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Cushing’s Disease Pipeline 2025

As Cushing’s disease continues to rise worldwide and contributes to comorbidities such as diabetes, cardiovascular disease, and certain cancers, there is an increasing need for safer and more effective treatment options. DelveInsight reports that the Cushing’s disease pipeline includes over four pharmaceutical and biotech companies developing multiple therapeutic candidates. These therapies are advancing through various stages of clinical and preclinical development, reflecting strong innovation and dedication to addressing this significant health challenge.

DelveInsight’s “Cushing’s Disease Pipeline Insight 2025” offers a comprehensive and strategic assessment of the active R&D landscape. The report examines clinical trial progress, emerging therapies, mechanisms of action, competitive dynamics, and key initiatives by leading companies, serving as a valuable resource for researchers, healthcare investors, and decision-makers seeking in-depth insights into the evolving Cushing’s disease therapeutics market and the innovations shaping its future.

Explore the Cutting-Edge Landscape of Cushing’s disease Drug Development @ https://www.delveinsight.com/report-store/cushings-syndrome-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr

Key Takeaways from the Cushing’s disease Pipeline Report:

• DelveInsight’s Cushing’s disease pipeline report highlights a dynamic landscape, with over four active companies developing multiple therapeutic candidates for the treatment of Cushing’s disease.

• In April 2025, the FDA approved a supplemental New Drug Application (sNDA) for Isturisa (osilodrostat), extending its indication to treat endogenous hypercortisolemia in adults with Cushing’s syndrome who are not surgical candidates or whose surgery was not curative. Originally approved in March 2020 for Cushing’s disease, this expanded label is supported by data from more than 350 patients across the LINC‑3, LINC‑4, LINC‑6, and LINC‑7 trials.

• In March 2025, Corcept Therapeutics submitted a New Drug Application (NDA) for relacorilant, a selective glucocorticoid receptor modulator, targeting endogenous hypercortisolism (Cushing’s syndrome). This submission is based on positive Phase 3 trial results (GRACE, GRADIENT), demonstrating significant improvements in hypertension, hyperglycemia, and other cortisol-related symptoms.

• Key companies, including Relacorilant, SPI 62, CRN-04894, and others, are actively developing new therapies to enhance the Cushing’s disease treatment landscape. Promising pipeline candidates include Relacorilant and several other therapies at various stages of development.

Cushing’s disease Overview:

Cushing’s syndrome, also called hypercortisolism, is a hormonal disorder resulting from prolonged exposure to elevated cortisol levels in the body. The condition is classified into ACTH-dependent and ACTH-independent forms and is considered rare, most commonly affecting adults between 20 and 50 years of age. In ACTH-dependent cases, excessive ACTH production—often due to a pituitary tumor—disrupts the normal hypothalamic-pituitary-adrenal (HPA) axis, leading to overproduction of cortisol by the adrenal glands. Chronic cortisol excess can cause a variety of health problems, increase mortality risk, and reduce overall quality of life.

Typical symptoms include central obesity, moon-shaped face, thinning limbs, fragile skin prone to bruising, acne, hypertension, type 2 diabetes, muscle weakness, and psychological effects such as anxiety and depression. Women may experience irregular menstrual cycles and excessive hair growth, men may have reduced fertility, and children may exhibit stunted growth. Causes of the syndrome include prolonged corticosteroid use, pituitary tumors, or adrenal disorders.

In ACTH-independent Cushing’s syndrome, symptoms are driven directly by high circulating cortisol, whereas ACTH-dependent forms may also cause skin and gum hyperpigmentation due to ACTH’s indirect stimulation of melanin production. Early diagnosis and treatment are critical to managing symptoms and preventing serious complications.

Download the Cushing’s disease sample report to know in detail about the Cushing’s disease treatment market @ https://www.delveinsight.com/sample-request/cushings-syndrome-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr

Cushing’s disease Pipeline Analysis

The Cushing’s disease pipeline insights report 2025, provides insights into:

• Provides comprehensive insights into key companies developing therapies in the Cushing’s disease Market.

• Categorizes Cushing’s disease therapeutic companies by development stage: early, mid, and late-stage.

• Highlights major companies involved in targeted therapy development, including both active and inactive (paused/discontinued) projects.

• Reviews emerging Cushing’s disease drugs under development based on:

  • Stage of development

  • Cushing’s disease Route of administration

  • Target receptor

  • Monotherapy vs. combination therapy

  • Cushing’s disease Mechanism of action

  • Molecular type

• Offers detailed analysis of:

  • Company-to-company and company-academia collaborations

  • Cushing’s disease Licensing agreements

  • Funding and investment activities supporting future Cushing’s disease market advancement.

Unlock key insights into emerging Cushing’s disease therapies and market strategies here: https://www.delveinsight.com/report-store/cushings-syndrome-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr

Cushing’s disease Emerging Drugs

• Relacorilant: Corcept Therapeutics

Relacorilant (CORT 125134) is a non-steroidal, selective glucocorticoid receptor type II (GR II) antagonist. It functions by competitively binding to GR II receptors, thereby preventing their activation. This mechanism inhibits the translocation of the ligand-receptor complex into the cell nucleus and blocks the expression of glucocorticoid-regulated genes. Corcept Therapeutics is exploring relacorilant for the treatment of several serious conditions, including Cushing’s syndrome, as well as adrenal, ovarian, and pancreatic cancers.

The drug has received orphan drug designation in the U.S. for both Cushing’s syndrome and pancreatic cancer, and in both the U.S. and EU for Cushing’s syndrome. In December 2024, Sparrow Pharmaceuticals submitted a New Drug Application (NDA) to the U.S. FDA for relacorilant, seeking approval for the treatment of endogenous hypercortisolism (Cushing’s syndrome).

Cushing’s disease Pipeline Therapeutic Assessment

Cushing’s disease Assessment by Product Type

• Mono

• Combination

• Mono/Combination

Cushing’s disease By Stage

• Late-stage products (Phase III)

• Mid-stage products (Phase II)

• Early-stage product (Phase I) along with the details of

• Pre-clinical and Discovery stage candidates

• Discontinued & Inactive candidates

Cushing’s disease Assessment by Route of Administration

• Oral

• Parenteral

• Intravenous

• Subcutaneous

• Topical

Cushing’s disease Assessment by Molecule Type

• Recombinant fusion proteins

• Small molecule

• Monoclonal antibody

• Peptide

• Polymer

• Gene therapy

Download sample pages to get an in-depth assessment of the emerging Cushing’s disease therapies and key Cushing’s disease companies

Table of Contents

1. Report Introduction

2. Executive Summary

3. Cushing’s disease Current Treatment Patterns

4. Cushing’s disease – DelveInsight’s Analytical Perspective

5. Therapeutic Assessment

6. Cushing’s disease Late-Stage Products (Phase-III)

7. Cushing’s disease Mid-Stage Products (Phase-II)

8. Early Stage Products (Phase-I)

9. Pre-clinical Products and Discovery Stage Products

10. Inactive Products

11. Dormant Products

12. Cushing’s disease Discontinued Products

13. Cushing’s disease Product Profiles

14. Cushing’s disease Key Companies

15. Cushing’s disease Key Products

16. Dormant and Discontinued Products

17. Cushing’s disease Unmet Needs

18. Cushing’s disease Future Perspectives

19. Cushing’s disease Analyst Review

20. Appendix

21. Report Methodology

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About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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