Key Highlights

Risk & Performance

Pipeline Risk Assessment

Based on historical performance

High Risk

Score: 70/100

Failure Rate

34.7%

17 terminated/withdrawn out of 49 trials

Success Rate

48.5%

-38.1% vs industry average

Late-Stage Pipeline

18%

9 trials in Phase 3/4

Results Transparency

106%

17 of 16 completed trials have results

Key Signals

11 recruiting17 with results17 terminated

Enrollment Performance

Analytics

Phase 2

19(42.2%)

Phase 1

16(35.6%)

Phase 3

7(15.6%)

Phase 4

2(4.4%)

N/A

1(2.2%)

45Total

Phase 2(19)

Phase 1(16)

Phase 3(7)

Phase 4(2)

+1 more

Activity Timeline

Global Presence

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Clinical Trials (49)

Showing 20 of 49 trials

NCT06143514Active Not Recruiting

A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk

Role: lead

NCT07680946Phase 2Recruiting

Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia

Role: lead

NCT06433752Recruiting

A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)

Role: lead

NCT04130997Phase 3Active Not Recruiting

An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

Role: lead

NCT07673744Phase 2Recruiting

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

Role: lead

NCT07211633Phase 3Active Not Recruiting

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

Role: lead

NCT06433765Recruiting

A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)

Role: lead

NCT07503873Phase 2Recruiting

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)

Role: lead

NCT05877963Phase 3Recruiting

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

Role: lead

NCT07220252Phase 2Recruiting

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

Role: lead

NCT06680037Phase 1Recruiting

A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders

Role: lead

NCT06864936Not ApplicableRecruiting

Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis

Role: collaborator

NCT07577583Not Yet Recruiting

Long-term Follow-up (LTFU) of Participants Who Received Azer-Cel

Role: lead

NCT07389590Phase 4Recruiting

Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis

Role: collaborator

NCT07225361Phase 4Recruiting

Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

Role: collaborator

NCT04624633Phase 2Active Not Recruiting

Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL

Role: collaborator

NCT04163718Phase 2Terminated

TGR-1202 (Umbralisib) in Treatment Naïve Patients With Chronic Lymphocytic Leukemia (CLL)

Role: collaborator

NCT02612311Phase 3Terminated

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

Role: lead

NCT02268851Phase 1Completed

A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL

Role: collaborator

NCT04806035Phase 1Terminated

Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia

Role: lead