Ublituximab
Also known as Briumvi, Ublituximab-xiiy
TG THERAPEUTICS, INC. TGTX · Chronic Lymphocytic Leukemia; Relapsing Multiple Sclerosis; Relapsing Multiple Sclerosis (RMS); Small Lymphocytic Lymphoma; Diffuse Large B-Cell Lymphoma
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
10
From ClinicalTrials.gov
Latest FDA action
Approved
BLA761238,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- TG THERAPEUTICS, INC. TGTX Source: Company record for TG THERAPEUTICS, INC. (opens in a new tab)
- Indications
- Chronic Lymphocytic Leukemia; Relapsing Multiple Sclerosis; Relapsing Multiple Sclerosis (RMS); Small Lymphocytic Lymphoma; Diffuse Large B-Cell Lymphoma Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- BLA 761238 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761238 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 CompletedFirst trial start 25 May 20163 linked trials
- Phase 3 CompletedFirst trial start 27 Jan 201510 linked trials
- Filed Completed
- Approved Current stageFirst approval 28 Dec 2022
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Ublituximab. Editors add each one with its source.
Filed application
No filed application is on record for Ublituximab. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Ublituximab.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07220252ClinicalTrials.gov record for NCT07220252 (opens in a new tab) | Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis | Phase 2/3 | Recruiting | 240 (estimated) | 1 Jan 2030 (estimated) | No |
| NCT07211633ClinicalTrials.gov record for NCT07211633 (opens in a new tab) | A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS) | Phase 3 | Active, not recruiting | 360 (estimated) | 31 Oct 2026 (estimated) | No |
| NCT05877963ClinicalTrials.gov record for NCT05877963 (opens in a new tab)ENHANCE | Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab | Phase 3 | Recruiting | 800 (estimated) | 21 Jan 2027 (estimated) | No |
| NCT04130997ClinicalTrials.gov record for NCT04130997 (opens in a new tab) | An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis | Phase 3 | Active, not recruiting | 1,100 (estimated) | 31 May 2032 (estimated) | No |
Publications listing NCT04130997 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03801525ClinicalTrials.gov record for NCT03801525 (opens in a new tab)ULTRA-V | Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V) | Phase 2/3 | Terminated | 277 (actual) | 20 Dec 2022 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03801525 (opens in a new tab) |
Posted results on ClinicalTrials.gov for ULTRA-V
Serious adverse events (Up to 43.2 months): Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) 84 of 165; Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V) 12 of 56; Phase 3: Ublituximab + Umbralisib (U2) 16 of 53 Source: ClinicalTrials.gov results for NCT03801525 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT03277261ClinicalTrials.gov record for NCT03277261 (opens in a new tab)ULTIMATE 1 | Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 ) | Phase 3 | Completed | 549 (actual) | 23 Jul 2020 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03277261 (opens in a new tab) |
Posted results on ClinicalTrials.gov for ULTIMATE 1
Serious adverse events (From the first dose of study drug through the end of the study (up to approximately 116 weeks)): Ublituximab + Oral Placebo 31 of 273; Teriflunomide + IV Placebo 19 of 275 Source: ClinicalTrials.gov results for NCT03277261 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing ULTIMATE 1 (4), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03277248ClinicalTrials.gov record for NCT03277248 (opens in a new tab)ULTIMATE II | Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) | Phase 3 | Completed | 545 (actual) | 4 Aug 2020 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03277248 (opens in a new tab) |
Posted results on ClinicalTrials.gov for ULTIMATE II
Serious adverse events (From the first dose of study drug through the end of the study (up to approximately 116 weeks)): Ublituximab + Oral Placebo 28 of 272; Teriflunomide + IV Placebo 21 of 273 Source: ClinicalTrials.gov results for NCT03277248 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing ULTIMATE II (4), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT02793583ClinicalTrials.gov record for NCT02793583 (opens in a new tab)UNITY-NHL | Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma | Phase 2/3 | Terminated | 710 (actual) | 31 May 2022 (actual) | No |
Publications listing UNITY-NHL (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT02612311ClinicalTrials.gov record for NCT02612311 (opens in a new tab)UNITY-CLL | Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia | Phase 3 | Terminated | 603 (actual) | 22 Feb 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02612311 (opens in a new tab) |
Posted results on ClinicalTrials.gov for UNITY-CLL Serious adverse events (From first dose of study treatment up to end of study (up to approximately 87 months)): Experimental: Arm A: Ublituximab + Umbralisib 118 of 206; Active Comparator: Arm B: Obinutuzumab + Chlorambucil 47 of 200; Experimental: Arm C: Ublituximab 33 of 91; Experimental: Arm D: Umbralisib 34 of 86 Source: ClinicalTrials.gov results for NCT02612311 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT02301156ClinicalTrials.gov record for NCT02301156 (opens in a new tab)GENUINE | Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL) | Phase 3 | Completed | 126 (actual) | 1 Apr 2020 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02301156 (opens in a new tab) |
Posted results on ClinicalTrials.gov for GENUINE
Serious adverse events (Adverse Events: From the first dose up to 30 days after the last dose of study drug (up to 57.3 months); All-Cause Mortality: From the first dose up to end of study (up to 62 months)): Ublituximab + Ibrutinib 38 of 59; Ibrutinib 31 of 58 Source: ClinicalTrials.gov results for NCT02301156 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing GENUINE (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| BLA761238Action letter for BLA761238 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Briumvi (EMEA/H/C/005914)
- Authorised
- Therapeutic area
- Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis
- Marketing authorisation holder
- Neuraxpharm Pharmaceuticals S.L.
- Active substance (INN)
- ublituximab
- ATC code
- L04
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Briumvi (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 761238 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07220252 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT07211633 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05877963 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04130997 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03801525 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03277261 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03277248 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02793583 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02612311 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02301156 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA BLA761238 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.