About Apalutamide (Amorphous & Form B) API
Therapeutic Category Oncology
CAS Number
956104-40-8
API Technology
Synthetic
Dose Form
Tablets
Dr Reddy's Development Status
Available
Available Regulatory Filing
Brazil DMF, USDMF
Mechanism of Action
Apalutamide is an Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. Apalutamide inhibits AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription. A major metabolite, N-desmethyl apalutamide, is a less potent inhibitor of AR, and exhibited one-third the activity of apalutamide in an in vitro transcriptional reporter assay. Apalutamide administration caused decreased tumor cell proliferation and increased apoptosis leading to decreased tumor volume in mouse xenograft models of prostate cancer.
Indication
ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.
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Related Resources
US DMF for Apalutamide - Now available
FAQs
This medicine may cause dizziness, tiredness, seizures, and an increase risk for falls and fractures. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If you plan to have children, talk with your doctor before using this medicine.
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Amorphous form is stable for 3 months at room temperature and recommended storage conditions of 2-8°C. Extended stability will be established.
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We offer Crystalline Form-B
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Available in Tablet dosage form with strength of 60 Mg
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Dr.Reddys is the early mover in Apalutamide API manufacturing and files the USDMF
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Apalutamide belongs to class 2 of BCS classification.
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Apalutamide is an androgen receptor inhibitor used to treat non metastatic, castration resistant prostate cancer.
Disclaimer
No information on this website, 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, in certain cases, at Dr. Reddy's sole discretion, and subject to local legal requirement, the research quantities of such products may be offered for the purpose of regulatory submissions under Section 107A of the Indian Patent Act (Bolar exemption), wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the product or service including, patent scenario in their respective markets and will be responsible for all patent related liabilities Dr. Reddy's disclaims all warranties, express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose and non-infringement.