About Darolutamide API

Mechanism of Action

Darolutamide belongs to a class of drugs called androgen receptor antagonists. Here's how it disrupts prostate cancer cell growth:

Androgen and Androgen Receptors: Prostate cancer cells rely on male hormones called androgens, particularly testosterone, to grow and survive. These androgens bind to androgen receptors located inside the cancer cells.

Blocking Androgen Binding: Darolutamide acts by competitively binding to these androgen receptors. By occupying the receptor sites, it prevents testosterone and other androgens from attaching and triggering growth signals.

Downstream Effects: This blockade disrupts the normal function of androgen receptors, ultimately leading to a decrease in prostate cancer cell proliferation and potentially a reduction in tumor size.

Indication

Darolutamide is currently approved for two main indications in adult males:

Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC): This refers to prostate cancer that has not yet spread to other parts of the body (non-metastatic) but is no longer responding to treatments that lower testosterone levels (castration-resistant). Darolutamide is typically used in combination with surgical or medical castration.

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): This is a more advanced stage of prostate cancer where the cancer has already spread (metastatic) but still responds to lowering testosterone levels (hormone-sensitive). Here, Darolutamide is used in combination with docetaxel (chemotherapy medication).

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 Darolutamide 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 Darolutamide 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.