Cushing's Disease Pipeline 2025: Breakthrough Clinical Progress Led by 4+ Global Innovators – DelveInsight
Cushing's Disease Pipeline 2025, DelveInsight
As Cushing's disease continues to rise worldwide and contributes significantly to serious comorbidities such as diabetes, cardiovascular disorders, and certain cancers, the need for safer and more effective therapeutic options is becoming increasingly urgent. According to DelveInsight, the Cushing's disease pipeline currently includes 4+ pharmaceutical and biotechnology companies actively advancing 4+ therapeutic candidates aimed at treating the condition. These investigational therapies span multiple stages of clinical and non-clinical development, reflecting strong innovation and sustained efforts to address this complex and challenging disorder.
DelveInsight’s “Cushing's Disease Pipeline Insight 2025” report delivers an in-depth and strategic assessment of the evolving research and development landscape. The report examines clinical trial advancements, emerging drug candidates, mechanisms of action, competitive dynamics, and major corporate strategies. It serves as a valuable resource for stakeholders—including researchers, healthcare investors, and industry decision-makers—seeking a comprehensive understanding of the advancing Cushing's disease therapeutics market and the innovations shaping its future.
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Key Highlights from the Cushing's Disease Pipeline Report
DelveInsight’s analysis highlights a dynamic pipeline with 4+ active players developing 4+ pipeline therapies for Cushing's disease treatment.
In April 2025, the U.S. FDA approved a supplemental New Drug Application (sNDA) for Isturisa (osilodrostat), broadening its indication to include adults with endogenous hypercortisolemia associated with Cushing's syndrome when surgery is not an option or has failed. Initially approved in March 2020 for Cushing's disease, the expanded label is supported by data from over 350 patients enrolled in the LINC-3, LINC-4, LINC-6, and LINC-7 clinical trials.
In March 2025, Corcept Therapeutics submitted an NDA for relacorilant, a selective glucocorticoid receptor modulator, for the treatment of endogenous hypercortisolism (Cushing's syndrome). The application is supported by positive Phase III GRACE and GRADIENT trial results, demonstrating meaningful improvements in hypertension, hyperglycemia, and other cortisol-related clinical manifestations.
Key companies involved in the Cushing's disease pipeline include developers of Relacorilant, SPI-62, CRN-04894, among others, all working to enhance treatment outcomes and expand therapeutic options.
Several promising pipeline candidates, including Relacorilant and other emerging therapies, are advancing across different stages of development.
Cushing's Disease Overview
Cushing's syndrome, also referred to as hypercortisolism, is a rare endocrine disorder caused by prolonged exposure to excessive cortisol levels. The condition is broadly classified into ACTH-dependent and ACTH-independent forms and most commonly affects adults aged 20 to 50 years. In ACTH-dependent cases, a pituitary adenoma often leads to excessive adrenocorticotropic hormone (ACTH) secretion, disrupting the hypothalamic-pituitary-adrenal (HPA) axis and triggering overproduction of cortisol by the adrenal glands.
Chronic cortisol excess results in multiple systemic complications, including increased mortality risk, reduced quality of life, and numerous comorbidities. Common clinical features include central obesity, moon-shaped face, muscle wasting, fragile skin, acne, hypertension, type 2 diabetes, muscle weakness, and neuropsychiatric symptoms such as anxiety and depression. Women may experience menstrual irregularities and hirsutism, while men may develop fertility issues. In children, growth retardation is frequently observed.
ACTH-independent Cushing's syndrome arises from autonomous cortisol secretion, while ACTH-dependent forms may also present with skin and mucosal hyperpigmentation due to ACTH-mediated melanocyte stimulation. Early diagnosis and timely intervention are critical to preventing long-term complications.
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Cushing's Disease Pipeline Analysis
The Cushing's disease Pipeline Insight Report 2025 provides detailed coverage of:
Comprehensive profiling of leading companies developing therapies for the Cushing's disease market
Classification of therapeutic candidates by development stage (early, mid, and late)
Identification of major players involved in targeted therapies, including active, paused, and discontinued programs
The report evaluates emerging Cushing's disease drugs based on:
Development stage
Route of administration
Target receptor
Monotherapy versus combination therapy
Mechanism of action
Molecular classification
Additionally, the report offers in-depth insights into:
Company-to-company and industry-academia collaborations
Licensing and partnership agreements
Funding and investment trends supporting future market growth
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Cushing's Disease Emerging Drugs
Relacorilant – Corcept Therapeutics
Relacorilant (CORT125134) is a non-steroidal, selective antagonist of the glucocorticoid receptor type II (GR II). The drug competitively binds to the receptor, inhibiting its activation and preventing nuclear translocation of the receptor-ligand complex, thereby suppressing glucocorticoid-regulated gene expression.
Corcept Therapeutics is evaluating relacorilant for multiple serious conditions, including Cushing's syndrome, as well as adrenal, ovarian, and pancreatic cancers. The therapy has received orphan drug designation in the U.S. for both Cushing's syndrome and pancreatic cancer, and in the U.S. and EU for Cushing's syndrome.
In December 2024, Sparrow Pharmaceuticals submitted an NDA to the U.S. FDA seeking approval of relacorilant for the treatment of endogenous hypercortisolism associated with Cushing's syndrome.
Investigator/Academic Trial: S-707106
Sponsor: Investigator-initiated (not a corporate sponsor)
Mechanism: 11β-HSD1 inhibitor (reduces intracellular cortisol conversion)
Phase: Phase I/IIa
Trial Type: Open-label clinical study in Cushing’s syndrome patients (includes some CD cases)
Details: Oral S-707106 administered daily for 24 weeks to participants with inoperable or recurrent CS. Demonstrated glucose tolerance effects but not a traditional industry Phase 1–3 trial.
Clinical Trial Registry: Not listed under a company sponsor in public registries
Latest: Published in 2021; no corporate sponsorship or subsequent development announcements in public sources.
Cushing's Disease Pipeline Therapeutic Assessment
Assessment by Product Type
Monotherapy
Combination therapy
Mono/Combination
Assessment by Development Stage
Late-stage (Phase III)
Mid-stage (Phase II)
Early-stage (Phase I)
Preclinical and discovery-stage candidates
Discontinued and inactive programs
Assessment by Route of Administration
Oral
Parenteral
Intravenous
Subcutaneous
Topical
Assessment by Molecule Type
Recombinant fusion proteins
Small molecules
Monoclonal antibodies
Peptides
Polymers
Gene therapies
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Table of Contents
Report Introduction
Executive Summary
Cushing's Disease Current Treatment Patterns
DelveInsight’s Analytical Perspective
Therapeutic Assessment
Late-Stage Products (Phase III)
Mid-Stage Products (Phase II)
Early-Stage Products (Phase I)
Preclinical and Discovery-Stage Products
Inactive Products
Dormant Products
Discontinued Products
Product Profiles
Key Companies
Key Products
Dormant and Discontinued Products
Unmet Needs
Future Outlook
Analyst Review
Appendix
Research Methodology
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Contact Information
Mehul Malhotra
Marketing Executive – Marketing & Branding
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About DelveInsight
DelveInsight is a leading business consulting and market research firm dedicated exclusively to the life sciences sector. The company supports pharmaceutical and biotechnology organizations with comprehensive, end-to-end solutions designed to enhance strategic decision-making and overall market performance.
