iptacopan
iptacopan: sourced relationships with 1 company · 16 clinical trials tracked · 1 FDA decision.
iptacopan evidence translation
What we can confirm
1 FDA record · 16 tracked trials
What it means
What to watch
Prepared research question
How could iptacopan → NVS affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence6 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| Novartis AG (NVS) Reported 2023-12-05 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (16)showing 10 most recent
A Single-arm, Multicenter, Phase III Study to Assess Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients of 2 to <18 Years of Age With Primary Immunoglobulin A Nephropathy (IgAN)
Primary endpoint: Log-transformed ratio to Baseline in UPCR (based on FMV)
An Open-label, Single-arm, Multicenter, Phase 3 Study to Assess Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric PNH Patients 2 to <18 Years of Age
Primary endpoint: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
A Multi-center, Ambispective Cohort Study to Evaluate the Impact of Iptacopan on Disease Management, Treatment-Related Outcomes and Healthcare Resource Utilization for Adult Patients With Paroxysmal Nocturnal Hemoglobinuria in China
Primary endpoint: Change from baseline in hemoglobin (Hb) levels at designated time points
Post-authorization Safety Study of Iptacopan in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Using Data From the Non-interventional IPIG PNH Registry
Primary endpoint: Number of patients with infections caused by encapsulated bacteria
A Multicenter, Single Arm, Open Label Biopsy Study to Evaluate Structural and Functional Changes in Kidneys of Adult Patients With IgA Nephropathy Receiving Iptacopan on Top of Supportive Care
Primary endpoint: Proportion of participants achieving a reduction of minimum one order of magnitude in complement C3c mesangial deposition.
A Randomized, Controlled Study to Evaluate LNP023 (Iptacopan) in Patients With Active ANCA-associated Vasculitis
Primary endpoint: Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48.
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Iptacopan in Patients With Generalized Myasthenia Gravis, Followed by an Open-label Extension Phase
Primary endpoint: Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score
A Multicenter, Single Arm, Open-label Study to Evaluate Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With aHUS
Primary endpoint: Percentage of participants free of TMA manifestation
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Idiopathic Immune-complex-mediated Membranoproliferative Glomerulonephritis (IC-MPGN)
Primary endpoint: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 6 months.
An Adaptive, Randomized, Double-blind, Dose Exploration, Parallel Group, Placebo Controlled, Multicenter Phase 2 Trial to Evaluate the Efficacy, Safety and Tolerability of LNP023 in Combination With Standard-of-care With and Without Oral Corticosteroids in Patients With Active Lupus Nephritis Class III-IV, +/- V
Primary endpoint: Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with iptacopan?
iptacopan has dated SEC/FDA relationship records for Novartis AG.
How many clinical trials involve iptacopan?
BioSniper tracks 16 clinical trials involving iptacopan.
What is iptacopan's latest FDA decision?
The most recent tracked FDA decision for iptacopan is Approval, dated December 5, 2023.