Drugs / Avacincaptad Pegol

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) IZERVAY 2025-02-12 fda.gov
Approved US (FDA) IZERVAY 2023-08-04 fda.gov

Trials 11 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT06961370 Jul 2025 → Jan 2027 expected age-related macular degeneration, diffuse secondary choroid atrophy Hoffmann-La Roche Active not recruiting No outcome recorded
Phase 1 NCT00709527 Oct 2008 → Dec 2009 wet macular degeneration Ophthotech Corporation Completed No outcome recorded
Phase 25 trials
Phase 2 NCT03374670 Nov 2018 → Dec 2019 Ophthotech Corporation Withdrawn No outcome recorded
Phase 2 NCT03364153 Jan 2018 → Mar 2025 Stargardt disease Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 2 NCT03362190 Oct 2017 → Oct 2018 wet macular degeneration Ophthotech Corporation Completed No outcome recorded
Phase 2 NCT05571267 Oct 2016 → Apr 2018 wet macular degeneration IVERIC bio, Inc. Terminated No outcome recorded
Phase 2 NCT02397954 Mar → Oct 2015 Ophthotech Corporation Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT02686658 Dec 2015 → Sep 2019 diffuse secondary choroid atrophy, dry age related macular degeneration IVERIC bio, Inc. Completed No outcome recorded
Phase 32 trials
Phase 3 NCT05536297 Sep 2022 → Apr 2025 age-related macular degeneration, diffuse secondary choroid atrophy Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 3 NCT04435366 Jun 2020 → Jul 2022 age-related macular degeneration, diffuse secondary choroid atrophy IVERIC bio, Inc. Completed No outcome recorded
Phase 41 trial
Phase 4 NCT06970665 Jul 2025 → Jun 2027 expected age-related macular degeneration, diffuse secondary choroid atrophy Astellas Pharma Inc Active not recruiting No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00950638 Comparator Jul 2009 → Mar 2011 dry age related macular degeneration Ophthotech Corporation Completed No outcome recorded
Phase 21 trial
Phase 2 NCT06659445 Comparator Oct 2025 → Nov 2028 expected dry age related macular degeneration ONL Therapeutics Recruiting No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 13 sources stand behind the page.

FieldValueCited text
Known as Avacincaptad Pegol “Drug: Avacincaptad PegolNCT05571267
10

NCT00709527

NCT05536297

NCT04435366

NCT06970665

NCT03364153

NCT00950638

NCT06659445

NCT02686658

NCT03362190

NCT02397954

Known as Izervay ClinicalTrials.gov intervention name — accepted as the source's own label NCT06961370
Known as Zimura ClinicalTrials.gov intervention name — accepted as the source's own label NCT03374670
Action Inhibit “Zimura™ (Anti-C5 Aptamer)” NCT02397954
Modality Aptamer “Zimura™ (Anti-C5 Aptamer)” NCT02397954
Route Intravitreal “monthly intravitreous injections” NCT02397954
Target C5 “Zimura™ (Anti-C5 Aptamer)” NCT02397954