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Iptacopan (LNP023)

DRUG2 trials

Sponsors

Novartis Pharmaceuticals

Conditions

Age-Related Macular DegenerationParoxysmal Nocturnal Hemoglobinuria (PNH)

Phase 2

A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration
Active, not recruitingNCT05230537
Novartis PharmaceuticalsAge-Related Macular Degeneration
Start: 2022-02-17End: 2026-10-02Updated: 2025-07-03

Phase 3

Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy
CompletedNCT04820530
Novartis PharmaceuticalsParoxysmal Nocturnal Hemoglobinuria (PNH)
Start: 2021-07-19End: 2023-04-18Updated: 2024-10-09

Related Papers

The 2-year efficacy and safety of iptacopan monotherapy in patients with paroxysmal nocturnal hemoglobinuria with a history of aplastic anemia on concomitant immunosuppressive therapy who entered the roll-over extension program
Blood2025-11-03
Patient-Reported Meaningful Change in Symptoms and Impacts of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Three Phase III Clinical Trials of Iptacopan.
2025-07-22
Oral iptacopan monotherapy in paroxysmal nocturnal haemoglobinuria: final 48-week results from the open-label, randomised, phase 3 APPLY-PNH trial in anti-C5-treated patients and the open-label, single-arm, phase 3 APPOINT-PNH trial in patients previously untreated with complement inhibitors.
2025-06-015 citations
Effectiveness of Iptacopan Versus C5 Inhibitors in Complement Inhibitor‐Naive Patients With Paroxysmal Nocturnal Haemoglobinuria
eJHaem2025-05-201 citations
Patient-reported improvements in paroxysmal nocturnal hemoglobinuria treated with iptacopan from 2 phase 3 studies
Blood Advances2025-01-078 citations
Oral Iptacopan Monotherapy Leads to Long-Term Improvements in Patient (Pt)-Reported Health-Related Quality of Life (HRQoL) and Investigator-Assessed Signs and Symptoms of Paroxysmal Nocturnal Hemoglobinuria (PNH): 48-Week (Wk) Results from the Phase III APPLY-PNH and APPOINT-PNH Trials
Blood2024-11-052 citations
The Effect of Oral Iptacopan Monotherapy on Hematological Parameters in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Is Consistent Regardless of the Type of Prior Anti-C5 Treatment Received: A <i>Post Hoc</i> Analysis of 24-Week Data from the Randomized Phase III APPLY-PNH Trial
Blood2024-11-051 citations
Incremental Effectiveness of Iptacopan Compared with C5 Inhibitors in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria: Results from a Modelling Analysis
Blood2024-11-05
Iptacopan for the treatment of paroxysmal nocturnal hemoglobinuria.
2024-10-152 citations
Oral Iptacopan Monotherapy in Paroxysmal Nocturnal Hemoglobinuria
New England Journal of Medicine2024-03-13114 citations
Clinical Breakthrough Hemolysis (BTH) during Monotherapy with the Oral Factor B Inhibitor Iptacopan Is Generally Not Severe and Managed without Treatment Discontinuation: 48-Week Data from the Phase III Apply-PNH and Appoint-PNH Trials in Paroxysmal Nocturnal Hemoglobinuria (PNH)
Blood2023-11-0211 citations
Patient Experience Interviews with a Novel Treatment Iptacopan for Paroxysmal Nocturnal Hemoglobinuria
Blood2023-11-025 citations
Categorization of Hematological Responses to Oral Iptacopan Monotherapy in Anti-C5-Treated Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) and Persistent Anemia in the Phase III APPLY-PNH Trial and Complement Inhibitor-Naïve Patients in the Phase III APPOINT-PNH Trial
Blood2023-11-024 citations
Patient-Reported Improvements in Fatigue and Health-Related Quality of Life in the Phase 3 Studies Apply-PNH and Appoint-PNH Evaluating the Use of Iptacopan in C5 Inhibitor-Treated and Treatment-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria
Blood2023-11-023 citations
Exposure-Response Relationships between the Complement Factor B Inhibitor Iptacopan and Lactate Dehydrogenase (LDH) and Hemoglobin (Hb) in Patients (Pts) with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Blood2023-11-021 citations
Iptacopan in Idiopathic Immune Complex-Mediated Membranoproliferative Glomerulonephritis: Protocol of the APPARENT Multicenter, Randomized Phase 3 Study.
2023-10-2913 citations
P774: SUBSTANTIAL INCREASES IN PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) RED BLOOD CELL CLONE SIZE WITH ORAL IPTACOPAN MONOTHERAPY CONFIRMS CONTROL OF HEMOLYSIS IN COMPLEMENT INHIBITOR-NAÏVE PNH PATIENTS
HemaSphere2023-08-013 citations
Dose-Exposure-Response Relationships of Biomarkers and Efficacy Measures with Iptacopan, a Complement Factor B Inhibitor, in Patients (pts) with Paroxysmal Nocturnal Hemoglobinuria (PNH) with or without Concomitant Anti-C5 Therapy
Blood2022-11-152 citations
Iptacopan monotherapy in patients with paroxysmal nocturnal hemoglobinuria: a 2-cohort open-label proof-of-concept study
Blood Advances2022-05-1370 citations