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MS drug delivery showdown: belly vs. thigh, pen vs. syringe

NCT ID NCT07503873

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 5 times

Summary

This study tests a drug called ublituximab, given as a shot under the skin, in 350 people with relapsing multiple sclerosis. Researchers want to see how the drug moves through the body when injected in different spots (like the belly or thigh) and whether an autoinjector pen works as well as a regular syringe. The goal is to find the safest and most convenient way to give the medicine.

Why investors are watching

TG Therapeutics is testing whether its multiple sclerosis drug ublituximab can be given as a shot under the skin using a prefilled pen instead of a syringe. This matters because a pen could make the drug easier for patients to use at home, which could broaden its appeal. For a small company, this phase 2 study is a key step in expanding the drug's value beyond its current use.

If it works: If the study shows the pen delivers the drug as effectively as a syringe and is safe, TG Therapeutics could have a more convenient product option. That could help the company compete for patients who prefer an easier injection method.

If it fails: The trial could fail to show the pen works as well as a syringe, or the drug could cause safety problems at different injection sites. Trials often fail, and a poor result could set back the company's plans for this delivery method.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 350 people

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

Started

Apr 2026

Expected to finish

May 2029

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 relapsing multiple sclerosis (RMS) (2017 Revised McDonald criteria). 2. Expanded Disability Status Scale (EDSS) score less than or equal to (≤) 5.5 at screening. 3. Neurologically stable for more than (\>) 30 days prior to screening and Day 1. 4. Female participants of childbearing potential must consent to use an 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 received any approved therapy to treat MS within 5 half-lives of the medication prior to screening. 5. Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening. 6. Females who are pregnant or nursing. Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

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

Multiple sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    39 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Bihać, 77000, Bosnia and Herzegovina

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Sarajevo, 71000, Bosnia and Herzegovina

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Tuzla, 75000, Bosnia and Herzegovina

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Zenica, 72000, Bosnia and Herzegovina

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Tbilisi, 101, Georgia

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Tbilisi, 114, Georgia

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Tbilisi, 159, Georgia

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Tbilisi, 179, Georgia

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Shtip, 2000, North Macedonia

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Skopje, 1000, North Macedonia

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Bydgoszcz, 85-796, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Katowice, 40-568, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Katowice, 40-686, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Kielce, 25-726, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Lodz, 90-324, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Poznan, 61-853, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Warsaw, 04-141, Poland

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Belgrade, 11000, Serbia

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Kragujevac, 34 000, Serbia

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Chernihiv, 14001, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Chernihiv, 14029, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Ivano-Frankivsk, 76008, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Ivano-Frankivsk, 76018, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Ivano-Frankivsk, 76493, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Kyiv, 2000, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Kyiv, 2091, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Kyiv, 3037, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Kyiv, 3110, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Kyiv, 4050, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Kyiv, 4211, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Lviv, 79010, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Lviv, 79029, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Odesa, 65009, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Poltava, 36011, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Tbilisi, 159, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Ternopil, 46014, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Uzhhorod, 88018, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Vinnytsia, 21001, Ukraine

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Vinnytsia, 21009, Ukraine

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