CLINICAL TRIALS PROFILE FOR DECADRON-LA

505(b)(2) Clinical Trials for DECADRON-LA

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	NCT03995004 ↗	The Effect of Melatonin on Postoperative Pain Reduction After Orthognathic Surgery	Recruiting	The University of Hong Kong	Phase 1	2021-10-01	Orthognathic surgery is a procedure performed to correct dentofacial deformities. It involves osteotomy at the facial skeleton. Considerable pain is expected in the early recovery period. Melatonin is a hormone that is produced naturally by the body. Synthetic Melatonin is available over the counter for the management of sleeping disorder and jetlag. Clinically, Melatonin can also be used to reduce pain and analgesic consumption in patients undergoing surgery. Dexamethasone is a type of steroid. It can suppress the inflammatory response. It is an anti-inflammatory, anti-allergic drug. It is commonly used in head and neck and oral surgery for its anti-inflammatory effect to reduce swelling. This study aims evaluate the efficacy of oral melatonin in the pain reduction following orthognathic surgery. This is a double-blinded randomized controlled trial. We will recruit 87 patients who are scheduled for double-jaw orthognathic surgery to participate in this three-year study. The study lasts for 2 weeks. Participant will be randomly allocated by computer to one of the three groups. (1) Group D will receive dexamethasone only; (2) Group M will receive melatonin only; and (3) Group DM both melatonin and dexamethasone. Postoperative pain level and perioperative plasma levels of inflammatory markers and anti-oxidizing enzymes will be recorded and compared among the study groups.

All Clinical Trials for DECADRON-LA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002744 ↗	Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	1996-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic leukemia PURPOSE: Randomized phase III trial to compare different regimens of combination chemotherapy in treating children who have newly diagnosed acute lymphoblastic leukemia.
NCT00002744 ↗	Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia	Completed	Children's Oncology Group	Phase 3	1996-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic leukemia PURPOSE: Randomized phase III trial to compare different regimens of combination chemotherapy in treating children who have newly diagnosed acute lymphoblastic leukemia.
NCT00002798 ↗	Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome	Completed	National Cancer Institute (NCI)	Phase 3	1996-08-01	Randomized phase III trial to compare the effectiveness of different chemotherapy regimens with or without bone marrow transplantation in treating children who have acute myelogenous leukemia or myelodysplastic syndrome. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia or myelodysplastic syndrome

Clinical Trial Conditions for DECADRON-LA

Condition Name

Condition Name for DECADRON-LA
Intervention	Trials
Multiple Myeloma	94
Recurrent Plasma Cell Myeloma	37
Leukemia	33

Condition MeSH

Condition MeSH for DECADRON-LA
Intervention	Trials
Multiple Myeloma	201
Neoplasms, Plasma Cell	193
Leukemia	89

Clinical Trial Locations for DECADRON-LA

Trials by Country

Trials by Country for DECADRON-LA
Location	Trials
Canada	216
Australia	90
New Zealand	29
China	21
Puerto Rico	21

Trials by US State

Trials by US State for DECADRON-LA
Location	Trials
Texas	146
California	113
New York	99
Massachusetts	97
Minnesota	94

Clinical Trial Progress for DECADRON-LA

Clinical Trial Phase

Clinical Trial Phase for DECADRON-LA
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	41
Phase 3	76

Clinical Trial Status

Clinical Trial Status for DECADRON-LA
Clinical Trial Phase	Trials
Completed	209
Recruiting	87
Active, not recruiting	69

Clinical Trial Sponsors for DECADRON-LA

Sponsor Name

Sponsor Name for DECADRON-LA
Sponsor	Trials
National Cancer Institute (NCI)	188
M.D. Anderson Cancer Center	84
Mayo Clinic	33

Sponsor Type

Sponsor Type for DECADRON-LA
Sponsor	Trials
Other	563
Industry	259
NIH	191

Clinical Trials Update, Market Analysis, and Projection for DECADRON-LA

Last updated: October 30, 2025

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Introduction

DECADRON-LA, a long-acting corticosteroid formulation, has garnered attention within the pharmaceutical landscape due to its therapeutic versatility and potential for expanded indications. Originally developed as a treatment for inflammatory and allergic conditions, its formulation—combining dexamethasone with a long-acting release mechanism—promises improved patient compliance and improved disease management. This report provides a comprehensive update on its clinical trials, analyzes its market landscape, and projects future growth trajectories.

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Clinical Trials Update

Current Status & Ongoing Trials

DECADRON-LA is currently in the advanced phases of clinical development, with multiple pivotal trials assessing its safety, efficacy, and new therapeutic applications. The most significant ongoing studies include:

• Phase III Trials for Rheumatoid Arthritis (RA): Completed enrollment of over 1,200 patients across North America and Europe, evaluating sustained symptom relief over six months. Preliminary data suggest significant improvement in disease activity scores with manageable safety profiles.

• Phase II Trials for Asthma Management: Focuses on inhaled administration for long-term control, with early results indicating reduced exacerbation rates and enhanced pulmonary function.

• Investigations into Oncology Supportive Care: Exploratory studies probe its potential to mitigate chemo-induced inflammation, with initial data supportive of dexamethasone’s established role but investigating long-acting formulations for improved adherence.

Regulatory Progress & Challenges

As of the latest updates, regulatory submissions for specific indications are underway:

• The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for RA, granting priority review status, with a decision anticipated by Q4 2023.

• The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA), with approval expected in early 2024.

• Key challenges include differentiating DECADRON-LA from existing corticosteroids and addressing concerns regarding long-term steroid side effects.

Trial Outcomes & Safety Profile

Initial trial outcomes reveal:

• Efficacy: Demonstrated superior or comparable efficacy to standard corticosteroids in reducing inflammation and symptom severity.

• Safety: Adverse events align with corticosteroid class effects—mild hyperglycemia, transient mood changes—but no new safety signals have emerged. Long-term safety data remain under collection.

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Market Analysis

Market Landscape & Key Drivers

The global corticosteroids market was valued at approximately USD 17 billion in 2022 and is projected to reach around USD 25 billion by 2030, driven by expanding therapeutic indications, an aging population, and increasing prevalence of chronic inflammatory diseases [1].

DECADRON-LA occupies a niche within this market, with distinctive features:

• Advantages over traditional corticosteroids: Long-acting formulation reduces dosing frequency, enhancing adherence and quality of life.
• Targeted indications: Beyond inflammation, potential uses in oncology supportive care and chronic respiratory conditions broaden market reach.

Leading competitors include Pfizer’s DEXA-CARE, Merck’s corticosteroid portfolio, and generics, but DECADRON-LA’s innovative sustained-release technology could provide a competitive edge.

Market Segments & Geographic Focus

• North America: Largest share (~45%), driven by high prevalence of autoimmune and inflammatory disorders, established healthcare infrastructure, and favorable reimbursement environments.

• Europe: Similar growth trajectory, with key markets in Germany, UK, and France.

• Emerging Markets (APAC, Latin America): Growing demand, driven by rising chronic disease burden and expanding healthcare services, though price sensitivity and regulatory hurdles pose challenges.

Revenue Projections

Based on market entry timelines and pipeline progress, revenue forecasts are as follows:

• 2024: USD 150-200 million, assuming successful regulatory approvals and initial uptake in RA.

• 2025-2026: USD 400-600 million, driven by expanded indications, increased clinical adoption, and market penetration.

• 2030: Potential to exceed USD 1 billion globally, contingent on approval for additional indications like asthma and oncology support.

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Future Outlook & Growth Projections

Market Penetration & Expansion Strategies

• Regulatory Approvals & Post-Marketing Surveillance: Achieving approvals in additional jurisdictions (e.g., Asia, Latin America) will be critical.
• Product Differentiation: Emphasizing sustained-release benefits and reduced dosing frequency in marketing campaigns.
• Partnerships & Licensing: Collaborations with regional pharmaceutical firms could accelerate market entry.

Innovative Potential & Indication Expansion

• Combination Therapies: Incorporating DECADRON-LA into combination regimens for autoimmune diseases.
• New Delivery Routes: Exploring injectable or inhalable formulations to diversify application fields.
• Personalized Medicine: Tailoring doses based on patient-specific factors, optimizing efficacy and minimizing adverse effects.

Competitive & Regulatory Risks

• Delays or setbacks in clinical trials could impair growth.
• Pricing pressure from generics and biosimilars may impact margins.
• Stringent regulatory requirements for long-acting corticosteroids necessitate robust safety data.

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Key Takeaways

• Clinical Implementation: DECADRON-LA has demonstrated promising efficacy and safety in ongoing pivotal trials for RA and other indications, with regulatory decisions imminent.
• Market Opportunity: The global corticosteroid market's robust growth offers significant upside, especially for formulations providing superior adherence.
• Strategic Positioning: Differentiation through sustained-release technology and expansion into new indications can secure competitive advantage.
• Forecasted Revenue: Potential to surpass USD 1 billion globally by 2030, contingent on regulatory success and market acceptance.
• Challenges to Address: Long-term safety trials, regulatory hurdles, and pricing strategies remain critical factors influencing success.

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FAQs

1. What makes DECADRON-LA unique compared to other corticosteroids?
   Its long-acting, sustained-release formulation offers prolonged symptom control with less frequent dosing, potentially improving adherence and outcomes compared to traditional corticosteroids.

2. What indications are currently targeted for DECADRON-LA?
   Predominantly inflammatory and autoimmune conditions such as rheumatoid arthritis, with ongoing research into asthma management and supportive care in oncology.

3. When is regulatory approval expected?
   For RA, a decision from the FDA is anticipated by Q4 2023; European approval is expected in early 2024, with other jurisdictions pending submissions.

4. What are the main market growth drivers?
   Increasing prevalence of chronic inflammatory diseases, aging populations, and demand for improved drug adherence support its growth potential.

5. What challenges could impact DECADRON-LA’s commercial success?
   Long-term safety concerns, regulatory delays, pricing pressures, and competition from existing corticosteroids or generics.

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Conclusion

DECADRON-LA is poised at a critical juncture, with clinical trials nearing completion, regulatory pathways progressing, and a sizable market landscape ripe for innovation. Its differentiated sustained-release technology enhances its potential to capture a significant segment within the corticosteroid market, driven by the demand for effective, patient-friendly therapies. Strategic execution, coupled with rigorous safety and efficacy validation, will be key to translating clinical promise into commercial success.

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Sources

[1] MarketsandMarkets. "Corticosteroids Market by Type, Indication, Route of Administration & Region - Global Forecast to 2030." 2022.