Drugs / AU409
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06374485 | May 2024 → Dec 2025 overdue | hepatocellular carcinoma | Lee's Pharmaceutical Limited | Recruiting | No outcome recorded |
| Phase 1 | NCT05791448 | Mar 2023 → Mar 2027 expected | cholangiocarcinoma, hepatocellular carcinoma, metastatic malignant neoplasm | University of Southern California | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2022-11-09 | Lee's Pharmaceutical Limited | Regulatory Approval of a drug product AU409 manufactured by Zhaoke Guangzhou to conduct clinical trial in the United States leespharm.com ↗
AU409, an investigational new drug candidate, drug product manufactured by Zhaoke Pharmaceutical (Guangzhou) Limited (“Zhaoke Guangzhou”), a wholly-owned subsidiary of the Group, has been approved by the United States Food and Drug Administration (“US FDA”) to conduct clinical trial in patients with advanced primary liver cancers or advanced solid tumor with liver predominant metastatic disease in the United States. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2022-11-09 | Lee's Pharmaceutical Limited | Approval of a drug product AU409 manufactured by Zhaoke Guangzhou to conduct clinical trial in the United States leespharm.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AU409 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06374485 ↗ |
| Modality | Other / unclassified | “RNA transcription modulator AU-409” NCT05791448 ↗ |
| Route | Oral | “Patients receive AU409 orally (PO) on study.” NCT05791448 ↗ |