Overview
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Indication
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Research Report
Gridegalutamide (BMS-986365): A Comprehensive Clinical and Scientific Profile of a First-in-Class Androgen Receptor Ligand-Directed Degrader
The Evolving Challenge of Metastatic Castration-Resistant Prostate Cancer (mCRPC)
The Centrality of the Androgen Receptor (AR) Pathway as a Persistent Oncogenic Driver
Prostate cancer, across its entire pathological spectrum, is fundamentally a disease driven by the androgen receptor (AR) signaling pathway.[1] This nuclear receptor, when activated by androgens such as testosterone and its more potent metabolite 5α-dihydrotestosterone (DHT), regulates the transcription of a suite of genes critical for cellular growth and proliferation.[2] The dependence on this pathway is so profound that it remains the primary oncogenic driver for the survival and propagation of tumor cells even after the disease progresses to the metastatic castration-resistant prostate cancer (mCRPC) stage.[1] In this advanced setting, the cancer continues to grow despite serum testosterone levels being suppressed to castrate levels through androgen deprivation therapy (ADT), also known as hormonal castration.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/08 | Phase 3 | Recruiting | |||
2024/05/29 | Phase 1 | Completed | |||
2024/05/16 | Phase 1 | Completed | |||
2020/06/11 | Phase 1 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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