DNA topoisomerases are a group of enzymes that control DNA topology. DNA topoisomerase II has the ability to untangle double strands of DNA, due to which they are involved in many crucial nuclear processes such as transcription, replication or recombination. Topoisomerase II inhibitors bind to the N-terminal ATPase subunit of topoisomerase II, preventing the release of the separated DNA strands from the topoisomerase II dimer. Topoisomerase II inhibitors are indicated for infections of upper respiratory tract, urinary tract, and prostate, also for neoplastic conditions like leukaemia, lymphoma, breast cancer, neuroblastomas, carcinoma, sarcoma and others. Teva Pharmaceutical, CSPC Pharma, Orient Europharma, GSK, BMS, Kyowa Kirin International, and Daiichi Sankyo Company are some of the major players in the topoisomerase II inhibitors market.
Key Market Developments:
- In Sep 2022, Avacta’s AVA 6000, a type II DNA topoisomerase inhibitor, received Orphan Drug status as a second-line therapy for soft tissue sarcoma in the USA.
- In Jun 2023, Shasqi and Johnson and Johnson Innovation agreed to co-develop SQL 70 biopolymer, a type II DNA topoisomerase inhibitor.
Approved Drug Molecules and Brand Names for Topoisomerase II Inhibitors:
- Doxorubicin hydrochloride
- Etoposide IV
- Epirubicin
- Pegylated Liposomal Doxorubicin
- Levofloxacin
- Daunorubicin
- Mitoxantrone
- Idarubicin hydrochloride
- Ciprofloxacin oral
- Dactinomycin
- Moxifloxacin ophthalmic
- Dexrazoxane
- Etoposide oral
- Gatiflox (Gatifloxacin)
- Vumon (Teniposide)
- Amsidine (Amsacrine)
- Ofloxacin ophthalmic
- Gracevit (Sitafloxacin)
Drugs under the Pipeline for Topoisomerase II Inhibitors:
- Myocet (Non-Pegylated Liposomal Doxorubicin)
- Vyxeos (Cytarabine/Daunorubicin Liposomal formulation)
- Duoenda (Mitoxantrone liposomal)
- Duomeisu (Pegylated Liposomal Doxorubicin)
- Aldoxorubicin (INNO-206)
- Calsed (Amrubicin)
- Gepotidacin (GSK2140944)
- Pixuvri (Pixantrone)
- Tirazone (Tirapazamine)
- Qinprezo (Vosaroxin)
- ThermoDox (Lyso-Thermosensitive Liposomal Doxorubicin)
- Veyonda (Idronoxil)
- Valrubicin
- Berubicin (RTA 744)
- Quinamed (Amonafide)
- Zoptrex (Zoptarelin Doxorubicin)
- Doxorubicin (SGN-15)
- Ofloxacin oral
- Zabolante (Zabofloxacin)
- anti-HER2 antibody conjugated with Pegylated Liposomal Doxorubicin (MM-302)
- Camsirubicin (MNPR-201)
- Sabarubicin (MEN10755)
- Avarofloxacin (JNJ-Q2)
- Glutathione PEGylated Liposomal Doxorubicin (2X-111)
- Milatuzumab-Doxorubicin antibody-drug conjugate (hLL1-DOX)
- F14512
- HF158K1
- IT-141
- SQ3370
- T-1201
- THE001
- Talidox (Doxorubicin liposomal)
- Camptothecin/Podophyllotoxin (NEV-801)
- Etoposide Toniribate (CAP7.1)
- Pro-Doxorubicin (AVA6000)
Clinical Activity and Developments of Topoisomerase II Inhibitors:
Currently, there are more than 50 drug products in the topoisomerase II inhibitors, including 18 approved drug products and the rest of them are in the clinical development phases.
- In Jun 2023, Monopar Therapeutics released updated efficacy data from a phase-I clinical trials in soft tissue sarcoma for Camsirubicin.
- In Jan 2023, CNS Pharmaceuticals started early research in breast cancer and lung cancer in the USA for Berubicin.
|
Molecule Name |
Number of Studies |
|
Myocet (Non-Pegylated Liposomal Doxorubicin) |
85 |
|
Vyxeos (Cytarabine/Daunorubicin liposomal formulation) |
76 |
|
Duoenda (Mitoxantrone liposomal) |
51 |
|
Duomeisu (Pegylated Liposomal Doxorubicin) |
26 |
|
Aldoxorubicin (INNO-206) |
25 |
|
Calsed (Amrubicin) |
22 |
|
Gepotidacin (GSK2140944) |
22 |
|
Pixuvri (Pixantrone) |
20 |
|
Tirazone (Tirapazamine) |
20 |
|
Qinprezo (vosaroxin) |
17 |
|
ThermoDox (Lyso-Thermosensitive Liposomal Doxorubicin) |
16 |
|
Veyonda (Idronoxil) |
10 |
|
Valrubicin |
9 |
|
Berubicin (RTA 744) |
8 |
|
Quinamed (Amonafide) |
6 |
|
Zoptrex (Zoptarelin Doxorubicin) |
5 |
|
Doxorubicin (SGN-15) |
5 |
|
Ofloxacin oral |
5 |
|
Zabolante (Zabofloxacin) |
3 |
|
anti-HER2 antibody conjugated with Pegylated Liposomal Doxorubicin (MM-302) |
3 |
|
Camsirubicin (MNPR-201) |
3 |
|
Sabarubicin (MEN10755) |
3 |
|
Avarofloxacin (JNJ-Q2) |
2 |
|
Glutathione PEGylated Liposomal Doxorubicin (2X-111) |
2 |
|
Milatuzumab-Doxorubicin antibody-drug conjugate (hLL1-DOX) |
2 |
|
F14512 |
1 |
|
HF158K1 |
1 |
|
IT-141 |
1 |
|
SQ3370 |
1 |
|
T-1201 |
1 |
|
THE001 |
1 |
|
Talidox (Doxorubicin liposomal) |
1 |
|
Camptothecin/Podophyllotoxin (NEV-801) |
1 |
|
Etoposide Toniribate (CAP7.1) |
1 |
|
Pro-Doxorubicin (AVA6000) |
1 |
Target Indication Analysis of Topoisomerase II Inhibitors
Topoisomerase II inhibitors such as Doxorubicin, Donorubicin, Epirubicin, Idarubicin, and others are indicated in the treatment of neoplastic conditions such as acute lymphoblastic leukaemia, acute myeloblastic leukaemia, hodgkin and non-hodgkin lymphoma, metastatic breast cancer, metastatic Wilms tumor, metastatic neuroblastoma, metastaic soft tissue and bone sarcomas, metastatic ovarian carcinoma, thyroid cancer, gastric cancer, bladder carcinoma. Drugs such as ofloxacin, levofloxacin, gatifloxacin, ciprofloxacin, and others are used for the treatment of various infections caused by susceptible bacteria, including infections of the upper respiratory tract, skin, urinary tract, eye, and prostate.
Regional Analysis
Topoisomerase II Inhibitors Market
According to the World Health Organization, breast cancer is the most common cancer occurring in women (2,261,419 patients globally), with the highest number of cancer rates in the USA (253,465 patients), followed by France (58,083), and Australia (19,617 patients). China had the highest new cases for leukaemia (85,404), followed by the USA (61,252), and India (48,419) in 2020. Ovarian cancer had the highest number of new cases in 2020 in China (55,341), followed by India (45,701), and the USA (23,820). For thyroid cancer, China had the highest number of new cases (2,21,093), followed by the USA (52,912). Similarly, for bladder cancer, China (85,694 new cases), USA (80,617), and Japan (36,957) are among the top countries. In the case of non-hodgkin’s lymphoma, China had the maximum number of new cases (92,834), followed by the USA (73,652) and for hodgkin's lymphoma India was at the top with 9,221 new cases, followed by the US (8,107), and China (6,829). With the growing burden of cancer cases, the Topoisomerase II Inhibitors market is also expected to grow.
Latin America
Europe
Asia Pacific
Middle East
North America
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Frequently Asked Questions
Doxorubicin hydrochloride, Etoposide IV, Epirubicin, Levofloxacin, Daunorubicin, Mitoxantrone, Idarubicin hydrochloride, Ciprofloxacin oral, Dactinomycin are some of the approved topoisomerase II inhibitors.
Teva Pharmaceutical, CSPC Pharma, Orient Europharma, GSK, BMS, Kyowa Kirin International, and Daiichi Sankyo Company are some of the major players in the topoisomerase II inhibitors market.
Major indications for topoisomerase II inhibitors are acute lymphoblastic leukaemia, acute myeloblastic leukaemia, hodgkin and non-hodgkin lymphoma, metastatic breast cancer, metastatic Wilms tumor, metastatic neuroblastoma, various infections caused by susceptible bacteria, including infections of the upper respiratory tract, skin, urinary tract, eye, and prostate.
There are more than 30 molecules in the clinical development phases for topoisomerase II inhibitors.
- Teva Pharmaceutical
- CSPC Pharma
- Orient Europharma
- GSK
- BMS
- Kyowa Kirin International
- Daiichi Sankyo Company
- AbbVie
- Gilead Sciences