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MS patients may soon get a shot instead of an IV drip

NCT ID NCT07211633

Disease control Sponsor: TG Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether a shot (subcutaneous) of ublituximab works as well as the standard IV infusion for people with relapsing multiple sclerosis. About 360 participants are enrolled. The main goal is to compare drug levels in the blood over 24 weeks, along with safety and disease activity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ublituximab
What this could lead to
If successful, this could offer a more convenient injection option for people with multiple sclerosis, potentially replacing the need for IV infusions.
What could go wrong
This is a non-inferiority study, meaning it only aims to show the injection works as well as the IV, not better. The trial is still ongoing, and results may not confirm equivalence or could reveal safety differences.
Why investors are watching

TG Therapeutics is running a phase 3 trial to see if its multiple sclerosis drug ublituximab works just as well when injected under the skin as when given through an IV. For a small company, this readout matters because a subcutaneous version could make the drug easier for patients to use, which may widen its appeal and support the drug's commercial future.

If it works: If the trial shows the subcutaneous injection matches the IV version in controlling the disease, TG Therapeutics could offer a more convenient treatment option. That result might strengthen the drug's position in the market and give the company a stronger product to sell.

If it fails: If the trial fails to show the subcutaneous version is as effective, or if safety problems appear, the company would face a setback in its plans for this drug. Clinical trials often fail, so investors should treat a negative outcome as a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of RMS (2017 Revised McDonald criteria). 2. Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening. 3. Neurologically stable for \> 30 days prior to Screening and Day 1. 4. Female participants of childbearing potential must consent to use a highly effective method of contraception from consent and for 6 months after the last dose of ublituximab. Exclusion Criteria: 1. Primary-progressive Multiple Sclerosis (PPMS) or inactive Secondary Progressive Multiple Sclerosis (SPMS). 2. Active chronic disease of the immune system other than MS or immunodeficiency syndrome. 3. Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia. 4. Participants who previously received anti-CD20 therapy at any time; any approved therapy to treat MS within 5 half-lives of the medication prior to screening. Note: Other Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsing multiple sclerosis

Contacts and locations

Locations

  • TG Therapeutics Investigational Trial Site

    Banja Luka, 78000, Bosnia and Herzegovina

  • TG Therapeutics Investigational Trial Site

    Bihać, 77000, Bosnia and Herzegovina

  • TG Therapeutics Investigational Trial Site

    Mostar, 71000, Bosnia and Herzegovina

  • TG Therapeutics Investigational Trial Site

    Saravejo, 71000, Bosnia and Herzegovina

  • TG Therapeutics Investigational Trial Site

    Tulza, 75000, Bosnia and Herzegovina

  • TG Therapeutics Investigational Trial Site

    Pleven, 5800, Bulgaria

  • TG Therapeutics Investigational Trial Site

    Plovdiv, 4000, Bulgaria

  • TG Therapeutics Investigational Trial Site

    Sofia, 1000, Bulgaria

  • TG Therapeutics Investigational Trial Site

    Sofia, 1113, Bulgaria

  • TG Therapeutics Investigational Trial Site

    Veliko Tarnovo, 5000, Bulgaria

  • TG Therapeutics Investigational Trial Site

    Varaždin, 42000, Croatia

  • TG Therapeutics Investigational Trial Site

    Zagreb, 10000, Croatia

  • TG Therapeutics Investigational Trial Site

    Brno, 65691, Czechia

  • TG Therapeutics Investigational Trial Site

    Hradec Králové, 50005, Czechia

  • TG Therapeutics Investigational Trial Site

    Jihlava, 58601, Czechia

  • TG Therapeutics Investigational Trial Site

    Ostrava, 70300, Czechia

  • TG Therapeutics Investigational Trial Site

    Pardubice, 53002, Czechia

  • TG Therapeutics Investigational Trial Site

    Zlín, 76275, Czechia

  • TG Therapeutics Investigational Trial Site

    Tbilisi, 0112, Georgia

  • TG Therapeutics Investigational Trial Site

    Tbilisi, 0114, Georgia

  • TG Therapeutics Investigational Trial Site

    Tbilisi, 0159, Georgia

  • TG Therapeutics Investigational Trial Site

    Tbilisi, 0172, Georgia

  • TG Therapeutics Investigational Trial Site

    Tbilisi, 0178, Georgia

  • TG Therapeutics Investigational Trial Site

    Tbilisi, 0179, Georgia

  • TG Therapeutics Investigational Trial Site

    Tbilisi, 0180, Georgia

  • TG Therapeutics Investigational Trial Site

    Tbilisi, 3700, Georgia

  • TG Therapeutics Investigational Trial Site

    Budapest, H-1033, Hungary

  • TG Therapeutics Investigational Trial Site

    Budapest, H-1044, Hungary

  • TG Therapeutics Investigational Trial Site

    Budapest, H-1145, Hungary

  • TG Therapeutics Investigational Trial Site

    Kaposvár, H-7400, Hungary

  • TG Therapeutics Investigational Trial Site

    Kistarsca, H-2143, Hungary

  • TG Therapeutics Investigational Trial Site

    Pécs, H-7623, Hungary

  • TG Therapeutics Investigational Trial Site

    Shtip, 7240, North Macedonia

  • TG Therapeutics Investigational Trial Site

    Skopje, 1000, North Macedonia

  • TG Therapeutics Investigational Trial Site

    Kragujevac, 34 000, Serbia

  • TG Therapeutics Investigational Trial Site

    Niš, 18000, Serbia

  • TG Therapeutics Investigational Trial Site

    Cherkasy, 14029, Ukraine

  • TG Therapeutics Investigational Trial Site

    Ivano-Frankivsk, 76000, Ukraine

  • TG Therapeutics Investigational Trial Site

    Ivano-Frankivsk, 76018, Ukraine

  • TG Therapeutics Investigational Trial Site

    Ivano-Frankivsk, 76493, Ukraine

  • TG Therapeutics Investigational Trial Site

    Kyiv, 03037, Ukraine

  • TG Therapeutics Investigational Trial Site

    Kyiv, 03115, Ukraine

  • TG Therapeutics Investigational Trial Site

    Lviv, 79000, Ukraine

  • TG Therapeutics Investigational Trial Site

    Lviv, 79010, Ukraine

  • TG Therapeutics Investigational Trial Site

    Lviv, 79029, Ukraine

  • TG Therapeutics Investigational Trial Site

    Ternopil, 46027, Ukraine

  • TG Therapeutics Investigational Trial Site

    Vinnytsia, 21002, Ukraine

  • TG Therapeutics Investigational Trial Site

    Vinnytsia, 21009, Ukraine

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