeutics has 12 active clinical trials across 4 development stages, with 9 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline counts the active and recruiting trials listed on this page, from ClinicalTrials.gov. For companies that work outside rare disease, we list only trials for rare diseases we track, so the company's full pipeline may be larger.

Understand TG Therapeutics's pipeline
Answers with sources, in plain English
Start withor ask
2
Phase 22 trials
4
Phase 34 trials
2
Phase 4 / Post-Market2 trials
Recruiting
4
Other4 trials

TG Therapeutics Clinical Trials (12)

Active and recruiting clinical trials sponsored by TG Therapeutics, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

Ask about TG Therapeutics's trials
Answers with sources, in plain English
Start withor ask
RECRUITINGRecently updatedNCT06433752

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

Intervention: No Intervention

The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting

Ages 18 Years+111 locations
View full study
RECRUITINGPHASE2Recently updatedNCT07673744

A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)

Intervention: Ublituximab, Placebo

The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.

Ages 18 Years+6 locations
View full study
RECRUITINGPHASE2, PHASE3Recently updatedNCT07220252

Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis

Intervention: Ublituximab, Placebo, Placebo, Fingolimod

The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (\<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of ublituximab compared with fingolimod in pediatric RMS participants with body weight ≥ 25 kg (Part B). The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part C).

Ages 10 Years - 17 Years3 locations
View full study
RECRUITINGPHASE2Recently updatedNCT07503873

A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)

Intervention: Ublituximab, Ublituximab, Prefilled pen

The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with a prefilled pen versus syringe.

Ages 18 Years - 65 Years39 locations
View full study
RECRUITINGPHASE3Recently updatedNCT05877963

Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab

Intervention: Ublituximab, Placebo

The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.

Ages 18 Years - 65 Years51 locations
View full study
RECRUITINGRecently updatedNCT06433765

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

Intervention: No intervention

The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.

Ages 15 Years - 50 Years1 location
View full study
RECRUITINGNARecently updatedNCT06864936

Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis

Intervention: Ublituximab, Other disease modifying therapies

The purpose of the research study is to explore new retinal imaging biomarkers of immune cell activity in MS during use of ublituximab (Briumvi) treatment. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. This study will evaluate the efficacy of ublituximab to modulate MS pathology in a new manner. In order to assess this new biomarker, a specialized optical coherence tomography (OCT) scan will be performed at enrollment into the study and at 2 other timepoints throughout the study. Subjects asked to take part in this study should have been diagnosed with relapsing multiple sclerosis (MS) and have recently been advised to start the medication ublituximab (Briumvi) or are currently on another medication for the treatment of their MS. We plan to enroll 30 patients into this study. Fifteen (15) patients with Relapsing Remitting Multiple Sclerosis (RRMS) who are being initiated on B-cell depletion therapy by their treating physician at the University of Maryland Center for MS Treatment and Research will be offered enrollment into this study. Additionally, 15 age/sex matched patients with stable RRMS who are not undergoing any change in treatment and are not currently on B-cell depleting therapies will be enrolled as control subjects.

Ages 18 Years - 65 Years1 location
View full study
Follow a condition TG Therapeutics is studying

Pick a condition. One email when a new trial opens, a trial changes or the FDA decides, from any company, not only TG Therapeutics. Unsubscribe anytime.

You'll get new recruiting trials, changes to trials, FDA decisions and condition news for Gastrointestinal Stromal Tumor. Turn any of these off from the link in every email.

We never share your email. Unsubscribe anytime. Privacy policy · Check any health site

TG Therapeutics FDA-Approved Drugs (1)

Medications developed or marketed by TG Therapeutics that have received U.S. Food and Drug Administration approval. Drug data is sourced from the openFDA database and includes brand names, generic names, approval dates, and matched rare disease indications. Where a drug treats a condition covered by Trial Friend, the disease name links directly to that disease page.

Drug NameBrand NameRare DiseasesApproval Date
UBLITUXIMAB
CD20-directed Cytolytic Antibody [EPC]
BRIUMVI
intravenous
Dec 28, 2022

TG Therapeutics Trial Locations

TG Therapeutics clinical trials are running at 353 sites in 15 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

United States
184▼
Ukraine
52▼
Poland
29▼
Russia
22▼
Georgia
18▼
Bosnia and Herzegovina
9▼
Serbia
6▼
Czechia
6▼
Hungary
6▼
Belarus
5▼
Croatia
5▼
Bulgaria
5▼

Rare Disease Focus Areas (4)

Diseases targeted by TG Therapeutics's clinical trial and drug development programs

Patient Resources

Organizations and resources related to TG Therapeutics's rare disease focus areas

Frequently Asked Questions About TG Therapeutics

Common questions about TG Therapeutics's rare disease programs, clinical trials, and treatments.