Drug · Small Molecule

Topotecan

CI-DRUG-00000597Explore in graph →NCIt C1413 CHEMBL84 CIViC Approved

Regulatory

Approvals (29)

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-dpdRegulatory29 approval records from 3 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 TEVA-TOPOTECAN (DIN 02441071) under ATC L01CE01 TOPOTECAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 17, 2015	health-canada-dpd
CA Health Canada	—	Marketed in Canada as TOPOTECAN INJECTION (DIN 02390981) under ATC L01CE01 TOPOTECAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 5, 2014	health-canada-dpd
CA Health Canada	—	Marketed in Canada as TOPOTECAN HYDROCHLORIDE FOR INJECTION (DIN 02396378) under ATC L01CE01 TOPOTECAN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 21, 2013

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 14 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 4	67	37	84	367	29	CA, EU, US	May 28, 1996	1992-10
Malignant Lung Neoplasm	Approved	Phase 4	23	11	28	92	3	US	May 28, 1996	1993-09
Malignant Ovarian Neoplasm	Approved	Phase 3	12	6	29	86	2	EU, US	May 28, 1996	1992-10
Malignant Cervical Neoplasm	Approved	Phase 3	4	1	9	27	2

Curated evidence

Clinical evidence (1)

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

civicCuratedShowing 1–1 of 1 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
TOP1 EXPRESSION1
Carboplatin + Cyclophosphamide

Clinical trials

Trials with this intervention (372)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 372 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
NCT06619236	Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer(RAINFOL-02)	active not recruiting	Phase 3	584	GenmabINDUSTRY	18	Sep 28, 2026	clinicaltrials
NCT07099898	A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]

Molecule

Record

Kind: Small Molecule
Mechanism: DNA topoisomerase I inhibitor
Targets: 1 gene
UNII: 7M7YKX2N15
Aliases: 9-[(dimethylamino)methyl]-10-hydroxy-(20S)-camptothecin, Evotopin, Ff-10850 (liposomal topotecan), Hycamptamine, Hycamptin, HYCAMTIN, MYLAN-TOPOTECAN HYDROCHLORIDE, Nogitecan, NSC-609699, NSC-641007, PMS-TOPOTECAN, Potactasol, (s)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]-quinoline-3,14(4H,12H)-dione, SK&F-104864, SKF-104864, TEVA-TOPOTECAN, Topotecan, Topotecan Actavis, Topotecane, Topotecan Eagle, Topotecan Hospira, Topotecan Hydrochloride, TOPOTECAN HYDROCHLORIDE, Topotecan Lactone, Topotecan Teva

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (36)

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

System	Code	Label
ATC (WHO)	L01CE01	TOPOTECAN
DIN (Health Canada)	02231116