LNP023

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Iga NephropathyC3 GlomerulopathyParoxysmal Nocturnal Hemoglobinuria (PNH)

43 competitors in Iga Nephropathy

#DrugCompanyPhaseTrials

1

Cellcept

Roche

Approved

72

Rituxan

Roche

Approved

23

Lorelco

Sanofi

Approved

14

Fabhalta

Novartis

Approved

—5

Velcade

SShilpa Grover, MD, MPH

Approved

16

Tekturna

Tibotec Pharmaceuticals, Ireland

Approved

17

Kerendia

Bayer

Phase 3

28

Farxiga

AstraZeneca

Phase 3

19

Filspari

TTravere Therapeutics, Inc.

Phase 3

210

Vanrafia

Novartis

Phase 3

2Show 22 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Paroxysmal Nocturnal Hemoglobinuria2 trials

Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Completed·Novartis·Phase 2·NCT02534909·10 enrolled

Efficacy, Safety, Pharmacokinetics and Pharmacodynamics Study, Assessing Multiple LNP023 Doses in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria

Completed·Novartis·Phase 2·NCT03896152·13 enrolled

Anemia1 trial

Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment

Completed·Novartis·Phase 3·NCT04558918·97 enrolled

Membranous Nephropathy1 trial

Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous Nephropathy

Terminated·Novartis·Phase 2·NCT04154787·37 enrolled

Cohort Study1 trial

A Multi-center, Ambispective Cohort Study to Evaluate the Impact of Iptacopan for Adult Patients With PNH in China

Recruiting·Novartis··NCT06931691·80 enrolled

Efficacy and Safety1 trial

Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted

Completed·Novartis·Phase 2·NCT03832114·27 enrolled

5 more indications

Kidney Disease1 trial

Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by Inflammation

Completed·Novartis·Phase 2·NCT03373461·112 enrolled

Paroxysmal Nocturnal Hemoglobinuria (PNH)1 trial

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

Recruiting·Novartis·Phase 3·NCT06934967·12 enrolled

C3 Glomerulopathy1 trial

An Open-label, Non-randomized Extension Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Iptacopan (LNP023) in C3 Glomerulopathy or Idiopathic Immune-complex-membranoproliferative Glomerulonephritis

Recruiting·Novartis·Phase 3·NCT03955445·225 enrolled

Primary IgA Nephropathy1 trial

A Multicenter Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan in Adult Participants With Primary IgA Nephropathy Who Have Completed Study CLNP023X2203 or CLNP023A2301

Active, not recruiting·Novartis·Phase 3·NCT04557462·448 enrolled

IgA Nephropathy1 trial

SHINE-2: Iptacopan in IgA Nephropathy

Recruiting·Novartis·Phase 3·NCT04578834·580 enrolled

Details

Drug Info

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