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Drug

Crovalimab

Approved medicine
ClassComplement C5 inhibitorResearchOngoing clinical research

Also known as Piasky, IMMUNOGLOBULIN G1-KAPPA, ANTI-(HOMO SAPIENS C5 (COMPLEMENT 5)), MONOCLONAL ANTIBODYGAMMA1 HEAVY CHAIN (1-451) (VH (VICUGNA PACOS IGHV3S1*01 (70.4%)/HOMO SAPIENS IGHV3-66*01 (69.4%)-(IGHD)-HOMO SAPIENS IGHJ4*01 (100%)) (9.8.15) (1-123)-HOMO SAPIENS IGHG1*.

RxNorm2686619ChEMBLCHEMBL4594316ATCL04AJ07UNIIH9KH1GP3UU
6
Active clinical trials
Complement C5
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-08-26Results posted · ClinicalTrials.gov

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

Clinical trial2026-08-18Results posted · ClinicalTrials.gov

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)

Clinical trial2026-08-13Primary completion · ClinicalTrials.gov

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

Clinical trial2026-07-28Results expected Q2 2027 · ClinicalTrials.gov

A Randomized Double-Blind Phase IIA 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)

Clinical trial2026-04-09Completed · ClinicalTrials.gov

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)

Clinical trial2025-10-09Primary completion · ClinicalTrials.gov

A Phase IB Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Patients With Sickle Cell Disease (SCD)

Clinical trial2025-08-15Completed · ClinicalTrials.gov

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)

Clinical trial2025-07-04Primary completion · ClinicalTrials.gov

Approval: Piasky (EMA)

Regulatory2024-08-22EMA

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Patients With Guillain-Barré Syndrome

Clinical trial2026-09-30Withdrawn · ClinicalTrials.gov

A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating Efficacy, Safety, and Pharmacokinetics of Crovalimab in Patients With Antiphospholipid Syndrome (APS)

Clinical trial2030-12-02Withdrawn · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Crovalimab
Aliases & brands
PiaskyIMMUNOGLOBULIN G1-KAPPA, ANTI-(HOMO SAPIENS C5 (COMPLEMENT 5)), MONOCLONAL ANTIBODYGAMMA1 HEAVY CHAIN (1-451) (VH (VICUGNA PACOS IGHV3S1*01 (70.4%)/HOMO SAPIENS IGHV3-66*01 (69.4%)-(IGHD)-HOMO SAPIENS IGHJ4*01 (100%)) (9.8.15) (1-123)-HOMO SAPIENS IGHG1*
RxNorm CUI
2686619
ChEMBL ID
CHEMBL4594316
ATC codes
L04AJ07
UNII
H9KH1GP3UU
Primary mechanism
Complement C5 inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Complement C5
C5 · P01031
INHIBITORComplement C5 inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2024-08-22
Latest approval
2024-08-22
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2024-08-22Approval
Approval: Piasky (EMA)
Indication: Piasky as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age or older with a weight of 40 kg and above with paroxysmal nocturnal… Show full indication

Piasky as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age or older with a weight of 40 kg and above with paroxysmal nocturnal haemoglobinuria (PNH): In patients with haemolysis with clinical symptom(s) indicative of high disease activity. In patients who are clinically stable after having been treated with a complement component 5 (C5) inhibitor for at least the past 6 months.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

10 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
10
registered trials across all phases
LATEST COMPLETION 2026
6
Active studies
6
Late-stage (III+)
2
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 10
Phase 11Phase 1 / 21Phase 22Phase 36

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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 recruitingPH IIIHoffmann-La Rochen=832029

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 recruitingPH IIIHoffmann-La Rochen=412029

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 recruitingPH IIIHoffmann-La Rochen=1902027

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 recruitingPH IIIHoffmann-La Rochen=2102027

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 recruitingPH IIIHoffmann-La Rochen=512027
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.