CLINICAL TRIALS PROFILE FOR CORTISONE ACETATE

All Clinical Trials for Cortisone Acetate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00489840 ↗	Treatment of Chronic Central Serous Chorioretinopathy With Open-Label Anecortave Acetate	Completed	Alcon Research	Phase 1/Phase 2	2007-05-01	Investigation to evaluate Anecortave Acetate in the treatment of chronic central serous chorioretinopathy
NCT00489840 ↗	Treatment of Chronic Central Serous Chorioretinopathy With Open-Label Anecortave Acetate	Completed	LuEsther T. Mertz Retinal Research Center	Phase 1/Phase 2	2007-05-01	Investigation to evaluate Anecortave Acetate in the treatment of chronic central serous chorioretinopathy
NCT00489840 ↗	Treatment of Chronic Central Serous Chorioretinopathy With Open-Label Anecortave Acetate	Completed	Manhattan Eye, Ear & Throat Hospital	Phase 1/Phase 2	2007-05-01	Investigation to evaluate Anecortave Acetate in the treatment of chronic central serous chorioretinopathy
NCT00915343 ↗	Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency	Completed	Shire	Phase 2/Phase 3	2007-08-21	This is a randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral modified-release hydrocortisone in comparison to conventional thrice-daily oral hydrocortisone tablets in patients with adrenal insufficiency
NCT01771328 ↗	Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia	Unknown status	Haukeland University Hospital	Phase 2	2013-02-01	The conventional glucocorticoid replacement therapy in congenital adrenal hyperplasia (CAH) renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This method was recently applied to treat a patient through a critical phase of puberty. This is a clinical trial aiming to evaluate CSHI treatment in patients with CAH. The main objective is to determine the effects of CSHI on metabolic parameters (androstenedione and 17-hydroxyprogesterone profiles, and testosterone,adrenocorticotropic hormone(ACTH), cortisol, and bone markers), and to determine the required glucocorticoid doses. Secondary objectives are to determine effects on clinical status, body weight, blood pressure and other metabolic parameters, as well as on subjective health status (AddiQoL, SF36).
NCT01843530 ↗	Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema	Completed	Technische Universität München	Phase 3	2013-11-01	This trial is a randomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema. This study should show that Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top of standard treatment. This study should also compare the time to onset of relief as defined by an at least one point reduction on the severity scale of ACE-induced angioedema with Berinert versus placebo.
NCT01847690 ↗	Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal Failure	Unknown status	Haukeland University Hospital	Phase 2	2013-06-01	The conventional glucocorticoid replacement therapy in primary adrenal insufficiency- Addison's disease,renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Many patients take stress-doses that are extra doses of hydrocortisone or cortisone acetate before or during stressful physical or psychological events. However, the effect of such dosing has not been tested in scientific studies. In this double blind cross-over designed pilot trial we aim to test the effect of an extra dose of cortisol on physical activity and hormone levels.

Clinical Trial Conditions for Cortisone Acetate

Condition Name

Condition Name for Cortisone Acetate
Intervention	Trials
Adrenal Insufficiency	3
Atrial Fibrillation	1
Chronic Central Serous Chorioretinopathy	1
Degeneration of Lumbar or Lumbosacral Intervertebral Disc	1

Condition MeSH

Condition MeSH for Cortisone Acetate
Intervention	Trials
Adrenal Insufficiency	3
Hyperplasia	1
Atrial Fibrillation	1
Adrenogenital Syndrome	1

Clinical Trial Locations for Cortisone Acetate

Trials by Country

Trials by Country for Cortisone Acetate
Location	Trials
Norway	2
Germany	1
Netherlands	1
Brazil	1
United States	1

Trials by US State

Trials by US State for Cortisone Acetate
Location	Trials
New York	1

Clinical Trial Progress for Cortisone Acetate

Clinical Trial Phase

Clinical Trial Phase for Cortisone Acetate
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	3
Phase 3	1

Clinical Trial Status

Clinical Trial Status for Cortisone Acetate
Clinical Trial Phase	Trials
Completed	5
Unknown status	3
Not yet recruiting	1

Clinical Trial Sponsors for Cortisone Acetate

Sponsor Name

Sponsor Name for Cortisone Acetate
Sponsor	Trials
Haukeland University Hospital	2
University of Palermo	1
Shire	1

Sponsor Type

Sponsor Type for Cortisone Acetate
Sponsor	Trials
Other	13
Industry	2

Cortisone Acetate: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

What is the clinical-trial activity for Cortisone Acetate?

Cortisone acetate is an established systemic corticosteroid with long-standing market use. Public, drug-specific clinical development activity is limited relative to modern, patent-driven therapeutics. The dominant activity in public registries is consistent with ongoing safety, label-expansion, and routine use rather than late-stage, brand-formulation breakthrough programs.

Clinical-trials update (registry signals)

• ClinicalTrials.gov: Searches for “cortisone acetate” return low-volume, non-core-development records compared with active pipeline assets (no clear pattern of Phase 3 pivotal registrations for a new pivotal indication).
• EudraCT: Historical and ad hoc records exist for corticosteroid indications, but drug-specific cortisone acetate entries are generally sparse and not aligned with the cadence seen in current late-stage pipelines.

Implication for development strategy

• Commercial outcomes are driven primarily by formulary access, manufacturing continuity, and pricing rather than a near-term wave of new pivotal trials.
• Any incremental clinical evidence tends to cluster around biospecification, administration route handling, and pharmacovigilance, not full-scale indication expansion.

Where does Cortisone Acetate sit in the patent and exclusivity landscape?

Cortisone acetate is a legacy active ingredient. The market position is structurally consistent with:

• Generic and multi-source competition
• Low likelihood of meaningful, long-duration active exclusivity in major markets
• Formulation-specific IP (if present) that typically does not block generic entry for the base drug

This dynamic places the product closer to a commodity-like specialty profile rather than a single-brand, long-cycle monopoly asset.

What is the current market structure for Cortisone Acetate?

Supply and pricing dynamics

Cortisone acetate market behavior is shaped by:

• Generic penetration across major geographies
• Wholesaler and hospital tendering for systemic corticosteroids
• Short-cycle procurement in many institutional settings

Buyer demand drivers

Demand clusters around:

• Inflammatory and endocrine indications historically treated with systemic steroids
• Hospital and outpatient physician prescribing patterns
• Substitution within the corticosteroid class (prednisone, methylprednisolone, hydrocortisone and equivalents), which constrains price lift

Competitive set

The primary substitutes are other systemic corticosteroids rather than structurally novel anti-inflammatories:

• Prednisone / prednisolone
• Methylprednisolone
• Hydrocortisone (including derivatives)
• Dexamethasone (context-dependent for potency and regimen choice)

How big is the market and what are the realistic growth expectations?

Because cortisone acetate is legacy and widely genericized, market sizing is typically reported under:

• Systemic corticosteroids, and/or
• Steroid injection subcategories, where cortisone acetate is a subset

Baseline forecast logic for a legacy generic

• Unit volume tends to be stable-to-slightly declining in mature systems as dosing preferences shift to alternatives.
• Revenue is range-bound by:
  • Tender pricing
  • Competitive entry waves
  • Formulary restrictions
  • Manufacturing disruptions

Projection framework A credible projection for cortisone acetate over a multi-year horizon usually depends on:

1. No major formulation exclusivity that changes generic competition
2. No new pivotal indication that re-routes demand
3. Macroeconomic and tender behavior that maintains price pressure

Market projection: 2026 to 2031

Revenue outlook

For a mature, generic systemic corticosteroid, the most probable outcome profile is:

• Low single-digit CAGR in nominal revenue globally
• Modest unit stability with periodic price compression due to competitive tendering

Base-case projection (directional)

• 2026-2031 nominal growth: low single digits
• Upside: manufacturing continuity in key markets, tender cycles favoring supply reliability
• Downside: expanded substitution toward alternatives and further price compression

Volume outlook

• Unit volume: broadly stable with periodic fluctuations tied to hospital procurement cycles
• Switching risk: consistent with the class effect among systemic corticosteroids

Where do adoption and demand persist for Cortisone Acetate?

Cortisone acetate demand persists where:

• It is already established in formularies
• Clinicians maintain it for specific regimens
• Supply chains remain reliable at scale

Given the broader corticosteroid interchangeability, growth outside entrenched formularies is harder to sustain without:

• A differentiated formulation,
• Evidence supporting use in a narrow compartment,
• Or a supply-driven advantage that extends contract awards.

What is the practical clinical relevance in ongoing use?

In clinical practice, systemic corticosteroids remain widely used for acute inflammation and endocrine indications. For legacy molecules such as cortisone acetate, the clinical “update” is typically:

• Safety and risk management reinforcement rather than new efficacy claims
• Ongoing pharmacovigilance and label compliance

A key operational takeaway is that clinical development intensity is not the main value driver; access and supply continuity do.

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Key market metrics to monitor (investment and procurement lens)

1. Tender outcomes in hospital networks and integrated delivery systems (quarterly/annual cadence)
2. Price movement in major sourcing lanes (US, EU5, and select APAC procurement hubs)
3. Manufacturing continuity for injectable steroid SKUs (batch availability, recall risk)
4. Formulary substitution signals within systemic steroid class utilization
5. Regulatory label stability for key indications and administration forms

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Key Takeaways

• Clinical development is limited: public drug-specific late-stage pivotal signals for cortisone acetate are sparse relative to modern pipeline drugs.
• Market is mature and competitive: generic penetration and class substitution constrain pricing power.
• Projection expectation is range-bound: 2026 to 2031 growth is most consistent with low single-digit nominal CAGR driven by volume stability and mild pricing offsets.
• Commercial edge comes from execution: supply reliability, tender performance, and formulary retention matter more than new clinical claims.

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FAQs

1) Is Cortisone Acetate experiencing a surge in late-stage trials?

No. Public signals do not show the typical density and cadence of Phase 3 pivotal programs for a new lead indication.

2) What most limits revenue growth for Cortisone Acetate?

Generic competition plus substitution within systemic corticosteroids cap pricing and reduce brand-like revenue expansion.

3) What is the most likely driver of demand in hospitals?

Formulary status and tender-based procurement of systemic corticosteroids, with conversion driven by contracting rather than new clinical differentiation.

4) Could new clinical evidence materially change the market?

Material shifts typically require a differentiated route/formulation, or a clear narrow indication expansion with strong prescribing impact. Registry signals do not currently indicate such a pattern for cortisone acetate.

5) What should investors prioritize for this asset class?

Manufacturing stability, supply contract wins, and ongoing tender price trajectory in key geographies.

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References (APA)

[1] U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/
[2] European Medicines Agency. European Union Clinical Trials Register (EudraCT). https://www.clinicaltrialsregister.eu/
[3] FDA. Drug Safety and Availability / approved labeling resources. https://www.fda.gov/drugs/drug-safety-and-availability