crovalimab

Trade name: PIASKY

mAbapprovedOrphan Drug FDA

Approved

Jun 20, 2024

Clinical trial activity

10 trials · 2 clinical orgs · 2 marketing orgs

Phase 1
2
Phase 2
9
Phase 3
6
Phase 4
0

Earliest trial started Nov 14, 2016 (NCT03157635)

Timeline

2010s

  1. Jan 1, 2016

    Roche — Earliest Phase 1 Sponsor(trial)

  2. Sep 5, 2017

    Orphan Drug Designation

2020s

  1. Jan 1, 2020

    Roche — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2021

    Roche — Earliest Phase 2 Sponsor(trial)

  3. Jun 20, 2024

    Roche — Earliest FDA Approval

  4. Jun 20, 2024

    Genentech — Marketing Organization

  5. Jun 20, 2024

    Roche — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedJun 20, 2024

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • ro7112689

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07172022Phase 2Mar 16, 2026Roche
NCT05494619Phase 3Nov 30, 2022Roche
NCT05075824Phase 2Dec 17, 2021Roche
NCT04912869Phase 1Dec 15, 2021Roche
NCT04958265Phase 3Nov 20, 2021Chugai, Roche
NCT04861259Phase 3Oct 22, 2021Chugai, Roche
NCT04654468Phase 3Mar 10, 2021Roche
NCT04432584Phase 3Sep 1, 2020Chugai, Roche
NCT04434092Phase 3Aug 2, 2020Chugai, Roche
NCT03157635Phase 1/Phase 2 (Phase 2)Nov 14, 2016Roche
Showing 10 of 10 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RocheFor profit101032016
ChugaiFor profit4012020
2 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
GenentechFor profitMKTGJun 20, 2024
RocheFor profitNDAJun 20, 2024