Drugs / cilgavimab

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Withdrawn EU (EMA) Evusheld 2025-09-12 europa.eu
Approved EU (EMA) Evusheld 2022-03-25 europa.eu

Trials 16 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT05281601 Mar 2022 → Apr 2024 COVID-19 AstraZeneca Completed No outcome recorded
Phase 1 NCT05437289 Oct → Nov 2021 COVID-19 AstraZeneca Completed No outcome recorded
Phase 1 NCT04896541 Mar 2021 → Jun 2022 COVID-19 AstraZeneca Completed No outcome recorded
Phase 1 NCT04507256 Aug 2020 → Oct 2021 COVID-19 AstraZeneca Completed No outcome recorded
Phase 23 trials
Phase 2 NCT05465876 Oct 2023 → Oct 2024 B-cell chronic lymphocytic leukemia, COVID-19 Sunnybrook Health Sciences Centre Withdrawn No outcome recorded
Phase 2 NCT05375760 Jun 2022 → Oct 2023 COVID-19 AstraZeneca Terminated No outcome recorded
Phase 2 NCT05184062 Dec 2021 → Aug 2022 COVID-19 AstraZeneca Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT05648110 Dec 2022 → Mar 2024 COVID-19 AstraZeneca Completed No outcome recorded
Phase 2/3 NCT04518410 Aug 2020 → Apr 2022 COVID-19 National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 36 trials
Phase 3 NCT05438498 Jun 2022 → Apr 2023 COVID-19 MediMergent, LLC Terminated No outcome recorded
Phase 3 NCT05321394 Mar 2022 → Oct 2023 COVID-19 Azienda Ospedaliera Universitaria Integrata Verona Completed No outcome recorded
Phase 3 NCT05780437 Feb 2021 → Jan 2022 COVID-19 National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 3 NCT04723394 Jan → Aug 2021 COVID-19 AstraZeneca Completed No outcome recorded
Phase 3 NCT04501978 Aug 2020 → Apr 2022 COVID-19 National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 3 NCT04315948 Mar 2020 → Jul 2022 COVID-19 French National Institute of Health and Medical Research Completed No outcome recorded
Phase 41 trial
Phase 4 NCT05982704 Aug → Sep 2022 COVID-19 City Clinical Hospital No.52 of Moscow Healthcare Department Unknown No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT05166421 Comparator Nov 2021 → Jul 2023 COVID-19 AstraZeneca Completed No outcome recorded
Phase 21 trial
Phase 2 NCT05041907 Comparator Sep 2021 → Jan 2027 expected COVID-19 University of Oxford Recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT05271929 Background Apr 2022 → Jan 2024 COVID-19 German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen Terminated No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 20 sources stand behind the page.

FieldValueCited text
Known as cilgavimab “Safety, pharmacokinetics, and impact of race of pharmacokinetics on monoclonal antibodies tixagevimab and cilgavimab (AZD7442) were assessed in Chinese adult participants in a...” PMID 40910575 Sep 2025
12

“BACKGROUND: AZD7442 is a combination of extended half-life, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific neutralizing monoclonal antibodies...” PMID 36683419 May 2023

“AZD7442 (Evusheld) is a combination of two human anti-severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) monoclonal antibodies (mAbs), tixagevimab (AZD8895) and...” PMID 35797235 Jul 2022

“AZD7442, a combination of extended half-life monoclonal antibodies tixagevimab and cilgavimab, was shown to neutralize previously circulating SARS-CoV-2 variants.” PMID 40799036 Aug 2025

“EVUSHELD is a combination of 2 monoclonal antibodies (mAbs), Tixagevimab and Cilgavimab.” NCT05465876

“Monoclonal antibodies: 300mg tixagevimab/ 300 mg cilgavimab given once on D0” NCT05041907

“AZD1061 \[cilgavimab, a component of AZD7442 (EVUSHELD)\]” NCT05648110

“one each of 300 mg tixagevimab and 300 mg cilgavimabPMID 35688164 Jun 2022

“Tixagevimab / Cilgavimab (Evusheld)” NCT05271929

NCT05438498

NCT05375760

NCT05321394

NCT05982704

Known as 2130 ChEMBL registry synonym — accepted as the source's own label CHEMBL4650258
Known as AZD1061 “AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct...” NCT05780437
7

“AZD7442 will be supplied as separate vials of AZD8895 and AZD1061 containing 150 mg colorless to slightly yellow, clear to opalescent solutions for injection.” NCT04315948

“IM Administration: AZD8895 and AZD1061 (comprising AZD7442), must both be administered separately to the participant in a sequential order.” NCT05281601

“AZD7442, a combination of 2 of these mAbs (AZD8895 and AZD1061), is being evaluated for administration to treat or prevent COVID-19.” NCT04896541

“600 mg AZD5156 consisting of 300 mg AZD1061 at 100 mg/mL and 300 mg AZD3152 at 150 mg/mL” NCT05648110

“cilgavimab [investigational name, AZD1061]” NCT05375760

NCT04501978

NCT05166421

Known as COV2-2130 ChEMBL registry synonym — accepted as the source's own label CHEMBL4650258
Modality Monoclonal antibody “BACKGROUND: AZD7442 is a combination of extended half-life, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific neutralizing monoclonal antibodies...” PMID 36683419 May 2023
Route Intravenous “Participants randomized to the AZD7442 group will receive a total dose of 600 mg AZD7442 via a co-administered (300 mg AZD8895 and 300 mg AZD1061) single IV infusion on Day 1.” NCT04315948