Key Highlights

Risk & Performance

Pipeline Risk Assessment

Pipeline Risk Assessment

Based on historical performance

Moderate Risk

Score: 35/100

Failure Rate

15.3%

9 terminated/withdrawn out of 59 trials

Success Rate

83.0%

-3.5% vs industry average

Late-Stage Pipeline

42%

25 trials in Phase 3/4

Results Transparency

84%

37 of 44 completed trials have results

Key Signals

3 recruiting37 with results6 terminated

Enrollment Performance

Analytics

Phase 2
20(33.9%)
Phase 3
19(32.2%)
Phase 1
9(15.3%)
Phase 4
6(10.2%)
N/A
4(6.8%)
Early Phase 1
1(1.7%)
59Total
Phase 2(20)
Phase 3(19)
Phase 1(9)
Phase 4(6)
+2 more

Activity Timeline

Global Presence

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Clinical Trials (59)

Showing 20 of 59 trials
NCT07555483Phase 3Not Yet Recruiting

A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)

Role: lead

NCT07540221Phase 3Recruiting

A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Role: lead

NCT05645107Phase 3Recruiting

A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma

Role: lead

NCT01757418Phase 1Completed

Intravenous Gammaglobulin for Sickle Cell Pain Crises

Role: collaborator

NCT02796937Phase 3Enrolling By Invitation

Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency

Role: lead

NCT01983241Phase 3Active Not Recruiting

Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)

Role: lead

NCT03702920Phase 3Terminated

Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5%

Role: lead

NCT04722887Phase 1Completed

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin Deficiency

Role: lead

NCT03451292Phase 3Completed

Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites

Role: lead

NCT02472665Phase 4Recruiting

Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease

Role: lead

NCT04566692Phase 4Completed

A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency

Role: lead

NCT04561115Phase 3Completed

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency

Role: lead

NCT04547140Phase 2Terminated

Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19)

Role: lead

NCT04847141Phase 3Terminated

A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients

Role: lead

NCT04480424Phase 2Completed

Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)

Role: lead

NCT02281500Phase 1Completed

Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia

Role: lead

NCT02870348Phase 1Completed

Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE)

Role: lead

NCT04055389Phase 1Withdrawn

Preventing de Novo Portal Vein Thrombosis With Antithrombin-III in Patients With Cirrhosis

Role: collaborator

NCT03095287Phase 2Terminated

Alphanate in Immune Tolerance Induction Therapy

Role: lead

NCT02870309Phase 1Completed

Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin Deficiency

Role: lead