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CAS Number: 937263-43-9

Therapeutic Category
Anti-Cancer/ Oncology
API Technology
Dose Form
Oral Solid/Tablets
Dr Reddy's Development Status
Innovator Brand (USA)

Mechanism of Action

Tucatinib is a small molecule tyrosine kinase inhibitor (TKI) that works by blocking the activity of specific protein kinases involved in cancer cell proliferation and survival.

Tucatinib is a small molecule tyrosine kinase inhibitor (TKI) that works by blocking the activity of specific Tucatinib specifically targets the HER2 (human epidermal growth factor receptor 2) protein, which is often over-expressed in certain types of breast and gastric cancers. By blocking the activity of HER2, tucatinib inhibits the signaling pathways that drive cancer cell growth and survival, leading to cancer cell death.

Tucatinib has been approved by the US Food and Drug Administration (FDA) for the treatment of advanced HER2-positive breast cancer in combination with capecitabine and trastuzumab.


Tucatinib is a small molecule inhibitor of the HER2 protein and is indicated for the treatment of certain types of cancer. Specifically, it is approved for the treatment of advanced unresectable or metastatic HER2-positive breast cancer in combination with trastuzumab and capecitabine for adult patients who have received one or more prior anti-HER2-based regimens.

Tucatinib has shown to significantly improve progression-free survival compared to treatment with trastuzumab and capecitabine alone in clinical trials. However, it is important to note that the safety and effectiveness of tucatinib may vary depending on individual circumstances and that patients should consult their healthcare provider to determine if tucatinib is appropriate for their treatment.

Dr. Reddy's Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Tucatinib API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Tucatinib API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

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No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.