CLINICAL TRIALS PROFILE FOR METICORTEN

505(b)(2) Clinical Trials for Meticorten

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	NCT03742258 ↗	Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2019-03-13	The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
OTC	NCT03742258 ↗	Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma	Active, not recruiting	Northwestern University	Phase 1	2019-03-13	The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.

All Clinical Trials for Meticorten

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002618 ↗	Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	1994-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different doses may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.
NCT00002618 ↗	Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma	Completed	Children's Oncology Group	Phase 3	1994-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different doses may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.
NCT00003783 ↗	Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia	Completed	National Cancer Institute (NCI)	Phase 2	1999-03-01	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 combining drugs in different ways may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating children who have very high risk acute lymphocytic leukemia.
NCT00003783 ↗	Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia	Completed	Children's Oncology Group	Phase 2	1999-03-01	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 combining drugs in different ways may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating children who have very high risk acute lymphocytic leukemia.
NCT00004228 ↗	Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.

Clinical Trial Conditions for Meticorten

Condition Name

Condition Name for Meticorten
Intervention	Trials
Acute Lymphoblastic Leukemia	15
Leukemia	11
B Acute Lymphoblastic Leukemia	9
Untreated Adult Acute Lymphoblastic Leukemia	9

Condition MeSH

Condition MeSH for Meticorten
Intervention	Trials
Lymphoma	44
Precursor Cell Lymphoblastic Leukemia-Lymphoma	35
Leukemia	35
Leukemia, Lymphoid	34

Clinical Trial Locations for Meticorten

Trials by Country

Trials by Country for Meticorten
Location	Trials
Canada	95
Australia	36
New Zealand	14
Puerto Rico	10
Switzerland	8

Trials by US State

Trials by US State for Meticorten
Location	Trials
Texas	56
California	45
Illinois	41
Washington	39
New York	36

Clinical Trial Progress for Meticorten

Clinical Trial Phase

Clinical Trial Phase for Meticorten
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	23
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Meticorten
Clinical Trial Phase	Trials
Recruiting	38
Completed	25
Active, not recruiting	23

Clinical Trial Sponsors for Meticorten

Sponsor Name

Sponsor Name for Meticorten
Sponsor	Trials
National Cancer Institute (NCI)	84
M.D. Anderson Cancer Center	23
Children's Oncology Group	13

Sponsor Type

Sponsor Type for Meticorten
Sponsor	Trials
Other	99
NIH	87
Industry	44

METICORTEN (Prednisone): Clinical Trials, Market Analysis, and Projections

Introduction to METICORTEN (Prednisone)

METICORTEN, commonly known as prednisone, is a synthetic steroid that has been widely used in the treatment of various inflammatory and autoimmune diseases. Here, we will delve into the historical clinical trials, current market analysis, and any relevant projections for this medication.

Historical Clinical Trials

Early Clinical Trials

Prednisone was first introduced in the 1950s as a treatment for rheumatoid arthritis and other rheumatic diseases. One of the early clinical trials was conducted at the Beth Israel Hospital in New York City from November 1954 to February 1955. This trial involved 12 patients with active rheumatoid arthritis, as well as patients with disseminated lupus erythematosus, active rheumatic carditis, and acute gouty arthritis.

• Findings: The trial demonstrated the anti-rheumatic, anti-inflammatory, metabolic, and hormonal properties of prednisone. Patients showed significant improvement in their symptoms, although the study also highlighted potential side effects associated with steroid use[4].

Current Clinical Use

Prednisone remains a cornerstone in the treatment of various conditions, including rheumatoid arthritis, lupus, asthma, and certain types of cancer. Its efficacy and safety profile have been well-established over decades of clinical use.

Market Analysis

Market Presence and Competition

Prednisone is a generic medication, which means it is widely available from multiple manufacturers. This has led to a competitive market where the drug is priced relatively low compared to newer, patented medications.

• Generic Status: As a generic drug, prednisone benefits from lower production costs and is often preferred by healthcare providers and patients due to its affordability.
• Market Share: Given its long history and widespread use, prednisone holds a significant market share in the corticosteroid segment.

Pricing and Inflation

While prednisone itself is not expected to see significant price inflation due to its generic status, the broader pharmaceutical market is experiencing inflation.

• Overall Inflation: According to Vizient's summer 2024 Pharmacy Market Outlook, the overall drug price inflation rate for pharmaceuticals in 2025 is estimated to be 3.81%. However, this inflation is more likely to affect newer, specialty, and high-cost medications rather than established generics like prednisone[2][5].

Projections and Future Outlook

Stability in Demand

Prednisone is expected to continue being a staple in the treatment of inflammatory and autoimmune diseases. Its demand is likely to remain stable due to its established efficacy and safety profile.

• No Significant Changes: There are no indications that the demand for prednisone will decrease or increase dramatically in the near future. It will likely continue to be prescribed as a first-line or adjunct treatment for various conditions.

Regulatory Environment

The regulatory environment for generic drugs like prednisone is generally stable. However, any changes in regulatory policies or healthcare reimbursement strategies could potentially impact its market dynamics.

• Regulatory Stability: As a well-established generic drug, prednisone is less likely to be affected by regulatory changes compared to newer, patented medications.

Key Takeaways

• Historical Significance: Prednisone has a long history of clinical use and has been a cornerstone in the treatment of various inflammatory and autoimmune diseases.
• Market Stability: As a generic medication, prednisone benefits from a stable market presence and is less likely to be affected by significant price inflation.
• Future Outlook: The demand for prednisone is expected to remain stable, with no significant changes anticipated in its clinical use or market dynamics.

FAQs

What is METICORTEN (Prednisone) used for?

METICORTEN, or prednisone, is used to treat a variety of conditions including rheumatoid arthritis, lupus, asthma, and certain types of cancer due to its anti-inflammatory and immunosuppressive properties.

Is METICORTEN a generic drug?

Yes, METICORTEN (prednisone) is a generic medication, which means it is widely available from multiple manufacturers and is generally more affordable than patented drugs.

What was the outcome of early clinical trials for METICORTEN?

Early clinical trials demonstrated the efficacy of prednisone in reducing symptoms of rheumatoid arthritis and other rheumatic diseases, although they also highlighted potential side effects associated with steroid use.

How does the current market inflation affect METICORTEN?

The current market inflation in pharmaceuticals, estimated at 3.81% for 2025, is more likely to affect newer, specialty, and high-cost medications rather than established generics like prednisone.

What is the future outlook for METICORTEN in the market?

The demand for METICORTEN (prednisone) is expected to remain stable, with no significant changes anticipated in its clinical use or market dynamics due to its established efficacy and safety profile.

Sources

1. Preliminary Clinical Trials with Prednisone (Meticorten) in Rheumatic Diseases: Comparative Antirheumatic Potency, Metabolic Activity, and Hormonal Properties. JAMA Network.
2. Vizient projects drug price inflation at 3.81%: Vizient Inc.
3. Menarini Group announces Positive Topline Data from Pivotal Phase 3 BROADWAY & TANDEM Clinical Trials: PR Newswire.
4. Preliminary Clinical Trials with Prednisone (Meticorten) in Rheumatic Diseases: JAMA Network.
5. Vizient estimates a 3.81% inflation in drug prices in 2025: TechTarget.

Last updated: 2025-01-01