Drugs / Valrubicin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | VALSTAR PRESERVATIVE FREE | — | 2013-08-02 | fda.gov ↗ |
| Approved | US (FDA) | VALSTAR PRESERVATIVE FREE | — | 1998-09-25 | fda.gov ↗ |
Trials 5 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01606345 | Jul 2012 → Apr 2016 | urothelial carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00003129 | Sep 1998 → Nov 2002 | urinary bladder cancer | Eastern Cooperative Oncology Group | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01316874 | Nov 1993 → Apr 1997 | in situ carcinoma, urinary bladder cancer | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01310803 | May 2011 → Jan 2012 | in situ carcinoma, non-invasive bladder urothelial carcinoma | Endo USA Inc., a Keenova Therapeutics Company | Terminated | No outcome recorded |
| Phase 3 | NCT00003725 | Dec 1996 → ? | urinary bladder cancer | Anthra Pharmaceuticals | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT00003759 Background | Nov 1998 → Nov 2002 | urinary bladder cancer | Anthra Pharmaceuticals | Completed | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | valrubicin | “Maintenance Therapy With Valrubicin Versus no Maintenance” NCT01310803 ↗ |
| Known as | AD32 | “AD32 (valrubicin)” NCT01316874 ↗ |
| Known as | NSC-246131 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1096885 ↗ |
| Known as | Valrubicina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1096885 ↗ |
| Known as | Valrubicine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1096885 ↗ |
| Known as | Valstar | ChEMBL registry synonym — accepted as the source's own label CHEMBL1096885 ↗ |
| Known as | Valstar preservative free | ChEMBL registry synonym — accepted as the source's own label CHEMBL1096885 ↗ |
| Action | Inhibit | “DNA topoisomerase II alpha inhibitor” CHEMBL1096885 ↗ |
| Modality | Small molecule | — CHEMBL1096885 ↗ |
| Route | Other | “percutaneous valrubicin” NCT01606345 ↗ |
| Target | TOP2A | “DNA topoisomerase II alpha inhibitor” CHEMBL1096885 ↗ |