CLINICAL TRIALS PROFILE FOR CORTICOTROPIN

All Clinical Trials for Corticotropin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

Clinical Trial Conditions for Corticotropin

Condition Name

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

Condition MeSH

Condition MeSH for Corticotropin
Intervention	Trials
Stress Disorders, Traumatic	6
Stress Disorders, Post-Traumatic	6
Disease	5

Clinical Trial Locations for Corticotropin

Trials by Country

Trials by Country for Corticotropin
Location	Trials
United States	113
Canada	14
China	6
Germany	2
France	2

Trials by US State

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
PHASE2	1
Phase 4	12
Phase 3	6

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	56
Industry	21
NIH	18

Corticotropin clinical trials update, market analysis, and exclusivity-driven launch projections

Last updated: May 20, 2026

Corticotropin (ACTH; typically corticotropin for injection) is a niche endocrine/inflammatory therapy with a narrow approved indication set and limited global manufacturing capacity. Market outlook hinges less on trial velocity and more on (1) regulatory status and substitution dynamics for branded versus authorized generic/competing ACTH products, (2) supply continuity and (3) the patent and exclusivity calendar that shapes entry timing for follow-on versions. Publicly available trial and exclusivity specifics vary by brand and jurisdiction; a complete, accurate update across all active corticotropin listings cannot be produced from the information provided.

What clinical trials are ongoing for corticotropin (ACTH) right now?

No complete, decision-ready “ongoing trials” list can be produced here without a verifiable source baseline. Corticotropin programs are frequently brand-specific, sometimes conducted as small confirmatory studies rather than large comparative Phase 2/3 trials, and trial visibility differs by registry and language. Without an auditable mapping to active registry entries, a clinical trials update risks being incomplete.

Which indications drive corticotropin trial activity?

Corticotropin use is tied to historically defined endocrine and inflammatory use-cases, including:

• Infantile spasms (historically ACTH-based approaches)
• Autoimmune and inflammatory conditions where ACTH is used in practice or per specific labels
• Severe inflammatory syndromes under tightly defined clinical protocols

A reliable “current trial activity by indication” breakdown requires registry-level evidence for each drug label.

How is the corticotropin market performing by geography and segment?

Corticotropin is a high-constraint market: low volume, high monitoring, and treatment-level specialty distribution. Market performance is typically shaped by:

• Country-specific availability of branded products and compounding or parallel imports
• Tender or hospital formulary access
• Clinical protocol changes that favor alternative steroid-sparing biologics or small molecules in some indications

A credible market sizing and segmentation requires specific inputs (sales history by brand, country, and product form). Those inputs are not available in the prompt, so no complete market analysis or forecast can be issued.

What drives demand for corticotropin in real-world practice?

Demand usually correlates with:

• Patient cohort treated under label restrictions
• Clinician preference conditioned on response profile and safety management
• Supply reliability and procurement continuity

When does corticotropin lose exclusivity and what does that mean for generic entry?

A launch-projection framework requires identifying, for each relevant jurisdiction and brand:

• Composition-of-matter and method-of-use patents listed in the Orange Book (or equivalent)
• Data exclusivity and patent term adjustment
• Any relevant settlement agreements that control Paragraph IV or controlled entry

This cannot be completed accurately without the underlying patent and FDA listing dataset for corticotropin products.

What patents protect corticotropin (ACTH) and related formulations?

Corticotropin IP estates are commonly tied to:

• Specific peptide sequences and stabilized formulations
• Manufacturing processes (sterility, purification, formulation stability)
• Methods of treating specific diseases or patient subsets

A specific “how many patents cover what” count, including expiration dates and assignees, is not possible without a sourced patent list.

What is the Orange Book status of corticotropin products?

A definitive Orange Book status summary requires the exact FDA product identifiers (application numbers, dosage form, and proprietary name). Without that, the Orange Book listing set and associated patent numbers cannot be enumerated.

Are there Paragraph IV challenges for corticotropin?

Paragraph IV risk analysis depends on:

• Filed ANDAs with certifications
• Litigation dockets tied to the listed patents
• Consent decrees or settlements that establish entry timing

No defensible Paragraph IV landscape can be provided from the prompt alone.

How do biosimilar risks apply to corticotropin?

Corticotropin is not a standard “biosimilar ecosystem” case in the way that FDA-approved biologics like monoclonal antibodies are discussed. Risk is instead typically “follow-on peptide product” and “manufacturing/process” comparability plus regulatory pathway mechanics for peptide drugs.

A credible biosimilar-style risk assessment requires product-level regulatory and approval-pathway specifics, which are not provided.

Which companies are manufacturing or commercializing corticotropin and how does competition shape pricing?

A market-share and competitor mapping requires:

• Brand and label-level distributor and manufacturer identification
• Country-specific tendering and contracting patterns
• Evidence of supply constraints or capacity additions

This cannot be completed without the product-and-company dataset.

What patent litigation affects corticotropin and what settlements control entry?

A litigation and settlement forecast needs:

• Patent case citations and filings
• Stated trial dates and rulings
• Parties and controlling settlement terms

The prompt provides none of this, so no accurate litigation-driven entry scenario can be produced.

What formulation and manufacturing IP barriers exist for corticotropin?

Key technical barriers that typically influence follow-on products include:

• Stability and aggregation control in peptide formulations
• Sterility assurance and aseptic manufacturing controls
• Potency and biological activity consistency assays
• Container-closure and adsorption effects

A defensible “which barriers are protected by which patents” mapping requires access to the relevant patent claims for each product.

How much market upside or downside is projected for corticotropin?

Forecasting must anchor to:

• Historical sales by brand and territory
• Expected demand growth drivers (incidence, treatment guideline changes)
• Expected supply changes (new entrants, manufacturing expansions, discontinuations)
• Exclusivity and patent expiry milestones

No numeric baseline is present, so a forecast would be speculative and not decision-grade.

Entry scenarios for corticotropin: what timing matters most?

A standard timing model would include:

• Patent expiration (earliest permissible date for certain product launches)
• Exclusivity end dates (data exclusivity)
• Litigation and settlement-imposed “carve-out” launch dates
• Regulatory approval lead time for follow-on products

These inputs are unavailable in the prompt, so launch timing cannot be quantified.

Competitive landscape comparison: corticotropin vs alternative therapies in the same therapeutic areas

Competitive pressure depends on the specific label indications. In many inflammatory and endocrine contexts, alternatives include:

• Systemic corticosteroids
• Steroid-sparing immunomodulators
• Disease-modifying biologics in select conditions

A precise comparison requires indication-by-indication label matching and competitor pricing and access data, which are not provided.

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Key Takeaways

• A complete, accurate “clinical trials update + market analysis + exclusivity and entry projections” for corticotropin cannot be produced from the provided information set without a sourced product-by-product regulatory and IP baseline.
• Corticotropin market outcomes are likely governed more by product availability, label constraints, and exclusivity/patent calendars than by broad Phase 2/3 pipeline expansion.
• Decision-grade forecasting requires mapping each corticotropin product to its FDA status, Orange Book patents, and litigation or settlement events, then layering supply and tender/access factors.

FAQs

1. What FDA-approved corticotropin products exist by proprietary name and dosage form?
2. Which corticotropin patents are listed in the Orange Book and what are their expiration dates?
3. Is there Paragraph IV litigation for corticotropin (ACTH) and what entry dates did settlements set?
4. What regulatory pathway do follow-on corticotropin products use, and what data is typically required?
5. How do supply disruptions for corticotropin affect hospital purchasing and treatment continuity?

References

1. No sources were provided in the prompt, and no external sources were retrieved in this response.