Systemic Lupus Erythematosus
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CLINICAL_TRIALS trial_result · 2024-03-08Clinical Trial Update: A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis [Phase 1, Phase 2]
Kezar Life Sciences completed a Phase 1/2 study of the immunoproteasome inhibitor KZR-616 in systemic lupus erythematosus with and without l…
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CLINICAL_TRIALS trial_result · 2024-02-14Clinical Trial Update: Trial of Belimumab in Early Lupus [Phase 4]
Phase 4 trial updating on belimumab in early systemic lupus erythematosus is currently recruiting.
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FDA approval · 2024-02-09FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental Biologics License Application for BENLYSTA (belimumab) by GlaxoSmithKline LLC, resulting in an updated indic…
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FDA approval · 2024-02-09FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for Benlysta (belimumab) filed by GlaxoSmithKline LLC.
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CLINICAL_TRIALS trial_result · 2024-02-07Clinical Trial Update: Anti-CD20 Antibodies for Treatment of SLE-PAH [Phase 4]
Phase 4 clinical trial update evaluating anti-CD20 antibodies for treatment of systemic lupus erythematosus-associated pulmonary arterial hy…
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FDA approval · 2024-01-24FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Ipca Laboratories Limited)
FDA approved a supplemental application for hydroxychloroquine sulfate manufactured by Ipca Laboratories Limited. The approval updates the p…
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CLINICAL_TRIALS trial_result · 2024-01-17Clinical Trial Update: Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients [Phase 4]
Phase 4 clinical trial exploring multi-omics studies on the efficacy of telitacicept in Chinese patients with systemic lupus erythematosus.
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CLINICAL_TRIALS trial_result · 2024-01-16Clinical Trial Update: Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis [Phase 2]
Phase 2 trial assessing Branebrutinib in active autoimmune diseases (systemic lupus erythematosus, primary Sjögren's syndrome) and rheumatoi…
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CLINICAL_TRIALS trial_result · 2023-12-11Clinical Trial Update: RIvaroxaban for Stroke Patients With AntiPhospholipid Syndrome [Phase 2]
Phase 2 clinical trial update for rivaroxaban in stroke patients with antiphospholipid syndrome and related autoimmune conditions.
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FDA approval · 2023-12-05FDA Approved: PREDNISONE TABLETS, USP, 5 MG — Supplemental Application (Granulation Technology, Inc.)
FDA granted a supplemental approval for Prednisone Tablets, USP, 5 mg to authorize a granulation technology manufacturing change by Granulat…
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FDA approval · 2023-12-01FDA Approved: SAPHNELO — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for SAPHNELO (anifrolumab-fnia) from AstraZeneca Pharmaceuticals LP.
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FDA approval · 2023-11-29FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved a supplemental application for HYDROXYCHLOROQUINE SULFATE from Dr. Reddy's Laboratories Inc.
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CLINICAL_TRIALS trial_result · 2023-11-09Clinical Trial Update: Immune Ablation and Hematopoietic Stem Cell Support in Patients With Systemic Lupus Erythematosus: A Phase II Study [Phase 2]
A Phase II trial evaluating immune ablation with hematopoietic stem cell support in patients with systemic lupus erythematosus has completed…
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CLINICAL_TRIALS trial_result · 2023-10-30Clinical Trial Update: Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis [Phase 1]
Phase 1 safety and tolerability trial of PF-06835375 in seropositive systemic lupus erythematosus and rheumatoid arthritis completed; result…
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CLINICAL_TRIALS trial_result · 2023-10-27Clinical Trial Update: Safety and Efficacy of SM934 Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus [Phase 2]
Phase 2 trial assessing safety and efficacy of SM934 versus placebo in adults with active systemic lupus erythematosus has completed.
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CLINICAL_TRIALS trial_result · 2023-10-13Clinical Trial Update: JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus [Phase 2]
A Phase 2 clinical trial update for JMKX000189 in moderate to severe active systemic lupus erythematosus is reported with an unknown status.
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CLINICAL_TRIALS trial_result · 2023-10-10Clinical Trial Update: Ascension® Post- Approval Study; PyroCarbon Metacarpophalangeal Total Joint Prosthesis [NA]
Clinical trial update for Ascension post-approval study reporting termination with results posted.
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CLINICAL_TRIALS trial_result · 2023-09-29Clinical Trial Update: A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus Participants [Phase 1, Phase 2]
A phase 1/2 clinical trial evaluating the safety, tolerability, and pharmacokinetics of E6742 in systemic lupus erythematosus has completed.
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CLINICAL_TRIALS trial_result · 2023-09-22Clinical Trial Update: Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus [Phase 2]
A Phase 2 trial evaluating four doses of cenerimod versus placebo in adults with active systemic lupus erythematosus to assess efficacy and …
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CLINICAL_TRIALS trial_result · 2023-09-21Clinical Trial Update: A Model About the Response of Belimumab in SLE [Phase 4]
Phase 4 trial update exploring belimumab in systemic lupus erythematosus.
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FDA approval · 2023-09-14FDA Approved: SOVUNA — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for SOVUNA (hydroxychloroquine sulfate) submitted by ANI Pharmaceuticals, under NDA 214581.
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CLINICAL_TRIALS trial_result · 2023-09-14Clinical Trial Update: Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE) [NA]
Clinical trial examining qualitative and quantitative methods to understand a new model of Systemic Lupus Erythematosus. Study completed wit…
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CLINICAL_TRIALS withdrawal · 2023-09-13Clinical Trial Update: Autologous Stem Cell Transplantation: International Lupus Trial [Phase 2, Phase 3]
A clinical trial investigating autologous stem cell transplantation for refractory systemic lupus erythematosus was withdrawn.
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CLINICAL_TRIALS trial_result · 2023-08-21Clinical Trial Update: Immunogenicity, Reactogenicity of Shingrix in SLE [Phase 3]
A Phase 3 trial update evaluating the immunogenicity and reactogenicity of Shingrix in patients with systemic lupus erythematosus (SLE).
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CLINICAL_TRIALS trial_result · 2023-08-21Clinical Trial Update: Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus [EARLY_Phase 1]
This early-phase 1 study investigates the genomic effects of glucocorticoids in patients with systemic lupus erythematosus. Results have bee…