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Ublituximab (TG-1101) is an infusion being developed for relapsing MS by TG Therapeutics

Current phase of trial:
Phase 3
Type of MS:
Relapsing MS

Find out more about ublituximab

How does ublituximab work?

• Ublituximab is an antibody, just like those found in the immune system (where antibodies help fight infection)

• It is allso being tested in phase 3 trials for cancer, including leukaemia and lymphoma

• Ublituximab works in a similar way to Ocrevus (ocrelizumab), binding to the surface of a type of immune cell (called a B cell) and reducing their numbers. These cells are thought to be one of the immune cells that attacks myelin in MS.

How is ublituximab taken?

Ublituximab is given as an infusion.

In a phase 2 trial, ublituximab was given as an infusion at Day 1, 15 and then after that every 6 months.

Latest research

ULTIMATE 1 and ULTIMATE 2

• These phase 3 trials found ublituximab reduced relapses and new or growing brain lesions on MRI scans significantly more than the licensed treatment Aubagio (teriflunomide).

• The two identical trials involved 1094 people with relapsing MS in 10 countries. 

Earlier research

Phase 2 trial A small trial of 40 people due to finish in November 2018. It’s testing whether different doses of ublituximab (150 – 600 mg) can reduce B cell numbers in people with relapsing MS. It is also looking to see whether ublituximab can reduce the number of relapses people have.

In February 2018, preliminary results from this trial were announced at ACTRIMS. At week 4, ublituximab nearly wiped out B cells, with only 1% remaining. This was sustained at week 24. Ublituximab also completely suppressed the development of new MRI lesions, and 97.5% of people taking the treatment were relapse free at week 24.

What are the side effects of ublituximab?

Ublituximab has not been widely tested in people with MS. In the phase 2 trial, ublituximab was reported to be well-tolerated after 24 weeks. The most common side effect reported was a reaction to the infusion .

How does ublituximab compare with current therapies?

Two phase 3 trials found ublituximab reduced relapses and new or growing brain lesions on MRI scans more than the licensed treatment Aubagio (teriflunomide).

But we don't yet know how it compares to other therapies.

When is ublituximab likely to become available?

The treatment will now be reviewed by the Medicines and Healthcare products Regulatory Agency in the UK (MHRA). Once licensed by the MHRA, The National Institute for Health and Care Excellence (NICE) will decide if the drug should be available on the NHS in England and Wales. The Scottish Medicines Consortium (SMC) does this for NHS Scotland.