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About Darolutamide API

Product
  • Therapeutic Category抗がん/腫瘍

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Under Development

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の専門知識・技術

ハイデラバード(インド)に本社を構えるDr. Reddy’s Laboratoriesは、世界的に有名な原薬(API)供給業者です。Dr. Reddy’sのAPIビジネスは米国、ヨーロッパ、ブラジル、南米、日本、中国、韓国、その他の新興市場において製薬会社の推奨パートナーとなっています。

Dr. Reddy’sのAPIビジネスは、ステロイド、ペプチド、複合長鎖分子、高薬理活性API(HPAPI /腫瘍学薬)など、複合APIの開発・製造において、30年以上にわたり高度な技術的実績を築き上げ、成長しています。この専門知識・技術は弊社の知的財産および規制関連業務の実績と共に、一貫して規制基準を満たし、それを超える優れた価値を生み出しています。Dr. Reddyの(-) API, R&D (研究開発)、IP、規制の高度な専門知識・技能の結果です。

顧客が真っ先に市場に参入するのに重要な要素は、機敏な供給網です。弊社は全施設を効率的に、そしてコストを最適化して稼働させ、品質と安全性、また、生産性の最新基準に従うことで、そうした供給網を実現させます。オフィスと工場の結びつきを強化し、ダイナミックな市場の変化に迅速に対応しています。そうした理由から、弊社は不足を解消して突発的な供給を満たすことができるのです。

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Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.