zilucoplan

Trade name: ZILBRYSQ

Small moleculeapprovedOrphan Drug FDA

Approved

Oct 17, 2023

Clinical trial activity

18 trials · 6 clinical orgs · 1 marketing orgs

Phase 1
2
Phase 2
13
Phase 3
10
Phase 4
0

Earliest trial started Feb 1, 2017 (NCT03030183)

Timeline

2010s

  1. Jan 1, 2017

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2019

    Earliest Phase 3 Sponsor(trial)

  3. Aug 26, 2019

    Orphan Drug Designation

2020s

  1. Oct 17, 2023

    UCB — Earliest FDA Approval

  2. Oct 17, 2023

    UCB — Marketing Organization

  3. Oct 17, 2023

    UCB — NDA Organization

  4. Jan 1, 2024

    UCB — Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedOct 17, 2023

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • ra101495

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07215949Phase 3Dec 1, 2025Ohio State University, UCB
NCT06961747Phase 1Jul 9, 2025UCB
NCT06435312Phase 3Oct 28, 2024UCB
NCT06471361Phase 3Aug 27, 2024UCB
NCT06511076Phase 1Aug 5, 2024UCB
NCT06055959Phase 2/Phase 3 (Phase 3)Jan 31, 2024UCB
NCT05514873Phase 3Oct 31, 2022UCB
NCT04590586Phase 3Nov 24, 2020Amgen
NCT04436497Phase 2/Phase 3 (Phase 3)Jun 30, 2020Harvard University, Ra Pharmaceuticals
NCT04297683Phase 2/Phase 3 (Phase 3)May 31, 2020Harvard University
NCT04382755Phase 2May 31, 2020Ghent University, UCB
NCT04225871Phase 3Jan 31, 2020Ra Pharmaceuticals
NCT04025632Phase 2Nov 30, 2019Ra Pharmaceuticals
NCT04115293Phase 3Oct 1, 2019Ra Pharmaceuticals
NCT03315130Phase 2Oct 11, 2017Ra Pharmaceuticals
NCT03225287Phase 2Jul 17, 2017Ra Pharmaceuticals
NCT03078582Phase 2Mar 1, 2017Ra Pharmaceuticals
NCT03030183Phase 2Feb 1, 2017Ra Pharmaceuticals
Showing 18 of 18 trials
Page 1 / 1

Organizations

Research & Development (6)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Ra PharmaceuticalsFor profit8722017
UCBFor profit8632020
Harvard UniversityAcademic/Hospital2212020
AmgenFor profit1112020
Ghent UniversityAcademic/Hospital1112020
Ohio State UniversityAcademic/Hospital1112025
6 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
UCBFor profitMKTGOct 17, 2023
UCBFor profitNDAOct 17, 2023