CLINICAL TRIALS PROFILE FOR DECADRON

505(b)(2) Clinical Trials for Decadron

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

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.
NCT00002812 ↗	Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia	Completed	Children's Oncology Group	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.

Clinical Trial Conditions for Decadron

Condition Name

Condition Name for Decadron
Intervention	Trials
Multiple Myeloma	94
Recurrent Plasma Cell Myeloma	37
Leukemia	33
Refractory Plasma Cell Myeloma	32

Condition MeSH

Condition MeSH for Decadron
Intervention	Trials
Multiple Myeloma	201
Neoplasms, Plasma Cell	193
Leukemia	89
Precursor Cell Lymphoblastic Leukemia-Lymphoma	80

Clinical Trial Locations for Decadron

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Decadron

Clinical Trial Phase

Clinical Trial Phase for Decadron
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	41
Phase 3	76

Clinical Trial Status

Clinical Trial Status for Decadron
Clinical Trial Phase	Trials
Completed	209
Recruiting	87
Active, not recruiting	69

Clinical Trial Sponsors for Decadron

Sponsor Name

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

Sponsor Type

Sponsor Type for Decadron
Sponsor	Trials
Other	563
Industry	259
NIH	191

Decadron (dexamethasone) Clinical Trials Update, Market Analysis, and Projections

Last updated: April 28, 2026

What is Decadron and how is it positioned clinically?

Decadron is a brand name for dexamethasone, a synthetic corticosteroid. Dexamethasone is used across multiple therapeutic areas where anti-inflammatory and immunosuppressive effects matter, including severe inflammatory and allergic disorders, neurologic inflammation, ocular inflammation, hematologic malignancies (as part of combination regimens), and critical care settings where corticosteroids can reduce mortality in selected indications.

Regimen adoption and trial activity around dexamethasone has been shaped by:

• Expansion in hospital and critical-care protocols after evidence in severe respiratory illness.
• Long-standing use in oncology supportive care (premedication, antiemetic and anti-inflammatory components).
• Continued interest in dose optimization, route of administration (oral vs injectable formulations), and combination strategies in high-acuity disease settings.

Clinical Trials Update: What is active or relevant for dexamethasone branded as Decadron?

No brand-specific pipeline is typically maintained for Decadron because dexamethasone is widely available generically and branded formulations generally do not support distinct, sponsor-led late-stage programs. Clinical trial activity is therefore best tracked at the active ingredient (dexamethasone) level, then mapped to likely commercial impact on branded versus generic dexamethasone products.

Where dexamethasone trials concentrate by clinical theme

Across the clinical landscape, dexamethasone trial designs cluster into four categories:

1. Severe inflammatory/critical care protocols

   • Trials evaluate dosing, timing, and duration in severe respiratory disease and other hyperinflammatory syndromes.
   • Common endpoints include mortality, time to clinical improvement, organ support requirements, and inflammatory biomarkers.

2. Autoimmune and inflammatory diseases

   • Trials focus on steroid-sparing strategies, taper schedules, and combination regimens.
   • Endpoints include relapse rates, symptom scores, corticosteroid exposure, and safety metrics.

3. Oncology support and anti-inflammatory control

   • Trials often embed dexamethasone into regimens (antiemetic prophylaxis, reduction of treatment-associated inflammatory effects).
   • Endpoints align with regimen tolerability, response durability, and adverse event profiles.

4. Neurologic inflammation and eye inflammation

   • Trials focus on route, penetration, and reduced adverse events relative to long systemic exposure.

Practical implication for Decadron commercial read-through

Because clinical programs typically do not distinguish branded Decadron from generic dexamethasone, commercial impact tracks to:

• Formulation demand (e.g., tablets vs injectable solutions and suspensions),
• Institutional prescribing habits (formularies often list generics and branded equivalents),
• Tender and supply dynamics for injectable steroids used in hospitals.

How does Decadron fit the current evidence base that drives prescribing?

Key evidence that continues to shape real-world use

The landmark evidence that continues to underpin dexamethasone protocols in severe respiratory illness came from:

• RECOVERY trial results showing reduced mortality with dexamethasone in hospitalized patients requiring oxygen/ventilation (with no benefit, and potential harm, in less severe disease). (Cited sources below include RECOVERY publication.)

This evidence has translated into durable guideline incorporation and hospital formulary normalization, which keeps baseline demand for dexamethasone high even as new trials continue to refine protocols.

Market Analysis: What does the dexamethasone market look like and where does Decadron sit?

Market structure

Dexamethasone is a mature, widely manufactured corticosteroid, leading to:

• Strong generic penetration in most geographies
• Low brand premium relative to older steroid brands unless a formulation or supply contract drives demand
• Pricing pressure in outpatient settings and competitive tendering in hospital settings

Demand drivers

1. Hospital protocols for severe inflammatory and respiratory indications
   • Dexamethasone use is embedded in acute care care pathways in multiple countries.
2. Oncology supportive care
   • Dexamethasone remains a core adjunct in multiple regimen settings for inflammation control and antiemetic prophylaxis.
3. Broad therapeutic label coverage
   • Wide indications increase the addressable prescriber base.

Supply and pricing dynamics

For a mature generic-heavy product, the near-term price lever is typically input cost and manufacturing capacity, not incremental clinical differentiation. Demand is steadier where it is protocolized (acute care).

Projections: Where is the market likely headed for dexamethasone/Decadron?

Base-case commercial trajectory (qualitative)

Given maturity and generic dominance, branded Decadron tends to follow market-level demand rather than expanding via new patents.

Near-term (next 2 to 3 years):

• Demand remains stable to moderately growing, driven by persistent use in acute care protocols and oncology supportive care.
• Branded share depends on formulary placement, pharmacy channel behavior, and substitution policies.

Medium-term (3 to 7 years):

• Growth remains limited and mostly linked to:
  • Population-driven utilization increases,
  • Broader adoption of corticosteroid use in additional protocol-defined settings,
  • Local reimbursement and tender practices.

High-level outcome for branded vs generic:

• Branded Decadron is likely to maintain volume with limited pricing lift.
• Any growth is more likely to accrue to the overall molecule market, not to differentiated branded revenue, unless a specific formulation or supply constraint shifts channel economics.

What would change the curve

• A major new evidence readout that expands dexamethasone use earlier in disease severity strata or adds new combinations could increase overall utilization.
• Evidence that curtails steroid use in specific subpopulations would reduce demand.
• Manufacturing disruptions can temporarily lift pricing and branded share, but they are usually transient.

Competitive landscape: Who matters commercially?

In dexamethasone, competitive intensity is usually driven by:

• Generic manufacturers of oral and injectable dexamethasone
• Hospital contract suppliers
• Availability of injectable presentations (often the most protocol-critical)

Branded Decadron competes primarily through:

• Supply reliability,
• Formulary acceptance,
• Institutional preference based on presentation size, stability, and substitution policies.

IP and regulatory context: Why Decadron behaves like a mature product

Dexamethasone is off patent in most developed markets. As a result:

• There is no meaningful late-stage branded exclusivity pathway tied to Decadron itself.
• Clinical trial activity is mainly about protocol optimization and new indications rather than securing market exclusivity for a branded formulation.

Actionable diligence checklist for R&D or investment decisions

1) Separate “molecule trials” from “brand impact”

• Most trials will not translate into branded Decadron share unless they include a specific branded formulation or route that affects procurement.

2) Track protocol adoption, not only trial completion

Commercial outcomes will align with:

• Guideline updates,
• Hospital pathway implementation,
• Tender cycle outcomes.

3) Model demand by presentation

• Injectable steroids typically show stronger institutional pull.
• Oral tablets and liquids may track outpatient and oncology supportive demand more slowly.

4) Price and share modeling

• Include generic substitution and contract pricing.
• Assume limited branded pricing premium under competitive conditions.

Key Takeaways

• Decadron is dexamethasone and behaves commercially as a mature, generic-dominated corticosteroid with demand anchored to protocolized hospital and oncology supportive uses.
• Clinical trial activity generally informs dose, timing, and combination optimization rather than creating branded exclusivity.
• Market growth is likely modest and primarily tied to utilization expansion in acute care and supportive oncology, not to branded pricing power.
• Branded share depends on formulary placement and procurement mechanics, especially for injectable presentations.
• The most material commercial inflection points come from major evidence readouts and guideline-driven adoption, not incremental studies.

FAQs

1. Is Decadron the same as dexamethasone in trials?
   Most clinical evidence for “Decadron” prescribing is captured at the dexamethasone level because the molecule is the same even when branded vs generic products differ by formulation and supply.

2. What indication most drives ongoing dexamethasone utilization?
   Hospital protocols in severe inflammatory and respiratory illness settings drive the largest protocolized demand component.

3. Will new dexamethasone trials create patent-protected growth for Decadron?
   Not in the typical setting for an off-patent molecule; trials more often support label refinement and protocol adoption than brand exclusivity.

4. How should investors think about pricing for Decadron?
   Pricing is usually constrained by generic competition and contract tendering, so branded revenue growth is limited unless procurement favors branded supply.

5. What should be monitored to predict demand changes?
   Look for guideline updates, hospital pathway uptake, and any evidence that expands or restricts steroid use in specific patient severity strata.

References

[1] RECOVERY Collaborative Group. (2021). Dexamethasone in Hospitalized Patients with Covid-19. The New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMoa2021436
[2] U.S. National Library of Medicine. (n.d.). RECOVERY Trial (NCT04381962). ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04381962
[3] U.S. Food and Drug Administration. (n.d.). Dexamethasone drug information and labeling (access via Drugs@FDA). https://www.accessdata.fda.gov/scripts/cder/daf/