Crovalimab History and Updates

37 events · 2016 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: September 24, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-09-10Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Crovalimab since 2016, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (7)

2026

Results postedCrovalimab Trial Results in Pediatric aHUS Show Dialysis Changes· Sep 9, 2026
Primary completionCrovalimab Phase 3 Trial for Guillain-Barré Syndrome Withdrawn· Mar 19, 2026

2025

Results postedCrovalimab Phase 3 Trial for PNH Shows Non-Inferiority to Eculizumab· Nov 10, 2025
Primary completionCrovalimab for Atypical Hemolytic Uremic Syndrome Completes Phase 3 Primary…· Oct 9, 2025
Primary completionCrovalimab Phase 3 Trial for Atypical Hemolytic Uremic Syndrome Reaches…· Jul 4, 2025

2022

Primary completionCrovalimab Phase 3 PNH Trial Reports Comparable Outcomes· Nov 16, 2022
Primary completionCrovalimab Phase 3 Primary Completion for Paroxysmal Nocturnal Hemoglobinuria· Feb 10, 2022

Upcoming & expected milestones

Primary completionApr 18, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT04432584

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemo

Primary completionSep 30, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT04432584

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemo

Primary completionMar 11, 2030· ClinicalTrials.gov

Phase 2 primary completion: NCT07172022

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

Past events

2026

Primary completionSep 30, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT03157635

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

Results postedSep 9, 2026· ClinicalTrials.gov

Trial results posted: NCT04958265

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolyt

Primary completionAug 13, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT03157635

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

Primary completionMar 19, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05494619

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

Trial startedMar 16, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07172022

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

2025

Results postedNov 10, 2025· ClinicalTrials.gov

Trial results posted: NCT04434092

A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) No

Primary completionOct 9, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT04861259

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypi

Trial registeredSep 15, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07172022

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

Primary completionJul 4, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT04958265

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolyt

Primary completionJun 11, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05075824

A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occ

FDA approval (supplemental)May 14, 2025· FDA

FDA approved supplemental application for Piasky (crovalimab) — REMS (BLA 761388 S-1)

Sponsor: GENENTECH INC. Class: REMS.

2024

Primary completionDec 23, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT04912869

A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-

FDA approvalJun 20, 2024· FDA

FDA approved Piasky (crovalimab) (BLA 761388)

Sponsor: GENENTECH INC. Class: Type 1 - New Molecular Entity.

2023

Results postedJun 5, 2023· ClinicalTrials.gov

Trial results posted: NCT04654468

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemog

2022

Trial startedNov 30, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05494619

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

Primary completionNov 16, 2022· ClinicalTrials.gov

Phase 3 primary completion: NCT04434092

A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) No

Trial registeredAug 10, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05494619

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

Trial startedMar 26, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT04912869

A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-

Trial startedMar 9, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05075824

A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occ

Primary completionFeb 10, 2022· ClinicalTrials.gov

Phase 3 primary completion: NCT04654468

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemog

2021

Trial startedNov 17, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04958265

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolyt

Trial startedOct 22, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04861259

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypi

Trial registeredOct 13, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05075824

A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occ

Trial registeredJul 12, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04958265

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolyt

Trial registeredJun 3, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04912869

A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-

Trial registeredApr 27, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04861259

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypi

Trial startedMar 17, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04654468

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemog

2020

Trial registeredDec 4, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04654468

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemog

Trial startedOct 8, 2020· ClinicalTrials.gov

Phase 3 trial started: NCT04434092

A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) No

Trial startedSep 30, 2020· ClinicalTrials.gov

Phase 3 trial started: NCT04432584

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemo

Trial registeredJun 16, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04432584

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemo

Trial registeredJun 16, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04434092

A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) No

2017

Trial registeredMay 17, 2017· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT03157635

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

2016

Trial startedNov 14, 2016· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT03157635

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

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.