COMPANY

Grifols

HQ: Barcelona, Spain source · grifols.com ↗

FDA-cleared device company Clinical Phase 3

Profile checked Oct 10, 2026

Keywords: Alpha1-Antitrypsin Deficiency Alpha 1 Antitrypsin Deficiency Primary Immunodeficiency COVID-19 Cystic Fibrosis Immunologic Deficiency Syndrome CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy) Pulmonary Emphysema in Alpha-1 PI Deficiency Hypogammaglobulinemia Bacterial Infections B-cell Chronic Lymphocytic Leukemia Multiple Myleoma Non-Hodgkin Lymphoma Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency Von Willebrand Disease Decompensated Cirrhosis and Ascites Congenital Afibrinogenemia Congenital Hemophilia A Amyotrophic Lateral Sclerosis Myasthenia Gravis Exacerbations Myasthenia Gravis Cardiac Surgery Cardiopulmonary Bypass Generalized Myasthenia Gravis Type 1 Diabetes Mellitus Alpha₁-Antitrypsin Deficiency Acute Peripheral Arterial Occlusion Arterial Occlusive Diseases Purpura, Thrombocytopenic, Idiopathic Relapsing-Remitting Multiple Sclerosis Chronic Inflammatory Demyelinating Polyradiculoneuropathy Macular Degeneration Tetanus Acute Ischemic Stroke Rabies Emphysema Alpha 1-antitrypsin Deficiency Agammaglobulinemia

46Trials (company is sponsor)

Timeline

May 5, 2026 Trial start Phase 3: 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 source ↗
Apr 2, 2026 Trial start Phase 3: A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy source ↗
Dec 26, 2022 Trial start Phase 3: 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 Infect source ↗
Dec 16, 2021 Trial start Phase 1/Phase 2: A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin De source ↗
Apr 28, 2021 Trial start Phase 3: A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients source ↗
Jan 29, 2021 Trial start Phase 2: Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19) source ↗
Nov 24, 2020 Trial start Phase 4: A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency source ↗
Sep 17, 2020 Trial start Phase 2: 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) W source ↗
Sep 2, 2020 Trial start Phase 3: 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 source ↗
2019-12 Trial start Phase 3: Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency source ↗
Jul 24, 2018 Trial start Phase 3: Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites source ↗
Jan 3, 2018 Trial start Phase 2: Alphanate in Immune Tolerance Induction Therapy source ↗
Oct 31, 2017 Trial start Phase 4: Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human) source ↗
Aug 29, 2016 Trial start Phase 2: Efficacy and Safety of Plasma Exchange With Albutein® 5% in Participants With Amyotrophic Lateral Sclerosis source ↗
Jul 29, 2016 Trial start Phase 1/Phase 2: Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE) source ↗
Jul 29, 2016 Trial start Phase 1/Phase 2: Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin Deficiency source ↗
Jul 22, 2016 Trial start Phase 1/Phase 2: Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia source ↗
2016-07 Trial start Phase 3: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency source ↗
2016-06 Trial start Phase 3: Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency source ↗
2016-01 Trial start Phase 3: Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency source ↗
2015-08 Trial start Phase 2: A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis source ↗
2015-06 Trial start Phase 2: Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis source ↗
2015-03 Trial start Phase 3: A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis Exacerbations source ↗
2014-10 Trial start Phase 2/Phase 3: A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency source ↗
Jun 26, 2014 Trial start Phase 2: Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass source ↗

Showing 25 of 46 dated events.

Upcoming milestones

Sep 30, 2027 (ESTIMATED) · Phase 3 · 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-Antitryp · NCT07555483
Dec 31, 2027 (ESTIMATED) · Phase 3 · A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy · NCT07540221
2028-09 (ESTIMATED) · Phase 3 · Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency · NCT02796937
2029-08 (ESTIMATED) · Phase 3 · 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 Asso · NCT05645107

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 46

Record	Title	Phase	Status	Start	Primary completion
NCT07540221	A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy	Phase 3	Recruiting	Apr 2, 2026	Dec 31, 2027 (estimated)
NCT04722887	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	Phase 1/Phase 2	Completed	Dec 16, 2021	Aug 1, 2025 (actual)
NCT01983241	Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)	Phase 3	Completed	Apr 1, 2014	Jul 7, 2026 (actual)
NCT05645107	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	Phase 3	Recruiting	Dec 26, 2022	2029-08 (estimated)
NCT07555483	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)	Phase 3	Recruiting	May 5, 2026	Sep 30, 2027 (estimated)
NCT02796937	Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency	Phase 3	Enrolling by invitation	2016-07	2028-09 (estimated)
NCT02472665	Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease	Phase 4	Withdrawn	2013-12	Dec 10, 2024 (actual)
NCT03451292	Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites	Phase 3	Completed	Jul 24, 2018	May 21, 2024 (actual)
NCT04566692	A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency	Phase 4	Completed	Nov 24, 2020	Jul 18, 2022 (actual)
NCT04561115	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	Phase 3	Completed	Sep 2, 2020	Mar 28, 2022 (actual)
NCT04547140	Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19)	Phase 2	Terminated	Jan 29, 2021	Dec 13, 2021 (actual)
NCT04847141	A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients	Phase 3	Terminated	Apr 28, 2021	Nov 10, 2021 (actual)
NCT04480424	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)	Phase 2	Completed	Sep 17, 2020	Aug 25, 2021 (actual)
NCT02281500	Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia	Phase 1/Phase 2	Completed	Jul 22, 2016	Nov 11, 2019 (actual)
NCT02870348	Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE)	Phase 1/Phase 2	Completed	Jul 29, 2016	Feb 16, 2021 (actual)
NCT03095287	Alphanate in Immune Tolerance Induction Therapy	Phase 2	Terminated	Jan 3, 2018	Sep 18, 2020 (actual)
NCT02870309	Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin Deficiency	Phase 1/Phase 2	Completed	Jul 29, 2016	Mar 15, 2017 (actual)
NCT02872142	Efficacy and Safety of Plasma Exchange With Albutein® 5% in Participants With Amyotrophic Lateral Sclerosis	Phase 2	Completed	Aug 29, 2016	Aug 15, 2019 (actual)
NCT02806986	Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency	Phase 3	Completed	2016-06	May 15, 2019 (actual)
NCT02413580	A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis Exacerbations	Phase 3	Completed	2015-03	2018-04 (actual)
NCT03814798	Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency	Phase 3	Withdrawn	2019-12	2020-09 (estimated)
NCT02473965	Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis	Phase 2	Completed	2015-06	2019-02 (actual)
NCT02604810	Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency	Phase 3	Completed	2016-01	2017-09 (actual)
NCT03351933	Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)	Phase 4	Completed	Oct 31, 2017	Apr 27, 2018 (actual)
NCT02037555	Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass	Phase 2	Completed	Jun 26, 2014	Jan 25, 2018 (actual)
NCT02473952	A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis	Phase 2	Completed	2015-08	2018-01 (actual)
NCT02093221	Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus	Phase 2	Terminated	2014-03	2017-01 (actual)
NCT02282527	A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency	Phase 2/Phase 3	Completed	2014-10	2016-01 (actual)
NCT01222117	A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion	Phase 2	Completed	2010-12	2015-12 (actual)
NCT00418483	A Dose Escalation and Safety Study of Plasmin (Human) In Acute Lower Extremity Native Artery or Bypass Graft Occlusion	Phase 1	Completed	2007-03	2010-04 (actual)
NCT00220727	Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP	Phase 2	Completed	2003-07	2003-10 (actual)
NCT00220779	Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis	Phase 2	Completed	2002-12	2005-02 (actual)
NCT00220740	Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Phase 3	Completed	2004-04	2006-06 (actual)
NCT00220805	Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration	Phase 2	Completed	2004-01	2005-05 (actual)
NCT01684410	Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis	Phase 2	Completed	2012-08	2013-10 (actual)
NCT00437671	Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels	Phase 4	Terminated	2007-03	2007-09 (actual)
NCT01014975	A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients	Phase 1/Phase 2	Completed	2009-11	2013-11 (actual)
NCT00389324	A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency	Phase 2	Completed	2006-11	2008-08 (actual)
NCT01465958	Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency	Phase 4	Completed	2011-11	2013-10 (actual)
NCT00295061	Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults	Phase 3	Completed	2006-05	2007-02 (actual)
NCT00263887	Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)	Phase 2	Completed	2003-12	2007-01 (actual)
NCT00486837	Deposition of Inhaled Prolastin in Cystic Fibrosis Patients	Phase 2	Completed	2003-12	2004-06 (actual)
NCT00301366	The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency	Phase 3	Completed	2006-06	2007-03 (actual)
NCT02139657	An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human)	Phase 1	Completed	2014-03	2014-05 (actual)
NCT01213043	Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency	Phase 2	Completed	2010-11	2012-01 (actual)
NCT00220766	Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients	Phase 3	Completed	2002-08	2002-08 (actual)