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Drug

Topotecan

Approved · EMA
Emerging researchLate-stage developmentCooling momentum
Also known as Hycamtin, hycamptamine, Topotecane, Topotecan Hydrochloride+1 more

Hycamtin, hycamptamine, Topotecane, Topotecan Hydrochloride, Topotecanum.

6
Research papers
28
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase II Open Label Basket Trial Study Using Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

Clinical trial2026-07-09Results expected Q2 2031 · ClinicalTrials.gov

Phase I Study of ATR Inhibitor M6620 in Combination With Topotecan in Patients With Advanced Solid Tumors.

Research2017-12-18Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Improved survival with bevacizumab in advanced cervical cancer.

Research2014-02-01The New England journal of medicine

Approval: Potactasol (EMA)

Regulatory2011-01-06EMA

Approval: Topotecan Hospira (EMA)

Regulatory2010-06-09EMA

Approval: Hycamtin (EMA)

Regulatory1996-11-12EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Topotecan
Aliases & brands
HycamtinhycamptamineTopotecaneTopotecan HydrochlorideTopotecanum
RxNorm CUI
57308
ChEMBL ID
CHEMBL84
ATC codes
L01CE01
UNII
7M7YKX2N15
Regulatory jurisdictions
ema

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1996-11-12
Latest approval
2011-01-06
Authorities
EMA
Total events
3
emaEuropean Medicines Agency· 3 events
2011-01-06Approval
Approval: Potactasol (EMA)
Indication: 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 relapsedShow full indication

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).

Evidence ↗
2010-06-09Approval
Approval: Topotecan Hospira (EMA)
Indication: 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 consideredShow full indication

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.

Evidence ↗
1996-11-12Approval
Approval: Hycamtin (EMA)
Indication: Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen isShow full indication

Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

193 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
193
registered trials across all phases
LATEST COMPLETION 2026
28
Active studies
22
Recruiting
44
Late-stage (III+)
124
Completed
41
Discontinued
PHASE DISTRIBUTIONn = 193
Early Phase 13Phase 154Phase 1 / 219Phase 273Phase 2 / 33Phase 337Phase 41Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

6 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20092021
Most influential
Recent papers
Major research themes2
Lung Neoplasms1Small Cell Lung Carcinoma1
Journals, researchers & institutions
Top journals
  • Gynecologic oncology2
  • Advances in therapy1
  • Cancer1
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
  • The New England journal of medicine1
Leading researchers
  • Sill MW2
  • Aladjem MI1
  • Alewine CC1
  • Aljumaily R1
  • Andric ZG1
  • Antal JM1
  • Bates SE1
  • Beck JT1
Leading institutions
free-text, unnormalised
  • Clinical Hospital Center Bezanijska Kosa1
  • Columbia University1
  • Emory University1
  • From the University of California1
  • Institute for Oncology and Radiology of Serbia1
  • Institute for Pulmonary Diseases of Vojvodina1

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 3 of the same disease areas as Topotecan in the shared literature.

3 shared diseases1 shared paper

Studied across 3 of the same disease areas as Topotecan in the shared literature.

3 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.