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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR CASODEX


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505(b)(2) Clinical Trials for Casodex

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01416870 ↗ Bioequivalence of Bicalutamide New Formulation in Japan Terminated AstraZeneca Phase 1 2010-07-01 The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Casodex

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002855 ↗ Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer Completed National Cancer Institute (NCI) Phase 3 1996-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
NCT00002855 ↗ Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer Completed M.D. Anderson Cancer Center Phase 3 1996-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
NCT00002874 ↗ Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy Unknown status National Cancer Institute (NCI) Phase 3 1998-02-01 RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Casodex

Condition Name

Condition Name for Casodex
Intervention Trials
Prostate Cancer 60
Adenocarcinoma of the Prostate 9
Prostate Adenocarcinoma 6
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Condition MeSH

Condition MeSH for Casodex
Intervention Trials
Prostatic Neoplasms 84
Adenocarcinoma 17
Breast Neoplasms 6
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Clinical Trial Locations for Casodex

Trials by Country

Trials by Country for Casodex
Location Trials
United States 588
Canada 44
Italy 27
United Kingdom 19
China 13
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Trials by US State

Trials by US State for Casodex
Location Trials
California 25
Texas 25
New York 22
Illinois 21
Wisconsin 19
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Clinical Trial Progress for Casodex

Clinical Trial Phase

Clinical Trial Phase for Casodex
Clinical Trial Phase Trials
Phase 4 5
Phase 3 23
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Casodex
Clinical Trial Phase Trials
Completed 54
Active, not recruiting 16
Terminated 12
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Clinical Trial Sponsors for Casodex

Sponsor Name

Sponsor Name for Casodex
Sponsor Trials
National Cancer Institute (NCI) 26
AstraZeneca 16
M.D. Anderson Cancer Center 7
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Sponsor Type

Sponsor Type for Casodex
Sponsor Trials
Other 99
Industry 54
NIH 27
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CASODEX (Bicalutamide): Clinical Trials, Market Analysis, and Projections

Introduction

CASODEX, also known as bicalutamide, is a non-steroidal anti-androgen drug widely used in the treatment of prostate cancer. Here, we will delve into the latest updates on clinical trials, market analysis, and future projections for this medication.

Clinical Trials Update

Ongoing and Completed Trials

Several clinical trials have been conducted to evaluate the efficacy and safety of CASODEX in various settings.

  • Non-Metastatic Prostate Cancer: A Phase 3 randomized, double-blind trial compared bicalutamide 150 mg once daily with placebo in patients with non-metastatic prostate cancer. This study aimed to assess the effect of adjuvant or immediate hormonal therapy versus placebo in these patients[4].
  • Advanced Prostate Cancer: Clinical trials have shown that CASODEX, when used in combination with an LHRH analog, is effective in treating advanced prostate cancer. These trials have highlighted the drug's tolerability and efficacy, with common adverse reactions including hot flashes, nausea, and vomiting[1][3].

Safety and Efficacy Findings

  • Adverse Reactions: Clinical trials have reported various adverse reactions associated with CASODEX, including abnormal liver function tests, hot flashes, and cardiovascular events. However, the drug has generally been well tolerated, with few withdrawals due to adverse events[1][3].
  • Liver Function: It is crucial to monitor liver function tests, especially during the first four months of treatment, due to the risk of hepatotoxicity. Clinical trials have shown that hepatitis or marked increases in liver enzymes leading to drug discontinuation occurred in approximately 1% of patients[1].

Special Populations

  • Pediatric Use: The safety and effectiveness of CASODEX in pediatric patients have not been established. However, a study involving CASODEX and anastrozole in pediatric patients with precocious puberty showed that the drug could be titrated to achieve therapeutic concentrations similar to those in adults[1].

Market Analysis

Global Market Overview

The global prostate cancer therapeutics market, which includes CASODEX, is expected to grow significantly. By 2030, this market is projected to reach USD 21.5 billion, expanding at a CAGR of 8.2% from 2022 to 2030. This growth is driven by the increasing prevalence of prostate cancer and the demand for novel therapeutics[5].

China Market

In China, the bicalutamide market experienced a decline in 2020 due to the COVID-19 pandemic but is expected to recover from 2021 to 2025. AstraZeneca's CASODEX still dominates the market, accounting for more than 70% of the sales value in 2020, although local generic versions are gaining market share[2].

Market Share and Competitors

CASODEX remains a leading anti-androgen drug in the market, known for its good tolerability and high bioavailability. However, other anti-androgen drugs like Xtandi are also significant competitors. Local Chinese companies such as Shanxi Zhendong Pharmaceutical, Shanghai Fosun Zhaohui Pharmaceutical, and Zhejiang Hisun Pharmaceutical are increasing their market presence with generic versions of bicalutamide[2].

Projections and Future Outlook

Market Growth

The bicalutamide market is expected to see recovery growth in sales volume and value from 2021 to 2025, driven by the increasing demand for prostate cancer treatments. The global prostate cancer therapeutics market, which includes hormonal therapy where CASODEX is a key player, is anticipated to expand significantly over the next decade[2][5].

Emerging Trends

  • Increased Awareness and Funding: Government funding and public initiatives to enhance awareness about prostate cancer treatments are expected to boost the market. The rise in online drug purchasing and awareness about online pharmacies will also contribute to the growth[5].
  • Generic Competition: While CASODEX remains dominant, the entry of generic versions from local companies in regions like China is expected to increase competition and potentially reduce market share for the branded version[2].

Challenges and Opportunities

  • Side Effects and Monitoring: The need for regular monitoring of liver function and other potential side effects presents both a challenge and an opportunity for healthcare providers to improve patient care and adherence to treatment.
  • Combination Therapies: The use of CASODEX in combination with other therapies, such as LHRH analogs, offers opportunities for improved treatment outcomes and expanded market potential[1][3].

Key Takeaways

  • Clinical Trials: CASODEX has been extensively studied in various clinical trials, demonstrating its efficacy and safety in treating prostate cancer.
  • Market Dominance: Despite competition from generics, CASODEX remains a leading anti-androgen drug globally, especially in China.
  • Future Growth: The market for bicalutamide is projected to grow, driven by increasing demand for prostate cancer treatments and recovering from pandemic-related declines.
  • Monitoring and Side Effects: Regular monitoring of liver function and other potential side effects is crucial for patient safety.

FAQs

What is CASODEX used for?

CASODEX (bicalutamide) is used for the treatment of prostate cancer, particularly in advanced stages and in combination with LHRH analogs.

What are the common side effects of CASODEX?

Common side effects include hot flashes, nausea, vomiting, and abnormal liver function tests. Cardiovascular events and interstitial lung disease have also been reported in some cases.

Is CASODEX safe for pediatric use?

The safety and effectiveness of CASODEX in pediatric patients have not been established, although it has been studied in combination with anastrozole in pediatric patients with precocious puberty.

How does CASODEX compare to other anti-androgen drugs?

CASODEX is known for its good tolerability and high bioavailability, making it a first-line treatment for advanced prostate cancer. However, other drugs like Xtandi are also significant competitors in the market.

What is the projected market growth for CASODEX?

The bicalutamide market is expected to see recovery growth from 2021 to 2025, driven by increasing demand for prostate cancer treatments and recovering from pandemic-related declines.

Sources

  1. CASODEX (bicalutamide) tablet, for oral use - FDA Label[1]
  2. China Bicalutamide Market Research Report 2021 - Business Wire[2]
  3. CASODEX® PRODUCT MONOGRAPH - AstraZeneca Canada[3]
  4. A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (casodex) 150mg Once Daily with Placebo in Patients with Non-metastatic Prostate Cancer - AstraZeneca Clinical Trials[4]
  5. Prostate Cancer Therapeutics Market Size, Share & Trends Analysis - ResearchAndMarkets[5]

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