Briumvi (ublituximab)
An approved treatment for Multiple Sclerosis.
The same compound appears under different names depending on the context. Here is how to identify Ublituximab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Ublituximab
- Brand name
- Briumvi
- Development code
- TG1101
- Drug class
- Anti-CD20 monoclonal antibody (B-cell depleting)
- Manufacturer
- TG Therapeutics
- How it's taken
- Given as an IV infusion under the supervision of an experienced healthcare professional.
An anti-CD20 antibody infusion approved by the FDA on December 28, 2022 for adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive MS. After 2 starting doses 2 weeks apart, it is given as a 1-hour IV infusion every 24 weeks. In 2 trials against the oral MS drug teriflunomide, it lowered the yearly relapse rate by 59% and 49%.
Where Ublituximab fits
One of the anti-CD20 antibodies used for relapsing MS, alongside ocrelizumab (Ocrevus) and ofatumumab (Kesimpta). TG Therapeutics describes it as the only anti-CD20 MS treatment given as a 1-hour infusion twice a year after the starting doses. It has not been compared head-to-head with the other anti-CD20 drugs.
How Ublituximab works
B cells are white blood cells that make antibodies and help steer other immune cells. Ublituximab attaches to CD20, a marker on the surface of most B cells, and the immune system then destroys the marked cells. The label says exactly how this helps in MS is unknown, but it is presumed to work by removing B cells that feed the immune attack on myelin, the protective coating around nerves. TG Therapeutics describes the antibody as glycoengineered, meaning some sugar molecules normally found on antibodies were removed, which the company says lets it deplete B cells efficiently at low doses. B-cell counts drop within 24 hours of an infusion, and after the last dose they took a median of about 70 weeks to return to normal or starting levels in the trials.
Mechanism: Glycoengineered anti-CD20 monoclonal antibody that attaches to B cells and triggers their destruction, depleting the B cells presumed to drive inflammation in multiple sclerosis
Side effects and safety
- Infusion reactions. Seen in 48% of trial patients, mostly within 24 hours of the first infusion. Premedication is given before every infusion, and patients are watched for at least 1 hour after the first 2 infusions. Reactions can happen up to 24 hours later.
- Infections, including hepatitis B reactivation and PML. Serious infections were more common than on teriflunomide (5% against 3%). Hepatitis B screening is required before starting, infusions are delayed during an active infection, and new weakness, vision changes or confusion should be reported right away.
- Low antibody (immunoglobulin) levels. Immunoglobulin levels are checked before, during and after treatment. Stopping may be considered with serious or repeated infections.
- Liver injury. Reported after approval with anti-CD20 MS drugs, including Briumvi. Liver tests before starting and during treatment as needed; report yellow skin or eyes, dark urine, nausea or unusual tiredness.
- Harm to an unborn baby. Effective birth control during treatment and for 6 months after the last dose. Babies exposed in the womb should not get live vaccines until their B cells recover.
- Hepatitis B screening before the first dose
- Immunoglobulin levels before starting, during treatment and after stopping until B cells recover
- Liver tests (ALT, AST, alkaline phosphatase, bilirubin) before starting and as needed
- Check for active infection before every infusion
- Live vaccines at least 4 weeks before starting; none during treatment until B cells recover
Briumvi has no boxed warning. It must not be given to people with active hepatitis B or anyone who has had a life-threatening infusion reaction to it. In the 2 main trials, which compared it with teriflunomide rather than placebo, the most common side effects on Briumvi against teriflunomide were infusion reactions (48% against 12%), upper respiratory infections (45% against 41%), lower respiratory infections (9% against 7%), herpes virus infections (6% against 5%), pain in the arms or legs (6% against 4%), insomnia (6% against 3%) and fatigue (5% against 4%). Infusion reactions such as fever, chills, headache and flu-like symptoms were most common with the first infusion (43%) and fell to 10% with the second and 8% with the third; 0.6% were serious. Serious infections occurred in 5% against 3%, and 3 infection-related deaths in the trials all occurred on Briumvi. The label also warns about hepatitis B coming back, PML (a rare, serious brain infection), low antibody levels (IgM fell below normal in about 21% of patients by week 96), liver injury reported after approval, and possible harm to an unborn baby, so women who could become pregnant should use effective birth control during treatment and for 6 months after the last dose[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Ublituximab
Given as an IV infusion under the supervision of an experienced healthcare professional. The first dose is 150 mg over 4 hours, the second is 450 mg over 1 hour given 2 weeks later, and after that each dose is 450 mg over 1 hour every 24 weeks, counted from the first infusion. Before every infusion, patients receive 100 mg of IV methylprednisolone (a steroid) or an equivalent about 30 minutes ahead and an antihistamine such as diphenhydramine 30 to 60 minutes ahead, and acetaminophen may be added. Patients are watched for at least 1 hour after the first 2 infusions. Before the first dose, the care team screens for hepatitis B and checks immunoglobulin levels and liver tests, and any live vaccines should be given at least 4 weeks ahead. Infusions must be at least 5 months apart[1]. TG Therapeutics reported in 2026 that its Phase 3 ENHANCE trial showed a single 600 mg starting infusion gives the same drug exposure as the current 2-dose start; that simpler schedule is not in the label as of September 2026[7].
Availability and cost
Only available as the brand-name product.
Help paying for Briumvi
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
BRIUMVI Copay Assistance Program: eligible patients 18 and older with commercial insurance may pay as little as $0 copay per Briumvi treatment, up to an annual maximum of $20,000. Other eligibility requirements and full terms apply.
For: private insurance · source - Other support
Infusion and administration costs: eligible commercially insured patients with out-of-pocket infusion costs may be covered up to $550 for the first infusion and up to $350 per infusion after that, through the same copay program.
For: private insurance · source - Other support
BRIUMVI Patient Assistance Program for people who are uninsured or underinsured and meet certain financial eligibility criteria. Ask a BRIUMVI Patient Support case manager for details; income limits and what the program provides are not published on the page.
For: no insurance, underinsured · source - Insurance and case manager help
BRIUMVI Patient Support case managers answer questions and support the treatment journey. Call 1-833-BRIUMVI (1-833-274-8684), Monday to Friday, 8 AM to 8 PM ET. The page also points patients who do not qualify for TG programs to independent charitable foundations.
The official page does not say who qualifies. Ask the program. · source
Good to know: Phone is 1-833-BRIUMVI. Copay program is for commercially insured adults only. The page does not say what the Patient Assistance Program provides, so it is listed as 'other' rather than 'free-drug'. Full copay terms PDF: https://briumvi.com/wp-content/uploads/2024/02/US-UBL-2200076v3_BRIUMVI-Copay-Assistance-Program-Full-Copay-Terms-Conditions_13Feb2024.pdf (not read).
- From a charity · TotalAssist (formerly PAN Foundation)Multiple Sclerosis fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $8,000 per year. Requires Medicare, Medicaid or TRICARE.
- From a charity · The Assistance FundMultiple Sclerosis fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
Access and eligibility
Approved for adults with relapsing forms of MS: clinically isolated syndrome, relapsing-remitting MS and active secondary progressive MS. It is not approved for primary progressive MS, and safety and effectiveness in children have not been established. People with active hepatitis B cannot receive it. The trials enrolled adults with an EDSS disability score of 0 to 5.5 who had a recent relapse or an active lesion on MRI.
Source: Briumvi financial assistance
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
ULTIMATE I (NCT03277261) and ULTIMATE II (NCT03277248) were 2 identical 96-week trials that compared Briumvi with teriflunomide (Aubagio), a daily MS pill, in 1,094 adults with relapsing MS. Each patient also got a dummy version of the other drug, so no one knew who was on which. The yearly relapse rate was 0.076 on Briumvi against 0.188 on teriflunomide in ULTIMATE I (59% lower) and 0.091 against 0.178 in ULTIMATE II (49% lower). Briumvi also sharply reduced active inflammation on MRI, with 97% fewer gadolinium-enhancing lesions and 90% to 92% fewer new or enlarging T2 lesions in each trial. Disability worsening confirmed at 12 weeks occurred in 5.2% on Briumvi and 5.9% on teriflunomide in a pooled analysis, a difference that was not statistically significant[1]. The results were published in the New England Journal of Medicine in August 2022[4].
Development history
TG Therapeutics developed ublituximab and started the ULTIMATE trials in 2017. The FDA received the application on September 28, 2021, extended the review by 3 months after major amendments in 2022, and approved Briumvi on December 28, 2022 for relapsing forms of MS in adults[2][3]. The label has since been updated: a liver injury warning was added in August 2025, and while TG's 2022 safety information said no PML cases had occurred in MS patients on Briumvi, the current label says PML has been observed with it[1][3]. In 2026, TG reported positive Phase 3 ENHANCE results for a single-infusion start and said its Phase 3 trial of a subcutaneous (under the skin) version was fully enrolled, with topline results expected around the end of 2026 or early 2027[7].
Explore Multiple Sclerosis trials
Other Multiple Sclerosis treatments
Relapsing MS has more than 20 FDA-approved disease-modifying therapies, given as injections, pills or infusions. Anti-CD20 antibodies are among the high-efficacy options. BTK inhibitors, a new class of pills, are in late-stage trials, and TG is testing a subcutaneous form of ublituximab.
Common questions about Ublituximab
▸What is Ublituximab (Briumvi)?
An anti-CD20 antibody infusion approved by the FDA on December 28, 2022 for adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive MS. After 2 starting doses 2 weeks apart, it is given as a 1-hour IV infusion every 24 weeks. In 2 trials against the oral MS drug teriflunomide, it lowered the yearly relapse rate by 59% and 49%.
▸How does Ublituximab work?
B cells are white blood cells that make antibodies and help steer other immune cells. Ublituximab attaches to CD20, a marker on the surface of most B cells, and the immune system then destroys the marked cells. The label says exactly how this helps in MS is unknown, but it is presumed to work by removing B cells that feed the immune attack on myelin, the protective coating around nerves. TG Therapeutics describes the antibody as glycoengineered, meaning some sugar molecules normally found on antibodies were removed, which the company says lets it deplete B cells efficiently at low doses. B-cell counts drop within 24 hours of an infusion, and after the last dose they took a median of about 70 weeks to return to normal or starting levels in the trials.
▸What are the side effects of Ublituximab?
Briumvi has no boxed warning. It must not be given to people with active hepatitis B or anyone who has had a life-threatening infusion reaction to it. In the 2 main trials, which compared it with teriflunomide rather than placebo, the most common side effects on Briumvi against teriflunomide were infusion reactions (48% against 12%), upper respiratory infections (45% against 41%), lower respiratory infections (9% against 7%), herpes virus infections (6% against 5%), pain in the arms or legs (6% against 4%), insomnia (6% against 3%) and fatigue (5% against 4%). Infusion reactions such as fever, chills, headache and flu-like symptoms were most common with the first infusion (43%) and fell to 10% with the second and 8% with the third; 0.6% were serious. Serious infections occurred in 5% against 3%, and 3 infection-related deaths in the trials all occurred on Briumvi. The label also warns about hepatitis B coming back, PML (a rare, serious brain infection), low antibody levels (IgM fell below normal in about 21% of patients by week 96), liver injury reported after approval, and possible harm to an unborn baby, so women who could become pregnant should use effective birth control during treatment and for 6 months after the last dose[1].
▸How is Ublituximab taken?
Given as an IV infusion under the supervision of an experienced healthcare professional. The first dose is 150 mg over 4 hours, the second is 450 mg over 1 hour given 2 weeks later, and after that each dose is 450 mg over 1 hour every 24 weeks, counted from the first infusion. Before every infusion, patients receive 100 mg of IV methylprednisolone (a steroid) or an equivalent about 30 minutes ahead and an antihistamine such as diphenhydramine 30 to 60 minutes ahead, and acetaminophen may be added. Patients are watched for at least 1 hour after the first 2 infusions. Before the first dose, the care team screens for hepatitis B and checks immunoglobulin levels and liver tests, and any live vaccines should be given at least 4 weeks ahead. Infusions must be at least 5 months apart[1]. TG Therapeutics reported in 2026 that its Phase 3 ENHANCE trial showed a single 600 mg starting infusion gives the same drug exposure as the current 2-dose start; that simpler schedule is not in the label as of September 2026[7].
▸Is Ublituximab FDA approved?
Yes, Ublituximab (Briumvi) is FDA approved (2022) for the treatment of Multiple Sclerosis.
▸How often do you get Briumvi infusions?
After 2 starting doses (150 mg, then 450 mg 2 weeks later), Briumvi is given as a 450 mg infusion every 24 weeks, about twice a year. The first infusion takes about 4 hours and later ones about 1 hour, plus premedication beforehand and at least 1 hour of observation after the first 2 infusions.
▸What are the most common side effects of Briumvi?
In the main trials the most common side effects were infusion reactions (48% against 12% on teriflunomide) and upper respiratory infections (45% against 41%). Infusion reactions such as fever, chills and headache were most likely with the first infusion. Serious infections occurred in 5% of patients against 3% on teriflunomide.
▸Is there a copay card for Briumvi?
Yes. Through the BRIUMVI Copay Assistance Program, eligible adults with commercial insurance may pay as little as $0 per treatment, up to $20,000 a year, with separate help for infusion costs. It does not apply to Medicare, Medicaid or other government insurance. Uninsured or underinsured patients can ask a BRIUMVI Patient Support case manager at 1-833-274-8684 about the patient assistance program.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed. BRIUMVI (ublituximab-xiiy) injection, for intravenous use: prescribing information (revised January 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a77cd8c-811b-407c-9140-d0c5c26435c2
- U.S. Food and Drug Administration · 2022-12-28. BLA 761238 approval letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761238Orig1s000ltr.pdf
- TG Therapeutics · 2022-12-28. TG Therapeutics Announces FDA Approval of BRIUMVI (ublituximab-xiiy). https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-announces-fda-approval-briumvitm-ublituximab
- New England Journal of Medicine · 2022-08-25. Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis. https://www.nejm.org/doi/full/10.1056/NEJMoa2201904
- ClinicalTrials.gov. Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (ULTIMATE 1). https://clinicaltrials.gov/study/NCT03277261
- ClinicalTrials.gov. Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Multiple Sclerosis (ULTIMATE II). https://clinicaltrials.gov/study/NCT03277248
- TG Therapeutics · 2026-08-03. TG Therapeutics Reports Second Quarter 2026 Financial Results and Raises BRIUMVI Revenue Guidance. https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-reports-second-quarter-2026-financial-results
- TG Therapeutics. Financial Assistance. https://briumvi.com/financial-assistance/