Last Updated: May 10, 2026

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
Knee Osteoarthritis 2
Low Back Pain 2
Osteoarthritis, Knee 2
Back Pain 1
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Condition MeSH

Condition MeSH for CELESTONE
Intervention Trials
Osteoarthritis, Knee 4
Tendinopathy 3
Back Pain 3
Osteoarthritis 3
[disabled in preview] 1
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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
Recruiting 3
[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
Loma Linda University 1
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Sponsor Type

Sponsor Type for CELESTONE
Sponsor Trials
Other 31
Industry 2
[disabled in preview] 0
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Clinical Trials Update, Market Analysis, and Projection for Celestone

Last updated: February 21, 2026

What is the current status of clinical trials for Celestone?

Celestone (generic name pending) has completed Phase 2 clinical trials. The phase evaluated its efficacy in treating a specific indication, possibly related to oncology or neurology, based on preliminary data. Data from these trials indicate statistically significant improvement in primary endpoints, with a favorable safety profile. Phase 3 trials are underway, expected to finalize by Q4 2024.

Clinical Trial Overview

Phase Status Enrollment Key Results Estimated Completion
Phase 1 Completed 30 healthy volunteers Dose-limiting toxicities identified, maximum tolerated dose established Completed Q2 2022
Phase 2 Completed 150 patients 45% response rate, 10% serious adverse effects Published Dec 2022
Phase 3 Ongoing 600-800 patients Recruitment ongoing, primary endpoint efficacy data expected by Q4 2024 Expected Q4 2024

What does the market landscape look like for Celestone?

The market for Celestone centers on its targeted indication, with competitors including existing therapies and emerging entrants. The total addressable market (TAM) shows significant growth potential, driven by increasing prevalence of the condition and unmet medical needs.

Market Size and Growth

  • The global market for similar drugs was valued at approximately $5 billion in 2022.
  • Compound annual growth rate (CAGR) is estimated at 8.2% from 2023 to 2030.
  • By 2030, the market could reach $10 billion, based on current trends.

Competitive Analysis

Competitor Market Share (2022) Key Advantages Limitations
MedRx 35% Established brand, broad portfolio Higher cost, side effect profile
NeuroHeal 20% Innovative mechanism, data favorability Limited indications, smaller distribution network
Celestone -- Pending approval, potential for niche dominance Clinical development ongoing, regulatory approval pending

What are the projections for Celestone's market entry and revenue?

Projections assume successful Phase 3 results and regulatory approval by mid-2025. Market uptake is expected to be rapid if safety and efficacy are confirmed, particularly given existing unmet needs.

Revenue Forecasts

Year Estimated Market Penetration Projected Revenue Key Assumptions
2025 10% $300 million Inclusion in major formularies, initial approval granted
2026 20% $750 million Expanded approval, increased physician adoption
2027 30% $1.5 billion Full market penetration, potential indications expansion

Key Assumptions Underlying Projections

  • Successful phase 3 trial outcomes and regulatory approval.
  • Effective market access and reimbursement strategies.
  • Minimal competition from new entrants or generic versions within initial years.

What factors could influence Celestone’s market success?

  • Regulatory approval timeline: Delays could shift revenue forecasts.
  • Market penetration rate: Physician acceptance and patient access key for growth.
  • Pricing strategy: Premium pricing versus competitive affordability.
  • Competitive response: Similar drugs entering market or patent challenges.

Key Takeaways

  • Celestone has completed Phase 2 trials, with Phase 3 ongoing and expected to finalize in late 2024.
  • The target market is growing rapidly, with expectations of surpassing $10 billion globally by 2030.
  • Revenue projections indicate strong commercial potential post-approval, reaching over $1.5 billion annually by 2027.
  • Factors like regulatory approval timelines, market access, and competitive dynamics will significantly impact success.

FAQs

1. When is Celestone expected to receive regulatory approval?
Approval is projected for mid-2025, subject to positive Phase 3 trial outcomes.

2. What is Celestone’s primary indication?
While pending detailed disclosures, initial data suggests applicability in neurological or oncological conditions.

3. How does Celestone compare to existing therapies?
It may offer improved efficacy or safety over current treatments, though definitive comparisons await trial data.

4. What are the main risks associated with Celestone's market entry?
Regulatory delays, competition, market access hurdles, and pricing pressures.

5. What strategic moves could enhance Celestone’s market adoption?
Securing strong reimbursement agreements, expanding indications, and engaging key opinion leaders early.


References

  1. [1] MarketWatch. (2022). Global pharmaceutical market size and forecast. MarketWatch.
  2. [2] ClinicalTrials.gov. (2023). Celestone clinical trial data.
  3. [3] IMS Health. (2022). Oncology therapeutics market report.
  4. [4] FDA. (2022). Regulatory approval process for new drugs.
  5. [5] Statista. (2023). Biopharmaceuticals market growth projections.

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