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Last Updated: April 13, 2025

CLINICAL TRIALS PROFILE FOR CYTADREN


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All Clinical Trials for CYTADREN

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00006371 ↗ A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer Terminated Janssen Pharmaceuticals Phase 2 2000-05-01 RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as aminoglutethimide or ketoconazole may stop the adrenal glands from producing hormones. Combining hydrocortisone with either aminoglutethimide or ketoconazole may be an effective treatment for prostate cancer. PURPOSE: Phase II trial to study the effectiveness of combining hydrocortisone with either aminoglutethimide or ketoconazole in treating patients who have localized stage IV prostate cancer.
NCT00006371 ↗ A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer Terminated National Cancer Institute (NCI) Phase 2 2000-05-01 RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as aminoglutethimide or ketoconazole may stop the adrenal glands from producing hormones. Combining hydrocortisone with either aminoglutethimide or ketoconazole may be an effective treatment for prostate cancer. PURPOSE: Phase II trial to study the effectiveness of combining hydrocortisone with either aminoglutethimide or ketoconazole in treating patients who have localized stage IV prostate cancer.
NCT00006371 ↗ A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer Terminated H. Lee Moffitt Cancer Center and Research Institute Phase 2 2000-05-01 RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as aminoglutethimide or ketoconazole may stop the adrenal glands from producing hormones. Combining hydrocortisone with either aminoglutethimide or ketoconazole may be an effective treatment for prostate cancer. PURPOSE: Phase II trial to study the effectiveness of combining hydrocortisone with either aminoglutethimide or ketoconazole in treating patients who have localized stage IV prostate cancer.
>Trial ID>Title>Status>Phase>Start Date>Summary
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Clinical Trial Conditions for CYTADREN

Condition Name

10-0.100.10.20.30.40.50.60.70.80.911.1Prostate Cancer[disabled in preview]
Condition Name for CYTADREN
Intervention Trials
Prostate Cancer 1
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Condition MeSH

10-0.100.10.20.30.40.50.60.70.80.911.1Prostatic Neoplasms[disabled in preview]
Condition MeSH for CYTADREN
Intervention Trials
Prostatic Neoplasms 1
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Clinical Trial Locations for CYTADREN

Trials by Country

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Trials by Country for CYTADREN
Location Trials
United States 1
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Trials by US State

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Trials by US State for CYTADREN
Location Trials
Florida 1
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Clinical Trial Progress for CYTADREN

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 2[disabled in preview]
Clinical Trial Phase for CYTADREN
Clinical Trial Phase Trials
Phase 2 1
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Terminated[disabled in preview]
Clinical Trial Status for CYTADREN
Clinical Trial Phase Trials
Terminated 1
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Clinical Trial Sponsors for CYTADREN

Sponsor Name

trials000001111111Janssen PharmaceuticalsNational Cancer Institute (NCI)H. Lee Moffitt Cancer Center and Research Institute[disabled in preview]
Sponsor Name for CYTADREN
Sponsor Trials
Janssen Pharmaceuticals 1
National Cancer Institute (NCI) 1
H. Lee Moffitt Cancer Center and Research Institute 1
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Sponsor Type

33.3%33.3%33.3%0-0.100.10.20.30.40.50.60.70.80.911.1IndustryNIHOther[disabled in preview]
Sponsor Type for CYTADREN
Sponsor Trials
Industry 1
NIH 1
Other 1
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Clinical Trials, Market Analysis, and Projections for Cytadren

Introduction

Cytadren, also known as aminoglutethimide, is a medication used primarily for the suppression of adrenal function in patients with Cushing’s syndrome and for the treatment of advanced breast cancer. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Cushing’s Syndrome

Cytadren has been used to reduce adrenal steroid production in patients with Cushing’s syndrome. Clinical trials have shown that it can decrease morning plasma cortisol levels significantly. For instance, in patients with adrenal carcinoma and ectopic ACTH-producing tumors, plasma cortisol levels were reduced to about half of the pretreatment levels, and in patients with adrenal hyperplasia, levels were reduced to about two-thirds of the pretreatment levels during 1-3 months of therapy[1][4].

Advanced Breast Cancer

In the context of advanced breast cancer, Cytadren suppresses estrogen biosynthesis, leading to tumor regression in patients with estrogen receptor-positive tumors. Studies indicate that approximately one-third of unselected postmenopausal women with metastatic breast carcinoma show objective responses to Cytadren therapy. Patients with metastases in soft tissue and bone exhibit the highest response rates[4].

Mechanism of Action

Cytadren works by inhibiting several steps in steroid synthesis, including the hydroxylation of steroids in the adrenal cortex, mediated through the binding of Cytadren to cytochrome P-450 complexes. This inhibition reduces the production of glucocorticoids and mineralocorticoids, making it effective for conditions like Cushing’s syndrome and advanced breast cancer[1][4].

Safety and Adverse Effects

While Cytadren is effective, it comes with several adverse effects. Common side effects include drowsiness, headache, hypotension, vomiting, and skin rash. More severe side effects can include adrenal insufficiency, hypothyroidism, and masculinization or hirsutism in females. It is also known to cause fetal harm when administered during pregnancy[1].

Market Analysis

Current Market

The market for drugs treating conditions like Cushing’s syndrome and advanced breast cancer is niche but significant. However, Cytadren is not a major player in the broader oncology or endocrinology markets. Its use is primarily as an interim measure or in specific cases where other treatments are not appropriate[1][4].

Competitive Landscape

The oncology market, particularly for breast cancer and other solid tumors, is dominated by newer therapies such as immune checkpoint inhibitors and targeted therapies. For instance, the non-small cell lung cancer (NSCLC) market, which is a broader segment, is expected to grow significantly due to the adoption of premium-priced immunotherapies and targeted therapies[2].

Market Projections

Given the specific indications and the limited patient population for Cytadren, its market growth is not expected to be substantial. The drug's use is largely confined to specialized cases, and it does not compete directly with the newer, more expensive therapies that are driving the growth in the oncology market.

Future Outlook

Regulatory and Clinical Trends

The life sciences industry is facing significant challenges, including pricing and access issues, competition from generics and biosimilars, and the patent cliff. However, these trends do not directly impact Cytadren, as it is an older drug with established use in specific niches[5].

Technological and Research Advancements

The increasing use of digital technologies and personalized medicine in clinical trials may not directly benefit Cytadren, given its established mechanism of action and clinical use. However, advancements in diagnostic technologies could potentially identify more patients who might benefit from Cytadren, albeit in a limited capacity[3].

Key Takeaways

  • Efficacy: Cytadren is effective in reducing adrenal steroid production and estrogen biosynthesis, making it useful for Cushing’s syndrome and advanced breast cancer.
  • Safety: The drug has several adverse effects, including adrenal insufficiency, hypothyroidism, and potential fetal harm.
  • Market: Cytadren operates in a niche market with limited growth potential due to its specific indications and the dominance of newer therapies in broader oncology markets.
  • Future Outlook: The drug's use will likely remain stable, with no significant market growth expected due to its established role in specialized cases.

FAQs

Q: What is the primary use of Cytadren?

A: Cytadren is primarily used for the suppression of adrenal function in patients with Cushing’s syndrome and for the treatment of advanced breast cancer.

Q: How does Cytadren work?

A: Cytadren inhibits several steps in steroid synthesis by binding to cytochrome P-450 complexes, reducing the production of glucocorticoids and mineralocorticoids.

Q: What are the common side effects of Cytadren?

A: Common side effects include drowsiness, headache, hypotension, vomiting, and skin rash.

Q: Can Cytadren be used during pregnancy?

A: No, Cytadren can cause fetal harm and should not be used during pregnancy unless absolutely necessary and under strict medical supervision.

Q: What is the market outlook for Cytadren?

A: The market for Cytadren is expected to remain stable with limited growth potential due to its specific indications and the dominance of newer therapies in broader oncology markets.

Sources

  1. Cytadren - accessdata.fda.gov
  2. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025
  3. Global Clinical trials market size, share and growth report, 2030
  4. Cytadren - E-lactancia
  5. 2025 life sciences outlook | Deloitte Insights

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