Drugs / cilgavimab
cilgavimab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Evusheld | — | 2025-09-12 | europa.eu ↗ |
| Approved | EU (EMA) | Evusheld | — | 2022-03-25 | europa.eu ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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NCT05465876 | Oct 2023 → Oct 2024 | B-cell chronic lymphocytic leukemia, COVID-19 | Sunnybrook Health Sciences Centre | Withdrawn | No outcome recorded Stop: Business |
| 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 · 1 met primary | ||||||
| Phase 2/3 | NCT05648110 | Dec 2022 → Mar 2024 | COVID-19 | AstraZeneca | Completed | Met primary |
| 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 · 1 met primary · 3 missed | ||||||
| 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 | Missed primary |
| Phase 3 | NCT04723394 | Jan → Aug 2021 | COVID-19 | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT04501978 | Aug 2020 → Apr 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 3 | NCT04315948 | Mar 2020 → Jul 2022 | COVID-19 | French National Institute of Health and Medical Research | Completed | Missed primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT05982704 | Aug → Sep 2022 | COVID-19 | City Clinical Hospital No.52 of Moscow Healthcare Department | Unknown | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT05166421 Comparator | Nov 2021 → Jul 2023 | COVID-19 | AstraZeneca | Completed | Mixed |
| Phase 2 | NCT05041907 Comparator | Sep 2021 → Jan 2027 expected | COVID-19 | University of Oxford | Recruiting | Mixed |
| Phase 3 | NCT05271929 Background | Apr 2022 → Jan 2024 | COVID-19 | German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen | Terminated | Met primary Stop: Enrollment |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2023-01-26 | AstraZeneca | Regulatory Update on US Food and Drug Administration Emergency Use Authorisation of Evusheld astrazeneca.com ↗
Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorised for Emergency Use for pre-exposure prophylaxis (prevention) of COVID-19 in the US until further notice |
| 2022-10-20 | AstraZeneca | Results IDWeek data reinforces AstraZeneca’s commitment to advance science in vaccines and immune therapies astrazeneca.com ↗
Additional analyses from TACKLE Phase III treatment trial further demonstrate Evusheld’s potential to reduce COVID-19 severity and mortality |
| 2022-09-20 | AstraZeneca | Regulatory Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19 astrazeneca.com ↗ |
| 2022-09-16 | AstraZeneca | Regulatory Evusheld long-acting antibody combination recommended for approval in the EU for the treatment of COVID-19 astrazeneca.com ↗
AstraZeneca's Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID‑19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID‑19. |
| 2022-08-30 | AstraZeneca | Regulatory Evusheld long-acting antibody combination approved for prevention and treatment of COVID-19 in Japan astrazeneca.com ↗
AstraZeneca's Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection. |
| 2022-06-08 | AstraZeneca | Results Evusheld significantly prevented COVID-19 disease progression or death in TACKLE Phase III treatment trial astrazeneca.com ↗ |
| 2022-04-20 | AstraZeneca | Results Evusheld significantly protected against symptomatic COVID-19 for at least six months in PROVENT Phase III trial in high-risk populations astrazeneca.com ↗
Detailed results from the PROVENT Phase III pre-exposure prophylaxis (prevention) trial showed that AstraZeneca’s Evusheld (tixagevimab and cilgavimab), formerly AZD7442, reduced the risk of developing symptomatic COVID-19 by 77% in the primary analysis and by 83% in the six month follow-up analysis, compared to placebo. |
| 2022-03-28 | AstraZeneca | Regulatory Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population astrazeneca.com ↗ |
| 2022-03-24 | AstraZeneca | Regulatory Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19 astrazeneca.com ↗ |
| 2022-03-17 | AstraZeneca | Regulatory AstraZeneca’s antibody combination, Evusheld▼ (tixagevimab co-packaged with cilgavimab) authorised for use in Great Britain for pre-exposure prophylaxis (prevention) of COVID-19 astrazeneca.com ↗
AstraZeneca's Evusheld ▼ (tixagevimab co-packaged with cilgavimab) is authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) and is the first antibody combination for pre-exposure prophylaxis (PrEP) against COVID-19 licensed in Great Britain. |
| 2021-12-23 | AstraZeneca | Results Evusheld long-acting antibody combination retains neutralising activity against Omicron variant in studies from Oxford and Washington Universities astrazeneca.com ↗
Evusheld’s Inhibitory Concentration 50 (IC50), a measure of neutralising potency of an antibody, was 273 ng/ml and 147 ng/ml in the Oxford and Washington University studies, respectively. |
| 2021-12-16 | AstraZeneca | Results Evusheld long-acting antibody combination retains neutralising activity against Omicron variant in independent FDA study astrazeneca.com ↗ |
| 2021-12-08 | AstraZeneca | Regulatory Evusheld (formerly AZD7442) long-acting antibody combination authorised for emergency use in the US for pre-exposure prophylaxis (prevention) of COVID-19 astrazeneca.com ↗
AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination, has received emergency use authorisation (EUA) in the US for the pre-exposure prophylaxis (prevention) of COVID-19, with first doses expected to become available very soon. |
| 2021-11-18 | AstraZeneca | Results New analyses of two AZD7442 COVID-19 Phase III trials in high-risk populations confirm robust efficacy and long-term prevention astrazeneca.com ↗
In an analysis of the ongoing PROVENT trial evaluating a median six months of participant follow-up, one 300mg IM dose of AZD7442 reduced the risk of developing symptomatic COVID-19 compared to placebo by 83%. |
| 2021-10-11 | AstraZeneca | Results AZD7442 reduced risk of developing severe COVID-19 or death in TACKLE Phase III outpatient treatment trial astrazeneca.com ↗
Positive high-level results from the TACKLE Phase III COVID-19 treatment trial showed AstraZeneca's AZD7442, a long acting antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalised patients with mild-to-moderate symptomatic COVID-19. |
| 2021-09-27 | AstraZeneca | Results AstraZeneca COVID-19 and RSV presentations at IDWeek 2021 will showcase scientific progress in infectious diseases astrazeneca.com ↗
The data showed that AZD7442 compared to placebo achieved a statistically significant reduction in the risk of developing symptomatic COVID-19 prior to virus exposure (pre-exposure prophylaxis). |
| 2021-08-20 | AstraZeneca | Results AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in preventing COVID-19 astrazeneca.com ↗
Positive high-level results from the PROVENT Phase III pre-exposure prophylaxis trial showed AstraZeneca's AZD7442 achieved a statistically significant reduction in the incidence of symptomatic COVID-19, the trial's primary endpoint. |
All press releases naming this drug 17 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited 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 202512“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 cilgavimab” PMID 35688164 ↗ Jun 2022 “Tixagevimab / Cilgavimab (Evusheld)” NCT05271929 ↗ |
| 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 ↗ |
| 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 ↗ |