Mitosis is an elaborate process in actively proliferating cells, resulting in the division of duplicated sets of chromosomes and two genetically identical daughter cells. Failure of cell-cycle checkpoint regulations often results in aneuploidy and genetic instability, culminating either in cell death or cancer. Some of the mitotic inhibitors interfere with the normal function of microtubule growth, specifically the beta-subunit of tubulin, by forming a microtubule-drug complex and thereby inhibiting the polymerization of cells, whereas some of the other mitotic inhibitors stabilize the cell function by depolymerizing the microtubules proliferation. Different mitotic inhibitors are used to treat types of cancers such as leukemia, lymphoma, breast cancer, lung cancer, and other types of cancers. Teva Pharmaceuticals, Pfizer, Eisai, Bristol-Myers Squibb, Celgene Corporation, Novartis, and Merck are the key companies that are currently providing mitotic inhibitors for the treatment of cancer patients in the market.
Key Developments
- In Jul 2022, Intas Pharmaceutical's DoceAqualip’s (Docetaxel nano somal) lipid suspension monotherapy was effective and well-tolerated in patients with advanced non-small cell lung cancer who were previously treated with platinum-based chemotherapy.
- In Mar 2023, Phoenix Biotech’s conducted a study in which Breastin moderately inhibited breast cancer xenograft tumors in vivo. Remarkably, in contrast to what was observed with Paclitaxel monotherapy, the combination of Paclitaxel and Bresatin prevented tumor relapse, indicating Breastin’s potential for drug combination regimens.
- In Mar 2023, Theratechnolgies’s Sudotaxel zendusortide (TH 1902), in the first demonstration was observed that immune cell infiltration patterns play a pivotal role in the anti-tumoral response. The combination of TH1902 with checkpoint inhibitors (anti-PD-L1) further reveals that this may lead to improved clinical outcomes in future immunotherapy translational approaches.
Approved Mitotic Inhibitors
- TAXOTERE (Docetaxel)
- HALAVEN (Eribulin)
- TAXOL (Paclitaxel)
- ABRAXANE (Paclitaxel protein-bound)
- VINCASAR PFS (Vincristine)
- VUMON (Teniposide)
- VEPESID (Etoposide)
- VELBAN (Vinblastine)
- TOPOSAR (Etoposide)
- ONXOL (Paclitaxel)
- ONCOVIN (Vincristine)
- NAVELBINE (Vinorelbine)
- JEVTANA (Cabazitaxel)
- IXEMPRA (Ixabepilone)
- ETOPOPHOS (Etoposide)
- EMCYT (Estramustine)
- DOCEFREZ (Docetaxel)
- RYBREVANT (Amivantamab)
Drugs under the Pipeline for Mitotic Inhibitors
- Albumin-Bound Docetaxel (CPO100)
- Docetaxel Oral
- Nanoxel m (Docetaxel Polymeric Micelle)
- Fosciclopirox (CPX-POM)
- Nanodoce (Docetaxel Nanoformulation)
- T-1101
- Docetaxel (CPC634)
- Docetaxel Liposomal (LE-DT)
- Doceaqualip (Docetaxel Nanosomal)
- MLN8054
- Oradoxel (Oral Docetaxel)
- Dendrimer Docetaxel (DEp Docetaxel)
- Docetaxel-Loaded Nanopharmaceutical (CRLX301)
- Actikerall (Fluorouracil Salicylic Acid)
- B003
- Doceplus (Docetaxel Liposomal)
- Exelbine (Vinorelbine)
- Keaili (Albumin Bound Paclitaxel)
- Docetaxel (ANX-514)
- Docetaxel Micellar
- Liposomal Vinorelbine (TLC178)
- Nanodotax (NZ-DTX)
- Nanoencapsulated Paclitaxel (FID-007)
- Sudocetaxel Zendusortide (TH 1902)
Clinical Activity and Development of Mitotic Inhibitors
There are about 18 approved drug products as mitotic inhibitors in the market and more than 20 products are in the pipeline which are being developed by 29 companies.
- In May 2022, Cristal Therapeutics’s Docetaxel (CPC634)-entrapping polymeric nanoparticle, at a diagnostic dose, in PET/CT imaging reflected on-treatment accumulation and thus opened the possibility for patient stratification in cancer nanomedicine with polymeric nanoparticles.
- In Feb 2023, Modra Pharma’s Docetaxel oral/Ritonavir (ModraDoc006/r) was observed to be superior to i.v. docetaxel in terms of median time above cytotoxic threshold levels, indicating superior cytotoxicity and inhibition of tumor growth compared to i.v. administration for relatively docetaxel-sensitive tumors.
- In May 2023, Samyang Grpoup’s Nanoxel M (Docetaxel polymeric micelle) and Nippon Kayaku, Mundipharma, Celltrion, and Teva’s Herzuma (Trastuzumab-pkrb) combination for patients with HER2-positive SDC has shown some promising anti-tumor activities with an objective response rate of 69.8%, disease control rate of 93.0%, median progression-free survival of 7.9%.
Target Indication Analysis of Mitotic Inhibitors
The Mitotic inhibitor, Docetaxel is indicated as a single agent for the treatment of locally advanced or metastatic breast cancer after chemotherapy failure and with Doxorubicin and Cyclophosphamide as adjuvant treatment of operable node-positive breast cancer. It is also indicated as a single agent for locally advanced or metastatic non-small cell lung cancer after platinum therapy failure and with Cisplatin for unresectable, locally advanced, or metastatic NSCLC. Docetaxel is indicated with Cisplatin and Fluorouracil for the treatment of metastatic castration-resistant prostate cancer and for untreated, advanced gastric adenocarcinoma, including the gastroesophageal junction. Cisplatin and Fluorouracil are also used for induction treatment of locally advanced squamous cell carcinoma of the head and neck in combination with Docetaxel.
Regional Analysis of Mitotic Inhibitors
Mitotic Inhibitors Market
Bristol Myers Squibb’s (BMS) Abraxane (Paclitaxel protein-bound) saw a decline in sales of US$ 811 million in 2022 to US$ 1,181 million in 2021 primarily due to entry of authorized generics and lower demands, however, a major chunk of the product sale was from the USA market accounting for US$ 580 million. Moreover, the USA patent for BMS’s Taxol (Paclitaxel) will expire in Dec 2023. Breast cancer is the most common cancer occurring in women (22,61,419 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). Similarly, some of the other indications of mitotic inhibitors, such as lung cancer, is 2nd most common cancer (22,06,771 patients) worldwide, affecting the world population.
Latin America
Europe
Asia Pacific
Middle East
North America
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Frequently Asked Questions
Taxotere (Docetaxel), Halaven (Eribulin), Taxol (Paclitaxel) Abraxane (Paclitaxel protein-bound), Vincasar PFS (Vincristine), Vumon (Teniposide) are some of the approved Mitotic Inhibitors.
The global sale of Abraxane for 2022 was US$ 811 million.
Teva Pharmaceuticals, Pfizer, Eisai, Bristol-Myers Squibb, Celgene Corporation, Novartis, and Merck are a few major players in the mitotic inhibitors space.
More than 23,00,000 women are affected by breast cancer globally.
- Pfizer (USA)
- Eisai Co. Ltd. (Japan)
- Bristol Myers Squibb (USA)
- Teva Pharmaceuticals (USA)
- Enzo Life Sciences (USA)
- Sanofi (USA)
- Merck (USA)
- Novartis (Switzerland)