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Polymyositis

3
Pipeline Programs
4
Companies
4
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
1
0
1
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Japan Blood Products Organization
1 program
1
GB-0998Phase 31 trial
Active Trials
NCT00335985Completed26Est. Mar 2009
Sandoz
SandozAustria - Kundl
1 program
1
BAF312Phase 2
Restem
RestemCA - Corona
1 program
1
Umbilical Cord Lining Stem CellsPhase 11 trial
Active Trials
NCT04723303Completed10Est. Mar 2024
Kezar Life Sciences
Kezar Life SciencesCA - South SF
2 programs
KZR-616PHASE_21 trial
KZR-616PHASE_21 trial
Active Trials
NCT04628936Completed18Est. Jun 2023
NCT04033926Completed25Est. Apr 2022

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Japan Blood Products OrganizationGB-0998
Kezar Life SciencesKZR-616
Kezar Life SciencesKZR-616
RestemUmbilical Cord Lining Stem Cells

Clinical Trials (4)

Total enrollment: 79 patients across 4 trials

Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)

Start: Jun 2006Est. completion: Mar 200926 patients
Phase 3Completed

Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.

Start: Nov 2020Est. completion: Jun 202318 patients
Phase 2Completed

A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis

Start: Jan 2020Est. completion: Apr 202225 patients
Phase 2Completed
NCT04723303RestemUmbilical Cord Lining Stem Cells

Phase 1 Study of ULSC in Patients With Polymyositis (PM) and Dermatomyositis (DM)

Start: Oct 2021Est. completion: Mar 202410 patients
Phase 1Completed

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
4 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.