“Cushing’s Syndrome Pipeline Insight, 2025“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Cushing’s Syndrome Market.

The Cushing’s Syndrome Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Cushing’s Syndrome Pipeline Report:

• Companies across the globe are diligently working toward developing novel Cushing’s Syndrome treatment therapies with a considerable amount of success over the years.

• Cushing’s Syndrome companies working in the treatment market are Crinetics Pharmaceuticals, AstraZeneca, Novartis, Sparrow Pharmaceuticals, Corcept Therapeutics, RECORDATI GROUP, Cortendo AB, HRA Pharma, Cortendo AB, Sparrow Pharmaceuticals, and others, are developing therapies for the Cushing’s Syndrome treatment

• Emerging Cushing’s Syndrome therapies such as – CRN-04894, AZD4017, SOM230, SPI 62, Relacorilant, osilodrostat, Levoketoconazole, metyrapone, evoketoconazole, SPI-62, and others are expected to have a significant impact on the Cushing’s Syndrome market in the coming years.

• In July 2025, The investigational drug relacorilant, a selective glucocorticoid receptor modulator currently under FDA review, has demonstrated significant benefits in managing symptoms of Cushing’s syndrome. In two phase III trials—GRACE and GRADIENT—relacorilant improved key clinical parameters in patients with adrenal hypercortisolism, including reductions in blood pressure, fasting glucose levels, and body weight. Pooled results showed that patients treated with relacorilant experienced notable decreases in systolic and diastolic blood pressure (-10.1 mm Hg and -6.3 mm Hg, respectively) as measured by 24-hour ambulatory monitoring, compared to placebo, which showed slight increases (1.5 mm Hg and 2.2 mm Hg). These findings were presented by Dr. Corin Badiu of the Carol Davila University of Medicine and Pharmacy and the National Institute of Endocrinology in Romania.

• In June 2025, A study from the Netherlands suggests that sequential treatment with ketoconazole to reduce cortisol levels, followed by octreotide to maintain control, may benefit certain individuals with mild Cushing’s disease. Among three patients who responded to this approach, two showed normalized cortisol levels along with improvements in weight, waist size, and blood pressure, indicating symptom relief. Ketoconazole, sold as Ketoconazole Esteve in Europe, is approved there for Cushing’s disease but not in the U.S. It works by inhibiting enzymes involved in cortisol production, the hormone responsible for the symptoms of Cushing’s when present in excess.

• In April 2025, The US Food and Drug Administration (FDA) approved osilodrostat (Isturisa, Recordati) for a new use: as a second-line treatment for adults with endogenous Cushing syndrome. This condition, caused by excessive cortisol production, can lead to complications like weight gain, high blood sugar, high blood pressure, osteoporosis, fragile skin, and muscle weakness. Osilodrostat, an oral medication that inhibits cortisol synthesis, was already approved for Cushing disease, a form of the syndrome triggered by pituitary overstimulation. Both approvals apply to patients unable to undergo surgery or those for whom surgery was not successful.

• In March 2025, The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for relacorilant, a potential treatment for patients with Cushing syndrome (hypercortisolism). Relacorilant is a selective cortisol modulator that targets the glucocorticoid receptor. The NDA submission is backed by results from the phase 3 GRACE trial (NCT03697109) and the confirmatory GRADIENT trial (NCT04308590).

• In February 2025, Sterotherapeutics, a US-based clinical-stage company, initiated a Phase II clinical trial for its investigational drug ST-002 to treat Cushing’s Syndrome, a rare endocrine disorder. The study aims to evaluate the drug’s efficacy, safety, and tolerability in affected individuals and will be conducted across multiple clinical sites in Europe.

• In December 2024, Corcept Therapeutics, a US-based biotechnology company, announced positive long-term results from its Phase III study evaluating relacorilant for endogenous hypercortisolism (Cushing’s syndrome). The treatment demonstrated sustained cardiometabolic benefits and was well tolerated for up to six years. The open-label extension study included 116 participants who had previously completed the GRACE or GRADIENT studies or a Phase II clinical trial in hypercortisolism.

• In October 2024, Sparrow Pharmaceuticals, a clinical-stage biopharmaceutical company focused on developing targeted therapies for unmet needs in endocrinology and immunology, announced the completion of the Phase 2 RESCUE trial evaluating clofutriben, a potent and selective HSD-1 inhibitor, for endogenous Cushing’s syndrome. All eligible patients who completed the trial chose to continue treatment under an open-label extension (OLE) protocol.

Cushing’s Syndrome Overview

Cushing’s syndrome is a hormonal disorder caused by prolonged exposure to high levels of cortisol, a hormone produced by the adrenal glands. It can result from various factors, including excessive use of corticosteroid medications or overproduction of cortisol by the adrenal glands or tumors elsewhere in the body.

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Emerging Cushing’s Syndrome Drugs Under Different Phases of Clinical Development Include:

• CRN-04894: Crinetics Pharmaceuticals

• AZD4017: AstraZeneca

• SPI 62: Sparrow Pharmaceuticals

• Relacorilant: Corcept Therapeutics

• SPI-62: Sparrow Pharmaceuticals

Route of Administration

Cushing’s Syndrome pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

• Oral

• Parenteral

• Intravenous

• Subcutaneous

• Topical

Molecule Type

Products have been categorized under various Molecule types, such as

• Monoclonal Antibody

• Peptides

• Polymer

• Small molecule

• Gene therapy

Cushing’s Syndrome Pipeline Therapeutics Assessment

• Cushing’s Syndrome Assessment by Product Type

• Cushing’s Syndrome By Stage and Product Type

• Cushing’s Syndrome Assessment by Route of Administration

• Cushing’s Syndrome By Stage and Route of Administration

• Cushing’s Syndrome Assessment by Molecule Type

• Cushing’s Syndrome by Stage and Molecule Type

DelveInsight’s Cushing’s Syndrome Report covers around 4+ products under different phases of clinical development like

• Late-stage products (Phase III)

• Mid-stage products (Phase II)

• Early-stage product (Phase I)

• Pre-clinical and Discovery stage candidates

• Discontinued & Inactive candidates

• Route of Administration

Further Cushing’s Syndrome product details are provided in the report. Download the Cushing’s Syndrome pipeline report to learn more about the emerging Cushing’s Syndrome therapies

Cushing’s Syndrome Pipeline Analysis:

The Cushing’s Syndrome pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Cushing’s Syndrome with aggregate therapies developed by each company for the same.

• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Cushing’s Syndrome Treatment.

• Cushing’s Syndrome key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

• Cushing’s Syndrome Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Cushing’s Syndrome market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Cushing’s Syndrome drugs and therapies

Cushing’s Syndrome Pipeline Market Drivers

• Entrance of novel therapies will drive Cushing’s syndrome market growth, increase in the number of research and development activities are some of the important factors that are fueling the Cushing’s Syndrome Market.

Cushing’s Syndrome Pipeline Market Barriers

• However, high cost associated treatment, strict regulatory policies and lack of awareness among people and other factors are creating obstacles in the Cushing’s Syndrome Market growth.

Scope of Cushing’s Syndrome Pipeline Drug Insight

• Coverage: Global

• Key Cushing’s Syndrome Companies: Crinetics Pharmaceuticals, AstraZeneca, Novartis, Sparrow Pharmaceuticals, Corcept Therapeutics, RECORDATI GROUP, Cortendo AB, HRA Pharma, Cortendo AB, Sparrow Pharmaceuticals, and others

• Key Cushing’s Syndrome Therapies: CRN-04894, AZD4017, SOM230, SPI 62, Relacorilant, osilodrostat, Levoketoconazole, metyrapone, evoketoconazole, SPI-62, and others

• Cushing’s Syndrome Therapeutic Assessment: Cushing’s Syndrome current marketed and Cushing’s Syndrome emerging therapies

• Cushing’s Syndrome Market Dynamics: Cushing’s Syndrome market drivers and Cushing’s Syndrome market barriers

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Table of Contents

*The Table of Contents (TOC) is not exhaustive; the final content may vary. Refer to the sample report for the complete table of contents.

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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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