Drugs / BACILLUS ANTHRACIS PROTECTIVE ANTIGEN, ADSORBED
BACILLUS ANTHRACIS PROTECTIVE ANTIGEN, ADSORBED
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | anthrax infection | 2022-06-24 | “announced today that the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for AV7909” emergentbiosolutions.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials | ||||||
| Phase 2 | NCT05997264 | Dec 2023 → Aug 2025 | anthrax infection | Biomedical Advanced Research and Development Authority | Completed | No outcome recorded |
| Phase 2 | NCT04067011 | Aug 2019 → Mar 2020 | anthrax infection | Emergent BioSolutions | Completed | Mixed |
| Phase 2 | NCT03518125 | May 2018 → Jan 2019 | anthrax infection | Biomedical Advanced Research and Development Authority | Completed | No outcome recorded |
| Phase 2 | NCT01770743 | Jan 2013 → Feb 2014 | anthrax infection | Emergent BioSolutions | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03877926 | Mar 2019 → Aug 2020 | anthrax infection | Emergent BioSolutions | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT04660201 Comparator | May 2022 → Nov 2023 | anthrax infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-07-20 | Emergent BioSolutions | Regulatory Emergent BioSolutions Receives U.S. FDA Approval of CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, a Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis Use emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. |
| 2022-06-24 | Emergent BioSolutions | Regulatory Emergent BioSolutions Announces FDA Acceptance of Biologics License Application for AV7909 Anthrax Vaccine Candidate emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted). |
| 2018-12-28 | Emergent BioSolutions | Regulatory Emergent BioSolutions Announces Submission to FDA of Application Covering Emergency Use Authorization for NuThrax™ emergentbiosolutions.com ↗ |
| 2011-06-09 | Emergent BioSolutions | Regulatory Emergent BioSolutions' Investigational Anthrax Vaccine, NuThrax, Granted Fast Track Designation emergentbiosolutions.com ↗
Emergent BioSolutions Inc. (NYSE:EBS) announced today that its investigational anthrax vaccine, NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). |
All press releases naming this drug 12 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BACILLUS ANTHRACIS PROTECTIVE ANTIGEN, ADSORBED | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068494 ↗ |
| Known as | Anthrax Vaccine Adsorbed, Adjuvanted | “This double-blinded randomized Phase 3 study evaluated the immunogenicity and safety of CYFENDUS® vaccine (AV7909; Anthrax Vaccine Adsorbed, Adjuvanted) to support licensure...” PMID 41401704 ↗ Dec 2025 |
| Known as | AV7909 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04067011 ↗ |
| Known as | Bacillus anthracis strain v770-np1-r antigens | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068494 ↗ |
| Known as | CYFENDUS | “This double-blinded randomized Phase 3 study evaluated the immunogenicity and safety of CYFENDUS® vaccine (AV7909; Anthrax Vaccine Adsorbed, Adjuvanted) to support licensure...” PMID 41401704 ↗ Dec 2025 |
| Modality | Vaccine | “an anthrax vaccine” NCT01770743 ↗ |
| Route | Intramuscular | “Route of administration: Intramuscular” NCT01770743 ↗ |