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.

emaRegulatory7 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.	withdrawnsince Oct 2, 2014	Dec 22, 2011	ema
EU EMA	Cervical Carcinoma	Topotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy- patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1). Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).	approved	Jan 6, 2011	ema
EU EMA	—	Topotecan monotherapy is indicated for the treatment of patients with relapsed small-cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination.

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 11 hours 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
NCT02502266	Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer	active not recruiting	Phase 2 / Phase 3	582	National Cancer Institute (NCI)NIH	5	Sep 29, 2026	clinicaltrials
NCT06619236	Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer

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 14 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