PIASKY

(Crovalimab)

Phase 3Monoclonal antibody

PIASKY is a monoclonal antibody that works as a C5 Inhibitor.[2] It is being investigated across 3 indications, with its most advanced program in Phase 3.[1]

PIASKY is one of 88 monoclonal antibody programs targeting Antiphospholipid Syndrome. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Antiphospholipid SyndromeActive, not recruiting

Paroxysmal Nocturnal HemoglobinuriaActive, not recruiting

Sickle Cell DiseaseRecruiting

Antiphospholipid SyndromePhase 2

Active, not recruiting

Paroxysmal Nocturnal HemoglobinuriaPhase 1/Phase 2

Active, not recruiting

Sickle Cell DiseasePhase 3

Recruiting

Competition

Competitive Landscape

272 competitors in Sickle Cell Disease

#DrugCompanyPhaseTrials

Adakveo

Novartis

Phase 3

7 2

Exjade

Novartis

Phase 3

4 3

Brilinta

AstraZeneca

Phase 3

3 4

Campath

GGenzyme, a Sanofi Company

Phase 3

12 5

Ritalin

Novartis

Phase 3

2 6

Cysteine Hydrochloride

Novartis

Phase 3

2 7

Eliquis

Bristol-Myers Squibb

Phase 3

1 8

Oxbryta

GGlobal Blood Therapeutics

Phase 3

5 9

Aqvesme

AAgios Pharmaceuticals, Inc.

Phase 3

4 10

Effient

CCosette Pharmaceuticals, Inc.

Phase 3

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

Timeline

Expected Milestones

Q3 2026

Phase 1/2Active, not recruiting

Paroxysmal Nocturnal Hemoglobinuria

NCT03157635

Q4 2026

Phase 3Active, not recruiting

Paroxysmal Nocturnal Hemoglobinuria

NCT04654468

Q3 2027

Phase 3Active, not recruiting

Paroxysmal Nocturnal Hemoglobinuria

NCT04432584

Phase 3Active, not recruiting

Paroxysmal Nocturnal Hemoglobinuria

NCT04434092

Q2 2029

Phase 3Active, not recruiting

Atypical Hemolytic-Uremic Syndrome

NCT04958265

Clinical

Trials by Indication[1]

Paroxysmal Nocturnal Hemoglobinuria4 trials

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04432584·190 enrolled

A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04434092·210 enrolled

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04654468·51 enrolled

Show 1 more trial

Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria

Active, not recruiting· Roche logo

Roche·Phase 1/2·NCT03157635·59 enrolled

Sickle Cell Disease2 trials

A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)

Active, not recruiting· Roche logo

Roche·Phase 2·NCT05075824·90 enrolled

A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Participants With Sickle Cell Disease (SCD).

Completed· Roche logo

Roche·Phase 1·NCT04912869·30 enrolled

Atypical Hemolytic-Uremic Syndrome2 trials

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04958265·41 enrolled

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04861259·83 enrolled

Efficacy1 trial

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Participants With Guillain-Barré Syndrome (GBS)

Withdrawn· Roche logo

Roche·Phase 3·NCT05494619

Antiphospholipid Syndrome1 trial

A Study to Evaluate Crovalimab in People With Antiphospholipid Syndrome (APS)

Withdrawn· Roche logo

Roche·Phase 2·NCT07172022

Regulatory

FDA Approval Timeline[4]

Jun 20, 2024

PIASKY

BLA BLA761388

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Crovalimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Crovalimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Crovalimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761388). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: C5 Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Roche

PIASKY

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q3 2027

Q2 2029

Trials by Indication[1]

Paroxysmal Nocturnal Hemoglobinuria4 trials

Sickle Cell Disease2 trials

Atypical Hemolytic-Uremic Syndrome2 trials

Efficacy1 trial

Antiphospholipid Syndrome1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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