Endogenous Cushing’s Syndrome (CS) Emerging Therapy and TPP Insights

Thelansis’s “Endogenous Cushing’s Syndrome (CS) Emerging Therapy, with Unmet Needs and TPP Insights Report – 2025″ provides a comprehensive analysis of the emerging competitive landscape, unmet needs, target product profiles (TPPs), trial designs, and KOL insights on key emerging therapies and key drug development opportunities in the indication.

Endogenous Cushing’s Syndrome (CS) Overview

Endogenous Cushing’s syndrome (CS) is an uncommon endocrine disorder characterized by an overproduction of cortisol stemming from either ACTH-dependent conditions, typically an ACTH-producing pituitary adenoma (known as Cushing’s disease), or ACTH-independent causes, most commonly a benign adrenal adenoma. While the primary effects of endogenous Cushing’s syndrome are evident in its phenotypic changes and metabolic consequences, it also significantly impacts other endocrine axes. Inappropriate cortisol secretion can disrupt the activity of the hypothalamus-pituitary-thyroid axis, resulting in clinical and biochemical features indicative of “central hypothyroidism.” Medical treatment for Cushing’s disease is primarily utilized as a secondary option following unsuccessful surgery or recurrence. It involves various pituitary-directed medications, adrenal steroidogenesis inhibitors, and a glucocorticoid receptor blocker, some of which have received approval from the US Food and Drug Administration (FDA). Notably, recent consensus guidelines from the Pituitary Society endorse osilodrostat, an oral 11β-hydroxylase inhibitor, as an effective FDA-approved medical therapy for Cushing’s disease. Despite achieving remission, patients often contend with several persistent comorbidities that can significantly impact their quality of life. Hence, prompt and accurate diagnosis, followed by timely intervention, is imperative for mitigating the chronic complications associated with excessive glucocorticoid levels and enhancing patient well-being.

Geography coverage:

G8 (United States, EU5 [France, Germany, Italy, Spain, U.K.], Japan, and China)

Insights driven by surveys* with physician / key opinion leaders:

• Survey findings are corroborated and enriched by insights from interviews with leading KOLs

*Survey is customized based on client requirements

Deliverables format:

• PowerPoint presentation
• MS Excel

Key business questions answered:

• Detailed emerging competitive landscape
  • Pipeline analysis
  • Target patients for emerging therapies
  • Key companies
  • Key mechanism of actions
  • Launch date estimates, etc.
• Clinical trial landscape analysis
  • Target patient segments
  • Trial endpoints
  • Trial design
  • Recruitment criteria, etc.
• Unmet Needs and Opportunities
  • Performance of key current therapies
  • Top areas of unmet needs
  • Opportunity sizing for key unmet needs
• Target Product Profiles
  • Attributes and levels
  • Physician likelihood of prescribing
  • Expected patient shares
• KOL insights on key emerging therapies
  • Level of awareness
  • Expected use / line of therapy
  • Extent to fulfil key unmet needs
  • KOL quotes

1. Key Findings and Analyst Commentary

• Key trends: market snapshots, SWOT analysis, commercial benefits and risk,etc.

2. Disease Context

• Disease definition, classification, etiology and pathophysiology, drug targets,etc.

3. Epidemiology

• Key takeaways
• Incidence / Prevalence
• Diagnosed and Drug-Treated populations
• Comorbidities
• Other relevant patient segments

4. Market Size and Forecast

• Key takeaways
• Market drivers and constraints
• Drug-class specific trends
• Country-specific trends

5. Competitive Landscape

• Current therapies
  • Key takeaways
  • Dx and Tx journey/algorithm
  • Key current therapies – profiles and KOL insights
• Emerging therapies
  • Key takeaways
  • Notable late-phase emerging therapies – profiles, launch expectations, KOL insights
  • Notable early-phase pipeline

6. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

7. Regulatory and Reimbursement Environments (by country and payer insights)

8. Appendix (e.g., bibliography, methodology)