AZD7442

Overview

AZD7442 is a combination of SARS-CoV-2 antibodies (AZD8895 + AZD1061) currently undergoing phase I clinical trials for the prevention and treatment of COVID-19. It was developed by AstraZeneca with the goal of conferring at least 6 months of protection against COVID-19 - a significantly longer window of efficacy than that of other vaccines.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)	2023/03/22	NCT05780437	Phase 3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study	2022/12/13	NCT05648110	Phase 2	Completed	AstraZeneca
A Study to Evaluate the Safety and Tolerability of AZD7442 in Healthy Chinese Adults	2022/06/29	NCT05437289	Phase 1	Completed	AstraZeneca
A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19	2022/05/17	NCT05375760	Phase 2	Terminated	AstraZeneca
AZD7442 Pharmacokinetics, Pharmacodynamics, and Safety Evaluation in Pediatrics	2022/03/16	NCT05281601	Phase 1	Completed	AstraZeneca
A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults	2022/01/11	NCT05184062	Phase 2	Completed	AstraZeneca
Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061) vs AZD8895 and AZD1061 Individually in Adult Healthy Participants	2021/12/22	NCT05166421	Phase 1	Completed	AstraZeneca
Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults	2021/01/25	NCT04723394	Phase 3	Completed	AstraZeneca
Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.	2020/11/12	NCT04625725	Phase 3	Completed	AstraZeneca
Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults	2020/11/12	NCT04625972	Phase 3	Completed	AstraZeneca

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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