Cushing Syndrome - Pipeline Insight, 2024

This “Cushing Syndrome - Pipeline Insight, 2024” report provides comprehensive insights about 4+ companies and 4+ pipeline drugs in Cushing Syndrome pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Cushing Syndrome: Understanding

Cushing Syndrome: Overview

Cushing's syndrome, or hypercortisolism is a hormonal disorder caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol. Causes of Cushing syndrome are typically divided into two basic categories: those that are adrenocorticotropic hormone (ACTH)-dependent and those that are ACTH-independent. It is a rare disorder and most commonly affects adults aged 20 to 50.

The pituitary tumor overproduces ACTH and lacks hypothalamic-pituitary-adrenal (HPA) axis feedback regulation; thus, excessive amounts of cortisol are secreted from the adrenal glands. Prolonged systemic exposure to elevated cortisol levels results in a significant clinical burden in patients with CD due to comorbidities, increased mortality, and impaired health-related quality of life (HRQoL).

Cushing's syndrome manifests with various signs and symptoms such as weight gain, particularly in the upper body and face, a round and red face, thin arms and legs, thin and fragile skin that bruises easily, acne, high blood pressure, type 2 diabetes, muscle weakness, and emotional symptoms like depression and anxiety. Other indications include irregular menstrual periods in women, reduced fertility in men, excessive hair growth in women, and stunted growth in children. These symptoms can be caused by factors like long-term corticosteroid use, pituitary tumors, or adrenal gland issues. Early diagnosis and appropriate treatment are essential to manage the condition effectively and prevent complications.

In patients suffering from hypercortisolism that is ACTH-independent, clinical manifestations are primarily the result of excessive concentrations of circulating corticosteroids (e.g. cortisol). In patients with hypercortisolism that is ACTH-dependent, hyperpigmentation of the skin and gums may occur (because ACTH indirectly stimulates melanin synthesis).

The diagnosis of Cushing's syndrome is based on medical history, a physical examination, and laboratory tests. X rays of the adrenal or pituitary glands can be useful in locating tumors. To confirm a diagnosis tests like 24-hour urinary free-cortisol test, late-night salivary cortisol test, low-dose dexamethasone suppression test, and/or dexamethasone-CRH test are done. Tests to assess the levels of ACTH include a urine test, a blood test, and a saliva test. Cushing's syndrome may involve surgical removal of adrenal gland tumors or pituitary tumors, radiation therapy, and medications to control cortisol levels.

These medications can include ketoconazole, osilodrostat, mitotane, levoketoconazole, metyrapone, mifepristone, and pasireotide. Additionally, lifestyle changes like ensuring adequate calcium and vitamin D intake and monitoring mental health are important. Long-term management may involve cortisol replacement medicine and regular monitoring with healthcare providers.

"Cushing Syndrome- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Cushing Syndrome pipeline landscape is provided which includes the disease overview and Cushing Syndrome treatment guidelines. The assessment part of the report embraces, in depth Cushing Syndrome commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Cushing Syndrome collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Cushing Syndrome R&D. The therapies under development are focused on novel approaches to treat/improve Cushing Syndrome.

Cushing Syndrome Emerging Drugs Chapters

This segment of the Cushing Syndrome report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Cushing Syndrome Emerging Drugs

Relacorilant: Corcept Therapeutics

Relacorilant (CORT 125134) is a non-steroidal, selective glucocorticoid receptor II (GR II) antagonist. Upon administration, relacorilant competitively binds to and blocks GRs. This inhibits the activity of GRs, and prevents both the translocation of the ligand-GR complexes to the nucleus and gene expression of GR-associated genes. Corcept is studying relacorilant in a variety of serious disorders, including Cushing’s syndrome and adrenal, ovarian and pancreatic cancer. Relacorilant has received orphan drug designation in the United States for the treatment of Cushing’s syndrome and pancreatic cancer and both the United States and the European Union for the treatment of Cushing’s syndrome.

Cushing Syndrome: Therapeutic Assessment

This segment of the report provides insights about the different Cushing Syndrome drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Cushing Syndrome

• There are approx. 4+ key companies which are developing the therapies for Cushing Syndrome. The companies which have their Cushing Syndrome drug candidates in the most advanced stage, i.e. Phase III include, Corcept Therapeutics.

Phases

The 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) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Cushing 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
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Cushing Syndrome: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Cushing Syndrome therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Cushing Syndrome drugs.

Cushing Syndrome Report Insights

• Cushing Syndrome Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Cushing Syndrome Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Cushing Syndrome drugs?
• How many Cushing Syndrome drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Cushing Syndrome?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Cushing Syndrome therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Cushing Syndrome and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Corcept Therapeutics
• Sparrow Pharmaceuticals
• Crinetics Pharmaceuticals

Key Products

• Relacorilant
• SPI 62
• CRN-04894

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