Drug research

Ublituximab

Open a linked trial to see its study details and recorded changes, or check the regulatory events below and follow their sources.

Drug identity checked against registry records

Also recorded as BRIUMVI; TG-1101

A drug appearing in a clinical trial does not mean it is FDA-approved. Check the original regulatory source for any approval claim.

Included trials

Trial	Sponsor	Phase	Status	Primary completion
A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304NCT02656303	TGTX	Phase 2	Terminated	2022-05-26Actual
A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)NCT07673744	TGTX	Phase 2	Recruiting	2028-07-01Estimated
Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of UblituximabNCT05877963	TGTX	Phase 3	Recruiting	2027-01-21Estimated
Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple SclerosisNCT07220252	TGTX	Phase 2, Phase 3	Recruiting	2030-01-01Estimated
Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic LeukemiaNCT02612311	TGTX	Phase 3	Terminated	2023-02-22Actual
Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or VenetoclaxNCT04016805	TGTX	Phase 2	Terminated	2022-05-22Actual
Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular LymphomaNCT03828448	TGTX	Phase 2	Terminated	2022-05-16Actual
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)NCT03801525	TGTX	Phase 2, Phase 3	Terminated	2022-12-20Actual
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)NCT07211633	TGTX	Phase 3	Active not recruiting	2026-10-31Estimated
An Extension Study of Ublituximab in Participants With Relapsing Multiple SclerosisNCT04130997	TGTX	Phase 3	Active not recruiting	2032-05-31Estimated
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)NCT07503873	TGTX	Phase 2	Recruiting	2027-07-31Estimated

A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304

TGTXTerminatedPrimary completion: 2022-05-26 · Actual

Trial details

Registry ID: NCT02656303
Phase: Phase 2

A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)

TGTXRecruitingPrimary completion: 2028-07-01 · Estimated

Trial details

Registry ID: NCT07673744
Phase: Phase 2

Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab

TGTXRecruitingPrimary completion: 2027-01-21 · Estimated

Trial details

Registry ID: NCT05877963
Phase: Phase 3

Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis

TGTXRecruitingPrimary completion: 2030-01-01 · Estimated

Trial details

Registry ID: NCT07220252
Phase: Phase 2, Phase 3

Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia

TGTXTerminatedPrimary completion: 2023-02-22 · Actual

Trial details

Registry ID: NCT02612311
Phase: Phase 3

Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax

TGTXTerminatedPrimary completion: 2022-05-22 · Actual

Trial details

Registry ID: NCT04016805
Phase: Phase 2

Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma

TGTXTerminatedPrimary completion: 2022-05-16 · Actual

Trial details

Registry ID: NCT03828448
Phase: Phase 2

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)

TGTXTerminatedPrimary completion: 2022-12-20 · Actual

Trial details

Registry ID: NCT03801525
Phase: Phase 2, Phase 3

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)

TGTXActive not recruitingPrimary completion: 2026-10-31 · Estimated

Trial details

Registry ID: NCT07211633
Phase: Phase 3

An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

TGTXActive not recruitingPrimary completion: 2032-05-31 · Estimated

Trial details

Registry ID: NCT04130997
Phase: Phase 3

A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)

TGTXRecruitingPrimary completion: 2027-07-31 · Estimated

Trial details

Registry ID: NCT07503873
Phase: Phase 2

Regulatory dates and decisions

No regulatory events match this view.Try another date range or view. Events appear after automated source checks. This does not mean no FDA events have occurred. Dates that a source does not disclose stay undisclosed.