Drugs / tosatoxumab
tosatoxumab
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01589185 | May 2012 → May 2016 | staphylococcus aureus pneumonia | Aridis Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT03816956 | May 2019 → Oct 2022 | respiratory tract infectious disorder, staphylococcus aureus infection | Aridis Pharmaceuticals, Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-07-12 | Aridis Pharmaceuticals, Inc. | Regulatory Aridis AR-301 Monoclonal Antibody is Among the First Biologics to Receive FDA’s Qualified Infectious Diseases Product (QIDP) Designation aridispharma.com ↗ |
| 2023-06-20 | Aridis Pharmaceuticals, Inc. | Regulatory Aridis Pharmaceuticals’ AR-301 Eligible for Consideration under FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs(LPAD) aridispharma.com ↗
Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti -infective therapies for treating life-threatening infections, today announced that its AR-301 clinical program has been deemed eligible for consideration under the U.S. Food and Drug Administration’s (FDA) Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). |
| 2023-05-31 | Aridis Pharmaceuticals, Inc. | Regulatory Aridis Receives Agreement from the FDA on a Single Confirmatory Phase 3 Study of AR-301 and the Clinical Study Design aridispharma.com ↗
FDA agreed on the design of the single confirmatory Phase 3 superiority study required to support the submission of a Biologics License Application (BLA). |
| 2023-01-25 | Aridis Pharmaceuticals, Inc. | Results Aridis Reports Top-Line Results of the Phase 3 Double-Blinded, Superiority Trial of AR-301 For the Treatment of Staphylococcus aureus Ventilator Associated Pneumonia (VAP) aridispharma.com ↗ |
All press releases naming this drug 5 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tosatoxumab | “AR-301 (tosatoxumab) 20 mg/kg administered once intravenously the day of enrolment.” NCT03816956 ↗ |
| Known as | AR-301 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03816956 ↗ |
| Known as | KBSA301 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01589185 ↗ |
| Modality | Monoclonal antibody | — CHEMBL4594526 ↗ |
| Route | Intravenous | “single intravenous administration of KBSA301” NCT01589185 ↗ |