Drugs / Sipavibart
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed COVID-19 1 milestone | |||||
| Filed | EU (EMA) | — | COVID-19 | 2024-07-01 | “AstraZeneca’s Marketing Authorisation Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA)” astrazeneca.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Kavigale | — | 2025-01-20 | europa.eu ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05932641 | Jul 2023 → Dec 2024 | COVID-19 | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05872958 | May 2023 → Aug 2024 | COVID-19 | AstraZeneca | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06057064 | Sep 2023 → May 2024 | COVID-19 | AstraZeneca | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT05648110 | Dec 2022 → Mar 2024 | COVID-19 | AstraZeneca | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT07021794 Comparator | Jul 2025 → Sep 2027 expected | long COVID-19 | Nancy Klimas | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2024-07-01 | AstraZeneca | Regulatory Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention astrazeneca.com ↗
AstraZeneca’s Marketing Authorisation Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients. |
| 2024-05-16 | AstraZeneca | Results SUPERNOVA Phase III trial of sipavibart long-acting antibody met primary endpoints in preventing COVID-19 in immunocompromised patient population astrazeneca.com ↗
SUPERNOVA demonstrated the potential benefit of sipavibart in an evolving variant landscape in which COVID-19 cases captured over the course of the trial were caused by several different SARS-CoV-2 variants. |
| 2024-04-17 | AstraZeneca | Results AstraZeneca advances the science of infectious disease protection at ECCMID 2024 astrazeneca.com ↗
Pharmacokinetics and safety of the SARS-CoV-2 monoclonal antibody AZD3152 are consistent with those of tixagevimab/cilgavimab |
| 2023-10-11 | AstraZeneca | Results AstraZeneca reinforces commitment to protecting the most vulnerable from serious infectious diseases at IDWeek 2023 astrazeneca.com ↗
The SARS-CoV-2 monoclonal antibody AZD3152 potently neutralises historical and emerging variants and is being developed for the prevention and treatment of COVID-19 in high-risk individuals |
All press releases naming this drug 4 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sipavibart | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07021794 ↗ |
| Known as | AZD3152 | “This placebo-controlled, randomized, blinded, two-arm phase II study will test the safety and potential efficacy of the targeted mAb, Sipavibart (formerly AZD3152) in patients...” NCT07021794 ↗ |
| Action | Inhibit | “AZD3152 binds to the back left shoulder of the SARS-CoV-2 spike protein receptor binding domain and prevents interaction with the human angiotensin-converting enzyme 2 receptor.” PMID 38924429 ↗ Jun 2024 |
| Modality | Monoclonal antibody | “AZD3152, a SARS-CoV-2-neutralizing monoclonal antibody designed to provide improved potency and coverage against emerging variants.” PMID 38924429 ↗ Jun 2024 |
| Route | Intramuscular | “1 IM injection (thigh) of 2 mL of AZD3152 on Visit 1 Day 1 and on Visit 5 Day 181” NCT05648110 ↗ |