Cold Agglutinin Disease
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS research · 2026-04-22Clinical Trial Update: Cold Agglutinin Disease Real World Evidence Registry
This is a real-world evidence registry for cold agglutinin disease (CAD) and cold agglutinin syndrome (CAS) sponsored by RECORDATI GROUP. Th…
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CLINICAL_TRIALS research · 2026-03-06Clinical Trial Update: Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease [Phase 1]
Phase 1 clinical trial update evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and pilot effica…
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CLINICAL_TRIALS trial_result · 2026-03-06Clinical Trial Update: Zanubrutinib in Primary Cold Agglutinin Disease [Phase 2]
Phase 2 trial of zanubrutinib for primary cold agglutinin disease is currently active but not recruiting.
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CLINICAL_TRIALS trial_result · 2025-10-30Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD) [Phase 3]
Phase 3 study evaluating pegcetacoplan for cold agglutinin disease has completed, with trial results posted.
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CLINICAL_TRIALS trial_result · 2025-09-22Clinical Trial Update: A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease [Phase 1]
This clinical trial update reports the completion of a Phase 1 safety and tolerability study of BIVV020 in adults with cold agglutinin disea…
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CLINICAL_TRIALS trial_result · 2025-09-11Clinical Trial Update: Safety and Tolerability Study in Adults With Cold Agglutinin Disease Previously Treated With SAR445088 or Never Treated With SAR445088 [Phase 1]
Phase 1 safety and tolerability study of SAR445088 in adults with cold agglutinin disease, previously treated vs untreated, has been termina…
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EMA approval · 2025-08-01EMA Authorised: Enjaymo (sutimlimab) — Recordati Rare Diseases
EMA authorised Enjaymo (sutimlimab) for the treatment of cold agglutinin disease (autoimmune hemolytic anemia), with orphan medicine designa…
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CLINICAL_TRIALS research · 2025-07-04Clinical Trial Update: An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias [Phase 1, Phase 2]
Open-label Phase 1/2 study evaluating povetacicept in autoimmune cytopenias. The study includes immune thrombocytopenia and idiopathic throm…
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CLINICAL_TRIALS trial_result · 2025-03-19Clinical Trial Update: Basket Study to Assess Efficacy, Safety and PK of Iptacopan (LNP023) in Autoimmune Benign Hematological Disorders [Phase 2]
A Phase 2 basket study evaluating the efficacy, safety and pharmacokinetics of iptacopan (LNP023) in autoimmune benign hematological disorde…
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CLINICAL_TRIALS trial_result · 2024-12-12Clinical Trial Update: Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) [Phase 2]
A Phase 2 trial evaluating APL-2 in warm autoimmune hemolytic anemia and cold agglutinin disease has completed with results posted.
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CLINICAL_TRIALS research · 2024-10-15Clinical Trial Update: Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia
This clinical trial update describes a prospective evaluation of diagnosis and treatment among patients with autoimmune cytopenias, includin…
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FDA approval · 2024-02-08FDA Approved: ENJAYMO — Supplemental Application (Recordati Rare Diseases, Inc.)
The FDA approved a supplemental application for ENJAYMO (sutimlimab-jome) submitted by Recordati Rare Diseases, Inc.
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CLINICAL_TRIALS trial_result · 2023-10-03Clinical Trial Update: Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan [Phase 3]
Clinical trial update indicates that adults with cold agglutinin disease in Japan completed Phase 3 studies of sutimlimab (CARDINAL or CADEN…
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FDA approval · 2023-01-25FDA Approved: ENJAYMO — Supplemental Application (Recordati Rare Diseases, Inc.)
FDA approved a supplemental application for ENJAYMO (sutimlimab-jome) from Recordati Rare Diseases, Inc.
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CLINICAL_TRIALS trial_result · 2022-12-23Clinical Trial Update: A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion [Phase 3]
Phase 3 trial evaluating sutimlimab (BIVV009) for cold agglutinin disease has completed with posted results.
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CLINICAL_TRIALS trial_result · 2022-10-31Clinical Trial Update: A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study) [Phase 3]
Phase 3 trial evaluating sutimlimab (BIVV009) for primary cold agglutinin disease; study completed with results posted.
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FDA approval · 2022-09-23FDA Approved: ENJAYMO — Supplemental Application (Recordati Rare Diseases, Inc.)
FDA approved a supplemental application for ENJAYMO (sutimlimab-jome) filed by Recordati Rare Diseases, Inc., approving changes described in…
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FDA approval · 2022-02-04FDA Approved: ENJAYMO — Original Application (Recordati Rare Diseases, Inc.)
FDA approved ENJAYMO (sutimlimab-jome) for adults with cold agglutinin disease, marking the original approval for this therapy. The drug inh…
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CLINICAL_TRIALS trial_result · 2017-10-27Clinical Trial Update: Short Course of Bortezomib in Anemic Patients With Refractory Cold Agglutinin Disease [Phase 2]
Phase 2 trial evaluating a short course of bortezomib in anemic patients with refractory cold agglutinin disease has been completed.
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CLINICAL_TRIALS trial_result · 2017-07-19Clinical Trial Update: Therapy of Chronic Cold Agglutinin Disease With Eculizumab [Phase 2]
This document reports a completed Phase 2 clinical trial evaluating eculizumab for Cold agglutinin disease.
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CLINICAL_TRIALS trial_result · 2017-01-09Clinical Trial Update: Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease [Phase 2]
Phase 2 trial update for bendamustine plus rituximab in Cold Agglutinin Disease; the study has completed.
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CLINICAL_TRIALS research · 2012-10-23Clinical Trial Update: The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders
An observational ClinicalTrials.gov update (RITAI Cohort) investigates off-label use of rituximab for autoimmune disorders, including pemphi…
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CLINICAL_TRIALS trial_result · 2011-05-02Clinical Trial Update: A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia [Phase 2]
Phase 2 single-arm pilot study evaluating low-dose rituximab plus standard prednisone for idiopathic autoimmune hemolytic anemia; the trial …
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CLINICAL_TRIALS trial_result · 2010-06-22Clinical Trial Update: Therapy for Chronic Cold Agglutinin Disease [Phase 2]
Phase 2 clinical trial evaluating a therapy for chronic Cold agglutinin disease has completed.