This is a clinical pharmacology study to characterize the biotransformation and excretion of [14C]CC-90001 and to evaluate the safety and tolerability of [14C]CC-90001 following a single oral dose of [14C]CC-90001 in healthy male subjects. Approximately 8 subjects will be enrolled into the study with a goal of 6 subjects being eligible for analysis.

开始日期2020-12-16

申办/合作机构

Celgene Corp.

NCT04048876 / Terminated临床2期

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study To Evaluate The Efficacy and Safety Of CC-90001 In Subjects With Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver fibrosis.
This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.

开始日期2019-08-14

申办/合作机构

Celgene Corp.

NCT03958864 / Completed临床1期

A PHASE 1, OPEN LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY/TOLERABILITY OF CC-90001 IN JAPANESE HEALTHY SUBJECTS

This is a Phase 1, open-label, randomized, parallel design study to evaluate the PK and safety/tolerability of CC 90001 in Japanese and Caucasian healthy adult subjects.
The study will consist of multiple oral doses of IP (QD x 7 days) in 3 planned dose level cohorts of 100 mg, 200 mg, and 400 mg. Each cohort will have 20 subjects (10 Japanese subjects and 10 Caucasian subjects, with a minimum of 8 subjects to complete in each group) who will receive IP (see below).

开始日期2019-04-04

申办/合作机构

Celgene Corp.

100 项与 CC-90001 相关的临床结果

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100 项与 CC-90001 相关的转化医学

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100 项与 CC-90001 相关的专利（医药）

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项与 CC-90001 相关的文献（医药）

2023-06-28·Clinical pharmacology in drug development

Safety, Pharmacokinetics, and Antifibrotic Activity of CC-90001 (BMS-986360), a c-Jun N-Terminal Kinase Inhibitor, in Pulmonary Fibrosis.

Article

作者: Gerald Horan ; Ying Ye ; Mary Adams ; Anastasia Parton ; Dorota Cedzik ; Shaojun Tang ; Elizabeth A Brown ; Liangang Liu ; Jim Nissel ; Leonidas N Carayannopoulos ; Allison Gaudy ; Peter Schafer ; Maria Palmisano ; Francisco Ramirez-Valle

Approved treatments for idiopathic pulmonary fibrosis have tolerability concerns and limited efficacy. CC-90001, a c-Jun N-terminal kinase inhibitor, is under investigation as a therapy for fibrotic diseases. A Phase 1b safety, pharmacokinetics, and pharmacodynamics study of oral CC-90001 (100, 200, or 400 mg) administered once daily for 12 weeks was conducted in patients with pulmonary fibrosis (NCT02510937). Sixteen patients with a mean age of 68 years were studied. The most common treatment-emergent adverse events were nausea and headache; all events were of mild or moderate intensity. Pharmacokinetic profiles were similar between the patients in this trial and healthy adults in previous studies. Forced vital capacity increased in the 200- and 400-mg cohorts from baseline to Week 12, and dose-dependent reductions in fibrosis biomarkers were observed. Antifibrotic activity of CC-90001 was also evaluated in vitro in transforming growth factor beta 1 (TGF-β1)-stimulated cells. CC-90001 reduced in vitro profibrotic gene expression in both lung epithelial cells and fibroblasts, supporting a potential direct antifibrotic action of c-Jun N-terminal kinase inhibition in either or both cell types. Overall, CC-90001 was generally safe and well tolerated, and treatment was associated with forced vital capacity improvement and reductions in profibrotic biomarkers.

2023-05-03·European journal of medicinal chemistry

Synthesis-accessibility-oriented design of c-Jun N-terminal kinase 1 inhibitor.

Article

作者: Hewen Qian ; Yuanqing Ding ; Xingyu Deng ; Weiwei Huang ; Zhenzhen Li ; Fengling Liu ; Jie Zhang ; Lihui Wang ; Junping Liu ; Yaxia Yuan ; Shurong Hou ; Xiabin Chen ; Lei Ma

Idiopathic pulmonary fibrosis (IPF) is a severe and progressive lung disease with poor prognosis and limited treatment options. The c-Jun N-Terminal Kinase 1 (JNK1), a key component of the MAPK pathway, has been implicated in the pathogenesis of IPF and represents a potential therapeutic target. However, the development of JNK1 inhibitors has been slowed, partly due to synthetic complexity in medicinal chemistry modification. Here, we report a synthesis-accessibility-oriented strategy for designing JNK1 inhibitors based on computational prediction of synthetic feasibility and fragment-based molecule generation. This strategy led to the discovery of several potent JNK1 inhibitors, such as compound C6 (IC₅₀ = 33.5 nM), which exhibited comparable activity to the clinical candidate CC-90001 (IC₅₀ = 24.4 nM). The anti-fibrotic effect of C6 was further confirmed in animal model of pulmonary fibrosis. Moreover, compound C6 could be synthesized in only two steps, compared to nine steps for CC-90001. Our findings suggest that compound C6 is a promising lead for further optimization and development as a novel anti-fibrotic agent targeting JNK1. In addition, the discovery of C6 also demonstrates the feasibility of synthesis-accessibility-oriented strategy in lead discovery.

2022-10-18·Clinical pharmacology in drug development

Safety, Pharmacokinetics, and Pharmacodynamics of CC-90001 (BMS-986360), a c-Jun N-terminal Kinase Inhibitor, in Phase 1 Studies in Healthy Participants.

Article

作者: Ying Ye ; Allison Gaudy ; Michael Thomas ; Josephine Reyes ; Barbara Burkhardt ; Gerald Horan ; Liangang Liu ; Jian Chen ; Atalanta Ghosh ; Leonidas N Carayannopoulos ; Daniel A Tatosian ; Maria Palmisano

CC-90001 selectively inhibits c-Jun N-terminal kinase (JNK), a stress-activated protein implicated in fibrosis. In 3 phase 1 trials evaluating CC-90001 pharmacokinetics, pharmacodynamics, and safety, healthy adults (N = 184) received oral CC-90001 in a single dose (10-720 mg) or multiple doses (30-480 mg once daily for 7-18 days) or placebo. CC-90001 was rapidly absorbed (median time to maximum concentration, 1-4 hours) and eliminated with a mean terminal elimination half-life of 12-28 hours. Steady state was reached on day 5, with a mean accumulation ratio of 1.5- to 2-fold following daily dosing. Exposure was similar in fed versus fasted participants and in Japanese versus non-Japanese participants. CC-90001 demonstrated dose- and exposure-dependent inhibition of JNK as determined by histopathological analysis of c-Jun phosphorylation in ultraviolet-irradiated skin. The most common treatment-emergent adverse events were nausea and headache; all were mild or moderate in intensity. Based on exposure-response analysis using high-quality electrocardiogram data, no clinically relevant QT prolongation liability for CC-90001 was observed. Overall, single- and multiple-dose CC-90001 were generally safe and well tolerated at the tested doses and demonstrated JNK pathway engagement. These results support further clinical evaluation of CC-90001.

项与 CC-90001 相关的新闻（医药）

2023-05-25

·PRNewswire

Idiopathic Pulmonary Fibrosis Clinical Trial Pipeline Appears Robust With 80+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

The prevalence of idiopathic pulmonary fibrosis has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of idiopathic pulmonary fibrosis and the growing research and development activities to develop novel therapies to treat idiopathic pulmonary fibrosis to drive the market. The companies developing the potential therapies in the last stage of development include FibroGen, Boehringer Ingelheim, and several others. LAS VEGAS, May 25, 2023 /PRNewswire/ -- DelveInsight's ' Idiopathic Pulmonary Fibrosis Pipeline Insight – 2023 ' report provides comprehensive global coverage of pipeline idiopathic pulmonary fibrosis therapies in various stages of clinical development, major pharmaceutical companies working to advance the pipeline space, and future growth potential of the idiopathic pulmonary fibrosis pipeline domain. Key Takeaways from the Idiopathic Pulmonary Fibrosis Pipeline Report DelveInsight's idiopathic pulmonary fibrosis pipeline report depicts a robust space with 80+ active players working to develop 100+ pipeline therapies for idiopathic pulmonary fibrosis treatment. Key idiopathic pulmonary fibrosis companies such as FibroGen, United Therapeutics, Bellerophon Therapeutics, MediciNova, Novartis, Endeavor BioMedicines, Pliant Therapeutics, Nitto Denko, Kadmon Pharmaceuticals, Calliditas Therapeutics, Avalyn Pharmaceuticals, PureTech Health, Taiho Pharmaceutical, Bristol-Myers Squibb, Galecto Biotech AB, CSL Behring, Celgene Pharmaceutical, Vicore Pharma, Boehringer Ingelheim, Guangdong Raynovent, Sunshine Lake Pharma co, Suzhou Zelgen Biopharmaceuticals, Algernon Pharmaceuticals, Horizon Therapeutics, Daewoong Pharmaceutical, Metagone Biotech, AstraZeneca, Lung Therapeutics, Bridge Biotherapeutics, AstraZeneca, Kinarus AG, Insmed, Reviva Pharmaceuticals, Annapurna Bio, Guangdong Hengrui Pharmaceutical Co., Ltd, Ark Biosciences, Ocean Biomedical, and others are evaluating new idiopathic pulmonary fibrosis drugs to improve the treatment landscape. Promising idiopathic pulmonary fibrosis pipeline therapies in various stages of development include Pamrevlumab, Treprostinil, Nitric oxide inhalation - INOpulse, MN-001 (tipelukast), VAY736, ENV-101, PLN-74809, ND-L02-s0201, KD025, GKT137831, AP 01, LYT-100, TAS-115, BMS-986278, GB0139, CSL312, CC-90001, C21, BI1015550, ZSP1603, HEC585, Jaktinib Dihydrochloride Monohydrate, Ifenprodil, HZN-825, DWN12088, MG-S-2525, Saracatinib, LTI-03, BBT-877, AZD5055, KIN001-IPF, Treprostinil palmitil inhalation powder (TPIP), Brilaroxazine, ANPA 0073, SHR 1906, AK 3280, OCF 203, and others. In May 2023, Kinarus Therapeutics announced the signing of a strategic convertible loan agreement for a CHF 1.5 million investment by ChaoDian (Hangzhou) Investment Management Co., Ltd., an investment company based in Hangzhou City, China ("CDIM"). Further, this agreement forms the basis for discussions on the introduction, development and commercialization of KIN001 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in China. Great Health Companion Group Ltd (GHCG), a subsidiary of Hakim Unique Group, introduced CDIM to Kinarus. In April 2023, AGC Biologics announced it signed a service agreement with The Jikei University in Japan. Under the agreement, AGC Biologics will assume a technology transfer and feasibility study for a drug product focused on the treatment of Idiopathic pulmonary fibrosis at the CDMO's center of Cell and Gene Excellence in Milan. In February 2023, Insilico Medicine announced that the US Food and Drug Administration (FDA) had granted Orphan Drug Designation to INS018_055 for the treatment of Idiopathic Pulmonary Fibrosis (IPF). In February 2023, Arrowhead Pharmaceuticals Inc. announced that it had dosed the first subjects in a Phase I/IIa clinical trial of ARO-MMP7, the company's investigational RNA interference (RNAi) therapeutic designed to reduce the expression of matrix metalloproteinase 7 (MMP7) as a potential treatment for idiopathic pulmonary fibrosis (IPF). In February 2023, South Korea's Daewoong Pharmaceutical secured an exclusive licensing agreement with CS Pharmaceuticals for a first-in-class PRS inhibitor Bersiporocin in the Greater China region, including mainland China, Hong Kong, Taiwan, and Macau. Under this agreement, CSP will in-license Bersiporocin for Idiopathic Pulmonary Fibrosis (IPF) and potentially other fibrotic indications for a total consideration of up to $336 million, including up to $76 million in upfront and development milestone payments and double-digit royalties on Net Sales. In January 2023, Insilico Medicine announced the positive topline results of safety, tolerability, and pharmacokinetics (PK) from the Phase 1 clinical trial of INS018_055, a potential first-in-class drug discovered by Insilico's end-to-end AI platform for idiopathic pulmonary fibrosis (IPF). In January 2023, Pliant Therapeutics announced 12-week interim data from the 320 mg dose group of INTEGRIS-IPF, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF). In December 2022, Vallon Pharmaceuticals announced that they entered into a definitive agreement (the "Merger Agreement") pursuant to which GRI Bio will merge with a wholly-owned subsidiary of Vallon in an all-stock transaction (the "Merger"). The combined company will focus on advancing GRI Bio's innovative pipeline of NKT cell regulators for the treatment of inflammatory, fibrotic and autoimmune diseases. Following the closing of the Merger, the combined company is expected to operate under the name "GRI Bio, Inc." Request a sample and discover the recent advances in idiopathic pulmonary fibrosis drug treatment @ Idiopathic Pulmonary Fibrosis Pipeline Report The idiopathic pulmonary fibrosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage idiopathic pulmonary fibrosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the idiopathic pulmonary fibrosis clinical trial landscape. Idiopathic Pulmonary Fibrosis Overview Idiopathic pulmonary fibrosis (IPF) is a rare, chronic, progressive fibrosing interstitial pneumonia that primarily affects middle-aged and older adults. It affects lung tissue by thickening, stiffening, or persistent and progressive scarring that worsens irreversibly over time. Scarring affects the air sacs of IPF patients, decreasing the amount of oxygen that enters the circulation. With less oxygen in the blood, ordinary tasks such as walking can cause dyspnea. This set of lung illnesses is also known as 'Diffuse Parenchymal Lung Diseases,' and it is distinguished by a broader umbrella of 'Interstitial Lung Diseases (IDLs)'. The cause of IPF is uncertain; experts believe the condition is caused by a mix of hereditary and environmental factors. There is a significant chance that genetic variations enhance a person's risk of acquiring IPF and then being exposed to environmental variables that aggravate the condition. However, much remains unknown about this new field of study. Find out more about drugs for idiopathic pulmonary fibrosis @ New Idiopathic Pulmonary Fibrosis Drugs A snapshot of the Idiopathic Pulmonary Fibrosis Pipeline Drugs mentioned in the report: Learn more about the emerging idiopathic pulmonary fibrosis pipeline therapies @ Idiopathic Pulmonary Fibrosis Clinical Trials Idiopathic Pulmonary Fibrosis Therapeutics Assessment The idiopathic pulmonary fibrosis pipeline report proffers an integral view of idiopathic pulmonary fibrosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Idiopathic Pulmonary Fibrosis Pipeline Report Coverage: Global Idiopathic Pulmonary Fibrosis Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Idiopathic Pulmonary Fibrosis Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Idiopathic Pulmonary Fibrosis Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravitreal, Subretinal, Topical Idiopathic Pulmonary Fibrosis Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Idiopathic Pulmonary Fibrosis Therapeutics Assessment By Mechanism of Action: Connective tissue growth factor inhibitors, 5-lipoxygenase inhibitors, Leukotriene D4 receptor antagonists, Leukotriene receptor antagonists, Phospholipase C inhibitors, Thromboxane A2 receptor antagonists, Type 3 cyclic nucleotide phosphodiesterase inhibitors, Type 4 cyclic nucleotide phosphodiesterase inhibitors, Integrin alphavbeta1 inhibitors, Integrin alphaVbeta6 inhibitors, Antibody-dependent cell cytotoxicity, Interleukin 4 receptor antagonists, SMO protein inhibitors, Galectin 3 inhibitors Key Idiopathic Pulmonary Fibrosis Companies: FibroGen, United Therapeutics, Bellerophon Therapeutics, MediciNova, Novartis, Endeavor BioMedicines, Pliant Therapeutics, Nitto Denko, Kadmon Pharmaceuticals, Calliditas Therapeutics, Avalyn Pharmaceuticals, PureTech Health, Taiho Pharmaceutical, Bristol-Myers Squibb, Galecto Biotech AB, CSL Behring, Celgene Pharmaceutical, Vicore Pharma, Boehringer Ingelheim, Guangdong Raynovent, Sunshine Lake Pharma co, Suzhou Zelgen Biopharmaceuticals, Algernon Pharmaceuticals, Horizon Therapeutics, Daewoong Pharmaceutical, Metagone Biotech, AstraZeneca, Lung Therapeutics, Bridge Biotherapeutics, AstraZeneca, Kinarus AG, Insmed, Reviva Pharmaceuticals, Annapurna Bio, Guangdong Hengrui Pharmaceutical Co., Ltd, Ark Biosciences, Ocean Biomedical, and others. Key Idiopathic Pulmonary Fibrosis Pipeline Therapies: Pamrevlumab, Treprostinil, Nitric oxide inhalation - INOpulse, MN-001 (tipelukast), VAY736, ENV-101, PLN-74809, ND-L02-s0201, KD025, GKT137831, AP 01, LYT-100, TAS-115, BMS-986278, GB0139, CSL312, CC-90001, C21, BI1015550, ZSP1603, HEC585, Jaktinib Dihydrochloride Monohydrate, Ifenprodil, HZN-825, DWN12088, MG-S-2525, Saracatinib, LTI-03, BBT-877, AZD5055, KIN001-IPF, Treprostinil palmitil inhalation powder (TPIP), Brilaroxazine, ANPA 0073, SHR 1906, AK 3280, OCF 203, and others. Dive deep into rich insights for new drugs for idiopathic pulmonary fibrosis treatment; visit @ Idiopathic Pulmonary Fibrosis Medications Table of Contents For further information on the idiopathic pulmonary fibrosis pipeline therapeutics, reach out @ Idiopathic Pulmonary Fibrosis Drug Treatment Related Reports Idiopathic Pulmonary Fibrosis Market Idiopathic Pulmonary Fibrosis Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key idiopathic pulmonary fibrosis companies, including FibroGen, Hoffmann-La Roche Ltd, United Therapeutics, Boehringer Ingelheim, Pliant Therapeutics, Inc., Galecto Biotech, Horizon Therapeutics, CSL Behring, Kadmon Corporation, LLC, among others. Idiopathic Pulmonary Fibrosis Epidemiology Forecast Idiopathic Pulmonary Fibrosis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and idiopathic pulmonary fibrosis epidemiology trends. Pulmonary Fibrosis Pipeline Pulmonary Fibrosis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key pulmonary fibrosis companies, including Roche, Boehringer Ingelheim, Galecto Biotech, Cipla, Gilead Sciences, Fibrogen, Bristol-Myers Squibb, among others. Pulmonary Fibrosis Market Pulmonary Fibrosis Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pulmonary fibrosis companies, including Roche, Boehringer Ingelheim, Galecto Biotech, Cipla, Gilead Sciences, Fibrogen, Bristol-Myers Squibb, 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] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

临床1期引进/卖出孤儿药临床2期

100 项与 CC-90001 相关的药物交易

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研发状态

适应症	最高研发状态	国家/地区	公司
特发性间质性肺炎	临床2期	哥伦比亚更多	Celgene Corp. 更多
病理过程	临床2期	英国更多	Celgene Corp. 更多
纤维化	临床2期	澳大利亚更多	Celgene Corp. 更多
肝硬化	终止	法国更多	Celgene Corp. 更多
非酒精性脂肪性肝炎	终止	德国更多	Celgene Corp. 更多

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临床结果

适应症

分期

评价

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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


NCT02510937 (ERS2017) 人工标引	临床1期	肺纤维化	16	CC-90001 (100mg)	(觸遞窪觸壓積醖鏇築網) = The most common AEs were GI in nature (all mild to moderate). 糧構窪觸製蓋鑰壓淵餘 (選獵簾廠願獵製獵鬱壓 )	积极	2017-12-06
				CC-90001 (200/400mg)
NCT04048876 (CTgov)	临床2期	代谢功能障碍相关的脂肪肝病 \| 肝纤维化 \| 非酒精性脂肪性肝炎 \| 肝硬化	56	CC-90001 (CC-90001 100mg)	網顧鏇糧窪顧鏇築遞鏇(廠獵夢廠鑰構壓網廠願) = 願觸獵簾網膚鑰醖製顧繭窪鹹鑰膚鏇鹽鑰襯鹽 (鹽夢鏇繭壓願顧簾餘製, 蓋齋窪顧壓鏇鬱蓋簾願 ~ 艱鹽蓋鹹鑰顧製獵淵衊) 更多	-	2023-06-07
				CC-90001 (CC-90001 200mg)	網顧鏇糧窪顧鏇築遞鏇(廠獵夢廠鑰構壓網廠願) = 齋齋餘顧膚網餘糧膚鬱繭窪鹹鑰膚鏇鹽鑰襯鹽 (鹽夢鏇繭壓願顧簾餘製, 簾淵鏇範鹹壓壓襯夢壓 ~ 積衊餘鏇襯窪餘膚窪鏇) 更多