A Phase 1 Randomized, Open-Label, Two-Period,Two-Sequence Crossover Study to Evaluate the Relative Oral Bioavailability of Levoketoconazole and Ketoconazole Tablets in Healthy Subjects

This is a phase 1, randomized, open-label, single-dose, two-period, two-sequence crossover study in healthy male and female subjects to evaluate the relative oral bioavailability of levoketoconazole tablets (the test drug) and ketoconazole tablets (the reference drug product).

开始日期2019-12-16

申办/合作机构

Cortendo AB

NCT03880825 / Completed临床1期

A Phase I Open-Label, Fixed-Sequence Pharmacokinetic Drug Interaction Study to Evaluate the Effect of Levoketoconazole on the Single-Dose Pharmacokinetics of Metformin in Healthy Subjects

This is a phase I, open-label, fixed-sequence drug-drug interaction study to evaluate the effect of levoketoconazole on the single-dose PK of metformin in health subjects.

开始日期2019-03-28

申办/合作机构

Cortendo AB

NCT03621280 / Completed临床3期

An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome

This is a long-term, open-label extension study of levoketoconazole in subjects with endogenous Cushing's Syndrome.

开始日期2019-01-07

申办/合作机构

Cortendo AB

100 项与左旋酮康唑相关的临床结果

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100 项与左旋酮康唑相关的转化医学

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100 项与左旋酮康唑相关的专利（医药）

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项与左旋酮康唑相关的文献（医药）

2023-05-30·Foods (Basel, Switzerland)

Degradation Dynamics and Residue Analysis of Four Propiconazole Stereoisomers in "Fengtang" Plum during Storage by LC-MS/MS.

Article

作者: Deng, Pengyu ; Zhang, Yuping ; Hu, Deyu ; Ou, Guipeng ; Luo, Xin ; Mou, Lianhong

Herein, an accurate and sensitive method was developed for detecting four stereoisomers of propiconazole in "Fengtang" plum by LC-MS/MS. The mean recovery of four propiconazole stereoisomers ranged from 79.42 to 104.10% at three adding levels with reasonable RSD of 1.54-11.68%, and the LOD and LOQ of the four stereoisomers was 0.0005 mg/kg and 0.004 mg/kg, respectively. In addition, the residue and selective degradation of propiconazole stereoisomers in plums were investigated by storage at 20 °C and 4 °C. The half-lives of propiconazole stereoisomeric during storage were 9.49-15.40 d at 20 °C, and 21.00-28.88 d at 4 °C. The degradation of (2R,4R)-propiconazole and (2R,4S)-propiconazole in stored plums was slightly slower than that of the corresponding enantiomers (2S,4S)-propiconazole and (2S,4R)-propiconazole. The total residues of propiconazole were 0.026-0.487 mg/kg in the plum storage period, and the water washing could remove 49.35% to 54.65% of the propiconazole residue in plum. The hardness of plums treated with propiconazole was generally higher than that of control in the middle and late stages of storage. The effects of propiconazole on the total soluble solid content of plums were different at 20 °C and 4 °C. This study provides a scientific reference for the food safety evaluation of the "Fengtang" plum after the application of propiconazole during the storage period.

2022-12-01·Best Practice & Research Clinical Endocrinology & Metabolism

How best to monitor the specific side effects of medical treatments of Cushing’s disease

Review

作者: Castinetti, Frederic

The first-line treatment of Cushing's disease is transsphenoidal surgery. Medical treatment of Cushing's disease can be considered in several situations: as a presurgical treatment in patients with severe comorbidities, when surgery fails, or while waiting for the maximal efficacy of radiation techniques. Several modalities of medical treatment are possible, from adrenal-targeting drugs (steroidogenesis inhibitors) to pituitary-targeting drugs (somatostatin receptor ligand pasireotide or the dopamine agonist cabergoline), or even drugs that antagonize the glucocorticoid receptor (mifepristone). Given the morbidities associated with hypercortisolism, and the fact that medical treatment can be delivered on a long-term basis, it is important to obtain eucortisolism and to monitor the drug effectively. The efficacy of these drugs will not be detailed in this review, nor their roles in the therapeutic algorithm of Cushing's disease. This review will rather focus specifically on adverse events associated with these drugs (ketoconazole, levoketoconazole, metyrapone, osilodrostat, pasireotide, cabergoline and mifepristone), and the way in which to monitor and treat them, based on retrospective studies and the most recently published prospective studies.

2022-12-01·Pituitary

Levoketoconazole in the treatment of patients with endogenous Cushing’s syndrome: a double-blind, placebo-controlled, randomized withdrawal study (LOGICS)

Article

作者: Zacharieva, Sabina ; Tóth, Miklós ; Georgescu, Carmen Emanuela ; Cohen, Fredric ; Shimon, Ilan ; Badiu, Corin ; Fleseriu, Maria ; Brue, Thierry ; Elenkova, Atanaska ; Pivonello, Rosario ; Tsagarakis, Stylianos ; Stigliano, Antonio

Abstract:

Purpose:

The efficacy of levoketoconazole for endogenous Cushing’s syndrome was demonstrated in a phase 3, open-label study (SONICS). This study (LOGICS) evaluated drug-specificity of cortisol normalization.

Methods:

LOGICS was a phase 3, placebo-controlled, randomized-withdrawal study with open-label titration-maintenance (14–19 weeks) followed by double-blind, randomized-withdrawal (~ 8 weeks), and restoration (~ 8 weeks) phases.

Results:

79 patients received levoketoconazole during titration-maintenance; 39 patients on a stable dose (~ 4 weeks or more) proceeded to randomization. These and 5 SONICS completers who did not require dose titration were randomized to levoketoconazole (n = 22) or placebo (n = 22). All patients with loss of response (the primary endpoint) met the prespecified criterion of mean urinary free cortisol (mUFC) > 1.5 × upper limit of normal. During randomized-withdrawal, 21 patients withdrawn to placebo (95.5%) lost mUFC response compared with 9 patients continuing levoketoconazole (40.9%); treatment difference: − 54.5% (95% CI − 75.7, − 27.4; P = 0.0002). At the end of randomized-withdrawal, mUFC normalization was observed among 11 (50.0%) patients receiving levoketoconazole and 1 (4.5%) receiving placebo; treatment difference: 45.5% (95% CI 19.2, 67.9; P = 0.0015). Restoration of levoketoconazole reversed loss of cortisol control in most patients who had received placebo. Adverse events were reported in 89% of patients during treatment with levoketoconazole (dose-titration, randomized-withdrawal, and restoration phases combined), most commonly nausea (29%) and hypokalemia (26%). Prespecified adverse events of special interest with levoketoconazole were liver-related (10.7%), QT interval prolongation (10.7%), and adrenal insufficiency (9.5%).

Conclusions:

Levoketoconazole reversibly normalized urinary cortisol in patients with Cushing’s syndrome. No new risks of levoketoconazole treatment were identified.

项与左旋酮康唑相关的新闻（医药）

2024-04-03

·BioSpace

Xeris Pharmaceuticals Announces Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) - April 03, 2024

CHICAGO--(BUSINESS WIRE)-- Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that on April 1, 2024, the Compensation Committee of Xeris’ Board of Directors granted restricted stock units for an aggregate of 103,000 shares of its common stock to 18 new employee(s) under Xeris’ Inducement Equity Plan. Xeris’ Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously employed by Xeris or one of its subsidiaries as an inducement material to such individual's entering into employment with Xeris or one of its subsidiaries, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules. The restricted stock units will vest over a period of three years in equal annual installments, and are subject to the employees’ continued employment with Xeris or one of its subsidiaries. All equity awards are subject to the terms and conditions of Xeris’ Inducement Equity Plan and forms of award agreements covering the grants. About Xeris Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, a proven therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect®, supporting long-term product development and commercial success. Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit , or follow us on X, LinkedIn, or Instagram. View source version on businesswire.com: Contacts Investor Contact Allison Wey Senior Vice President, Investor Relations and Corporate Communications awey@xerispharma.com Source: Xeris Biopharma Holdings, Inc. View this news release online at:

2024-04-02

·BioSpace

Xeris Biopharma to Participate in the 23rd Annual Needham Virtual Healthcare Conference

CHICAGO--(BUSINESS WIRE)-- Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies, today announced that Paul R. Edick, Xeris’ Chairman and CEO, will present an overview of the Company at the 23rd Annual Needham Virtual Healthcare Conference on Tuesday, April 9, 2024 at 11:00 am Eastern Time. To access the presentation, please visit “Events” on the investor relations page of the Company’s website at . About Xeris Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, a proven therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect®, supporting long-term product development and commercial success. Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit , or follow us on X, LinkedIn, or Instagram. View source version on businesswire.com: Contacts Investor Contact Allison Wey Senior Vice President, Investor Relations and Corporate Communications awey@xerispharma.com Source: Xeris Biopharma Holdings, Inc. View this news release online at:

2024-02-28

·BioSpace

Xeris Biopharma to Report Fourth Quarter and Full Year 2023 Financial Results on March 6, 2024

CHICAGO--(BUSINESS WIRE)-- Xeris Biopharma, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies, today announced that the Company will release its fourth quarter and full year 2023 financial results before the open of the U.S. financial markets on Wednesday, March 6, 2024. Management will host a conference call and webcast at 8:30 a.m. Eastern Time that day to discuss the Company’s financial and operational results and provide full-year 2024 guidance. To pre-register for the conference call please use this link: Registration Link: . After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until Wednesday, March 20, 2024, at US: 1 929 458 6194, US Toll Free: 1 866 813 9403, UK: 0204 525 0658, Canada: 1 226 828 7578, or all other locations: +44 204 525 0658 Access Code 671547. In addition, a live audio of the conference call will be available as a webcast. To join the webcast, please visit “Events” on investor relations page of the Company’s website at . About Xeris Biopharma Holdings, Inc. Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, a proven therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect®, supporting long-term product development and commercial success. Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit , or follow us on X, LinkedIn or Instagram.

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100 项与左旋酮康唑相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10950	-	-	DB05667

研发状态

适应症	最高研发状态	国家/地区	公司
内源性库欣综合征	批准上市	美国更多	Strongbridge Ireland Ltd. 更多
2型糖尿病	终止	新西兰更多	DiObex, Inc. 更多
库欣综合征	无进展	塞尔维亚更多	Cortendo AB 更多

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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


Corporate Publications 人工标引	临床3期	库欣综合征	79	Levoketoconazole	衊窪範鹽膚壓願製顧糧(繭憲鏇蓋構願簾鹹廠顧) = 憲齋蓋餘膚範襯淵窪憲艱艱網夢蓋淵廠獵衊蓋 (選顧積築網顧蓋壓夢衊 ) 更多	积极	2022-05-12
				Placebo	衊窪範鹽膚壓願製顧糧(繭憲鏇蓋構願簾鹹廠顧) = 衊膚鬱選鑰鑰衊膚積糧艱艱網夢蓋淵廠獵衊蓋 (選顧積築網顧蓋壓夢衊 ) 更多
NCT01838551 (CTgov)	临床3期	内源性库欣综合征	94	Levoketoconazole	範蓋積願窪範餘蓋繭糧(艱餘廠願網簾鏇蓋遞壓) = 夢窪壓遞獵膚選獵簾簾網醖繭醖憲襯鏇膚廠鹽 (艱憲壓廠醖獵壓醖範選, 壓鏇襯膚齋壓繭衊築積 ~ 膚鹽廠積艱淵窪膚餘繭) 更多	-	2021-04-19
NCT01838551 (SONICS, Pubmed \| Front Endocrinol (Lausanne))	临床3期	糖尿病 \| 库欣综合征	94	Levoketoconazole (Patients with DM)	蓋願遞餘衊齋鹽積鏇鏇(鏇夢襯糧製積齋蓋選齋): P-Value = 0.0006 更多	-	2021-01-01
				Levoketoconazole (Patients without DM)
NCT03277690 (LOGICS, Biospace) 人工标引	临床3期	内源性库欣综合征	44	RECORLEV	積鑰襯淵觸鬱餘膚窪憲(膚網餘積窪繭範積鑰餘) = 獵顧遞餘鹽醖製窪廠衊顧壓繭窪觸衊積廠夢鑰 (範選製繭衊糧衊襯構憲 ) 更多	积极	2020-09-08
				placebo	積鑰襯淵觸鬱餘膚窪憲(膚網餘積窪繭範積鑰餘) = 艱積壓構觸襯夢遞窪築顧壓繭窪觸衊積廠夢鑰 (範選製繭衊糧衊襯構憲 ) 更多