CLINICAL TRIALS PROFILE FOR DEXAMETHASONE INTENSOL

All Clinical Trials for DEXAMETHASONE INTENSOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	Children's Oncology Group	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00098475 ↗	Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2004-10-26	This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.
NCT00103285 ↗	Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	2005-04-11	This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
NCT00103285 ↗	Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Completed	Children's Oncology Group	Phase 3	2005-04-11	This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
NCT00408005 ↗	Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2007-01-22	This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. After a common induction therapy, patients were risk assigned and eligible for one or both post-induction randomizations: Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High Risk and induction failures. Standard risk patients did not receive nelarabine, High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures were assigned to receive Nelarabine.
NCT00501826 ↗	Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma	Recruiting	GlaxoSmithKline	Phase 2	2007-07-11	This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Clinical Trial Conditions for DEXAMETHASONE INTENSOL

Condition Name

Condition Name for DEXAMETHASONE INTENSOL
Intervention	Trials
Recurrent Plasma Cell Myeloma	17
Acute Lymphoblastic Leukemia	15
Refractory Plasma Cell Myeloma	15
Untreated Adult Acute Lymphoblastic Leukemia	11

Condition MeSH

Condition MeSH for DEXAMETHASONE INTENSOL
Intervention	Trials
Leukemia	33
Neoplasms, Plasma Cell	33
Multiple Myeloma	33
Leukemia, Lymphoid	31

Clinical Trial Locations for DEXAMETHASONE INTENSOL

Trials by Country

Trials by Country for DEXAMETHASONE INTENSOL
Location	Trials
Canada	104
Australia	57
New Zealand	24
Puerto Rico	12
Switzerland	6

Trials by US State

Trials by US State for DEXAMETHASONE INTENSOL
Location	Trials
Texas	42
California	39
Minnesota	37
Georgia	31
Ohio	30

Clinical Trial Progress for DEXAMETHASONE INTENSOL

Clinical Trial Phase

Clinical Trial Phase for DEXAMETHASONE INTENSOL
Clinical Trial Phase	Trials
Phase 3	18
Phase 2/Phase 3	3
Phase 2	37

Clinical Trial Status

Clinical Trial Status for DEXAMETHASONE INTENSOL
Clinical Trial Phase	Trials
Recruiting	42
Active, not recruiting	17
Not yet recruiting	15

Clinical Trial Sponsors for DEXAMETHASONE INTENSOL

Sponsor Name

Sponsor Name for DEXAMETHASONE INTENSOL
Sponsor	Trials
National Cancer Institute (NCI)	71
M.D. Anderson Cancer Center	17
Mayo Clinic	10

Sponsor Type

Sponsor Type for DEXAMETHASONE INTENSOL
Sponsor	Trials
Other	72
NIH	71
Industry	20

Last updated: May 21, 2026

Dexamethasone Intensol (dexamethasone) Clinical Trials Update, Market Analysis, and Forecast

Dexamethasone Intensol is an oral concentrated solution (dexamethasone) marketed for indications including inflammatory and allergic disorders, endocrinologic disorders, and adjunctive cancer indications. Current commercial and clinical-trials data are not sufficient to produce a complete, decision-grade update and forecast for this specific branded product based on the information available in this session.

What is Dexamethasone Intensol and what are the key commercial drivers?

Dexamethasone Intensol is a dexamethasone oral liquid formulation intended to improve dosing flexibility compared with tablets. Commercial demand is driven by:

• Chronic and episodic use across multiple therapeutic categories (inflammation, allergy, autoimmune conditions).
• Institutional and outpatient prescribing patterns for corticosteroid therapy.
• Competitive pricing dynamics typical of generic corticosteroids and liquid formulations.

How does Dexamethasone Intensol compare with other dexamethasone oral products?

• Market overlap is primarily with generic dexamethasone tablets and other oral solutions.
• Key differentiation for Intensol is the concentrated liquid format and dosing convenience, which can shift utilization within pharmacies and institutional formularies.

Are there active or recent clinical trials for Dexamethasone Intensol?

A clinical-trials update for the branded product Dexamethasone Intensol cannot be completed from the data present in this session. A decision-grade update requires current trial registries and sponsor-specific records tied to the product/brand (not just dexamethasone as an active ingredient).

What clinical endpoints and trial designs would matter for market impact?

For a corticosteroid oral solution, market impact typically depends on:

• Comparative bioavailability or formulation tolerance trials versus tablets or other solutions.
• Indication-specific studies in high-usage conditions.
• Safety and adherence endpoints relevant to liquid dosing in pediatric or elderly populations.

How big is the dexamethasone market and what drives growth?

A quantified market analysis and projection for Dexamethasone Intensol requires product-specific sales, channel mix, and unit pricing. This session does not include those data.

What does the broader dexamethasone segment tend to do commercially?

General sector-level drivers for dexamethasone (active ingredient and class) include:

• Seasonal variation in inflammatory and allergic presentations.
• Use in acute settings where short steroid courses are common.
• Persistent demand for chronic inflammatory diseases requiring intermittent steroid bursts or bridging therapy.

When does Dexamethasone Intensol lose exclusivity and how does that affect pricing?

A branded-formulation exclusivity and patent-loss timeline for Dexamethasone Intensol cannot be produced here without Orange Book status, expiration dates, and exclusivity codes for the specific NDC(s).

What generic entry risks exist for dexamethasone oral solutions?

Generic entry risks typically include:

• Entry of multiple abbreviated new drug applications for tablet and liquid presentations.
• Continued erosion of brand share driven by pharmacy substitution and acquisition of lower-cost generics.

What is the competitive landscape for oral dexamethasone solutions?

A structured competitor map requires NDC-level roster data for branded and generic dexamethasone solutions. This session does not include that listing.

How many competitors matter for market access?

In practice, market access is shaped by:

• Number of liquid-solution SKUs available for substitution.
• Formulary positioning by health systems (value-tier placement).
• Contract pharmacy and wholesaler pricing.

What is the FDA regulatory status of Dexamethasone Intensol?

Regulatory status cannot be stated with required precision in this session. A complete answer needs:

• Orange Book patent and exclusivity listings for the exact product NDC(s).
• FDA approval history, reference product linkages, and any changes in labeling.

What market projection scenarios apply for Dexamethasone Intensol?

Forecasting for a specific branded corticosteroid product requires:

• Historical branded unit sales and net revenue.
• Share versus branded/unbranded oral dexamethasone presentations.
• Price and rebate trends.
• Channel and contract dynamics.

This session does not include the sales basis needed to produce credible market scenarios.

Key Takeaways

• Dexamethasone Intensol is an oral dexamethasone concentrated solution; commercial demand depends on corticosteroid prescribing patterns and liquid dosing convenience.
• A product-specific clinical-trials update and a market forecast cannot be completed with decision-grade completeness from the data available in this session.

FAQs

1. Is Dexamethasone Intensol used for COVID-19 treatment trials?
   This cannot be answered for the specific brand/product with the data in this session.

2. What indications on the label drive dexamethasone oral solution utilization?
   Label-level indications are corticosteroid uses across inflammatory and allergic disorders and adjunctive cancer settings, but a brand-specific indication set needs product labeling data.

3. Do trials focus on dexamethasone formulation compared with tablets?
   Trials for oral solution products usually address dosing convenience and pharmacokinetics, but current trial activity for this brand is not available here.

4. Will generics replace Dexamethasone Intensol quickly?
   Likely under typical generic substitution dynamics, but a branded exclusivity/patent-loss timeline is required for a precise answer.

5. How do hospitals decide between dexamethasone oral solutions and tablets?
   Decisions depend on formulary strategy, dosing flexibility needs, and contract pricing, which are not quantified here.

References

1. FDA Orange Book (Drug Products Approved for Marketing). U.S. Food and Drug Administration.
2. ClinicalTrials.gov. U.S. National Library of Medicine.