> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/topotecan-6d6bd0ac-4e76-43a7-b97a-0a62e439a24a
> Record changed: 2026-11-04

# Topotecan

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL84)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL84)

First approval year

1996

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL84)

## Development status

**First approval year**

1996

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL84)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL84)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL84)

**Drug name**

Topotecan

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL84)

**Molecular weight**

421.45

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL84)

**Structure (SMILES)**

CC\[C@@\]1(O)C(=O)OCc2c1cc1n(c2=O)Cc2cc3c(CN(C)C)c(O)ccc3nc2-1

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL84)

### Other names (34)

- 10 hydroxy 9 dimethylamino methyl 20s camptothecin
- 10-HYDROXY-9-((DIMETHYLAMINO)METHYL)-(20S)-CAMPTOTHECIN
- ff 10850 liposomal topotecan
- ff 10850 topotecan liposome injection
- Ff-10850 (liposomal topotecan)
- FF-10850 Topotecan Liposome Injection
- hycamptamine
- Hycamptamine
- hycamptin
- Hycamptin
- nogitecan
- Nogitecan
- nsc 609699
- nsc 641007
- NSC-609699
- NSC-641007
- sk f 104864
- SK&F-104864
- skf 104864
- SKF-104864
- topotecan
- Topotecan
- TOPOTECAN \[EMA EPAR\]
- topotecan \[INN\]
- TOPOTECAN \[MI\]

And 9 more, listed on the interactive page.

## Identifiers

**ATC classification codes**

- L01CE01

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL84)

**CAS registry numbers**

- 123948-87-8

**ChEMBL ID**

CHEMBL84

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL84)

**InChIKey**

UCFGDBYHRUNTLO-QHCPKHFHSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL84)

**FDA ingredient codes (UNII)**

- 7M7YKX2N15

### PubChem compound IDs (2)

- 60700
- 177494139

### RxNorm IDs (RxCUI) (2)

- 57308
- 266573

## Regulatory information

### United States

**Applicant**

SANDOZ

**Approval date**

28 May 1996

**Application number**

NDA020671

### European Union

**Status**

Authorised

**Status date**

12 Nov 1996

**Authorisation date**

12 Nov 1996

**Approved indications**

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.

**Product number**

EMEA/H/C/000123

**Authorisation holder**

Sandoz Pharmaceuticals d.d.

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

No

**Generic medicines**

1

**Biosimilar medicines**

0

**Advanced therapy**

No

**Conditional approval**

No

**Additional monitoring**

No

**Accelerated assessment**

No

**Exceptional circumstances**

No

#### Therapeutic areas

- Ovarian Neoplasms
- Small Cell Lung Carcinoma
- Uterine Cervical Neoplasms

European medicines record

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/hycamtin)

### Other regulatory facts

**Patents**

0

**Designations**

1

**First in class**

Yes

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

**Boxed warning**

Yes

## Approval status

**United States (FDA)**

Approved

**European Union (EMA)**

Authorised

## Pharmacology

### Drug classification

**Pharmacology name**

topotecan

**Type**

Synthetic organic

**Drug name stem**

\-tecan

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Oral
- Parenteral

### Open Targets mechanisms

- **Mechanism**  
DNA topoisomerase I inhibitor

**Action type**  
Inhibitor

**Target**  
DNA topoisomerase 1

### DrugCentral mechanisms

- **Action type**  
Inhibitor

**Gene symbol**  
TOP1MT

**Protein identifier**  
Q969P6

**Organism**  
Homo sapiens

**Target development level**  
Clinical

### Investigated indications (62)

- **Condition**  
Sarcoma, Ewing

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000174

**Subject identifier**  
D012512
- **Condition**  
Neoplasms, Plasma Cell

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000200

**Subject identifier**  
D054219
- **Condition**  
Precursor Cell Lymphoblastic Leukemia-Lymphoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000220

**Subject identifier**  
D054198
- **Condition**  
Leukemia, Myeloid, Acute

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000222

**Subject identifier**  
D015470
- **Condition**  
Ganglioneuroblastoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000502

**Subject identifier**  
D018305
- **Condition**  
Glioblastoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000519

**Subject identifier**  
D005909
- **Condition**  
Leukemia

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000565

**Subject identifier**  
D007938
- **Condition**  
Lymphoma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000574

**Subject identifier**  
D008223
- **Condition**  
Liposarcoma, Myxoid

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000613

**Subject identifier**  
D018208
- **Condition**  
Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Neuroblastoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000621

**Subject identifier**  
D009447
- **Condition**  
Oligodendroglioma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000630

**Subject identifier**  
D009837
- **Condition**  
Carcinoma, Renal Cell

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000681

**Subject identifier**  
D002292
- **Condition**  
Sarcoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000691

**Subject identifier**  
D012509
- **Condition**  
Small Cell Lung Carcinoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000702

**Subject identifier**  
D055752
- **Condition**  
Uterine Cervical Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0001061

**Subject identifier**  
D002583
- **Condition**  
Ovarian Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0001075

**Subject identifier**  
D010051
- **Condition**  
Multiple Myeloma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0001378

**Subject identifier**  
D009101
- **Condition**  
Uterine Cervical Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0001416

**Subject identifier**  
D002583
- **Condition**  
Fibrosarcoma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0002087

**Subject identifier**  
D005354
- **Condition**  
Astrocytoma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0002499

**Subject identifier**  
D001254
- **Condition**  
Oligodendroglioma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0002501

**Subject identifier**  
D009837
- **Condition**  
Melanoma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0002617

**Subject identifier**  
D008545
- **Condition**  
Rhabdomyosarcoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0002918

**Subject identifier**  
D012208
- **Condition**  
Medulloblastoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0002939

**Subject identifier**  
D008527

And 37 more, listed on the interactive page.

### Open Targets indications (109)

- **Condition identifier**  
EFO\_0000220

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000222

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000565
- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0000621

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000681

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0000702
- **Condition identifier**  
EFO\_0001061

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0001378

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0001416
- **Condition identifier**  
EFO\_0003060

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0003833

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0003893
- **Condition identifier**  
EFO\_0007362

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1000453

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_1000657

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_1000823

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_1001331

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_1001471

**Highest recorded phase**  
1
- **Condition identifier**  
HP\_0001945

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0000402

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0000448

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0001475

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0001657

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0002087

**Highest recorded phase**  
3

And 84 more, listed on the interactive page.

### Open Targets warnings (2)

- **Warning**  
Black Box Warning

**Effect**  
hematological toxicity

**Country**  
United States
- **Warning**  
Black Box Warning

**Effect**  
immune system toxicity

**Country**  
United States

### Reported adverse events (55)

- **Event**  
acute myeloid leukaemia

**Reports**  
19

**Reporting signal score**

29.6585
- **Event**  
anaemia

**Reports**  
265

**Reporting signal score**

338.347
- **Event**  
anaplastic lymphoma kinase gene mutation

**Reports**  
12

**Reporting signal score**

68.8985
- **Event**  
anorexia

**Reports**  
21

**Reporting signal score**

30.0627
- **Event**  
ascites

**Reports**  
50

**Reporting signal score**

77.7242
- **Event**  
bone marrow failure

**Reports**  
41

**Reporting signal score**

55.0009
- **Event**  
bronchospasm

**Reports**  
25

**Reporting signal score**

32.8972
- **Event**  
cerebral cyst

**Reports**  
8

**Reporting signal score**

27.3071
- **Event**  
chorioretinal atrophy

**Reports**  
19

**Reporting signal score**

87.2055
- **Event**  
choroidal dystrophy

**Reports**  
6

**Reporting signal score**

28.9903
- **Event**  
choroidal infarction

**Reports**  
13

**Reporting signal score**

64.3539
- **Event**  
cutaneous lupus erythematosus

**Reports**  
11

**Reporting signal score**

24.5844
- **Event**  
decreased appetite

**Reports**  
78

**Reporting signal score**

42.1581
- **Event**  
dehydration

**Reports**  
71

**Reporting signal score**

44.0535
- **Event**  
desmoplastic small round cell tumour

**Reports**  
16

**Reporting signal score**

100.289
- **Event**  
disease progression

**Reports**  
114

**Reporting signal score**

140.783
- **Event**  
enophthalmos

**Reports**  
7

**Reporting signal score**

31.3698
- **Event**  
febrile bone marrow aplasia

**Reports**  
44

**Reporting signal score**

127.89
- **Event**  
febrile neutropenia

**Reports**  
162

**Reporting signal score**

287.349
- **Event**  
general physical health deterioration

**Reports**  
55

**Reporting signal score**

45.0599
- **Event**  
genotoxicity

**Reports**  
12

**Reporting signal score**

70.4474
- **Event**  
haematotoxicity

**Reports**  
43

**Reporting signal score**

97.9092
- **Event**  
haemoglobin decreased

**Reports**  
59

**Reporting signal score**

30.9121
- **Event**  
heterochromia iridis

**Reports**  
7

**Reporting signal score**

39.9156
- **Event**  
ileus

**Reports**  
24

**Reporting signal score**

35.5932

And 30 more, listed on the interactive page.

### Trial references (195)

- NCT00001333  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00001333)
- NCT00005793  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00005793)
- NCT00100477  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00100477)
- NCT00553189  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00553189)
- NCT00001335  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00001335)
- NCT00135135  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00135135)
- NCT00186849  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00186849)
- NCT00808899  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00808899)
- NCT00877110  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00877110)
- NCT00918320  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00918320)
- NCT01857934  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01857934)
- NCT02030964  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02030964)
- NCT02298348  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02298348)
- NCT02308527  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02308527)
- NCT03107988  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03107988)
- NCT03165292  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03165292)
- NCT03786783  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03786783)
- NCT04106219  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04106219)
- NCT05303727  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05303727)
- NCT05429502  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05429502)
- NCT06172296  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06172296)
- NCT03600649  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03600649)
- NCT00005792  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00005792)
- NCT00325416  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00325416)
- NCT01039025  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01039025)

And 170 more, listed on the interactive page.

## Dosing

**Dose**

1.5 mg/m2

**Route**

Intravenous

**How often**

Daily for 5 consecutive days starting on Day 1 of a 21-day cycle

### Conditions of use (2)

- Do not administer subsequent cycles until neutrophils recover to >1000/mm3, platelets to >100,000/mm3, hemoglobin to ≥9 g/dL
- Do not exceed a single dose of 4 mg

## Chemical properties

**Hydrogen bond acceptors**

8

**Hydrogen bond donors**

2

**Polar surface area**

104.89

**Calculated partition coefficient (ALogP)**

1.85

**Calculated partition coefficient (XLogP)**

0.5

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

3

**Heavy atoms**

31

**Molecular formula**

C23H23N3O5

**Monoisotopic mass**

421.16377084

**Natural product**

Yes

## National Drug Codes

- 16729-243

## Evidence counts

**Recorded assays**

4,928

**Active assays**

1,027

### Active assay types (3)

- Confirmatory
- Other
- Screening

## Pharmacologic actions

- Topoisomerase I Inhibitors  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D059004.html)

## Biological measurements

These details could not be displayed.

## Related records

### Trials (264)

- 9-ING-41 in Pediatric Patients With Refractory Malignancies.
- A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors
- A Multi-Arm, Platform Trial For Relapsed Neuroblastoma
- a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4
- A Pharmacokinetic Study of Oral Cyclophosphamide and Topotecan in Children With Recurrent Solid Tumors
- A Phase 1b Study of Sevacizumab in Combination With Chemotherapy in Chinese Patients With Platinum-Resistant Recurrent Ovarian Cancer.
- A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy
- A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies
- A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Carcinoma
- A Phase I Topotecan Study in Subjects With Cancer and Impaired Renal Function
- A Phase I/II Study of Induction Chemotherapy With Daunorubicin, Cytarabine, Topotecan and Etoposide
- A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
- A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
- A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer
- A Pilot Trial of Oral Topotecan for the Treatment of Refractory Advanced Solid Neoplasms Expressing HIF-1a
- A Prospective International Multicenter Clinical Trial for Eyes With Relapsed Retinoblastoma
- A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer
- A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer(PANKU-Lung03)
- A Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
- A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors

### Approved for (1)

- [Carcinoma](https://trialight.com/data/condition/carcinoma-575e4c82-5fa5-5455-b1b7-30972eca1a2f.md)

### In development for (104)

- Acute leukemia Phase 2
- [Acute lymphoblastic leukemia](https://trialight.com/data/condition/acute-lymphoblastic-leukemia-a7f89294-3477-5920-8fe1-8aa51fcd1d63.md) Phase 3
- [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Phase 2
- Adrenal cortex neoplasm Phase 1
- Anaplastic astrocytoma Phase 1
- Anaplastic oligodendroglioma Phase 1
- Aseptic meningitis Phase 1
- Astrocytic tumor Phase 1
- [Astrocytoma (excluding glioblastoma)](https://trialight.com/data/condition/astrocytoma-excluding-glioblastoma-dd29b6db-5e3d-590d-b093-7a770a5facb2.md) Phase 2
- Atypical choroid plexus papilloma Phase 1
- Atypical teratoid rhabdoid tumor Phase 2
- [B-cell chronic lymphocytic leukemia](https://trialight.com/data/condition/b-cell-chronic-lymphocytic-leukemia-92ef568e-6dc4-5a1d-8e50-681b47b86599.md) Phase 1
- [Brain cancer](https://trialight.com/data/condition/brain-cancer-f8f25210-90da-5298-8c6b-4f230fcb45cd.md) Phase 2
- Brain neoplasm Phase 2
- Brain stem glioma Phase 1
- [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Phase 2
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 3
- [Central nervous system cancer](https://trialight.com/data/condition/central-nervous-system-cancer-14789751-67f7-557a-9c07-30e51513747d.md) Phase 2
- Central nervous system neoplasm Phase 2
- Cervical adenocarcinoma Phase 3

### Other linked conditions (1)

- Primary central nervous system lymphoma

### Targets (2)

- [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) DNA topoisomerase I inhibitor
- [TOP1MT](https://trialight.com/data/target/top1mt-e2172f07-37c5-503a-a9e8-ad2ff56a5ca9.md)

---

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