Drugs / Sipavibart
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Kavigale | — | 2025-01-20 | europa.eu ↗ |
Trials 4 · a red edge is where a trial was stopped
| 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 | ||||||
| Phase 2/3 | NCT05648110 | Dec 2022 → Mar 2024 | COVID-19 | AstraZeneca | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07021794 Comparator | Jun 2025 → Dec 2026 expected | long COVID-19 | Nancy Klimas | Recruiting | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-07-01 | AstraZeneca | Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention astrazeneca.com ↗ |
| 2024-05-16 | AstraZeneca | SUPERNOVA Phase III trial of sipavibart long-acting antibody met primary endpoints in preventing COVID-19 in immunocompromised patient population astrazeneca.com ↗ |
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 ↗ |