UPLIZNA

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Efficacy and SafetySystemic Lupus ErythematosusSystemic SclerosisMyasthenia GravisNeuromyelitis OpticaGeneralized Myasthenia GravisNMOSDAutoimmune HepatitisImmunoglobulin G4-Related Disease

242 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

1

UPLIZNA

HHorizon Therapeutics Ireland DAC

Approved

12

Rinvoq

AbbVie

Phase 3

43

Savaysa

Daiichi Sankyo

Phase 3

34

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

75

Rapamune

PPrism Pharmaceuticals

Phase 3

56

Rilutek

AAzurity Pharmaceuticals

Phase 3

37

Kineret

SSwedish Orphan Biovitrum

Phase 3

28

Becotatug Vedotin

FFudan University

Phase 3

19

Apatinib Mesylate

BBukwang Pharmaceutical

Phase 3

110

VAY736

Novartis

Phase 3

2Show 35 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Neuromyelitis Optica6 trials

N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders

Completed·AstraZeneca·Phase 2/3·NCT02200770·231 enrolled

Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder

Recruiting·Amgen·Phase 2·NCT05549258·15 enrolled

A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders

Unknown status·HHansoh BioMedical R&D Company·Phase 4·NCT06212245·33 enrolled

Show 3 more trials

Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders

Unknown status·FFeng Jinzhou··NCT06068829·80 enrolled

Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)

Active, not recruiting·Amgen·Phase 4·NCT06180278·32 enrolled

Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders

Recruiting·XXuanwu Hospital, Beijing··NCT05891379·50 enrolled

Kidney Transplant1 trial

Safety and Tolerability of Inebilizumab, VIB4920, or the Combination in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor

Withdrawn·Amgen·Phase 2·NCT04174677

Encephalitis1 trial

The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis

Recruiting·UUniversity of Utah·Phase 2·NCT04372615·116 enrolled

Myasthenia Gravis1 trial

Myasthenia Gravis Inebilizumab Trial

Active, not recruiting·Amgen·Phase 3·NCT04524273·238 enrolled

Efficacy and Safety1 trial

A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease

Active, not recruiting·Amgen·Phase 3·NCT04540497·135 enrolled

9 more indications

Systemic Sclerosis1 trial

A Study of MT-0551 in Patients With Systemic Sclerosis

Active, not recruiting·Tanabe Pharma Corporation·Phase 3·NCT05198557·80 enrolled

Generalized Myasthenia Gravis1 trial

A Phase 2 Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age With Generalized Myasthenia Gravis (gMG)

Recruiting·Amgen·Phase 2·NCT06987539·15 enrolled

Neuromyelitis Optica Spectrum Disorder1 trial

An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy

Recruiting·Amgen··NCT05909761·60 enrolled

NMOSD1 trial

A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder

Not yet recruiting·MMassachusetts General Hospital·Approved·NCT07010302·540 enrolled

Immunoglobulin G4-related Disease1 trial

Open-label, Uncontrolled, Multicenter Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age With Immunoglobulin G4-related Disease (IgG4-RD)

Not yet recruiting·Amgen·Phase 2·NCT07222553·15 enrolled

Systemic Lupus Erythematosus1 trial

A Phase 2, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases

Recruiting·Amgen·Phase 2·NCT06570798·220 enrolled

Autoimmune Hepatitis1 trial

A Phase 2/3, Randomized, Double-blind, Multicenter, Placebo-controlled Study of Inebilizumab in Participants With Autoimmune Hepatitis

Not yet recruiting·Amgen·Phase 3·NCT07598825·180 enrolled

Post-acute Infectious Syndrome (PAIS)1 trial

Prospective, Randomized, Double-blind, Placebo-controlled Phase 2b Trial Evaluating the Efficacy and Safety of the Anti-CD19 Monoclonal Antibody Inebilizumab Compared With Placebo in Patients With Post-acute Infection Syndromes Fulfilling ME/CFS Criteria (PIONEER)

Not yet recruiting·CCharite University, Berlin, Germany·Phase 2·NCT07724834·38 enrolled

Unspecified1 trial

AMG 335 Expanded Access Program for IgG4-Related Disease

Approved for marketing·Amgen··NCT06590051

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

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