Dissecting the Contribution of glucocorticoid metabolism in Mild Autonomous Cortisol Secretion: a randomised controlled trial of the 11ß-HSD1 inhibitor SPI-62

开始日期2024-03-04

申办/合作机构

University of Oxford

NCT06281236

/ Suspended临床1期

A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR)

This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited.

开始日期2024-02-22

申办/合作机构

Sparrow Pharmaceuticals, Inc.

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项与克洛曲本相关的文献（医药）

2024-07-28·Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences

Advances in pharmacological treatment of Cushing's disease.

Review

作者: Liu, Yuke ; Chai, Jinbao ; Tan, Huiwen ; Tang, Yu ; Li, Jianwei

Cushing's disease is a rare endocrine disorder characterized by hypercortisolism. Chronic elevated cortisol levels can lead to dysfunction or complications in multiple organs of systems, including cardiovascular, glucose, and bone metabolism, severely impacting patients' quality of life and posing life-threatening risks. Surgery is the first-line treatment for Cushing's disease. However, in cases of delayed diagnosis, surgical contraindications, or suboptimal surgical outcomes, pharmacological therapy is often required. Currently, three categories of medications are commonly used: 1) Drugs targeting somatostatin and/or dopamine receptors to inhibit pituitary adrenocorticotropic hormone (ACTH) synthesis (e.g., pasireotide, cabergoline); 2) drugs targeting adrenal cortex-related receptors to suppress steroid synthesis (e.g., ketoconazole, metyrapone, mitotane, and osilodrostat); 3) drugs acting on glucocorticoid receptors (e.g., mifepristone). Research on pharmacological treatments for Cushing's disease is ongoing, with new drugs such as seliciclib, CRN04894, fimepinostat, vorinostat, and SPI-62 currently in phase II clinical trial. The development of novel drugs holds promise for more precise and effective treatment for Cushing's disease patients.

2024-07-02·EXPERT OPINION ON INVESTIGATIONAL DRUGS

Investigational agents for polymyalgia rheumatica treatment: assessing the critical needs for future development

Review

作者: Padoan, Roberto ; Iorio, Luca ; Bond, Milena ; Dejaco, Christian

INTRODUCTION:

Polymyalgia rheumatica (PMR) is an inflammatory rheumatic disorder characterized by pain and stiffness in the shoulder and pelvic girdles, constitutional symptoms, and elevated acute-phase reactants. Glucocorticoids (GCs) remain the first-choice treatment for PMR, but relapses are common. Identification of steroid-sparing agents is therefore of utmost importance.

AREAS COVERED:

The efficacy of conventional immunosuppressive drugs is controversial. The use of interleukin (IL)-6 receptor inhibitors proved to be effective and safe in treating PMR patients. Currently, there are 12 ongoing clinical trials exploring potential treatments such as leflunomide, low-dose IL-2, rituximab, abatacept, secukinumab, Janus kinase inhibitors, and selective inhibitors like SPI-62 and ABBV 154.

EXPERT OPINION:

The high efficacy of IL-6 R receptor inhibitors as well as the numerous drug trials currently recruiting suggest that several therapeutic options will be available in the near future. Accurate diagnosis and early stratification of PMR patients according to the giant cell arteritis-PMR Spectrum Disease 'GPSD' and potential risk factors for relapsing disease or GC-related adverse events are crucial to identify patients who would benefit most from GC-sparing agents. The development of internationally accepted definitions for remission and relapse is urgently needed. Early referral strategies to specialist settings would improve disease stratification and personalized treatment.

2023-09-01·CLINICAL PHARMACOKINETICS

Population Target-Mediated Pharmacokinetic/Pharmacodynamic Modeling to Evaluate SPI-62 Exposure and Hepatic 11β-Hydroxysteroid Dehydrogenase Type 1 (HSD-1) Inhibition in Healthy Adults

Article

作者: Wu, Nan ; An, Guohua ; Katz, David A ; Katz, David A.

INTRODUCTION:

SPI-62 is a small-molecule 11β-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor exhibiting complicated nonlinear pharmacokinetics (PK) in human. Previously, we developed a target-mediated drug disposition (TMDD) model to characterize the substantial nonlinear PK of SPI-62.

OBJECTIVE:

The aim of the current analysis was to perform population PK/PD analysis to further link SPI-62 exposure (i.e., PK) with its response (i.e., inhibition of hepatic HSD-1 activity) to gain a quantitative understanding of the SPI-62 dose-exposure-response relationship.

METHODS:

PK and PD data from the first-in-human (FIH) clinical trials, including single ascending dose (SAD) and multiple ascending dose (MAD) studies, were used for model development. During the model development process, the final model selection was based on biological and physiological plausibility, goodness-of-fit plots, stability of parameter estimates, and objective function value. The nonlinear-mixed effect modeling (NONMEM) software was used for both the implementation of the PK/PD model and model simulation. SPI-62 plasma levels and hepatic HSD-1 inhibition over time following various dose regimens were simulated.

RESULTS:

The final model was a two-compartment TMDD model component for SPI-62 and an inhibitory I_max model component for hepatic HSD-1 activity. The TMDD-hepatic PD model that we established adequately characterized all remarkable PK and PD behaviors of SPI-62, such as extremely low plasma exposures following the first low doses, nonlinear PK turned into linear PK after repeated low doses, and substantial and long-lasting hepatic HSD-1 inhibition following low doses. SPI-62 was estimated to bind to the target with a second-order association rate constant (K_on) of 8.43 nM^-1 h^-1 and first-order dissociation rate constant (K_off) value of 0.229 h^-1, indicating that SPI-62 binds rapidly to, and dissociates slowly from, its pharmacological target. The estimated target capacity (R_tot) of 5460 nmol corresponds to approximately 2.2 mg of SPI-62, which comports well with the dose range in which PK nonlinearity is prominent. Model simulation results reveal that a 6 mg once-daily regimen can lead to long-lasting and substantial hepatic HSD-1 inhibition.

CONCLUSIONS:

A population TMDD-PD model that explains SPI-62 nonlinear PK and hepatic HSD-1 inhibition following different dose regimens in healthy adults was successfully established. Our simulation results provide a solid foundation for model-informed development of SPI-62.

项与克洛曲本相关的新闻（医药）

2025-05-15

·PRNewswire

Cushing's Disease Market Poised for Significant Growth Across the 7MM During the Study Period (2020-2034) with Rising Awareness and Diagnostic Improvements | DelveInsight

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 . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准孤儿药临床2期

2024-12-11

·Business Wire

Sparrow Pharmaceuticals Collaborates with the University of Oxford and the University of Sheffield on DC-MACS, a Phase 2 Clinical Study of Clofutriben

PORTLAND, Ore.--( BUSINESS WIRE )-- Sparrow Pharmaceuticals, an emerging, clinical-stage biopharmaceutical company developing novel, targeted therapies to address unmet needs in both immunology and endocrinology, is collaborating with the University of Oxford and the University of Sheffield on DC-MACS, an investigator led, Phase 2 clinical study in the United Kingdom of clofutriben (SPI-62) for the treatment of autonomous cortisol secretion (ACS). ACS is a prevalent and serious condition caused by the overproduction of cortisol from a benign tumor of the adrenal gland. This study is being conducted with funding from the UK Research and Innovation Medical Research Council. Sparrow is supplying its lead product, clofutriben, and placebo. The study will be led by two distinguished researchers in the endocrinology field: University of Oxford Prof. Jeremy Tomlinson, PhD, a pioneering HSD-1 researcher who first described a patient with a Cushing’s tumor but no signs or symptoms of Cushing’s syndrome because of HSD-1 deficiency, and University of Sheffield Prof. John Newell-Price, PhD, the current President of the Endocrine Society. Professor Tomlinson is supported by the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Centre, and the study will be conducted jointly in the NIHR supported clinical research facilities in both Oxford and Sheffield. “In partnering with Sparrow for the DC-MACS trial, we hope to pioneer a completely novel intervention for this common, yet serious disease,” said Prof. Jeremy Tomlinson, PhD, University of Oxford. “If successful, this trial could provide patients with ACS with a treatment that could transform their health and quality of life.” “ACS today usually goes undiagnosed,” commented Prof. John Newell-Price, PhD, University of Sheffield. “This leaves many patients at risk of morbidity from their hypercortisolism, including cardiovascular disease and bone fractures, and even a higher risk of death. Hopefully, we can not only demonstrate a new potential treatment, but also raise awareness of this dangerous disease.” The objectives of the randomized, double-blind, placebo-controlled study are to evaluate the efficacy, safety, and pharmacological effects of clofutriben, a novel, highly potent, and selective HSD-1 inhibitor, for treating ACS. HSD-1, an intracellular enzyme, activates cortisol in target tissues in which cortisol excess is associated with morbidity including liver, adipose, muscle, and brain. This study will also evaluate endocrine markers such as insulin sensitivity, glucose disposal, and triglycerides during a hyperinsulinemic-euglycemic clamp, nighttime blood pressure, and bone biomarkers (osteocalcin, P1NP, CTX). Forty patients across 2 sites (Sheffield Teaching Hospitals NHS Foundation Trust and Oxford University Hospitals NHS Foundation Trust) will take part in the study. “Clofutriben substantially lowers intracellular cortisol, which can bind intracellular receptors and thereby cause the morbidity associated with ACS,” added David Katz, PhD, Chief Scientific Officer of Sparrow. “Clofutriben has potential to be the first targeted therapy for that common, serious, and currently underrecognized disease.” For more information about Sparrow Pharmaceuticals, visit the website at www.SparrowPharma.com . About Autonomous Cortisol Secretion Autonomous cortisol secretion (ACS) is caused by the overproduction of cortisol from a tumor of the adrenal gland. As patients with ACS lack the outward clinical features of Cushing’s, and their symptoms present as common, chronic conditions, it is often not diagnosed. Most patients with ACS are diagnosed when the tumor shows up on a scan for an unrelated health condition and the patient subsequently receives an adequate endocrine workup. As that occurs infrequently, patients with ACS are potentially exposed to excess circulating cortisol for long periods of time, leading them to face major health complications, significant healthcare costs, and increased risk of early death. The signs and symptoms of ACS include a wide range of mental and physical effects including diabetes, hypertension, bone fractures, and weight gain, as well as mood, cognition, and sleep disorders. There is currently no established drug treatment for this condition, and current practice (advocated by recent European guidelines) involves monitoring (for the development of complications), but not active treatment. About Sparrow Pharmaceuticals Sparrow Pharmaceuticals was founded to spare patients the ravages of steroids. Leveraging underappreciated scientific insights into glucocorticoid biology, the company is working to provide better treatment options for serious disorders of hypercortisolism, and to revolutionize the treatment of autoimmune and inflammatory conditions. Its lead product, clofutriben, is an oral, small molecule, novel therapeutic treatment designed to target the source of active intracellular glucocorticoids in key tissues.

临床2期

2024-12-11

·sparrowpharma.com

Sparrow Pharmaceuticals Collaborates with the University of Oxford and the University of Sheffield on DC-MACS, a Phase 2 Clinical Study of Clofutriben for Autonomous Cortisol Secretion

Portland, Oregon, December 11, 2024 — Sparrow Pharmaceuticals an emerging, clinical-stage biopharmaceutical company developing novel, targeted therapies to address unmet needs in both immunology and endocrinology, is collaborating with the University of Oxford and the University of Sheffield on DC-MACS, an investigator led, Phase 2 clinical study in the United Kingdom of clofutriben (SPI-62) for the treatment of autonomous cortisol secretion (ACS). ACS is a prevalent and serious condition caused by the overproduction of cortisol from a benign tumor of the adrenal gland. This study is being conducted with funding from the UK Research and Innovation Medical Research Council. Sparrow is supplying its lead product, clofutriben, and placebo. The study will be led by two distinguished researchers in the endocrinology field: University of Oxford Prof. Jeremy Tomlinson, PhD, a pioneering HSD-1 researcher who first described a patient with a Cushing’s tumor but no signs or symptoms of Cushing’s syndrome because of HSD-1 deficiency, and University of Sheffield Prof. John Newell-Price, PhD, the current President of the Endocrine Society. Professor Tomlinson is supported by the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Centre, and the study will be conducted jointly in the NIHR supported clinical research facilities in both Oxford and Sheffield. “In partnering with Sparrow for the DC-MACS trial, we hope to pioneer a completely novel intervention for this common, yet serious disease,” said Prof. Jeremy Tomlinson, PhD, University of Oxford. “If successful, this trial could provide patients with ACS with a treatment that could transform their health and quality of life.” “ACS today usually goes undiagnosed,” commented Prof. John Newell-Price, PhD, University of Sheffield. “This leaves many patients at risk of morbidity from their hypercortisolism, including cardiovascular disease and bone fractures, and even a higher risk of death. Hopefully, we can not only demonstrate a new potential treatment, but also raise awareness of this dangerous disease.” The objectives of the randomized, double-blind, placebo-controlled study are to evaluate the efficacy, safety, and pharmacological effects of clofutriben, a novel, highly potent, and selective HSD-1 inhibitor, for treating ACS. HSD-1, an intracellular enzyme, activates cortisol in target tissues in which cortisol excess is associated with morbidity including liver, adipose, muscle, and brain. This study will also evaluate endocrine markers such as insulin sensitivity, glucose disposal, and triglycerides during a hyperinsulinemic-euglycemic clamp, nighttime blood pressure, and bone biomarkers (osteocalcin, P1NP, CTX). Forty patients across 2 sites (Sheffield Teaching Hospitals NHS Foundation Trust and Oxford University Hospitals NHS Foundation Trust) will take part in the study. “Clofutriben substantially lowers intracellular cortisol, which can bind intracellular receptors and thereby cause the morbidity associated with ACS,” added David Katz, PhD, Chief Scientific Officer of Sparrow. “Clofutriben has potential to be the first targeted therapy for that common, serious, and currently underrecognized disease.”

临床2期

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适应症	最高研发状态	国家/地区	公司	日期
Acrocallosal综合征	临床2期	美国	Sparrow Pharmaceuticals, Inc.	2023-07-01
Acrocallosal综合征	临床2期	罗马尼亚	Sparrow Pharmaceuticals, Inc.	2023-07-01
Acrocallosal综合征	临床2期	英国	Sparrow Pharmaceuticals, Inc.	2023-07-01
ACTH非依赖性大结节样肾上腺增生症	临床2期	美国	Sparrow Pharmaceuticals, Inc.	2023-07-01
ACTH非依赖性大结节样肾上腺增生症	临床2期	罗马尼亚	Sparrow Pharmaceuticals, Inc.	2023-07-01
ACTH非依赖性大结节样肾上腺增生症	临床2期	英国	Sparrow Pharmaceuticals, Inc.	2023-07-01
肾上腺皮质腺瘤	临床2期	美国	Sparrow Pharmaceuticals, Inc.	2023-07-01
肾上腺皮质腺瘤	临床2期	罗马尼亚	Sparrow Pharmaceuticals, Inc.	2023-07-01
肾上腺皮质腺瘤	临床2期	英国	Sparrow Pharmaceuticals, Inc.	2023-07-01
库欣综合征	临床2期	美国	Sparrow Pharmaceuticals, Inc.	2022-09-01

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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


NCT05436652 (BusinessWire) 人工标引	临床2期	风湿性多肌痛	40	SPI-62/prednisolone	鹽衊艱膚鹹鹽夢鏇糧遞(選選憲淵構鬱鬱遞願壓) = A combination of prednisolone 20 mg with clofutriben showed similar efficacy as prednisolone 10 mg with placebo, based on analysis of participants’ symptoms, physical function, and biomarkers of inflammation. 蓋築簾繭製顧鏇鏇艱觸 (願鏇觸觸廠獵憲糧襯膚 ) 更多	积极	2024-09-19
				SPI-62 + placebo
BusinessWire 人工标引	临床2期	风湿性多肌痛	-	Prednisolone 10mg + clofutriben 6mg	夢鬱艱淵夢獵觸淵築醖(顧構艱獵襯衊膚願壓糧) = Prednisolone 10mg combined with clofutriben 6mg demonstrated less efficacy compared to prednisolone 10mg administered with placebo, Prednisolone 20mg combined with clofutriben 6mg demonstrated similar efficacy as determined by symptoms, physical function, and systemic inflammation, 積繭願艱憲鹽網艱艱夢 (構遞壓齋製觸膚壓鏇衊 ) 更多	积极	2024-06-15
				Prednisolone 20mg + clofutriben 6mg