Drug · Small Molecule

Valrubicin

CI-DRUG-00000704Explore in graph →CHEMBL1096885 Approved

Regulatory

Approvals (3)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory3 approval records from 2 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as VALTAXIN (DIN 02242466) under ATC L01DB09 VALRUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 1, 2017	Apr 23, 2001	health-canada-dpd
US FDA	—	Efficacy supplement 2013-08-02 (see label)	approved	Aug 2, 2013	openfda
US FDA	—	VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. ( 1 )	approved	Sep 25, 1998	openfda

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 15 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	0	0	2	5	3	CA, US	Sep 25, 1998	1993-11
Malignant Bladder Neoplasm	Phase3	Phase 3	0	0	2	4	0	—	—	1993-11

Computedclinicaltrialsci-drug-pipeline-v1Stage rules

Curated evidence

Clinical evidence (0)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

Data not yet available

No curated evidence item mentions this therapy yet.

Clinical trials

Trials with this intervention (5)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–5 of 5 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT00003129	Chemotherapy in Treating Patients With Early-Stage Bladder Cancer	completed	Phase 2	75	Eastern Cooperative Oncology GroupNETWORK	1	Jun 22, 2023	clinicaltrials
NCT01606345	Phase I Study of Percutaneous Valrubicin for Upper Tract Urothelial Carcinoma	completed	Phase 1	4

Molecule

Record

Kind: Small Molecule
Mechanism: DNA topoisomerase II alpha inhibitor; DNA inhibitor
Targets: 1 gene
UNII: 2C6NUM6878
Aliases: AD 32, NSC-246131, Valrubicin, Valrubicina, Valrubicine, VALRUBICIN INTRAVESICAL SOLUTION, VALSTAR, Valstar preservative free, VALTAXIN

Data updated 2 days agoSource updated unknown

Identifiers

Codes (3)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01DB09	VALRUBICIN
DIN (Health Canada)	02242466	VALTAXIN
DPD drug code	66191