预约演示
更新于：2025-06-23
Ketoconazole
酮康唑
更新于：2025-06-23
概要
基本信息
简介酮康唑是一种小分子化合物，可作为 CYP51A1 的抑制剂。该药物由著名的 Janssen Pharmaceutica NV 开发，于 1981 年 6 月首次获得批准。作为 CYP51A1 的抑制剂，其作用机制取决于抑制真菌酶羊毛甾醇 14α-脱甲基酶。后者在麦角甾醇的合成中起着不可或缺的作用 - 麦角甾醇是真菌细胞膜的基本成分。通过阻止这种关键的酶活性，酮康唑有效地破坏了真菌的生长，最终导致它们的死亡。值得注意的是，酮康唑可作为多种真菌感染的有效治疗选择，涵盖从皮肤感染到全身感染，包括头发和指甲。尽管最近副作用相对较少的抗真菌药物在很大程度上取代了酮康唑，但该药物在某些情况下仍具有重要意义，例如当替代治疗方式失败或存在禁忌症时。最终，酮康唑作为真菌感染管理中的关键治疗干预措施得以持续。 |
药物类型 小分子化药 |
别名 Ketoconazole (JP17/USP)、Ketoconazole Cream、Ketoconazole Gream + [20] |
靶点 |
作用方式 拮抗剂 |
作用机制 C14DM拮抗剂(C14DM拮抗剂)、咪唑类抗真菌药 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟) |
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结构/序列
分子式C26H28Cl2N4O4 |
InChIKeyXMAYWYJOQHXEEK-MKNUCDGGSA-N |
CAS号65277-42-1 |
关联
178
项与 酮康唑 相关的临床试验CTRI/2024/10/074823
A COMPARATIVE CLINICAL STUDY ON TUVARAK TAILA CREAM AND 2 PERCENT TOPICAL KETOCONAZOLE IN THE MANAGEMENT OF SIDHMA KUSHTHA (PITYRIASIS VERSICOLOR) IN CHILDREN- AN OPEN LABELLED RANDOMIZED CONTROLLED CLINICAL TRIAL - NIL
开始日期2025-05-01 |
申办/合作机构- |
IRCT20241028063523N4
Comparative efficacy of combined treatment with ketoconazole 2% cream and adapalene 0.1% gel versus ketoconazole 2% cream monotherapy in pityriasis versicolor.
开始日期2024-11-19 |
申办/合作机构- |
NCT05638763
Cytochrome P450 Inhibition With Ketoconazole to Decrease Dosage and Costs of Dasatinib for Chronic Myelogenous Leukemia
This phase 2 single-arm study aims to demonstrate the efficacy of strong cytochrome inhibition with ketoconazole to reduce dasatinib dosage for adults with chronic myelogenous leukemia. Researchers will describe response rates and adverse events.
开始日期2024-11-01 |
100 项与 酮康唑 相关的临床结果
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100 项与 酮康唑 相关的转化医学
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100 项与 酮康唑 相关的专利（医药）
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13,035
项与 酮康唑 相关的文献（医药）2025-12-01·IMMUNOLOGIC RESEARCH
Assessment of antipsoriatic potential of novel pemetrexed disodium–loaded transdermal patches in an imiquimod-induced mouse model
Article
作者: Yadav, Tejpal ; Gilhotra, Ritu ; Yadav, Hemant Kumar Singh
Psoriasis is a chronic autoimmune skin disorder characterized by keratinocyte hyperproliferation, inflammation, and angiogenesis, significantly impacting patients' quality of life. Current therapeutic strategies, including topical corticosteroids, phototherapy, and systemic biologics, often present limitations such as adverse effects, high costs, and inadequate skin penetration. Transdermal drug delivery offers a promising alternative by enhancing localized drug bioavailability and minimizing systemic side effects. In this study, we investigated the antipsoriatic potential of pemetrexed disodium, a multitargeted antifolate agent, formulated as a transdermal patch in an imiquimod-induced psoriasis mouse model. The patches were prepared using a solvent evaporation technique and optimized for controlled drug release. Mice treated with pemetrexed-loaded transdermal patches exhibited significant dose-dependent reductions in psoriasis severity, as evidenced by improvements in Psoriasis Area and Severity Index (PASI) scores, histopathological analysis, and suppression of inflammatory cytokines (TNF-α, IL-6) assessed via qRT-PCR and ELISA. The highest concentration (0.16 mg/cm2) demonstrated the most pronounced therapeutic effects, comparable to the standard ketoconazole treatment. These findings highlight the potential of pemetrexed disodium-loaded transdermal patches as an innovative, targeted therapy for psoriasis, warranting further clinical investigations.
2025-11-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY
DNA binding study of antifungal drug Ketoconazole by molecular docking and spectroscopic analysis
Article
作者: Akgül, Tunahan ; Özkul, Mustafa Alp ; Toksoy, Suleyman Can ; Dikmen, Gökhan ; Bozaslan, Mehmet Şerif
The process of developing new drug molecules is long-term, costly, and especially the process of moving to clinical trials takes a long time. Consequently, conducting experimental and theoretical binding studies of drugs or drug candidates with biological materials, such as DNA and RNA, are crucial to reduce costs and minimize time requirements. As the DNA a fundamental biological molecule constitutes a major target for numerous pharmaceuticals, binding studies of various molecules with DNA is a broad field of research. DNA binding properties of antifungal drugs are of great importance in understanding their biological activities and elucidating their mechanisms of action. DNA binding studies also provide critical information to optimize the effects of antifungal drugs on target cells and to increase the selective toxicity of drugs. Ketoconazole (KTZ) is an azole-containing antifungal drug, and azole-containing drugs have many pharmacological properties. In this study, the interaction between the KTZ molecule and calf-thymus DNA (ct-DNA) was examined using various spectroscopic methods. The binding constant between ct-DNA and KTZ molecule was calculated using results obtained from different spectroscopic methods. UV-vis and fluorescence studies indicated a binding constant was calculated as 5.8 × 104 M-1 and 6.21 × 104 M-1 for the interaction between KTZ and ct-DNA, respectively. ct-DNA quenched the fluorescence of KTZ with a quenching constant approximately equal to 13 × 1012 M-1.s-1. Fluorescence displacement experiments using ethidium bromide (EB) and Hoechst 33,258 revealed interaction between KTZ and ct-DNA occurred through minor groove binding mode. This conclusion was further supported by viscosity measurements, DNA melting studies, and KI quenching experiments. In light of experimental results, KTZ molecule quenches the fluorescence of DNA with a static mechanism due to the negative values of thermodynamic parameters such as ΔHo and ΔSo. In addition, the interaction of the KTZ molecule with ct-DNA was investigated theoretically by Molecular Docking. It interacts with the minor groove of DNA through a combination of van der Waals forces and hydrogen bonding interactions.
2025-09-01·JOURNAL OF PHOTOCHEMISTRY AND PHOTOBIOLOGY A-CHEMISTRY
Synthesis of novel bioactive amides derived from carbazole moiety with deep-blue and single-component white photoluminescence
作者: Sayed, Mostafa ; Al-Hossainy, A. F. ; Younis, Osama ; Tolba, Mahmoud S. ; Tsutsumi, Osamu ; Ahmed, Mostafa
This work focuses on the chem. synthesis of three fluorescent bioactive amides tethered carbazole moiety by coupling 3-amino-9-ethylcarbazole with different aliphatic carboxylic acids including valeric, hexanoic, and heptanoic acids.NMR spectroscopy and HRMS were utilized to confirm the claimed structure of the target compounds indicating good agreement.The antimicrobial activity of fluorescent amides was assessed against different strains of gram neg. and gram-neg. bacterial as well as fungi demonstrating outstanding activity close or same as the control.Moreover, the mol. design, DFT calculations, and photoluminescence characteristics of these dyes have been investigated.The examined materials solutions emitted a deep-blue emission.Interestingly, with the powders, on the other hand, a single component emitted white light.The creation of aggregated mols. in the solid state improved the emission intensity at long visible wavelengths, resulting in a change in the emission color from the solution to the powder.The studied materials also emitted consistently at high temperaturesFurthermore, the odd-even effect both on the mol. packing and emission characteristics has been proven.As a result, the mols. under investigation provide a unique combination of benefits: a simple mol. structure, deep-blue emitters, white emission from a single material, and an odd-even effect.
205
项与 酮康唑 相关的新闻（医药）2025-05-21
BOSTON, May 21, 2025 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a privately held pharmaceutical company focused on the development and commercialization of specialty therapies for specialists and community care providers, that address important medical and public health threats, today announced that the Company has completed its acquisition of Optinose, Inc. (NASDAQ:OPTN). This acquisition broadens Paratek’s commercial portfolio which now includes both its flagship antibiotic, NUZYRA® (omadacycline), and Optinose’s product XHANCE® (fluticasone propionate). “Adding XHANCE to our portfolio is a pivotal first step in achieving our long-term vision to become a multi‑product specialty therapeutics company, focused on addressing significant unmet medical needs,” said Evan Loh, MD, Chief Executive Officer of Paratek. “Our medical and commercial teams are deeply experienced with capabilities focused on bringing innovative treatments to specialists and primary care providers that address the needs of their patients. This transaction establishes a strong platform for us to continue to leverage these capabilities as we move forward to explore opportunities to expand our portfolio through future product acquisitions.” Under the terms of the merger agreement, Paratek acquired all outstanding shares of Optinose for approximately $330 million, including the assumption of debt and assuming full payment of the contingent value rights (CVRs), and Optinose shareholders were paid $9 per share in cash and received CVRs for up to $5 per share in cash payable in the event that certain net revenue milestones are achieved by XHANCE. Paratek will pay $1 per share if XHANCE achieves $150M in net sales in any calendar year prior to December 31, 2028, and $4 per share if XHANCE achieves $225M in net sales in any calendar year prior to December 31, 2029. Optinose shareholders approved the merger proposal at Optinose’s special meeting of shareholders held on May 16, 2025, and following completion of the merger Optinose's common stock will be delisted from the Nasdaq Global Select Market. The transaction was financed with capital from Paratek, B-FLEXION Life Sciences, and Novo Holdings, and debt financing from funds managed by Oaktree Capital Management, L.P. ("Oaktree"). Lazard acted as the exclusive financial advisor to Paratek Pharmaceuticals, and Skadden, Arps, Slate, Meagher & Flom LLP served as its legal advisor. Evercore acted as the exclusive financial advisor to Optinose, and Hogan Lovells US LLP served as its legal advisor. About Paratek Pharmaceuticals, Inc.Paratek Pharmaceuticals, Inc. is a privately held pharmaceutical company providing innovative specialty therapies for specialists and community care providers, addressing important medical and public health threats. Paratek's lead product, NUZYRA (omadacycline), is a once-daily oral and intravenous antibiotic indicated for adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek continues to diversify its portfolio to address unmet patient needs. Paratek was acquired in 2023 by B-FLEXION and Novo Holdings. For more information, visit https://www.paratekpharma.com/ or follow us on LinkedIn and X. About B-FLEXION Life SciencesB-FLEXION Life Sciences is part of the B-FLEXION group, a private, entrepreneurial investment firm with offices in Europe and the United States. B-FLEXION seeds, acquires and builds investment partnerships across a number of focused fields and makes principal investments into operating businesses in transformative industries. Through B-FLEXION Life Sciences there is also targeted investment across biopharma, diagnostics and a broad spectrum of innovative healthcare services. It is an active owner, applying the experience and skills of its investment and operationally experienced team to work closely with management to build its portfolio companies. www.bflexion.com About Novo Holdings A/SNovo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation. Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk and Novonesis and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Planetary Health Investments and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. As of year-end 2024, Novo Holdings had total assets of EUR 142 billion. www.novoholdings.dk About OaktreeOaktree is a leader among global investment managers specializing in alternative investments, with $203 billion in assets under management as of March 31, 2025. The firm emphasizes an opportunistic, value-oriented, and risk-controlled approach to investments in credit, equity, and real estate. The firm has more than 1,200 employees and offices in 25 cities worldwide. For additional information, please visit Oaktree’s website at http://www.oaktreecapital.com/. About NUZYRANUZYRA (omadacycline) is an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. A next-generation tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical, and other drug-resistant strains. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSNUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline-class antibacterial drugs or to any of the excipients. WARNINGS AND PRECAUTIONSMortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. NUZYRA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions, including photosensitivity, fixed drug eruption, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests), have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONSThe most common adverse reactions (incidence 2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation. DRUG INTERACTIONSPatients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. USE IN SPECIFIC POPULATIONSLactation: Breastfeeding is not recommended during treatment with NUZYRA. See full prescribing information here. About XHANCEXHANCE is a drug-device combination product that uses the Exhalation Delivery System™ (also known as the EDS®) designed to deliver a topical steroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for both the treatment of chronic rhinosinusitis without nasal polyps (also called chronic sinusitis) and chronic rhinosinusitis with nasal polyps (also called nasal polyps) in patients 18 years of age or older. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.WARNINGS AND PRECAUTIONS: Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma until healing has occurred.Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.Immunosuppression and infections can occur, including potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.Assess for decrease in bone mineral density initially and periodically thereafter. ADVERSE REACTIONS: Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence 3%) are epistaxis, headache, and nasopharyngitis.Chronic rhinosinusitis with nasal polyps: The most common adverse reactions (incidence 3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis. DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor patients for signs of increased drug exposure. See full prescribing information here. MEDIA CONTACT: Adam Silversteinadam@scientpr.com
并购上市批准临床结果
2025-05-16
来源：国家药监局 编辑：清风2025年05月16日，国家药监局发布公告，对盐酸雷尼替丁注射剂说明书进行统一修订，要求企业于2025年08月12日前报省级药品监督管理部门备案。 根据药品不良反应评估结果，为进一步保障公众用药安全，国家药监局决定对盐酸雷尼替丁注射制剂（包括：盐酸雷尼替丁注射液、注射用盐酸雷尼替丁、盐酸雷尼替丁氯化钠注射液）说明书内容进行统一修订。现将有关事项公告如下：一、所有上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按照附件要求修订说明书，于2025年8月12日前报省级药品监督管理部门备案。修订内容涉及药品标签的，应当一并进行修订；说明书及标签其他内容应当与原批准内容一致。自备案之日起生产的药品，不得继续使用原药品说明书。药品上市许可持有人应当在备案后9个月内对已出厂的药品说明书及标签予以更换或者以其他形式将说明书更新信息告知患者。二、药品上市许可持有人应当对新增不良反应发生机制开展深入研究，采取有效措施做好药品使用和安全性问题的宣传培训，指导医师、药师合理用药。三、临床医师、药师应当仔细阅读上述药品说明书的修订内容，在选择用药时，应当根据新修订说明书进行充分的获益/风险分析。四、患者用药前应当仔细阅读药品说明书，使用处方药的，应当严格遵医嘱用药。五、省级药品监督管理部门应当督促行政区域内上述药品的上市许可持有人按要求做好相应说明书修订和标签、说明书更换及说明书更新信息的告知工作，对违法违规行为依法严厉查处。盐酸雷尼替丁注射制剂说明书修订要求 本次修订包括以下药品通用名：盐酸雷尼替丁注射液、注射用盐酸雷尼替丁、盐酸雷尼替丁氯化钠注射液。一、【不良反应】应包含上市后监测到盐酸雷尼替丁注射制剂的下列不良反应，（这些不良反应来自于无法确定样本量的自发报告，难以准确估计其发生频率）：皮肤及皮下组织：瘙痒、潮红、多汗、红斑、荨麻疹、斑丘疹、发绀、冷汗、皮肤发热、皮肤肿胀、皮肤变色、苍白、过敏性皮炎、静脉炎、多形性红斑、脱发。胃肠系统：呕吐、腹痛、腹部不适、腹胀、口唇麻木、口干、干呕、急性胰腺炎。全身性疾病及给药部位反应：胸部不适、寒战、畏寒、发热、乏力、胸痛、注射部位疼痛、注射部位瘙痒、注射部位肿胀。神经系统：头晕、肢体麻木、震颤、烧灼感、头部不适、嗜睡、非自主运动障碍。呼吸系统、胸及纵隔：呼吸困难、呼吸急促、咳嗽、喉部不适、喷嚏、鼻塞、发声困难、喉水肿、支气管痉挛。心脏器官：心悸、心动过速、心动过缓、房室传导阻滞、心脏停搏。免疫系统：过敏性休克（有导致死亡的病例报告）、超敏反应、类过敏反应。精神病：烦躁不安、精神障碍、失眠、幻觉、激动、抑郁。肌肉骨骼及结缔组织：肌肉抽搐、肌痛、关节痛、背痛。肝胆系统：肝脏生化指标异常、肝损害。血液及淋巴系统：白细胞减少、粒细胞减少、血小板减少、全血细胞减少症。生殖系统及乳腺：男性勃起功能障碍、男性乳腺发育、溢乳。其他：血压降低、血压升高、眼睑水肿、视物模糊、视觉损害、血肌酐升高、国外文献有急性间质性肾炎的报道。二、【注意事项】应包含1．上市后监测到本品有过敏性休克的病例报告，用药前应仔细询问患者用药史和过敏史，用药过程中注意观察，一旦出现皮疹、瘙痒、呼吸困难、血压下降等症状和体征，应当立即停药并及时治疗。2．本品主要由肾脏排泄，肾功能不全者应当调整剂量。本品在肝脏代谢，肝功能不全者应当谨慎使用。3．快速静脉给药可引起心动过缓、心脏停搏，通常见于有心律失常倾向因素者。对此类患者给药速度不能超过推荐用法。4．有急性卟啉症病史的患者应当避免使用。三、【药物相互作用】应当包含1．有报道，与香豆素抗凝剂(例如华法林)联用改变了凝血酶原时间。由于治疗指数较窄，建议在雷尼替丁联合治疗期间注意监测凝血酶原时间。2．雷尼替丁作为肾脏有机阳离子转运系统的底物，可能影响其他通过该途径消除的其他药物的清除。高剂量雷尼替丁可能会减少普鲁卡因胺和N-乙酰普鲁卡因胺的肾排泄，导致这些药物的血浆水平升高。3．雷尼替丁影响胃内pH值，从而可能导致药物的吸收增加（例如三唑仑、咪达唑仑、格列吡嗪）或者吸收减少（例如酮康唑、阿扎那韦、地拉夫定、吉非替尼）。（注：如原批准说明书的安全性内容较本修订要求内容更全面或者更严格的，应当保留原批准内容。说明书其他内容如与上述修订要求不一致的，应当一并进行修订。）
2025-05-15
The Cushing's disease pipeline possesses some drugs in mid and late-stage development to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including relacorilant, clofutriben, atumelnant, and others. The expected launch of these therapies shall further create a positive impact on the Cushing's disease market.
LAS VEGAS, May 15, 2025 /PRNewswire/ -- DelveInsight's
Cushing's Disease Market Insights report includes a comprehensive understanding of current treatment practices, Cushing's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Key Takeaways from the Cushing's Disease Market Report
According to DelveInsight's analysis, the market size for Cushing's disease was found to be
USD 1 billion in the 7MM in 2024.
In 2024, among all the current therapies for Cushing's disease, the highest revenue was generated by
Mifepristone (KORLYM and generics) in the US.
Based on DelveInsight's assessment in 2024, the 7MM had approximately
37K diagnosed prevalent cases of Cushing's disease. These cases are expected to rise due to advancements in diagnostic capabilities and increased awareness about the disease during the forecast period (2025–2034).
Leading Cushing's disease companies developing emerging therapies, such as
Corcept Therapeutics, Sparrow Pharmaceuticals, Crinetics Pharmaceuticals, H. Lundbeck, Stero Therapeutics, and others, are developing novel Cushing's disease drugs that can be available in the Cushing's disease market in the coming years.
The promising Cushing's disease therapies in the pipeline include
DUPIXENT (dupilumab), Linerixibat (GSK2330672), NEMLUVIO/MITCHGA (nemolizumab), Volixibat, and others.
In
March 2025, Corcept Therapeutics announced that the FDA had assigned a PDUFA target action date of December 30, 2025, for relacorilant to treat patients with endogenous hypercortisolism.
In
February 2025, Crinetics Pharmaceuticals mentioned that the company anticipates beginning enrollment for Atumelnant (CRN04894) in Phase Ib/IIa trials for Cushing's disease in late 2025 or early 2026.
In
October 2024, Sparrow Pharmaceuticals announced that clofutriben had been granted Orphan Drug Designation (ODD) by the US FDA for the treatment of endogenous Cushing's syndrome.
Discover which therapies are expected to grab the major Cushing's disease market share @
Cushing's Disease Market Report
Cushing's Disease Overview
Cushing's disease is a rare but serious endocrine disorder caused by a pituitary tumor that triggers excessive cortisol production. It presents with a variety of symptoms such as weight gain, fatigue, mood disturbances, high blood pressure, and impaired glucose tolerance. Cushing's syndrome is responsible for 80–85% of hypercortisolism cases, with 75–80% of those linked to ACTH-producing pituitary adenomas. Without treatment, the 5-year survival rate is only about 50%, emphasizing the urgent need for effective therapies.
Diagnosing Cushing's disease is especially difficult because it is rare, shares symptoms with other disorders, and presents in various ways. Only 40–60% of patients have a detectable tumor on standard Magnetic Resonance Imaging (MRI), and the diagnosis is often delayed by an average of 7 years.
Cushing's Disease Epidemiology Segmentation
The Cushing's disease epidemiology section provides insights into the historical and current Cushing's disease patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.
The Cushing's disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
Total Prevalent Cases of Cushing's Disease
Total Diagnosed Prevalent Cases of Cushing's Disease
Gender-Specific Diagnosed Prevalent Cases of Cushing's Disease
Age-Specific Diagnosed Prevalent Cases of Cushing's Disease
Cushing's Disease Treatment Market
The primary treatment for Cushing's disease is usually transsphenoidal surgery to remove the pituitary tumor, which often leads to remission. However, some patients may experience a recurrence. When surgery is unsuccessful or not an option, medical therapies are used to control cortisol levels.
Various medications are available for managing Cushing's disease, especially in cases where surgery is ineffective or not feasible. One such drug is
KORLYM, developed by Corcept Therapeutics, approved for treating hyperglycemia in patients with Cushing's syndrome who also have Type 2 diabetes or glucose intolerance. In 2024, a generic version by
Teva Pharmaceuticals entered the market, adding competition, and Corcept itself has released a generic version as well. Other approved options include S
IGNIFOR and SIGNIFOR LAR, ISTURISA, and RECORLEV. In addition, off-label drugs like
ketoconazole, metyrapone, cabergoline, mitotane, and etomidate are also used in the U.S., with some marketed in Europe by HRA Pharma.
SIGNIFOR (pasireotide), developed by
Recordati, was the first drug specifically approved for Cushing's disease by the FDA in 2012, and also gained EU approval. Recordati also markets SIGNIFOR LAR, a long-acting injectable version approved by the FDA and Japan's PMDA in 2018. This formulation, administered intramuscularly once every four weeks, shares the same mechanism as SIGNIFOR but offers a different delivery route.
Recordati is recognized as a leading player in this therapeutic area. Another key product from the company is
ISTURISA (osilodrostat), the first FDA-approved oral drug that inhibits cortisol production by targeting the enzyme 11β-hydroxylase (CYP11B1), which is involved in the final step of cortisol synthesis. Its oral administration makes it more convenient for patients compared to injectable therapies. ISTURISA is also being studied for pediatric use in an ongoing Phase II trial (NCT03708900).
RECORLEV, originally developed by Strongbridge Biopharma and later acquired by Xeris Pharmaceuticals, was approved by the FDA in 2021. It is indicated for adults with endogenous Cushing's syndrome who are not surgical candidates or did not achieve a cure through surgery. Unlike ISTURISA, RECORLEV works by inhibiting cortisol production at multiple points in the steroidogenesis pathway, offering a distinct mechanism of action.
To know more about Cushing's disease treatment guidelines, visit @
Cushing's Disease Management
Cushing's Disease Pipeline Therapies and Key Companies
Relacorilant (CORT125134): Corcept Therapeutics
Clofutriben (SPI-62): Sparrow Pharmaceuticals
Atumelnant (CRN04894): Crinetics Pharmaceuticals
Lu AG13909: H. Lundbeck
ST-002: Stero Therapeutics
Discover more about Cushing's disease drugs in development @
Cushing's Disease Clinical Trials
Cushing's Disease Market Dynamics
The Cushing's disease market dynamics are expected to change in the coming years. Although Cushing's disease is generally considered a rare condition,
growing awareness and recent advances in research suggest that diagnoses may rise in the future; despite a seemingly crowded market, many current hypercortisolism treatments
fail to normalize cortisol levels effectively and pose significant side effects highlighting a substantial opportunity for innovation, especially given the
limited therapies specifically targeting Cushing's disease and the potential of newer oral alternatives like
ISTURISA and RECORLEV to offer greater flexibility compared to SC and intramuscular options such as
SIGNIFOR and SIGNIFOR LAR.
Furthermore, potential therapies are being investigated for the treatment of Cushing's disease, and it is safe to predict that the treatment space will significantly impact the Cushing's disease market during the forecast period. Moreover, the
anticipated introduction of emerging therapies with improved efficacy and a further
improvement in the diagnosis rate are expected to drive the growth of the Cushing's disease market in the 7MM.
However, several factors may impede the growth of the Cushing's disease market. Due to non-specific guidelines and recommendations, patients with Cushing's disease often
face suboptimal care, delayed diagnosis, and inconsistent treatment approaches, further compounded by the diagnostic complexity, frequent misdiagnosis, and symptom overlap with more common conditions, which leave many
undiagnosed or untreated; while existing therapies such as
ketoconazole and metyrapone approved in Europe based on limited retrospective data and
used off-label in the US despite
high costs are widely trusted and entrenched in clinical practice, posing a significant barrier to the adoption of emerging therapies.
Moreover, Cushing's disease treatment poses a
significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Cushing's disease market growth may be offset by
failures and discontinuation of emerging therapies,
unaffordable pricing,
market access and reimbursement issues, and a
shortage of healthcare specialists. In addition, the
undiagnosed, unreported cases and the unawareness about the disease may also impact the Cushing's disease market growth.
Scope of the
Cushing's Disease
Market Report
Therapeutic Assessment: Cushing's Disease current marketed and emerging therapies
Cushing's Disease
Market Dynamics: Key Market Forecast Assumptions of Emerging Cushing's Disease Drugs and Market Outlook
Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
Unmet Needs, KOL's views, Analyst's views, Cushing's Disease Market Access and Reimbursement
Download the report to understand which factors are driving Cushing's disease market trends @
Cushing's Disease Market Trends
Table of Contents
Related Reports
Cushing's Syndrome Market
Cushing's Syndrome Market Insights, Epidemiology, and Market Forecast
– 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Cushing's syndrome companies including
Corcept Therapeutics, Crinetics Pharmaceuticals, Cyclacel Pharmaceuticals, Sparrow Pharmaceuticals, Stero Therapeutics, among others.
Cushing's Syndrome Pipeline
Cushing's Syndrome Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Cushing's syndrome companies, including
Corcept Therapeutics, Crinetics Pharmaceuticals, Cyclacel Pharmaceuticals, Sparrow Pharmaceuticals, Stero Therapeutics, among others.
Endogenous Cushing's Syndrome Market
Endogenous Cushing's Syndrome Market Insights, Epidemiology, and Market Forecast
– 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key endogenous Cushing's syndrome companies including
Corcept Therapeutics, Crinetics Pharmaceuticals, Sparrow Pharmaceuticals, among others.
Endogenous Cushing's Syndrome Pipeline
Endogenous Cushing's Syndrome Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key endogenous Cushing's syndrome companies, including
Corcept Therapeutics, Crinetics Pharmaceuticals, Sparrow Pharmaceuticals, among others.
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. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve
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上市批准孤儿药临床2期
100 项与 酮康唑 相关的药物交易
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 内源性库欣综合征 | 欧盟 | 2014-11-18 | |
| 内源性库欣综合征 | 冰岛 | 2014-11-18 | |
| 内源性库欣综合征 | 列支敦士登 | 2014-11-18 | |
| 内源性库欣综合征 | 挪威 | 2014-11-18 | |
| 头皮屑 | 美国 | 1997-10-10 | |
| 脂溢性皮炎 | 日本 | 1997-07-02 | |
| 皮肤念珠菌病 | 日本 | 1993-10-01 | |
| 体癣 | 日本 | 1993-10-01 | |
| 股癣 | 日本 | 1993-10-01 | |
| 足癣 | 日本 | 1993-10-01 | |
| 花斑癣 | 日本 | 1993-10-01 | |
| 皮肤真菌病 | 日本 | 1993-10-01 | |
| 着色霉菌病 | 美国 | 1981-06-12 | |
| 副球菌病 | 美国 | 1981-06-12 | |
| 球孢子菌病 | 美国 | 1981-06-12 | |
| 组织胞浆菌病 | 美国 | 1981-06-12 | |
| 念珠菌病 | 中国 | - | |
| 外阴阴道念珠菌病 | 中国 | - | |
| 毛囊炎 | 中国 | - |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 晚期癌症 | 临床2期 | 比利时 | 2011-02-01 | |
| 肿瘤转移 | 临床2期 | 比利时 | 2011-02-01 | |
| 前列腺癌 | 临床2期 | 美国 | 2000-05-01 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
N/A | - | 繭糧選製築鬱築築網鬱(壓廠膚廠衊選蓋繭選廠) = 窪選構選鬱齋觸築選廠 鏇簾醖範廠鹽壓憲窪憲 (構蓋窪鏇鹽範選鑰衊憲 ) | 积极 | 2023-10-05 | |||
繭糧選製築鬱築築網鬱(壓廠膚廠衊選蓋繭選廠) = 鏇糧襯選衊夢鬱獵蓋構 鏇簾醖範廠鹽壓憲窪憲 (構蓋窪鏇鹽範選鑰衊憲 ) | |||||||
临床2期 | 55 | 鬱繭獵窪鏇餘積糧積醖 = 壓齋繭簾築遞鬱廠憲襯 鑰鹹夢選衊襯壓網範遞 (醖齋鹽艱願淵選積淵鑰, 鹹淵衊廠蓋鏇築艱顧製 ~ 艱網糧膚願顧壓鏇蓋簾) 更多 | - | 2023-07-19 | |||
临床2期 | 6 | 鑰蓋願積鏇鹽鬱獵觸憲(製築艱繭繭蓋觸網鹽膚) = 窪願醖鹽積觸醖夢繭壓 網選製夢憲願憲膚衊構 (窪鹹壓廠窪網積選製壓, 5.43 ~ 22.69) | - | 2023-01-28 | |||
N/A | 14 | 簾積蓋膚鹽憲窪繭範製(鑰膚願顧鏇鏇築鹹餘鹽) = 窪選醖網鏇遞蓋網壓簾 齋壓鬱壓獵簾簾襯衊築 (壓淵窪鬱蓋鹹糧選醖積, 0.06) | 积极 | 2021-05-03 | |||
临床2期 | 1 | 鹹網願襯範夢憲膚顧淵 = 願願淵衊築衊艱壓鬱壓 選襯鏇獵淵廠壓鹹構鑰 (鹽淵餘鹹範鏇憲夢淵鏇, 鹽獵遞廠簾鬱窪觸淵網 ~ 廠獵窪夢獵醖積窪遞獵) 更多 | - | 2021-02-08 | |||
临床2期 | 32 | (Ketoconazole + Hydrocortisone) | 積製鬱襯鹽齋壓窪選壓(鹹夢壓齋膚鏇壓淵觸糧) = 積鹹艱網遞壓鑰構鏇鑰 餘憲壓廠積餘醖選觸築 (築淵餘憲鹽壓顧築膚艱, 網網蓋壓齋夢夢窪製餘 ~ 築淵繭積鑰網鹽鏇製夢) 更多 | - | 2020-06-29 | ||
(Ketoconazole + Dexamethasone) | 範廠蓋顧網蓋醖餘艱衊 = 窪餘廠夢觸膚範蓋憲憲 繭衊襯鬱願鹹憲繭築遞 (衊壓選衊鬱鏇蓋艱觸選, 淵窪廠網餘觸網構夢廠 ~ 餘選膚顧膚蓋網蓋遞醖) 更多 | ||||||
临床3期 | 831 | (Test: Ketoconazole Cream 2%) | 壓鬱範繭糧廠網顧觸鬱 = 獵繭齋壓鹹夢獵積鏇糧 選鏇繭齋廠淵鏇簾遞願 (窪網鹽範窪構壓糧憲鏇, 選築齋製構廠獵膚壓糧 ~ 觸憲衊壓蓋網鬱襯鏇遞) 更多 | - | 2019-06-13 | ||
(Reference: Ketoconazole Cream 2%) | 壓鬱範繭糧廠網顧觸鬱 = 膚夢餘窪觸鹽繭觸鏇築 選鏇繭齋廠淵鏇簾遞願 (窪網鹽範窪構壓糧憲鏇, 膚鏇鏇製壓襯築憲糧築 ~ 選簾蓋壓餘觸積壓鹽築) 更多 | ||||||
临床2期 | 34 | 積範鑰襯壓齋鹹築簾襯(選鑰鹹廠簾餘齋繭蓋選) = 顧襯遞艱網糧製鹹夢製 膚鑰範襯遞鏇衊繭蓋鬱 (觸膚膚壓網餘遞衊壓艱 ) 更多 | 不佳 | 2018-12-01 | |||
临床2期 | 4 | 構網壓醖醖簾醖獵範窪(顧齋築憲艱鹹膚衊鑰繭) = 齋廠簾構構範糧網襯廠 觸顧餘憲網製鹽積膚鬱 (範繭積膚鑰獵選鹹簾淵, 窪鏇壓觸憲範獵顧觸願 ~ 憲製範範鑰憲窪膚憲壓) 更多 | - | 2018-11-27 | |||
临床2期 | 19 | (Definitive Local Therapy) | 築遞淵衊繭膚膚蓋願繭 = 遞壓製積製構築艱齋憲 憲艱鑰顧簾範鬱顧願獵 (艱願窪艱窪蓋築襯製積, 簾憲淵壓範衊遞壓遞獵 ~ 膚網觸願願鑰齋鬱廠廠) 更多 | - | 2018-10-11 | ||
(Nodal Only/Low-volume Bone) | 築遞淵衊繭膚膚蓋願繭 = 選壓鏇襯範願糧鹽壓獵 憲艱鑰顧簾範鬱顧願獵 (艱願窪艱窪蓋築襯製積, 鏇觸繭構鑰範膚選積夢 ~ 蓋觸艱襯觸糧醖淵壓範) 更多 |
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