Topotecan

Overview

An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA topoisomerases, type I.

Indication

用于小细胞肺癌（SCLC）和一线治疗失败的晚期转移性卵巢癌。

Associated Conditions

Acute Myeloid Leukemia
Ewing's Sarcoma
Refractory Neuroblastoma
Metastatic Rhabdomyosarcoma
Recurrent Stage IVB Cervical Cancer
Refractory CNS lymphoma
Refractory CNS malignancy
Refractory, metastatic Ovarian cancer
Relapsed Platinum Sensitive Small Cell Lung Cancer (SCLC)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Organoid-guided vs Topotecan Therapy in Relapsed Extensive-Stage Small Cell Lung Cancer	2025/08/06	NCT07106528	Not Applicable	Not yet recruiting	Peking Union Medical College Hospital
A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)	2025/08/01	NCT07099898	Not Applicable	Recruiting	GlaxoSmithKline
A Phase II/III Study of IBB0979 in Combination With Topotecan Versus Topotecan in Relapsed Small Cell Lung Cancer	2025/07/21	NCT07076095	Not Applicable	Not yet recruiting	SUNHO（China）BioPharmaceutical CO., Ltd.
High-dose Topotecan for Retinoblastoma With Recurrent or Refractory Vitreous Seed	2025/05/15	NCT06972602	Early Phase 1	Recruiting	Eye & ENT Hospital of Fudan University
A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer	2025/05/01	NCT06954246	Phase 3	Recruiting	Qilu Pharmaceutical Co., Ltd.
Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer	2025/04/16	NCT06930755	Phase 1	Recruiting	Nerviano Medical Sciences
HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer	2025/03/03	NCT06855069	Phase 3	Not yet recruiting	Hansoh BioMedical R&D Company
A Study of SHR-A1811 in Subjects With Ovarian Cancer	2025/02/14	NCT06828354	Phase 3	Recruiting	Jiangsu HengRui Medicine Co., Ltd.
Intravitreal Topotecan for Prevention or Treatment of Proliferative Vitreoretinopathy in Retinal Detachment	2025/02/10	NCT06818721	Phase 2	Not yet recruiting	Unity Health Toronto
Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer	2025/01/30	NCT06801834	Phase 3	Recruiting	Gilead Sciences

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Topotecan hydrochloride	Actavis Pharma, Inc.	45963-615	INTRAVENOUS	4 mg in 4 mL	8/31/2022
HYCAMTIN	Novartis Pharmaceuticals Corporation	0078-0674	INTRAVENOUS	4 mg in 4 mL	7/4/2015
HYCAMTIN	Novartis Pharmaceuticals Corporation	0078-0672	ORAL	.25 mg in 1 1	7/7/2017
Topotecan	Accord Healthcare Inc.	16729-243	INTRAVENOUS	1 mg in 1 mL	2/15/2024
Topotecan Hydrochloride	Fresenius Kabi USA, LLC	63323-762	INTRAVENOUS	4 mg in 4 mL	6/23/2021
HYCAMTIN	Novartis Pharmaceuticals Corporation	0078-0673	ORAL	1 mg in 1 1	7/7/2017
Topotecan	Hospira, Inc.	0409-0302	INTRAVENOUS	1 mg in 1 mL	12/31/2019
Topotecan	Meitheal Pharmaceuticals Inc.	71288-127	INTRAVENOUS	4 mg in 15 mL	11/15/2019
topotecan hydrochloride	Accord Healthcare, Inc.	16729-151	INTRAVENOUS	4 mg in 4 mL	11/5/2022
Topotecan Hydrochloride	Fresenius Kabi USA, LLC	63323-762	INTRAVENOUS	4 mg in 4 mL	12/31/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Potactasol	Actavis Group PTC ehf,Dalshraun 1,220 Hafnarfjörður,Iceland	Authorised	1/6/2011
Hycamtin	Sandoz Pharmaceuticals d.d.,Verovškova ulica 57,1000 Ljubljana,SLOVENIA	Authorised	11/12/1996
Topotecan Hospira	Pfizer Europe MA EEIG,Boulevard de la Plaine 17,1050 Bruxelles,Belgium	Authorised	6/9/2010

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
TOPOTECAN ACCORD topotecan (as hydrochloride) 4 mg/4 mL concentrated injection vial	310761	Accord Healthcare Pty Ltd	Medicine	A	12/4/2019
TOPOTECAN ACCORD topotecan (as hydrochloride) 1 mg/1 mL concentrated injection vial	310762	Accord Healthcare Pty Ltd	Medicine	A	12/4/2019
TOPOTECAN INTAS topotecan (as hydrochloride) 4 mg/4 mL concentrated injection vial	310763	Accord Healthcare Pty Ltd	Medicine	A	12/4/2019
TOPOTECAN AG topotecan (as hydrochloride) 4 mg powder for injection vial	178010	Alphapharm Pty Ltd	Medicine	A	3/30/2012
HYCAMTIN Topotecan (as hydrochloride) 4mg powder for injection vial	58598	Sandoz Pty Ltd	Medicine	A	3/12/1997
TOPOTECAN INTAS topotecan (as hydrochloride) 1 mg/1 mL concentrated injection vial	310760	Accord Healthcare Pty Ltd	Medicine	A	12/4/2019

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
TOPOTECAN ACCORD 1 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION	Accord Healthcare S.L.U.	76570	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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