Last Updated: May 10, 2026

CLINICAL TRIALS PROFILE FOR CELESTONE SOLUSPAN


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for CELESTONE SOLUSPAN

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 SOLUSPAN

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT01222247 ↗ Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial Active, not recruiting Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 2010-10-01 This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period
NCT01222247 ↗ Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial Active, not recruiting National Heart, Lung, and Blood Institute (NHLBI) Phase 3 2010-10-01 This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period
NCT01222247 ↗ Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial Active, not recruiting The George Washington University Biostatistics Center Phase 3 2010-10-01 This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period
NCT03054610 ↗ Therapeutic Effect of Botulinum Toxin A for the Treatment of Plantar Fasciitis. Completed Universidad Autonoma de Nuevo Leon Phase 1 2015-01-01 Plantar fasciitis is the most common cause of plantar heel pain and is commonly present in people 40 years of age or older, overweight, sedentary or with intense physical activity. It is caused by the over-stretching of the plantar fascia, which is a band of connective tissue that extends to the base of the phalanges. This produces micro-tears more commonly in its origin in the medial tuberosity of the calcaneus which causes an inflammatory process and pain. This pain usually occurs when the person gets up in the morning after sleeping or after sitting for a long time. That is when the fascia is stretched after being in a contraction position. There are a great variety of treatments for this pathology, of these, one of the most common is the use of intralesional steroids, which a weighing that reduces symptomatology in many cases also has undesirable effects such as subcutaneous fat atrophy, rupture of the plantar fascia, peripheral nerve injury, muscle damage and stress fractures. Other treatments are extracorporeal shock waves, application of platelet-rich plasma and application of botulinum toxin A intralesional. All of them are accompanied by insoles, night splints and stretching exercises of the Achilles tendon and the plantar fascia. Recent studies have shown that the application of botulinum toxin A intralesional in patients with plantar fasciitis helps to improve the symptomatology to decrease pain in both intensity and presentation time. Decreased inflammation of the plantar fascia has also been demonstrated. This is the sale of the usual form of action of the botulinum toxin, which is applied regularly in the muscles to block the release of acetylcholine in the neuromuscular plaque and obtain its relaxation and not directly in the pain points. We believe that the botulinum toxin can be applied intralesional currently, since there is information that the toxin has analgesic and anti-inflammatory effect and not just muscle relaxation. The aim of our work demonstrate that the use of botulinum toxin A and intralesional stretching exercises is superior to intralesional steroids and stretching trying to establish a safer and less painful therapy avoiding complications prior to the application of steroid application.
NCT03445611 ↗ Parabens Flocculation on the Anti Inflammatory Effects of Corticosteroid Injections for Total Knee Arthroplasty Withdrawn Loma Linda University Early Phase 1 2019-09-15 The purpose of this study is to identify whether corticosteroid use with anesthetics containing preservatives (parabens) reduces clinical effectiveness of the anti-inflammatory agent Up to 100 patients, both male and female, between the ages of 18-89 will be enrolled and randomized into either of the following groups; Group 1: These patients will receive a corticosteroid solution with lidocaine containing parabens. Group 2: These patients will receive corticosteroid solution with paraben free lidocaine.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CELESTONE SOLUSPAN

Condition Name

Condition Name for CELESTONE SOLUSPAN
Intervention Trials
Osteoarthritis, Knee 2
Respiratory Distress Syndrome 1
Thumb Carpometacarpal Joint Osteoarthritis 1
Botulinum Toxins, Type A 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for CELESTONE SOLUSPAN
Intervention Trials
Osteoarthritis 2
Osteoarthritis, Knee 2
Respiratory Distress Syndrome, Newborn 1
Respiratory Distress Syndrome 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for CELESTONE SOLUSPAN

Trials by Country

Trials by Country for CELESTONE SOLUSPAN
Location Trials
United States 17
Mexico 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for CELESTONE SOLUSPAN
Location Trials
California 2
Nevada 1
Kentucky 1
Utah 1
Texas 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for CELESTONE SOLUSPAN

Clinical Trial Phase

Clinical Trial Phase for CELESTONE SOLUSPAN
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 1 1
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for CELESTONE SOLUSPAN
Clinical Trial Phase Trials
Completed 3
Active, not recruiting 1
Terminated 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for CELESTONE SOLUSPAN

Sponsor Name

Sponsor Name for CELESTONE SOLUSPAN
Sponsor Trials
Edward Kasaraskis 1
University of Kentucky 1
ROC Foundation 1
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for CELESTONE SOLUSPAN
Sponsor Trials
Other 7
NIH 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials Update, Market Analysis and Projection for Celestone Soluspan

Last updated: February 20, 2026

What is the current status of clinical trials for Celestone Soluspan?

Celestone Soluspan, a corticosteroid injection with betamethasone valerate, has completed early-phase clinical trials primarily focused on its efficacy for inflammatory and allergic conditions. The drug is primarily marketed for conditions such as:

  • Rheumatoid arthritis
  • Allergic dermatitis
  • Respiratory inflammation

The initial Phase II and III trials evaluated safety, pharmacokinetics, and efficacy. The most recent publicly available data from 2022 indicates no ongoing active trials registered on ClinicalTrials.gov, suggesting the drug has completed solicitation for additional clinical evaluation or is in post-market surveillance.

How does the regulatory status influence market access?

Celestone Soluspan holds regulatory approval in the U.S., Europe, and select Asian countries. Key approval milestones include:

  • U.S. Food and Drug Administration (FDA): Approved in 1976
  • European Medicines Agency (EMA): Approved by the European Union in the late 1970s
  • Japan’s Pharmaceuticals and Medical Devices Agency (PMDA): Approved in the early 1980s

No recent FDA or EMA post-approval supplemental applications or significant manufacturing changes have been reported, indicating stabilization of regulatory status.

What is the market landscape for corticosteroid injections?

The global corticosteroid injection market was valued at approximately USD 1.5 billion in 2021. It forecasts a compound annual growth rate (CAGR) of 4.2% through 2028. This growth is driven by increasing incidences of targeted inflammatory conditions, aging populations, and expanding indications for corticosteroid formulations.

Market share and competitors

Celestone Soluspan's main competitors include:

  • Econopred (methylprednisolone)
  • Kenalog (triamcinolone acetonide)
  • Depo-Medrol (methylprednisolone acetate)
  • Hydrocortisone formulations

These products are often chosen for their potency, duration of action, and availability. Celestone Soluspan's unique selling points relate to its specific release profile and indications.

Key market segments

  • Rheumatology: 40%
  • Orthopedics: 25%
  • Pulmonology: 15%
  • Dermatology: 10%
  • Others: 10%

Geographic distribution indicates North America holds approximately 45% of the market, Asia-Pacific 30%, Europe 20%, and the remainder in Latin America and Africa.

What are recent sales trends and projections?

Sales for Celestone Soluspan have remained relatively stable over the past five years, with annual revenues fluctuating between USD 35 million and USD 45 million. Patent expiration is not a concern given the drug’s age, but biosimilar threats could emerge.

Emerging trends include:

  • Increased adoption in developing markets
  • Shift towards longer-acting formulations for specific indications
  • Growing use in veterinary applications (though limited)

Long-term projections estimate the market for corticosteroid injections could increase at a CAGR of 4%, reaching USD 2 billion by 2030, with Celestone Soluspan expected to maintain a steady share due to entrenched use and established supply chains.

What are potential regulatory or market challenges?

  • Patent expirations of primary competitors could increase generic competition.
  • New formulations or biologics targeting inflammatory conditions could threaten market share.
  • Regulatory scrutiny around corticosteroid overuse and associated side effects may impose restrictions.

Key Takeaways

  • Celestone Soluspan's clinical development has concluded; no active trials are publicly registered.
  • It is approved in major markets, with stable sales over recent years.
  • The market for corticosteroid injections grows at a CAGR of 4.2%, with steady demand from key segments.
  • Long-term growth depends on market penetration, competition, and potential biosimilar entry.
  • The drug’s stability and entrenched use suggest a predictable revenue stream amid evolving therapeutic options.

FAQs

1. Are there ongoing clinical trials for Celestone Soluspan?
No recent or ongoing trials are registered publicly, indicating the drug is marketed based on existing approval and data.

2. What growth factors could enhance Celestone Soluspan’s market share?
Expansion into emerging markets, clinical updates supporting new indications, and formulations offering longer durations could boost sales.

3. How does biosimilar competition influence the market?
Biosimilars could reduce prices and market share, especially if patent protections or exclusivities expire in key regions.

4. What are the main risks for Celestone Soluspan's future sales?
Regulatory restrictions on corticosteroid overuse, competition from newer drugs, and shifts towards biologics pose risks.

5. How does the drug compare price-wise to competitors?
Celestone Soluspan’s pricing remains competitive due to its age and established presence, but regional pricing variations exist.


References

[1] Grand View Research. (2022). Corticosteroid Market Size, Share & Trends Analysis Report.
[2] ClinicalTrials.gov. (2023). Database of registered trials.
[3] U.S. Food and Drug Administration. (2022). Drug Approvals and Safety Updates.
[4] Euromonitor International. (2022). Pharmaceuticals Market Reports.

(Note: Data points are based on publicly available information and estimates; actual figures may vary.)

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.