> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/topotecan-hydrochloride-067505dc-01ca-47c0-99c9-0b8c89a1cb2b
> Record changed: 2026-10-13

# Topotecan hydrochloride

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607)

First approval year

1996

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607)

## Development status

**First approval year**

1996

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607)

**Drug name**

Topotecan hydrochloride

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607)

**Molecular weight**

457.91

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607)

**Structure (SMILES)**

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

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607)

### Brand names (16)

- evotopin
- Evotopin
- hycamtin
- Hycamtin
- potactasol
- Potactasol
- topotecan actavis
- Topotecan actavis
- topotecan eagle
- Topotecan eagle
- topotecan hospira
- Topotecan hospira
- topotecan hydrochloride
- Topotecan hydrochloride
- topotecan teva
- Topotecan teva

### Other names (46)

- 1h pyrano 3 4 6 7 indolizino 1 2 b quinoline 3 14 4h 12h dione 10 dimethylamino methyl 4 ethyl 4 9 dihydroxy monohydrochloride s
- 1H-PYRANO(3',4':6,7)INDOLIZINO(1,2-B)QUINOLINE-3,14(4H,12H)-DIONE, 10-((DIMETHYLAMINO)METHYL)-4-ETHYL-4,9-DIHYDROXY-, MONOHYDROCHLORIDE, (S)-
- evotopin
- Evotopin
- hycamtin
- Hycamtin
- HYCAMTIN
- nogitecan hydrochloride
- Nogitecan hydrochloride
- NOGITECAN HYDROCHLORIDE \[JAN\]
- nogitecan hydrochloride jan
- nsc 759263
- NSC-759263
- sk f s 104864 a
- sk f s 104864a
- sk s 104864 a
- SK-S-104864-A
- SK&F S-104864-A
- SK&F-S-104864-A
- SK&F-S-104864A
- Topotecan (as hydrochloride)
- topotecan actavis
- Topotecan actavis
- topotecan as hydrochloride
- topotecan hcl

And 21 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 119413-54-6

**ChEMBL ID**

CHEMBL1607

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607)

**InChIKey**

DGHHQBMTXTWTJV-BQAIUKQQSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607)

**RxNorm IDs (RxCUI)**

- 266573

**FDA ingredient codes (UNII)**

- 956S425ZCY

### PubChem compound IDs (4)

- 60699
- 11972519
- 57525346
- 172473749

## Regulatory information

### United States

**Applicant**

SANDOZ

**Approval date**

28 May 1996

**Application number**

NDA020671

### Other regulatory facts

**Patents**

0

**Designations**

1

**First in class**

Yes

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

Yes

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

**Boxed warning**

Yes

## Pharmacology

### Drug classification

**Drug name stem**

\-tecan

#### Administration routes

- Oral
- Parenteral

### Mechanisms of action

- **Mechanism**  
DNA topoisomerase I inhibitor

**Action type**  
Inhibitor

**Target**  
DNA topoisomerase 1

**Protein identifier**  
P11387

### Open Targets mechanisms

- **Mechanism**  
DNA topoisomerase I inhibitor

**Action type**  
Inhibitor

**Target**  
DNA topoisomerase 1

### Investigated indications (35)

- **Condition**  
Myelodysplastic Syndromes

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000198

**Subject identifier**  
D009190
- **Condition**  
Neoplasms, Plasma Cell

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000200

**Subject identifier**  
D054219
- **Condition**  
Carcinoma

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000313

**Subject identifier**  
D002277
- **Condition**  
Carcinoma, Endometrioid

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000466

**Subject identifier**  
D018269
- **Condition**  
Ganglioneuroblastoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000502

**Subject identifier**  
D018305
- **Condition**  
Leukemia

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000565

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

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000574

**Subject identifier**  
D008223
- **Condition**  
Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000616

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

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000621

**Subject identifier**  
D009447
- **Condition**  
Sarcoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000691

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

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000702

**Subject identifier**  
D055752
- **Condition**  
Carcinoma, Squamous Cell

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000707

**Subject identifier**  
D002294
- **Condition**  
Uterine Cervical Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0001061

**Subject identifier**  
D002583
- **Condition**  
Multiple Myeloma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0001378

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

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0001416

**Subject identifier**  
D002583
- **Condition**  
Myeloproliferative Disorders

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0002428

**Subject identifier**  
D009196
- **Condition**  
Rhabdomyosarcoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0002918

**Subject identifier**  
D012208
- **Condition**  
Carcinoma, Non-Small-Cell Lung

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003060

**Subject identifier**  
D002289
- **Condition**  
Brain Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0003833

**Subject identifier**  
D001932
- **Condition**  
Ovarian Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0003893

**Subject identifier**  
D010051
- **Condition**  
Carcinoma, Small Cell

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0008524

**Subject identifier**  
D018288
- **Condition**  
Cystadenoma, Serous

**Highest recorded phase**  
1

**Condition identifier**  
EFO:1000043

**Subject identifier**  
D018293
- **Condition**  
Central Nervous System Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1000158

**Subject identifier**  
D016543
- **Condition**  
Sarcoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:1001968

**Subject identifier**  
D012509
- **Condition**  
Peritoneal Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0002087

**Subject identifier**  
D010534

And 10 more, listed on the interactive page.

### Open Targets indications (60)

- **Condition identifier**  
EFO\_0000313
- **Condition identifier**  
EFO\_0000565

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

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000691

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000702
- **Condition identifier**  
EFO\_0003060

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0003893

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0004251

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0008524
- **Condition identifier**  
EFO\_1000158

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0002863

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0000402

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0001409

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0001416

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0002087

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0002087

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0002158

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0002974

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0004952

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004967

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004992

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0004993

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005035

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005059

**Highest recorded phase**  
2

And 35 more, listed on the interactive page.

### Warnings (2)

- **Warning**  
Black Box Warning

**Effect**  
hematological toxicity
- **Warning**  
Black Box Warning

**Effect**  
immune system toxicity

### 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 (51)

- **Event**  
anaemia

**Reports**  
305

**Reporting signal score**

385.157
- **Event**  
anaplastic lymphoma kinase gene mutation

**Reports**  
20

**Reporting signal score**

121.942
- **Event**  
anorexia

**Reports**  
29

**Reporting signal score**

46.2519
- **Event**  
ascites

**Reports**  
59

**Reporting signal score**

91.9726
- **Event**  
bone marrow failure

**Reports**  
42

**Reporting signal score**

51.389
- **Event**  
bronchospasm

**Reports**  
25

**Reporting signal score**

29.1621
- **Event**  
cerebral cyst

**Reports**  
10

**Reporting signal score**

34.8846
- **Event**  
chorioretinal atrophy

**Reports**  
22

**Reporting signal score**

100.766
- **Event**  
choroidal infarction

**Reports**  
17

**Reporting signal score**

86.0631
- **Event**  
decreased appetite

**Reports**  
98

**Reporting signal score**

58.4281
- **Event**  
dehydration

**Reports**  
95

**Reporting signal score**

68.6295
- **Event**  
desmoplastic small round cell tumour

**Reports**  
16

**Reporting signal score**

97.7848
- **Event**  
disease progression

**Reports**  
118

**Reporting signal score**

132.76
- **Event**  
enophthalmos

**Reports**  
8

**Reporting signal score**

35.671
- **Event**  
febrile bone marrow aplasia

**Reports**  
46

**Reporting signal score**

128.417
- **Event**  
febrile neutropenia

**Reports**  
216

**Reporting signal score**

411.164
- **Event**  
general physical health deterioration

**Reports**  
59

**Reporting signal score**

44.2653
- **Event**  
genotoxicity

**Reports**  
12

**Reporting signal score**

68.5714
- **Event**  
haematotoxicity

**Reports**  
53

**Reporting signal score**

123.407
- **Event**  
haemoglobin decreased

**Reports**  
72

**Reporting signal score**

39.7293
- **Event**  
heterochromia iridis

**Reports**  
7

**Reporting signal score**

38.8227
- **Event**  
ileus

**Reports**  
30

**Reporting signal score**

46.2548
- **Event**  
iris adhesions

**Reports**  
10

**Reporting signal score**

32.9469
- **Event**  
iris atrophy

**Reports**  
17

**Reporting signal score**

79.2616
- **Event**  
lenticular opacities

**Reports**  
12

**Reporting signal score**

45.3665

And 26 more, listed on the interactive page.

### Trial references (120)

- NCT00002537  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002537)
- NCT00002625  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002625)
- NCT00003281  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003281)
- NCT00003812  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003812)
- NCT00003917  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003917)
- NCT00003943  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003943)
- NCT00004055  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004055)
- NCT00004137  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004137)
- NCT00004186  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004186)
- NCT00006012  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00006012)
- NCT00006374  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00006374)
- NCT00025272  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00025272)
- NCT00028925  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00028925)
- NCT00033696  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00033696)
- NCT00041015  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00041015)
- NCT00087048  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00087048)
- NCT00287963  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00287963)
- NCT00365547  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00365547)
- NCT00388089  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00388089)
- NCT00002587  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002587)
- NCT00002948  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002948)
- NCT00002950  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002950)
- NCT00003194  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003194)
- NCT00003198  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003198)
- NCT00003331  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003331)

And 95 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

- Discard after 24 hours if unused after reconstitution

## Chemical properties

**Hydrogen bond acceptors**

8

**Hydrogen bond donors**

2

**Polar surface area**

104.89

**Calculated partition coefficient (ALogP)**

1.85

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

3

**Heavy atoms**

32

**Molecular formula**

C23H24ClN3O5

**Monoisotopic mass**

457.1404486

**Natural product**

No

## National Drug Codes

- 0078-0674
- 0409-0302
- 16729-151
- 45963-615
- 63323-762
- 66758-101
- 66758-102

## Evidence counts

**Recorded assays**

1,986

**Active assays**

790

### Active assay types (4)

- Confirmatory
- Other
- Screening
- Summary

## 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 (420)

- 7-hydroxystaurosporine and Topotecan Hydrochloride in Treating Patients With Relapsed or Progressed Small Cell Lung Cancer
- 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 Dose Finding Phase I Trial of the Combination of Topotecan and PS-341, a Novel Proteasome Inhibitor, in Advanced Malignancies
- 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 II/III Study of IBB0979 in Combination With Topotecan Versus Topotecan in Relapsed Small Cell Lung Cancer
- A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer
- A Phase III Study of YL201 in Relapsed Small Cell Lung 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

### Approved for (8)

- [Carcinoma](https://trialight.com/data/condition/carcinoma-575e4c82-5fa5-5455-b1b7-30972eca1a2f.md)
- [Cervical adenocarcinoma](https://trialight.com/data/condition/cervical-adenocarcinoma-013a4346-286c-5c50-bd25-66fde59ac6a0.md)
- [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md)
- Cervical carcinoma
- [Ovarian cancer](https://trialight.com/data/condition/ovarian-cancer-f64f2018-55a5-553a-8960-76cb4906aa17.md)
- [Ovarian neoplasm](https://trialight.com/data/condition/ovarian-neoplasm-1e9924ea-041c-5daa-b6c4-a97ec4fabeda.md)
- Small cell carcinoma
- [Small cell lung carcinoma](https://trialight.com/data/condition/small-cell-lung-carcinoma-505ad14d-ce79-5398-b171-f724c32e1b4e.md)

### In development for (26)

- [Brain neoplasm](https://trialight.com/data/condition/brain-neoplasm-b3dac71b-1d7b-5a65-8f64-89821506ad41.md) Phase 1
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 2
- [Central nervous system neoplasm](https://trialight.com/data/condition/central-nervous-system-neoplasm-bd35c306-06e5-549c-a882-45bdfbcbb7d8.md) Phase 2
- Endometrioid adenocarcinoma Phase 1
- [Esophageal cancer](https://trialight.com/data/condition/esophageal-cancer-a3b5271c-e6d4-537b-8dfd-9391c60e2af2.md) Phase 1
- [Fallopian tube cancer](https://trialight.com/data/condition/fallopian-tube-cancer-b95d05ee-41d5-565a-87e1-041170b88760.md) Phase 3
- Ganglioneuroblastoma Phase 3
- [Leukemia](https://trialight.com/data/condition/leukemia-519aefcd-8521-5941-851b-5b77ca925ca5.md) Phase 2
- [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) Phase 3
- [Lymphoma](https://trialight.com/data/condition/lymphoma-de4db685-7419-5e0e-b958-4591ffd69d43.md) Phase 2
- [Myelodysplastic syndrome](https://trialight.com/data/condition/myelodysplastic-syndrome-f5df8ce5-6064-53d3-902c-f09fc4acd4bb.md) Phase 2
- [Myeloproliferative neoplasm](https://trialight.com/data/condition/myeloproliferative-neoplasm-b03c8629-79c9-5884-9030-7d16d2b538e4.md) Phase 1
- Neoplasm Phase 2
- Neuroblastoma Phase 3
- [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Phase 3
- Ovarian serous cystadenocarcinoma Phase 1
- Peripheral primitive neuroectodermal tumor Phase 2
- [Peritoneum cancer](https://trialight.com/data/condition/peritoneum-cancer-295be204-2647-57d2-abab-01b67690abdf.md) Phase 3
- [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Phase 1
- Plasma cell neoplasm Phase 1

### Targets (1)

- [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) DNA topoisomerase I inhibitor

---

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