KD-027(KD-027) - 药物靶点：PDE5A_专利_临床

概要

基本信息

药物类型

小分子化药

别名

+ [1]

靶点

PDE5A

作用机制

PDE5A抑制剂(磷酸二酯酶-5A抑制剂)

治疗领域

心血管疾病泌尿生殖系统疾病

在研适应症-

非在研适应症

勃起功能障碍高血压雷诺病

原研机构

Nano Terra, Inc.

在研机构-

非在研机构

Response Pharmaceuticals, Inc.Kadmon Holdings, Inc.

Nano Terra, Inc.

+ [2]

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

分子式C25H35N7O6S

InChIKeyKMBGDFWPWSDZTL-UHFFFAOYSA-N

CAS号906421-01-0

关联

6

项与 KD-027 相关的临床试验

NCT00562549 / Completed临床2期

A Pilot Phase IIa Randomised, Double-blind, Placebo-controlled, Crossover Study to Examine the Safety, Tolerability and Pharmacodynamic Effects on Blood Pressure of Repeat Oral Doses of SLx-2101 5, 10 or 20 mg Once Daily for up to 14 Days in Patients With Hypertension

The purpose is to determine the effective dosage and to study the effects of this dosage taken for 12 days on systolic and diastolic blood pressure in patients with hypertension.

开始日期2007-07-01

申办/合作机构

Response Pharmaceuticals, Inc.

EUCTR2007-001668-62-DE / Not yet recruitingN/A

A pilot Phase IIa, randomised, double blind, placebocontrolled, crossover study to examine the safety, tolerability and pharmacodynamic effects on blood pressure of repeat oral doses of SLx-2101 5 mg or 10 mg once daily for up to 14 days in patients with hypertension.

开始日期2007-06-25

申办/合作机构

Surface Logix, Inc.

EUCTR2007-000320-40-GB / Not yet recruiting临床2期

A pilot Phase IIa randomised, double blind, placebo-controlled, crossover study to examine the safety, tolerability and pharmacodynamic effects on blood pressure of repeat oral doses of SLx-2101 5, 10 or 20 mg once daily for up to 14 days in patients with hypertension.

开始日期2007-06-14

申办/合作机构

Surface Logix, Inc.

100 项与 KD-027 相关的临床结果

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100 项与 KD-027 相关的转化医学

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100 项与 KD-027 相关的专利（医药）

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10

项与 KD-027 相关的文献（医药）

2023-07-03·Expert Opinion on Investigational Drugs

Phosphodiesterase 5 inhibitors: preclinical and early-phase breakthroughs for impotence treatments

Review

作者: Bobo, Graham A ; Hellstrom, Wayne J G ; Nguyen, Tivoli ; Melchiode, Zachary ; Dawood, Omar

INTRODUCTIONErectile dysfunction (ED) is a condition that affects millions of men worldwide and is characterized by the inability to achieve or maintain an erection for satisfactory sexual performance. There are numerous treatment options for ED, including medications, mechanical assist devices, and surgical management; however, first-line treatment is usually a phosphodiesterase 5 (PDE5) inhibitor. There is a growing interest in developing novel, efficacious PDE5 inhibitors that provide better quality, safety, and tolerability profiles with less adverse effects. Our review of udenafil, mirodenafil, youkenafil, lodenafil, and SLx-2101 analyzes the safety, efficacy, and pharmacokinetic properties of these new ED drugs.AREAS COVEREDClinical trials demonstrated improved scores in questionnaires, such as the International Index of Erectile Function and Sexual Encounter Profile, for udenafil, mirodenafil, and lodenafil, while youkenafil and SLx-2101 revealed enhanced safety and tolerability in early pharmacokinetic studies.EXPERT OPINIONIt is our opinion that more robust clinical trials are required before these medications can be made available in the United States. Additionally, the field of urology may benefit from pursuing other avenues of pharmacotherapy, such as injections, tablets with a different mechanism of action, or stem cell therapy, to restore the integrity of the endothelium within the penis.

2021-03-01·International Journal of Hematology4区 · 医学

A study of carfilzomib and dexamethasone in patients with relapsed and refractory multiple myeloma in China

4区 · 医学

Article

作者: Tang, En-Tzu ; Liu, Peng ; Hou, Jian ; Shao, Zonghong ; Fang, Baijun ; Cai, Zhen ; Du, Juan ; Wang, Hongxiang ; Niu, Ting ; Li, Jian ; Zou, Dehui ; Xia, Zhongjun ; Wang, Shunqing ; Chen, Wenming ; Fu, Chengcheng ; Jin, Jie ; Hu, Jianda ; Li, Wei ; Kimball, Amy S

The second-generation proteasome inhibitor carfilzomib produces superior outcomes in relapsed or refractory multiple myeloma (MM). We conducted a single-arm trial of twice-weekly carfilzomib (27 mg/m²)-dexamethasone (Kd27) for relapsed and refractory MM in China. Kd27 was administered in 28-day cycles to 123 patients previously treated with ≥ 2 other regimens, including treatment with bortezomib and an immunomodulatory drug, and refractory to their most recent therapy. Overall response rate (ORR) was the primary endpoint; progression-free survival (PFS) and overall survival (OS) were key secondary endpoints. Primary analysis was conducted when all patients received ≥ 6 cycles of Kd27 or discontinued Kd27. Median age was 60 years; median number of prior regimens was 4; 74% were refractory to proteasome inhibitors and immunomodulatory drugs. ORR was 35.8% (95% CI 27.3-44.9), median PFS was 5.6 (95% CI 4.6-6.5) months, and median OS was 16.6 (95% CI 12.2-NE) months. Grade ≥ 3 adverse events (AEs) occurred in 76.4% of patients. Grade ≥ 3 AEs of interest included hypertension (13.8%), acute renal failure (3.3%), cardiac failure (0.8%), ischemic heart disease (0.0%), and peripheral neuropathy (0.0%); 5.7% of patients discontinued carfilzomib due to AEs. Carfilzomib-dexamethasone produced a clinically meaningful response without new safety findings in Chinese patients with previously treated MM.Trial registration: NCT03029234.

2020-06-02·Expert Review of Hematology4区 · 医学

Cost-effectiveness of once weekly carfilzomib 70 mg/m2 plus dexamethasone in patients with relapsed and refractory multiple myeloma in the United States

4区 · 医学

Article

作者: Dimopoulos, Meletios A. ; Campioni, Marco ; Kumar, Shaji K. ; Panjabi, Sumeet ; Majer, Istvan ; Medhekar, Rohan

BACKGROUNDIn the US, carfilzomib 70 mg⁄m² once-weekly plus dexamethasone (Kd70 QW) was recently indicated for relapsed and/or refractory multiple myeloma. In current US clinical practice, most patients treated with Kd receive carfilzomib at a previously approved dose of 27 mg/m² twice-weekly (Kd27 BIW). This analysis assessed the cost-effectiveness (CE) of Kd70 QW vs Kd27 BIW regimens which were compared in the randomized phase 3 ARROW trial.METHODSBased on clinical outcomes (overall survival and utilities) from ARROW, a partitioned survival model was developed to estimate life years (LYs) and quality-adjusted life years (QALYs). Long-term survival was extrapolated using SEER registry data matched to ARROW patients. Costs were estimated using a US healthcare payer perspective.RESULTSThe analysis estimated that treatment with Kd70 QW vs Kd27 BIW resulted in an increase of 1.10 LYs, 0.91 QALYs, and additional lifetime costs of $74,858, yielding an incremental CE ratio (ratio of incremental costs to QALYs) of $82,257 per QALY gained. Results were robust to sensitivity and subgroup analyses.CONCLUSIONSWhen compared with Kd27 BIW, Kd70 QW is the optimal dose that represents a cost-effective utilization of health care budget with incremental CE ratios well below the accepted willingness-to-pay thresholds in the US.

100 项与 KD-027 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
勃起功能障碍	临床2期	美国	Surface Logix LLC	-
高血压	临床2期	德国	Kadmon Pharmaceuticals LLC	-
高血压	临床2期	英国	Kadmon Pharmaceuticals LLC	-
高血压	临床2期	-	Kadmon Holdings, Inc.	-
高血压	临床2期	-	Nano Terra, Inc.	-
高血压	临床2期	德国	Kadmon Pharmaceuticals LLC	-
高血压	临床2期	英国	Kadmon Pharmaceuticals LLC	-
雷诺病	临床2期	德国	Surface Logix LLC	-
雷诺病	临床2期	德国	Surface Logix LLC	-
高血压	临床1期	-	Nano Terra, Inc.	-