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Last Updated: February 9, 2025

CLINICAL TRIALS PROFILE FOR CELESTONE


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505(b)(2) Clinical Trials for Celestone

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
OTC NCT03707795 ↗ Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study Completed Edward Kasaraskis Early Phase 1 2017-08-21 By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.
OTC NCT03707795 ↗ Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study Completed University of Kentucky Early Phase 1 2017-08-21 By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Celestone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00370799 ↗ Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain Completed Pain Management Center of Paducah Early Phase 1 2007-01-01 To demonstrate clinically significant improvements or lack thereof in the caudal epidural patients with our without steroids. To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids. To assess improvements among patients and compare steroid groups with each other and local anesthetic group. To evaluate and compare the adverse event profile in all patients
NCT00669383 ↗ Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants Completed American Lung Association N/A 2001-06-01 One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems. One course of antenatal steroids is the standard of care for threatened premature deliveries. It is unclear as to how long the benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if the steroids are given at least 24 hours before but within 7 days of a premature delivery. It is difficult to predict the timing of a preterm delivery so deliveries often do not occur within this time period. We hypothesize that the benefits of the steroids to the lungs wear off if the steroids are given more than 14 days before a preterm delivery, and that in these circumstances an extra course of steroids will help the premature baby's lungs and the premature baby will have less breathing problems as shown by lung function testing.
NCT00669383 ↗ Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants Completed Oregon Health and Science University N/A 2001-06-01 One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems. One course of antenatal steroids is the standard of care for threatened premature deliveries. It is unclear as to how long the benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if the steroids are given at least 24 hours before but within 7 days of a premature delivery. It is difficult to predict the timing of a preterm delivery so deliveries often do not occur within this time period. We hypothesize that the benefits of the steroids to the lungs wear off if the steroids are given more than 14 days before a preterm delivery, and that in these circumstances an extra course of steroids will help the premature baby's lungs and the premature baby will have less breathing problems as shown by lung function testing.
NCT00685880 ↗ Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis Terminated Mayo Clinic N/A 2008-05-01 Arthritis of the base of the thumb is a common debilitating problem. It is believed that laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be treated by securing the joint surgically or symptoms can be treated with hand therapy and/or injection of corticosteroids. Recently prolotherapy (sugar water) has been shown to decrease looseness of joints and also be helpful for hand and knee arthritis. We hypothesize that prolotherapy injections for thumb arthritis will be equally or more beneficial to the patients than steroids.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Celestone

Condition Name

Condition Name for Celestone
Intervention Trials
Low Back Pain 2
Osteoarthritis, Knee 2
Hypertrophic Scar 1
PPROM 1
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Condition MeSH

Condition MeSH for Celestone
Intervention Trials
Tendinopathy 3
Back Pain 3
Osteoarthritis, Knee 3
Osteoarthritis 3
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Clinical Trial Locations for Celestone

Trials by Country

Trials by Country for Celestone
Location Trials
United States 20
Canada 9
Australia 6
Spain 1
Greece 1
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Trials by US State

Trials by US State for Celestone
Location Trials
California 3
Kentucky 3
North Carolina 2
Pennsylvania 2
Oregon 2
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Clinical Trial Progress for Celestone

Clinical Trial Phase

Clinical Trial Phase for Celestone
Clinical Trial Phase Trials
Phase 4 9
Phase 3 1
Phase 2/Phase 3 1
[disabled in preview] 3
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Clinical Trial Status

Clinical Trial Status for Celestone
Clinical Trial Phase Trials
Completed 9
Not yet recruiting 4
Unknown status 2
[disabled in preview] 2
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Clinical Trial Sponsors for Celestone

Sponsor Name

Sponsor Name for Celestone
Sponsor Trials
Pain Management Center of Paducah 2
Oregon Health and Science University 2
University of Minnesota - Clinical and Translational Science Institute 1
[disabled in preview] 1
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Sponsor Type

Sponsor Type for Celestone
Sponsor Trials
Other 30
Industry 2
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Clinical Trials, Market Analysis, and Projections for Celestone: A Comprehensive Overview

Introduction

Celestone, a synthetic corticosteroid, is used in various medical conditions, including inflammatory and allergic disorders. While the primary focus of this article is not on Celestone specifically, we will delve into the broader context of clinical trials, market analysis, and projections in the pharmaceutical industry, drawing parallels and insights that could be relevant to drugs like Celestone.

Clinical Trials: General Overview and Recent Developments

Importance of Clinical Trials

Clinical trials are the backbone of drug development, ensuring the safety and efficacy of new treatments before they are approved for public use. These trials are meticulously designed and regulated to protect participants and provide reliable data.

Recent Developments in Clinical Trials

For instance, the Phase 3 YELLOWSTONE clinical trial program by Bristol Myers Squibb, although focused on Zeposia (ozanimod) for Crohn’s disease, highlights the complexity and challenges involved in clinical trials. This trial did not meet its primary endpoint of clinical remission at Week 12, but it underscores the commitment to transformative science in addressing unmet medical needs[1].

Examples from Other Drugs

  • CStone Pharmaceuticals' CS5001 (ROR1 ADC) is making significant progress in clinical trials, demonstrating anti-tumor activity in solid tumors and lymphomas. This rapid advancement in clinical stages, including dose escalation and expansion in multiple regions, shows the dynamic nature of clinical trial development[3].

Market Analysis: Trends and Projections

Global Pharmaceutical Market Trends

The global pharmaceutical market is expected to see significant growth driven by various factors, including the increasing incidence of diseases and the development of new therapies.

Non-Small Cell Lung Cancer (NSCLC) Market

For example, the NSCLC market is projected to rise to $26.8 billion by 2025, with a Compound Annual Growth Rate (CAGR) of 15.7%. This growth is fueled by the increasing incidence of NSCLC, particularly in China, where the market is expected to grow at a robust CAGR of 25.4%[2].

Regional Market Dynamics

  • The NSCLC market in China is expected to grow rapidly, driven by an increase in branded therapy prescriptions and a significant rise in incident cases. This trend is indicative of broader market shifts where emerging markets are gaining prominence[2].

Projections for Pharmaceutical Markets

Growth Drivers

Several factors drive the growth of pharmaceutical markets:

  • Increasing Incidence of Diseases: The rise in cases of diseases like NSCLC and other cancers drives the demand for effective treatments.
  • Advancements in Technology: Innovations in drug development, such as targeted therapies and immunotherapies, are expanding treatment options and improving patient outcomes.
  • Market Expansion: Emerging markets, particularly in Asia, are contributing significantly to the global pharmaceutical market growth[2].

Barriers to Growth

Despite the growth potential, there are several barriers:

  • Biosimilar Erosion: The introduction of biosimilars can reduce the market share of branded drugs, as seen with Avastin and its biosimilar bevacizumab[2].
  • Regulatory Challenges: Clinical trials and regulatory approvals are stringent and time-consuming, which can delay market entry and impact sales projections.

Market Projections for Specific Drugs

Example: Sugemalimab

CStone Pharmaceuticals' sugemalimab, an anti-PD-L1 therapy, has received multiple approvals and is under review for additional indications. This drug's success in various clinical trials and its potential for global market entry highlight the positive projections for innovative therapies[3].

Key Takeaways

  • Clinical Trials: These are crucial for drug development, and their outcomes significantly impact market projections.
  • Market Trends: The pharmaceutical market is driven by increasing disease incidence, technological advancements, and market expansion in emerging regions.
  • Growth Drivers: Innovations in drug development and expanding treatment options are key drivers of market growth.
  • Barriers: Biosimilar erosion and regulatory challenges can impact market projections.

FAQs

Q: What are the key factors driving the growth of the pharmaceutical market?

A: The growth is driven by the increasing incidence of diseases, advancements in drug development technologies, and market expansion in emerging regions.

Q: How do clinical trials impact market projections?

A: Clinical trials provide critical data on the safety and efficacy of drugs, which directly influence regulatory approvals and subsequent market performance.

Q: What are some of the barriers to growth in the pharmaceutical market?

A: Biosimilar erosion, regulatory challenges, and the high cost of drug development are significant barriers.

Q: Can you provide an example of a drug with positive market projections?

A: Sugemalimab by CStone Pharmaceuticals has received multiple approvals and is under review for additional indications, indicating strong market potential.

Q: How does the NSCLC market growth impact the broader pharmaceutical industry?

A: The NSCLC market growth, driven by increasing incidence and new therapies, reflects broader trends in the pharmaceutical industry, such as the importance of targeted and immunotherapies.

Sources

  1. Bristol Myers Squibb: "Bristol Myers Squibb Provides Update on the First Phase 3 YELLOWSTONE Trial Evaluating Zeposia (ozanimod) in Patients with Moderate to Severe Active Crohn’s Disease."
  2. GlobalData: "NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025."
  3. CStone Pharmaceuticals: "CStone Pharmaceuticals Reports 2023 Annual Results and Business Updates."

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