CLINICAL TRIALS PROFILE FOR CORTICOTROPIN

All Clinical Trials for CORTICOTROPIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001849 ↗	New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1999-05-20	Cushing Syndrome is an endocrine disorder causing an over production of the hormone cortisol. Cortisol is produced in the adrenal gland as a response to the production of corticotropin (ACTH) in the pituitary gland. Between 10% and 20% of patients with hypercortisolism (Cushing Syndrome) have ectopic production of the hormone ACTH. Meaning, the hormone is not being released from the normal site, the pituitary gland. In many cases the ectopic ACTH is being produced by a tumor of the lung, thymus, or pancreas. However, in approximately 50% of these patients the source of the ACTH cannot be found even with the use of extensive imaging studies such as computed tomography (CT) scans, magnetic resonance imaging (MRI), and nuclear scans (111-indium pentetreotide). The ability of these tests to locate the source of the hormone production is dependent on the changes of anatomy and / or the dose and adequate uptake of the radioactive agent. The inability to detect the source of ectopic ACTH production often results in unnecessary pituitary surgery or irradiation. Unlike the previously described tests, positron emission tomography (PET scan) has the ability to detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue. This study will test whether fluorine-18-fluorodeoxyglucose (FDG), fluorine-18-dihydroxyphenylalanine (F-DOPA) or use of a higher dose of 111-indium pentetreotide can be used to successfully localize the source of ectopic ACTH production.
NCT00004758 ↗	Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	1993-11-01	OBJECTIVES: I. Evaluate the efficacy of surgical resection of an identifiable zone of cortical abnormality versus multiple drug therapy in children with infantile spasms refractory to standard therapy. II. Assess how infantile spasms interfere with development and whether this is partially reversible. III. Determine the predictors of good surgical outcome and whether surgery permanently controls seizures and improves development.
NCT00004758 ↗	Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment	Completed	University of California, Los Angeles	Phase 2	1993-11-01	OBJECTIVES: I. Evaluate the efficacy of surgical resection of an identifiable zone of cortical abnormality versus multiple drug therapy in children with infantile spasms refractory to standard therapy. II. Assess how infantile spasms interfere with development and whether this is partially reversible. III. Determine the predictors of good surgical outcome and whether surgery permanently controls seizures and improves development.
NCT00001180 ↗	Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal Insufficiency	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)		1982-03-01	Corticotropin Releasing Hormone (CRH) is a hypothalamic hormone made up of 41 amino acids. Amino acids are proteins that when combined make up different substances, like hormones. The order of amino acids in CRH, has been determined, meaning that the hormone can now be synthetically reproduced in a laboratory setting. When CRH is released from the hypothalamus it stimulates the pituitary gland to secrete another hormone, ACTH. ACTH then causes the adrenal glands to make a third hormone, cortisol. This process is known as the hypothalamic-pituitary-adrenal axis. Problems can occur in any of the steps of this process and result in a variety of diseases (Cushing's Syndrome and adrenal insufficiency). Researchers hope that CRH created in a laboratory setting, ovine CRH (oCRH) can be used to help diagnose and treat conditions of the HPA axis. This study will test the relationship for single doses of oCRH in normal volunteers and patients with disorders of the HPA axis. The oCRH will be injected into the patients vein as a single injection or slowly through an IV line over 24 hours. The participants will have blood tests taken to measure hormone levels before, during, and after receiving the oCRH.

Clinical Trial Conditions for CORTICOTROPIN

Condition Name

Condition Name for CORTICOTROPIN
Intervention	Trials
Stress Disorders, Post-Traumatic	6
Brain Edema	4
Brain Tumor	4
Healthy	4

Condition MeSH

Condition MeSH for CORTICOTROPIN
Intervention	Trials
Stress Disorders, Traumatic	6
Stress Disorders, Post-Traumatic	6
Brain Edema	5
Brain Neoplasms	5

Clinical Trial Locations for CORTICOTROPIN

Trials by Country

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Trials by Country for CORTICOTROPIN
Location	Trials
United States	112
Canada	14
China	6
Germany	2
France	2

Trials by US State

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−

Trials by US State for CORTICOTROPIN
Location	Trials
California	13
Maryland	12
New York	8
Michigan	7
Texas	7

Clinical Trial Progress for CORTICOTROPIN

Clinical Trial Phase

Clinical Trial Phase for CORTICOTROPIN
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	6
Phase 2	19

Clinical Trial Status

Clinical Trial Status for CORTICOTROPIN
Clinical Trial Phase	Trials
Completed	34
Terminated	7
Unknown status	5

Clinical Trial Sponsors for CORTICOTROPIN

Sponsor Name

Sponsor Name for CORTICOTROPIN
Sponsor	Trials
Mallinckrodt	7
Celtic Pharma Development Services	5
VA Office of Research and Development	4

Sponsor Type

Sponsor Type for CORTICOTROPIN
Sponsor	Trials
Other	55
Industry	20
NIH	18

Corticotropic Hormone: Clinical Trials, Market Analysis, and Projections

Introduction

Corticotropic hormone, also known as adrenocorticotropic hormone (ACTH), is a crucial peptide hormone that plays a significant role in the body's response to stress and the regulation of the adrenal glands. This article delves into the current state of clinical trials, market analysis, and future projections for corticotropic hormone, particularly focusing on its therapeutic applications.

Clinical Evidence and Trials

Current State of Clinical Evidence

Recent studies have highlighted the limited clinical evidence supporting the use of corticotropin for most of its FDA-approved indications. A scoping review conducted by Hartung and colleagues found that the clinical evidence was predominantly weak, consisting mainly of uncontrolled or small placebo-controlled studies. This lack of robust evidence raises questions about the continued coverage of corticotropin by public payers like Medicare, especially when compared to the more cost-effective corticosteroids[1].

Specific Indications and Trials

• Infantile Spasms and Multiple Sclerosis (MS): While the evidence base for corticotropin is more credible for these indications, most trials indicate that it is no better than corticosteroids, which are significantly less expensive[1].
• Pulmonary Sarcoidosis: A Phase 4, multicenter, randomized, double-blind trial investigated the safety and efficacy of repository corticotropin injection (RCI, Acthar® Gel) in patients with pulmonary sarcoidosis. Although the study was terminated early due to low enrollment caused by the COVID-19 pandemic, the data suggested that RCI was safe and well-tolerated, with trends indicating greater improvement compared to placebo. However, the study's early termination precluded statistical analysis[4].

Market Analysis

Market Size and Growth

The adrenocorticotropic hormone market was estimated to be around $0.77 billion in 2022. This market is expected to grow significantly over the next decade, driven by various factors including increasing research and development activities, expanding applications, and growing demand from the pharmaceutical industry, research laboratories, and hospitals[2].

Segmentation and Distribution

The market is segmented by application (diagnosis of Cushing's syndrome, adrenal insufficiency treatment, research and development), end use (pharmaceutical industry, research laboratories, hospitals and clinics), formulation (injectable solutions, lyophilized powder, other formulations), and distribution channel (online pharmacies, retail pharmacies, hospitals). The pharmaceutical industry and hospitals are key end-users, with the injectable solutions formulation dominating the market[2].

Regional Insights

The adrenocorticotropic hormone market is geographically diverse, with significant presence in North America, Europe, Asia Pacific, South America, and the Middle East and Africa. Each region has its unique market dynamics, influenced by local healthcare policies, research activities, and patient demographics[2].

Market Projections

Growth Drivers

• Increasing Research and Development: The ongoing investments in clinical research and the need for innovative healthcare solutions are driving the growth of the adrenocorticotropic hormone market. The U.S. clinical trials market, for instance, is expected to grow from $27.07 billion in 2024 to $41.57 billion by 2033, with a CAGR of 4.88% during the forecast period[3].
• Expanding Applications: The use of corticotropic hormone in various therapeutic areas, including rheumatoid arthritis, ankylosing spondylitis, and pulmonary sarcoidosis, is expected to expand, although the efficacy and safety data will be crucial in determining its long-term market position[1][4].

Market Restraints

• Limited Clinical Evidence: The lack of robust clinical evidence supporting the use of corticotropin for many indications remains a significant restraint. This could impact its adoption and reimbursement by public payers[1].
• Cost and Competition: The higher cost of corticotropin compared to corticosteroids and other alternative treatments is another restraint. The market is also competitive, with several pharmaceutical companies developing alternative treatments for similar indications[1][5].

Competitive Landscape

The market for pituitary ACTH hypersecretion drugs, which includes corticotropic hormone, is highly competitive. Key players such as Alder Biopharmaceuticals Inc., Novartis AG, Corcept Therapeutics Incorporated, and others are actively involved in research and development. These companies are focusing on effective marketing strategies, market contribution, and recent advancements to maintain their market share[5].

Impact of COVID-19 and Global Events

The COVID-19 pandemic has had a significant impact on clinical trials, including those involving corticotropic hormone. The pandemic led to early termination of some trials due to low enrollment, as seen in the case of the pulmonary sarcoidosis trial. The Russia-Ukraine war has also influenced global market dynamics, affecting supply chains, consumer behavior, and overall market stability[4][5].

Key Takeaways

• Limited Clinical Evidence: The current clinical evidence supporting the use of corticotropin for most indications is weak.
• Specific Indications: Corticotropin shows more credible evidence for infantile spasms and MS, but its efficacy is comparable to that of corticosteroids.
• Market Growth: The adrenocorticotropic hormone market is expected to grow driven by research and development activities and expanding applications.
• Regional Variations: The market is geographically diverse with different dynamics in each region.
• Competitive Landscape: The market is highly competitive with several key players involved in research and development.

FAQs

What are the primary indications for corticotropic hormone?

Corticotropic hormone is used for various indications including infantile spasms, multiple sclerosis relapse, rheumatoid arthritis, and pulmonary sarcoidosis, although the evidence for some of these indications is limited.

How does the cost of corticotropic hormone compare to other treatments?

Corticotropic hormone is generally more expensive than corticosteroids, which are often used as alternative treatments for similar indications.

What impact has the COVID-19 pandemic had on clinical trials involving corticotropic hormone?

The COVID-19 pandemic has led to early termination of some clinical trials due to low enrollment, affecting the availability of robust clinical evidence.

Which regions are expected to drive the growth of the adrenocorticotropic hormone market?

North America, Europe, and the Asia Pacific are expected to be key regions driving the growth of the adrenocorticotropic hormone market.

What are the main restraints to the adoption of corticotropic hormone?

The main restraints include limited clinical evidence, higher cost compared to alternative treatments, and competitive market dynamics.

Sources

1. Hartung and colleagues, "Few randomized clinical trials support corticotropin injection for most indications," Healio, January 4, 2022.
2. Market Research Future, "Adrenocorticotropic Hormone Market Size, Growth, Trends, Report," Market Research Future, December 2024.
3. Biospace, "U.S. Clinical Trials Market Size Industry Analysis Report, 2033," Biospace, April 26, 2024.
4. PubMed, "Results From a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection in Pulmonary Sarcoidosis," PubMed, April 19, 2023.
5. Market Reports World, "Pituitary ACTH Hypersecretion Drug Market Analysis 2025-2032| Forecast Predicts Incredible Growth," Market Reports World, December 21, 2024.