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 65 monoclonal antibody programs targeting Atypical Hemolytic-Uremic Syndrome. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Atypical Hemolytic-Uremic SyndromeActive, not recruiting

Paroxysmal Nocturnal HemoglobinuriaActive, not recruiting

Sickle Cell DiseaseActive, not recruiting

Atypical Hemolytic-Uremic SyndromePhase 3

Active, not recruiting

Paroxysmal Nocturnal HemoglobinuriaPhase 3

Active, not recruiting

Sickle Cell DiseasePhase 3

Active, not recruiting

Competition

Competitive Landscape

98 competitors in Sickle Cell Disease

#DrugCompanyPhaseTrials

Campath

GGenzyme, a Sanofi Company

Phase 3

13 2

Ritalin

Novartis

Phase 3

2 3

Aqvesme

AAgios Pharmaceuticals, Inc.

Phase 3

4 4

Toradol

JJavelin Pharmaceuticals

Phase 3

2 5

Wayrilz

GGenzyme, a Sanofi Company

Phase 3

1 6

Fludara

Sanofi

Phase 2

9 7

Cellcept

Roche

Phase 2

6 8

Tepadina

Jazz Pharmaceuticals

Phase 2

4 9

Rapamune

PPrism Pharmaceuticals

Orencia

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

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Paroxysmal Nocturnal Hemoglobinuria

NCT04654468

Q2 2027

Phase 3Active, not recruiting

Paroxysmal Nocturnal Hemoglobinuria

NCT04434092

Phase 3Active, not recruiting

Paroxysmal Nocturnal Hemoglobinuria

NCT04432584

Q2 2029

Phase 3Active, not recruiting

Atypical Hemolytic-Uremic Syndrome

NCT04958265

Q3 2029

Phase 3Active, not recruiting

Atypical Hemolytic-Uremic Syndrome

NCT04861259

Clinical

Trials by Indication[1]

Paroxysmal Nocturnal Hemoglobinuria3 trials

A Phase III, Multicenter, Single Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04654468·51 enrolled

A Phase III, Randomized, Open-label, Active-controlled, Multicenter Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04434092·210 enrolled

A Phase III, Randomized, Open-label, Active-controlled, Multicenter Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamic and Efficacy of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04432584·190 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 Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Pediatric Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04958265·41 enrolled

A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04861259·83 enrolled

Antiphospholipid Syndrome1 trial

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

Withdrawn· Roche logo

Roche·Phase 2·NCT07172022

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

1 more indication

Paroxysmal Hemoglobinuria, Nocturnal1 trial

An Adaptive Phase I/II Study to Assess Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Crovalimab in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Completed· Roche logo

Roche·Preclinical·NCT03157635·59 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 20, 2024

PIASKY

BLA BLA761388

May 14, 2025

PIASKY

NDA 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 (NDA 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

Q1 2027

Q2 2027

Q2 2029

Q3 2029

Trials by Indication[1]

Paroxysmal Nocturnal Hemoglobinuria3 trials

Sickle Cell Disease2 trials

Atypical Hemolytic-Uremic Syndrome2 trials

Antiphospholipid Syndrome1 trial

Efficacy1 trial

Paroxysmal Hemoglobinuria, Nocturnal1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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