CDEK
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pegcetacoplan

Trade name: Empaveli

PeptideapprovedOrphan Drug FDAFast Track FDA

Approved

May 14, 2021

Clinical trial activity

31 trials · 5 clinical orgs · 1 marketing orgs

Phase 1
7
Phase 2
24
Phase 3
12
Phase 4
0

Earliest trial started Nov 1, 2014 (NCT02264639)

Timeline

2010s

  1. Jan 1, 2014

    Apellis Pharmaceuticals, Inc. — Earliest Phase 1 Sponsor(trial)

  2. Apr 20, 2014

    Orphan Drug Designation

  3. Jan 1, 2015

    Apellis Pharmaceuticals, Inc. — Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 2018

    Apellis Pharmaceuticals, Inc. — Earliest Phase 3 Sponsor(trial)

2020s

  1. May 14, 2021

    Apellis Pharmaceuticals, Inc. — Earliest FDA Approval

  2. May 14, 2021

    Apellis Pharmaceuticals, Inc. — Marketing Organization

  3. May 14, 2021

    Apellis Pharmaceuticals, Inc. — NDA Secondary Org

  4. May 14, 2021

    Apellis Pharmaceuticals, Inc. — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackMay 14, 2021

Chemistry & pharmacology

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

Oral

No

Parenteral

Yes

Topical

No

Black box warningFirst in class

Sources

Also known as

  • apl-2

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07213960Phase 2/Phase 3 (Phase 3)Dec 31, 2025Apellis Pharmaceuticals, Inc.
NCT07214298Phase 1/Phase 2 (Phase 2)Dec 1, 2025State University of New York, Buffalo
NCT07214740Phase 3Oct 31, 2025Apellis Pharmaceuticals, Inc.
NCT07020832Phase 3Sep 30, 2025Apellis Pharmaceuticals, Inc.
NCT06961370Phase 1Jul 16, 2025Roche
NCT07215390Phase 2Jun 23, 2025Apellis Pharmaceuticals, Inc.
NCT06722157Phase 2Dec 26, 2024Boehringer Ingelheim
NCT05809531Phase 3May 31, 2023Apellis Pharmaceuticals, Inc.
NCT05096403Phase 3Dec 31, 2021Swedish Orphan Biovitrum
NCT04919629Phase 2Dec 1, 2021State University of New York, Buffalo
NCT05148299Phase 2Dec 1, 2021Apellis Pharmaceuticals, Inc., Swedish Orphan Biovitrum
NCT05067127Phase 3Oct 31, 2021Apellis Pharmaceuticals, Inc.
NCT04770545Phase 3Mar 4, 2021Apellis Pharmaceuticals, Inc.
NCT04901936Phase 2Feb 4, 2021Apellis Pharmaceuticals, Inc.
NCT04572854Phase 2Nov 30, 2020Apellis Pharmaceuticals, Inc.
NCT04579666Phase 2Sep 30, 2020Apellis Pharmaceuticals, Inc.
NCT04085601Phase 3Aug 14, 2019Apellis Pharmaceuticals, Inc.
NCT03777332Phase 1Nov 5, 2018Apellis Pharmaceuticals, Inc.
NCT03525600Phase 3Aug 31, 2018Apellis Pharmaceuticals, Inc.
NCT03593200Phase 2Aug 31, 2018Apellis Pharmaceuticals, Inc.
Showing 20 of 31 trials
Page 1 / 2

Organizations

Research & Development (5)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Apellis Pharmaceuticals, Inc.For profit262542014
State University of New York, BuffaloAcademic/Hospital2212021
Swedish Orphan BiovitrumFor profit2222021
Boehringer IngelheimFor profit1112024
RocheFor profit1112025
5 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Apellis Pharmaceuticals, Inc.For profitMKTGMay 14, 2021
Apellis Pharmaceuticals, Inc.For profitNDA2May 14, 2021
Apellis Pharmaceuticals, Inc.For profitNDAMay 14, 2021