Last Updated: June 24, 2026

CLINICAL TRIALS PROFILE FOR DECADRON-LA


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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
NCT00002812 ↗ Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia Completed National Cancer Institute (NCI) Phase 3 1996-09-01 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 the drugs in different combinations may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of standard combination chemotherapy treatment with more intensive combination chemotherapy in treating children with acute lymphocytic leukemia.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
Refractory Plasma Cell Myeloma 32
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Condition MeSH

Condition MeSH for DECADRON-LA
Intervention Trials
Multiple Myeloma 201
Neoplasms, Plasma Cell 193
Leukemia 89
Precursor Cell Lymphoblastic Leukemia-Lymphoma 80
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Clinical Trial Locations for DECADRON-LA

Trials by Country

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

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

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

Sponsor Type for DECADRON-LA
Sponsor Trials
Other 563
Industry 259
NIH 191
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Last updated: May 25, 2026

DECADRON-LA (dexamethasone) clinical trials update, market analysis, and projection

Executive summary: A complete clinical trials update and market projection for DECADRON-LA cannot be produced from available, drug-specific public data in this environment. No source-anchored information is provided here to support (1) trial identifiers and status, (2) FDA approval pathway or Orange Book listing for this specific branded product, (3) current U.S. and ex-U.S. sales, or (4) forecast assumptions tied to confirmed patent exclusivity and launch timelines.

Given those constraints, no accurate, data-backed clinical-trial status, litigation/IP posture, or revenue forecast for DECADRON-LA can be generated without risking fabrication.

What clinical trials are ongoing or completed for DECADRON-LA?

Featured snippet answer: No DECADRON-LA trial registry status (NCT/clinical trial phase, endpoints, enrollment, completion dates) is available in the provided information.

Which NCT studies are tied to DECADRON-LA?

No trial identifiers or registry records are provided.

What indications and dosing regimens are being tested?

No indication-level or regimen-level DECADRON-LA study details are provided.

What are the latest enrollment and results milestones?

No enrollment, interim analysis, or results publication data is provided.

What is the FDA regulatory status of DECADRON-LA (approval date, label, pathway)?

Featured snippet answer: FDA approval pathway and label details specific to DECADRON-LA are not provided.

Is DECADRON-LA marketed as an NDA, ANDA, or 505(b)(2) product?

No application type is provided.

What dosage forms and strengths are on the label?

No label composition or strength data is provided.

Is DECADRON-LA listed in the Orange Book?

No Orange Book status is provided.

When does DECADRON-LA lose exclusivity and what drives generic timing?

Featured snippet answer: Exclusivity and patent expiration timing for DECADRON-LA cannot be established from the provided information.

What patents protect DECADRON-LA formulations or methods of use?

No patent numbers or expiration dates are provided.

Are Paragraph IV challenges filed against DECADRON-LA?

No ANDA/Paragraph IV filings are provided.

How do settlement agreements affect DECADRON-LA generic entry?

No settlements or court dockets are provided.

How big is the market for DECADRON-LA and what share does it hold?

Featured snippet answer: No DECADRON-LA market size, channel mix, or share data is provided.

U.S. demand drivers for depot dexamethasone products

No DECADRON-LA-specific utilization or payer trend data is provided.

International market exposure

No ex-U.S. country-level adoption data is provided.

Pricing trends and reimbursement dynamics

No net-price or ASP/AMP trend data is provided.

What revenue forecast models fit DECADRON-LA and what is the base case?

Featured snippet answer: A revenue projection requires verified inputs for volume growth, pricing, seasonality, payer mix, and competitive entry timing. Those inputs are not provided for DECADRON-LA.

Base-case assumptions (validated)

No validated assumptions are provided.

Downside case (generic erosion)

No exclusivity, patent, or competitor timing is provided.

Upside case (label expansion or increased uptake)

No label expansion or new evidence is provided.

What competitors sell against DECADRON-LA (same indication and same market segment)?

Featured snippet answer: Competitor mapping requires confirmed DECADRON-LA formulation, indication, and geography. None of that is provided.

Other dexamethasone brands and long-acting options

No competitor list is provided.

Authorized generics and unbranded depot steroids

No competitor roster or entry timeline is provided.

Therapeutic substitutes in the corticosteroid market

No substitution evidence is provided.

How does DECADRON-LA compare with alternative depot corticosteroids on access and adoption?

Featured snippet answer: Comparative evaluation needs label, supply status, pricing, and clinical guideline positioning specific to DECADRON-LA. None is provided.

Administration burden and patient/clinic adoption

No data is provided.

Tolerability and safety positioning in real-world practice

No DECADRON-LA safety postmarketing data is provided.

What patent estate strength does DECADRON-LA have and how does it affect investment risk?

Featured snippet answer: Patent estate strength cannot be assessed without a DECADRON-LA patent list, claim scope, and expiration schedule.

Granular patent coverage by aspect

No formulation, process, or method-of-use coverage is provided.

Litigation and enforceability

No litigation history is provided.

Generic entry risk and likely launch scenarios

No entry scenario can be supported without confirmed Orange Book and Paragraph IV status.

Key Takeaways

  • No DECADRON-LA-specific clinical trial updates, regulatory status, exclusivity timelines, or market figures are available in the provided inputs.
  • No data-backed market projection for DECADRON-LA can be produced without confirmed, product-specific sources tied to FDA, Orange Book, trial registries, and sales datasets.

FAQs

  1. Is DECADRON-LA approved for the same indications as other dexamethasone depot products?
  2. Are there any active NCT studies specifically listing DECADRON-LA?
  3. What is the Orange Book listing status of DECADRON-LA and how many patents are listed?
  4. Have any ANDAs filed Paragraph IV certifications for DECADRON-LA?
  5. What is the projected impact of generic entry on net pricing for dexamethasone depot products?

References

No sources were cited because no DECADRON-LA-specific facts were provided in the prompt.

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