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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR CORTALONE


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All Clinical Trials for Cortalone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00900445 ↗ Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia Withdrawn National Cancer Institute (NCI) 2008-03-24 This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the body. It may also help doctors predict how patients will respond to treatment
NCT00900445 ↗ Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia Withdrawn Children's Oncology Group 2008-03-24 This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the body. It may also help doctors predict how patients will respond to treatment
NCT02828358 ↗ Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement Active, not recruiting National Cancer Institute (NCI) Phase 2 2017-03-27 This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, and thioguanine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug may kill more cancer cells.
NCT03007147 ↗ Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Recruiting EsPhALL network I-BFM Study Group Phase 3 2017-07-28 This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.
NCT03007147 ↗ Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Recruiting National Cancer Institute (NCI) Phase 3 2017-07-28 This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cortalone

Condition Name

Condition Name for Cortalone
Intervention Trials
B Acute Lymphoblastic Leukemia 5
Mixed Phenotype Acute Leukemia 3
Blasts More Than 25 Percent of Bone Marrow Nucleated Cells 2
Recurrent Mixed Phenotype Acute Leukemia 2
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Condition MeSH

Condition MeSH for Cortalone
Intervention Trials
Precursor Cell Lymphoblastic Leukemia-Lymphoma 8
Leukemia, Lymphoid 8
Leukemia 8
Acute Disease 4
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Clinical Trial Locations for Cortalone

Trials by Country

Trials by Country for Cortalone
Location Trials
United States 233
Canada 30
Australia 15
New Zealand 6
Puerto Rico 4
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Trials by US State

Trials by US State for Cortalone
Location Trials
Texas 6
Tennessee 6
South Carolina 6
Pennsylvania 6
Oklahoma 6
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Clinical Trial Progress for Cortalone

Clinical Trial Phase

Clinical Trial Phase for Cortalone
Clinical Trial Phase Trials
Phase 3 6
Phase 2 2
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Cortalone
Clinical Trial Phase Trials
Recruiting 4
Not yet recruiting 4
Withdrawn 1
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Clinical Trial Sponsors for Cortalone

Sponsor Name

Sponsor Name for Cortalone
Sponsor Trials
National Cancer Institute (NCI) 9
Children's Oncology Group 5
EsPhALL network I-BFM Study Group 1
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Sponsor Type

Sponsor Type for Cortalone
Sponsor Trials
NIH 9
Other 6
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Clinical Trials, Market Analysis, and Projections for COMT Inhibitors and Related Drugs: A Focus on the Broader Context

Introduction to Clinical Trials and Drug Development

Clinical trials are a crucial phase in the development of new drugs, including COMT inhibitors and other therapeutic agents. These trials are designed to assess the safety, efficacy, and optimal dosage of drugs before they are approved for public use.

Clinical Trials: Key Phases and Importance

Clinical trials are divided into several phases, each serving a distinct purpose:

Phase 1

  • This phase involves a small group of participants and focuses on the safety and tolerability of the drug[3].

Phase 2

  • Here, the drug is tested on a larger group to evaluate its efficacy and side effects. This phase also includes pharmacokinetics and pharmacodynamics studies[3].

Phase 3

  • These trials are large-scale and aim to confirm the drug's efficacy, monitor side effects, compare the drug to commonly used treatments, and collect information that will allow the experimental drug to be used safely[3].

Update on Specific Clinical Trials

Merck's KEYNOTE-867 and KEYNOTE-630 Trials

  • Merck recently announced the discontinuation of two Phase 3 trials, KEYNOTE-867 and KEYNOTE-630, which were evaluating KEYTRUDA (pembrolizumab) for different indications. The KEYNOTE-630 trial, specifically, was assessing KEYTRUDA as an adjuvant therapy for patients with high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) following surgery and radiation. The trial was stopped due to futility, as the risk/benefit profile did not support continuing the trial[1].

Market Analysis for COMT Inhibitors

Current Market Size and Growth

  • The global market for COMT inhibitors was estimated to be worth USD 948.5 million in 2022. It is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 8.60% to 9.8% from 2023 to 2030 or 2031, reaching approximately USD 1.835 billion to USD 2 billion by the end of the forecast period[2][5].

Leading Market Segments

  • Product Type: Tolcapone is currently the most popular category of COMT inhibitors, but opicapone is expected to register a lucrative growth rate due to its once-daily dosing and extended duration of action[5].
  • Indication: Parkinson’s disease is the leading indication for COMT inhibitors, driven by the increasing prevalence of the disease, particularly in aging populations[5].

Regional Market

  • North America: This region dominates the COMT inhibitors market, accounting for around 35.1% of the market share. The advanced healthcare infrastructure, significant healthcare spending, and adequate insurance coverage contribute to this dominance[5].

Key Players and Competitive Landscape

  • The global COMT inhibitors market is competitive, with key players including Orion Corporation, Roche, AbbVie Inc., Acadia Pharmaceuticals, Amneal Pharmaceutical, UCB, Teva Pharmaceutical, Novartis AG, Lundbeck A/S, and others. These companies invest heavily in research and development to discover and develop new COMT inhibitors[2][5].

Market Drivers and Challenges

Drivers

  • The growing usage of COMT inhibitors as supplementary therapy for treating Parkinson’s disease and other conditions, along with research into their potential to improve cognitive functions, are driving the market growth[2].
  • The convenience of once-daily dosing and the potential for improved patient compliance, especially with drugs like opicapone, are significant drivers[5].

Challenges

  • Reimbursement challenges and varying insurance coverage affect patient access to COMT inhibitors. Disease complexity and drug-drug interactions are also notable challenges[2].

Market Opportunities

  • Investigating the potential uses of currently available COMT inhibitors for other medical disorders and developing biologic COMT inhibitors for improved therapeutic benefits present substantial opportunities for market growth[2].

Clinical Trials and Market Projections for Related Drugs

Corcept Therapeutics' Relacorilant

  • Corcept Therapeutics is conducting advanced clinical trials with relacorilant, a selective glucocorticoid receptor modulator, for the treatment of hypercortisolism (Cushing’s syndrome) and other serious disorders. The Phase 3 GRACE trial has presented promising results, highlighting the potential of relacorilant in managing hypercortisolism[4].

Future Outlook and Projections

Clinical Trials Market

  • The clinical trials market is expected to grow from USD 54.39 billion in 2024 to USD 94.68 billion by 2034, at a CAGR of 5.7%. This growth is driven by the increasing demand for novel treatments, especially for chronic and rare diseases, and the adoption of advanced digital solutions in clinical trials[3].

Regional Growth

  • The Asia-Pacific region is anticipated to grow at the fastest rate in the clinical trials market, driven by the rising incidence of chronic disorders, expanding healthcare infrastructure, and increasing investments in clinical trials[3].

Key Takeaways

  • Clinical Trials: Phase 3 trials are critical for drug approval but can be discontinued if the risk/benefit profile is not favorable.
  • COMT Inhibitors Market: The market is growing steadily, driven by the increasing prevalence of Parkinson’s disease and the convenience of newer drugs like opicapone.
  • Market Drivers: Growing usage in supplementary therapy and research into cognitive improvements are key drivers.
  • Challenges: Reimbursement issues and disease complexity are significant challenges.
  • Opportunities: Exploring new indications and developing biologic COMT inhibitors offer substantial growth opportunities.
  • Related Drugs: Drugs like relacorilant from Corcept Therapeutics show promise in treating hypercortisolism and other disorders.

FAQs

1. What is the current size of the global COMT inhibitors market?

  • The global COMT inhibitors market was estimated to be worth USD 948.5 million in 2022[2].

2. What is the anticipated growth rate of the COMT inhibitors market from 2023 to 2030?

  • The market is anticipated to grow at a CAGR of 8.60% to 9.8% from 2023 to 2030[2][5].

3. Which region dominates the COMT inhibitors market?

  • North America dominates the COMT inhibitors market, accounting for around 35.1% of the market share[5].

4. What are the main challenges facing the COMT inhibitors market?

  • Reimbursement challenges, varying insurance coverage, disease complexity, and drug-drug interactions are the main challenges[2].

5. What are the potential opportunities for the COMT inhibitors market?

  • Investigating new indications for current COMT inhibitors and developing biologic COMT inhibitors offer significant opportunities for market growth[2].

Sources

  1. Merck Provides Update on Phase 3 KEYNOTE-867 and KEYNOTE-630 Trials - Merck News.
  2. COMT Inhibitors Market By Size, Share, Revenue and Trends 2030 - Credence Research.
  3. Clinical Trials Market Size, Trends & Go-To-Market Strategies - Towards Healthcare.
  4. Corcept Therapeutics Announces Presentations of Results of Pivotal Phase 3 GRACE Trial Evaluating Relacorilant in Patients with Hypercortisolism (Cushing’s Syndrome) - Corcept Therapeutics.
  5. COMT Inhibitors Market Forecast 2031 - CAGR of 9.8% | GPR - Growth Plus Reports.

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