A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Evaluate Impact of Sunobinop (V117957) on Alcohol Craving in Subjects Diagnosed With Moderate to Severe Alcohol Use Disorder and Seeking Treatment

The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol craving in subjects with moderate to severe alcohol use disorder and these subjects are seeking treatment.

开始日期2025-01-28

申办/合作机构

Imbrium Therapeutics LP

[+1]

NCT06545916

/ Active, not recruiting临床2期

A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Evaluate Impact of Sunobinop (V117957) on Alcohol Consumption in Subjects Diagnosed With Moderate to Severe Alcohol Use Disorder and Seeking Treatment

The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol consumption in subjects with alcohol use disorder.

开始日期2024-10-14

申办/合作机构

Imbrium Therapeutics LP

[+1]

NCT06024642

/ Completed临床1期

Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Overactive Bladder Syndrome

The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with overactive bladder syndrome, compared to placebo.

开始日期2022-06-30

申办/合作机构

Imbrium Therapeutics LP

[+1]

100 项与 Sunobinop 相关的临床结果

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100 项与 Sunobinop 相关的转化医学

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100 项与 Sunobinop 相关的专利（医药）

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项与 Sunobinop 相关的文献（医药）

2026-01-01·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Efficacy and safety of a selective partial agonist for nociception/orphanin‐FQ peptide (NOP) receptors in patients with insomnia disorder

Article

作者: Whiteside, Garth T. ; Zhou, Mingyan ; He, Ellie ; Shet, Manjunath S. ; Harris, Stephen C. ; Ahmad, Maha

Aims:

Insomnia is a common sleep disorder, affecting up to 20% of the world population and adversely impacting productivity, health, and overall well‐being. Although pharmacologic options exist to treat insomnia, the health‐related quality of life for patients who are prescribed hypnotics is no higher than for those who are not, revealing a significant treatment gap. Sunobinop, an oral, selective, potent, partial agonist of the nociceptin receptor (NOP), was evaluated for efficacy and safety in the treatment of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM‐5) insomnia disorder.

Methods:

In this randomized, double‐blind, repeat‐dose, crossover, Phase 1 study, 30 patients were assigned to treatment with sunobinop 0.5 mg, 1.0 mg, 3.0 mg and 6.0 mg and placebo; changes in sleep parameters, measured by polysomnography (PSG), in addition to subjective sleep measures and safety‐related measures were assessed. Twenty‐nine patients completed the study.

Results:

Sunobinop demonstrated a dose‐dependent and significant increase in sleep efficiency compared with placebo. Sleep efficiency was statistically significantly increased by 12.1%, 14.7%, 17.6% and 19.0% over baseline at 0.5 mg, 1.0 mg, 3.0 mg and 6.0 mg, respectively ( P ≤ 0.001) compared to placebo. Sunobinop improved sleep maintenance, measured by wakefulness after sleep onset, at all doses compared with placebo. Sunobinop resulted in a significant dose‐dependent change in time spent in N1 and N2 sleep with no effect on rapid eye movement (REM) latency, differentiating sunobinop from other hypnotics. Results from PSG measures correlated well with those from subjective assessments. Adverse events (AEs) that occurred in this study were rated by investigators as largely mild.

Conclusions:

In this Phase 1 study of 30 patients, sunobinop was well tolerated by patients, with no study discontinuation due to AEs. Doses were identified that had a beneficial effect on sleep measures without eliciting next‐day residual effects (<3 mg). These data suggest that sunobinop has the potential to be developed as a therapeutic option for the treatment of sleep disturbances, including DSM‐5 insomnia; however, larger confirmatory studies are warranted.

2025-08-01·BIOCHEMICAL PHARMACOLOGY

In vitro pharmacological evaluation of the novel NOP receptor partial agonist sunobinop

Article

作者: Pola, Pietro ; Sturaro, Chiara ; Camilotto, Riccardo ; Ruzza, Chiara ; Frezza, Alessia ; Calo', Girolamo ; Malfacini, Davide ; Pacifico, Salvatore ; Ramalingam, Rahul ; Guerrini, Remo ; Whiteside, Garth ; Morrone, Erika

Sleep-related disorders affect a significant portion of the global population. The nociceptin/orphanin FQ (N/OFQ) peptide (NOP) receptor has become a promising candidate for the development of innovative drugs to treat sleep disorders. In this study, we conducted an in-depth pharmacological characterization of sunobinop, a selective NOP receptor partial agonist already under clinical evaluation for treating multiple conditions including insomnia, using a wide range of in vitro and ex vivo methodologies. Sunobinop exhibited partial agonist activity in calcium mobilization, NOP - G protein interaction, label-free bioimpedance, and cAMP inhibition assays. Notably, it demonstrated competitive antagonism in the NOP - β-Arrestin 2 recruitment and ex vivo electrically stimulated mouse Vas Deferens, assays characterized by low amplification. The findings reported here confirm and extend the characterization of sunobinop as a tool for studying NOP receptor pharmacology providing new insights into its mode of action, relevant to its clinical evaluation.

2024-07-01·Clinical pharmacology in drug development

Safety, Tolerability, and Pharmacokinetics of Single‐ and Multiple‐Ascending Doses of Sunobinop in Healthy Participants

Article

作者: Alessandra Cipriano ; Garth T. Whiteside ; Ram P. Kapil ; Stephen C. Harris ; Sandra K. Willsie ; Manjunath S. Shet ; Mingyan Zhou

Abstract:

Sunobinop is an investigational, potent, selective partial agonist at the nociceptin/orphanin FQ peptide receptor in vitro. Three phase 1 studies were conducted to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating single‐ and multiple‐dose administration of sunobinop in healthy participants. Study 1 was a randomized, double‐blind, placebo‐controlled, single‐ascending dose study. Study 2 was a randomized, double‐blind, placebo‐controlled, multiple‐ascending dose study. Study 3 was a randomized, open‐label, single‐dose, 4‐way crossover study of oral and sublingual sunobinop comparing morning (AM) and bedtime (PM) administration. Seventy participants were included. Systemic exposure (peak plasma concentration [Cmax], area under the plasma concentration‐time curve from time 0 to the time of last quantifiable concentration [AUC0‐t], and area under the plasma concentration–time curve from time 0 extrapolated to infinity [AUCinf]) of sunobinop was characterized by dose proportionality from 0.6 to 2 mg and increased less than proportionally from 3 to 30 mg. The PKs of sunobinop were similar, regardless of AM or PM administration, for both the oral and sublingual formulations. The majority of absorbed sunobinop was excreted unchanged in the urine within 8 hours of dosing, thereby showing rapid elimination with no appreciable accumulation following 14 consecutive days of once‐daily dosing and suggesting exclusive renal elimination. Most treatment‐emergent adverse events (TEAEs) were mild in severity; 1 severe TEAE occurred and all TEAEs resolved by the end of the studies. Sunobinop was generally well‐tolerated and safe across the range of doses evaluated and presents a clinical profile suitable for continued development.

项与 Sunobinop 相关的新闻（医药）

2026-01-01

·Business Wire

Insomnia Market Opportunity Assessment and Forecast Report 2022-2032: Z-Drugs Remain First-Line as Sparse Pipeline Adds $288 Million From Late-Stage Entrants - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Insomnia: Opportunity Assessment and Forecast Update" report has been added to ResearchAndMarkets.com's offering. This report covers the 7MM and provides an Excel-based forecast model for the Insomnia market through 2032. Z-drugs are the most common first-line treatment for insomnia across the US and 5EU. The insomnia pipeline in the 7MM is sparse but varied, containing products with varying mechanisms of action. There are five pipeline products in Phase II and III stages of clinical development for insomnia. The insomnia market across the 7MM was valued at $3.1 billion in the 2022 baseline year. Over the 10- year forecast period, the market is projected to grow at a compound annual growth rate (CAGR) of 2.1%, reaching $3.8 billion by 2032. The entry of the two pipeline products during the forecast period will have a significant impact on the market. They are anticipated to contribute $288 million in sales by 2032. Report Scope Reasons to Buy Key Topics Covered: 1. Preface 1.1. Contents 1.2. Abbreviations 1.3. Related Reports 2. Executive Summary 2.1. Summary of Updates 3. Disease Overview 3.1. Overview of Insomnia 3.2. Insomnia SWOT Analysis 3.3. Pathophysiology of Insomnia 3.4. Classification of Insomnia 4. Epidemiology 4.1. Total Prevalent Cases of Insomnia, Both Sexes, Ages 15 Years, 2022-32 4.2. Age-Specific Trends in the Total Prevalent Cases of Insomnia, Both Sexes, 2022 4.3. Sex-Specific Total Prevalent Cases of Insomnia, Both Sexes, Ages 15 Years, 2022 4.4. Sex-Specific Total Prevalent Cases of Acute Insomnia, Ages 15 Years, 2022 4.5. Sex-Specific Total Prevalent Cases of Chronic Insomnia, Ages 15 Years, 2022 4.6. Sources and Methodology for Acute and Chronic Insomnia Prevalence 4.7. Sources and Methodology - Total Prevalent Cases of Acute and Chronic Insomnia 5. Current Treatment Options 5.1. Treatment Paradigm 5.2. Current Treatment Options 5.3. Product Profile: Benzodiazepines (e.g., estazolam, temazepam, flurazepam) 5.4. Product Profile: Z-Drugs (zaleplon, zolpidem, zopiclone, eszopiclone) 5.5. Product Profile: Melatonin Receptor Agonists (ramelteon and melatonin ER) 5.6. Product Profile: Low-Dose Antidepressants (doxepin, trazodone, trimipramine) 5.7. Product Profile: Antihistamines (e.g., diphenhydramine, promethazine, hydroxyzine) 5.8. Product Profile: Gabapentinoids (e.g., gabapentin and pregabalin) 5.9. Product Profile: Merck & Co's Belsomra (suvorexant) 5.10. Product Profile: Eisai's Dayvigo (lemborexant) 5.11. Product Profile: Idorsia's Quviviq (daridorexant) 5.12. Product Profile: Taisho Pharmaceutical's Borzi (vornorexant) 5.13. Patient Flow: Insomnia in 2022 Across 7MM 6. Unmet Needs and Opportunities 6.1. Unmet Needs in Insomnia 6.2. New Therapeutic Options with Improved Efficacy 6.3. Improved Physician Awareness of Insomnia Treatments 6.4. Improved Patient Access to CBT-i 7. R&D Strategies 7.1. Trends in Clinical Trial Design in Insomnia 7.2. Trends in Deal-Making in Insomnia 8. Pipeline Assessment 8.1. Insomnia Pipeline Overview 8.2. Late-Stage Pipeline Agents for Insomnia 8.3. Product Profile: EUSOL Biotech's SM-1 8.4. Product Profile: Imbrium Therapeutics's Sunobinop 8.5. Product Profile: Vanda Pharmaceuticals's Hetlioz (tasimelteon) 8.6. Insomnia: Clinical Trials (Phase II/III) Overview 9. Market Outlook 9.1. Insomnia Market Forecast 9.2. Market Drivers and Barriers 10. Appendix 10.1. Primary Research: KOL Information 10.2. Primary Research: High-Prescriber Survey Information 10.3. Bibliography 10.4. About the Authors Companies Featured For more information about this report visit https://www.researchandmarkets.com/r/dns27p About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

临床2期

2025-06-16

·Business Wire

Imbrium Therapeutics to Showcase Pipeline Assets Open for Partnership at the BIO International Convention 2025

STAMFORD, Conn.--(BUSINESS WIRE)--Imbrium Therapeutics L.P. (“Imbrium”), a clinical-stage biopharmaceutical company, is presenting pipeline developments at the BIO International Convention on Wednesday, June 18, at 9:15 a.m. in Room 153B. Imbrium is actively seeking partnerships to advance the development of investigational therapeutics for multiple indications across several disease areas including genitourinary disorders, substance use disorders, and cancerous malignancies. Imbrium is discussing two investigational agents, sunobinop and tinostamustine, both of which could present substantial revenue opportunities*. Sunobinop is a novel, first-in-class, nociceptin receptor partial agonist. The orally active investigational drug is in Phase 1b/2a clinical development for multiple indications, including alcohol use disorder (AUD), interstitial cystitis/bladder pain syndrome (IC/BPS), and overactive bladder (OAB). Related to AUD, sunobinop’s pharmacological properties offer a unique approach under investigation for alcohol craving, consumption and sleep issues; it has the potential to be the first new modality in AUD in almost 20 years. Related to OAB and IC/BPS, sunobinop has been shown in early studies to target the sensory nerves in the bladder to affect urination, pain, and nocturia. Global or regional rights are available for partnership. Tinostamustine is a novel, first-in-class, investigational drug combining DNA alkylating activity and histone deacetylase inhibition in a single molecule. It has the potential to be a first-line agent to treat patients with glioblastoma multiforme (GBM), a highly aggressive form of brain cancer. In Phase 1 studies as an adjuvant to standard chemoradiation, tinostamustine was shown to improve survival in difficult-to-treat newly diagnosed patients and is on track for accelerated development. It has the potential to be the first new chemotherapeutic to treat GBM in more than 20 years. Tinostamustine has also shown promise in early clinical studies in other solid and hematological tumors. U.S. rights are available for partnership. “We are committed to securing partnerships that further advance promising novel therapies,” said David Saussy, Head of Licensing & Business Development. “We look forward to presenting these pipeline highlights at BIO and moving our research programs forward to help address unmet patient needs.“ Tinostamustine and all proposed indications for sunobinop are open to partnering. For more information, e-mail partnering@pharma.com. For more information about our pipeline, click here. *This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that sunobinop or tinostamustine will successfully complete development or gain FDA approval. About Imbrium Therapeutics L.P. Imbrium is a clinical-stage biopharmaceutical company dedicated to advancing medical science through the development of important new therapeutics. We are pursuing treatments for genitourinary disorders, disorders of the central nervous system, oncology chemotherapeutics, and non-opioid approaches to the management of pain. As a subsidiary of Purdue Pharma L.P., Imbrium strives to develop new medicines that serve the unmet needs of patients, physicians, and health systems worldwide. We have built a robust and diversified pipeline of investigational drug candidates, and we seek to actively collaborate with industry and academic partners to identify and advance future impactful medicines. For more information, please visit www.imbriumthera.com..

临床1期

2025-03-11

·Business Wire

Imbrium Therapeutics Achieves Last Patient Last Visit in Clinical Trial of Potential Treatment for Interstitial Cystitis/Bladder Pain Syndrome

STAMFORD, Conn.--(BUSINESS WIRE)--Imbrium Therapeutics L.P. (“Imbrium”), a subsidiary of Purdue Pharma L.P. (“Purdue”), has achieved last patient last visit in its Phase 1b study of the investigational drug sunobinop as a potential treatment for interstitial cystitis/bladder pain syndrome (IC/BPS)*. IC/BPS is a chronic painful and debilitating urologic disorder that negatively affects patients’ quality of life and can lead to radical lifestyle and behavioral modifications.1,2 Sunobinop is an investigational, novel and potential first-in-class oral compound designed to bind to and activate the nociceptin/orphanin-FQ peptide receptor (NOP), a protein that is widely expressed in the central and peripheral nervous system3 and involved in a range of physiologic processes, including bladder voiding function as well as sensory perception of bladder pain.4,5,6,7 Forty-seven female patients with IC/BPS were enrolled in this multicenter, randomized, double-blind, placebo-controlled, crossover study. The study was designed to assess impact of once-a-day sunobinop taken at bedtime for 6 weeks on key disease symptoms, such as bladder pain and discomfort as well as urinary urgency and frequency, in subjects with IC/BPS compared to placebo. IC/BPS has been reported to affect five times more women than men, yet the exact pathophysiology remains unclear.8 There is no cure and limited existing therapies for IC/BPS so new treatment options are needed.9 "Patients with interstitial cystitis experience very disruptive symptoms that can severely affect daily activities, work productivity, and overall quality of life. The findings from this study will help us understand sunobinop’s potential as a possible new treatment option for this chronic disorder,” said Craig Landau, MD, President and CEO of Purdue. “We look forward to reviewing and analyzing the results later this year, as we continue our commitment to innovation through research and development.” In addition to IC/BPS, Imbrium is evaluating sunobinop as a potential treatment for overactive bladder and also for alcohol use disorder. All indications for sunobinop are open to partnering. For more information, e-mail partnering@pharma.com. *This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that sunobinop will successfully complete development or gain FDA approval. About Imbrium Therapeutics L.P. Imbrium is a clinical-stage biopharmaceutical company dedicated to advancing medical science through development of important new therapeutics. We are pursuing treatments for genitourinary disorders, disorders of the central nervous system, oncology chemotherapeutics, and non-opioid approaches to the management of pain. As a subsidiary of Purdue Pharma L.P., Imbrium strives to develop new medicines that serve the unmet needs of patients, physicians, and health systems worldwide. We have built a robust and diversified pipeline of investigational drug candidates, and we seek to actively collaborate with industry and academic partners to identify and advance future impactful medicines. For more information, please visit www.imbriumthera.com. References Lin KB-S, Wu M-P, Lin Y-K, et al. Lifestyle and behavioral modifications made by patients with interstitial cystitis. Sci Rep. 2021;11(1):3055. Kirkham A, Swainston K. Women's experiences of interstitial cystitis/painful bladder syndrome. West J Nurs Res. 2022;44(2):125-132. Zaveri N. The nociceptin opioid receptor (NOP) as a therapeutic target: Progress in translation from preclinical research to clinical utility. J Med Chem. 2016;59(15):7011-7028. Lambert D. The nociception/orphanin FQ receptor: A target with broad therapeutic potential. Nat. Rev. 2008;7(8):694-710. Lazzeri M, Calò G, Spinelli M, et al. Daily intravesical instillation of 1 mg nociceptin/orphanin FQ for the control of neurogenic detrusor overactivity: A multicenter, placebo controlled, randomized exploratory study. J Urol. 2006;176(5):2098-2102. Whiteside G, Auge C, Lluel P. Effects of sunobinop (V117957) in a model of acute cystitis induced by cyclophosphamide. J Urol. 2023;209(4S):e152. Lazzeri M, Del Popolo G, Celso M, et al. O’Leary-Sant Questionnaire changes after intravesical administration of nociceptin/orphanin FQ (N/OFQ) in patients with interstitial cystitis/painful bladder syndrome (IC/PBS). A pilot study . J Urol. 2011;185(4S):849. Bitcon C, Anderson K, Cox A. Treatment of interstitial cystitis/bladder pain syndrome: A contemporary review. EMJ Urol . 2020,5(3):91-100. Hu J-C, Tzeng H-T, Lee W-C, et al. Promising experimental treatment in animal models and human studies of interstitial cystitis/bladder pain syndrome. Int J Mol Sci . 2024;25(15):8015. MR-08648

临床1期临床2期

100 项与 Sunobinop 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
酒精使用障碍	临床2期	美国	Imbrium Therapeutics LP	2019-09-23
入睡和睡眠障碍	临床2期	美国	Purdue Pharma LP	2019-09-23
术后疼痛	临床2期	美国	Purdue Pharma LP	2013-07-01
膀胱过度活动症综合征	临床1期	美国	Purdue Pharma LP	2022-06-30
间质性膀胱炎	临床1期	美国	Purdue Pharma LP	2022-05-26
神经痛	临床1期	美国	Shionogi & Co., Ltd.	2011-10-31

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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


NCT06285214 (CTgov)	临床1期	间质性膀胱炎	47	Placebo (Double-blind Treatment (Period 1))	鬱鹽遞糧壓築鑰淵糧積(鏇簾構鏇築鏇簾淵範範) = 獵簾齋範構觸艱糧網衊願築膚鏇膚膚顧網衊糧 (簾範範糧膚築鹽艱鬱淵, 1.41) 更多	-	2026-03-09
				V117957 (Double-blind Treatment (Period 2))	鬱鹽遞糧壓築鑰淵糧積(鏇簾構鏇築鏇簾淵範範) = 艱餘窪製築夢觸構壓鹽願築膚鏇膚膚顧網衊糧 (簾範範糧膚築鹽艱鬱淵, 2.08) 更多
NCT06024642 (CTgov)	临床1期	膀胱过度活动症综合征	51	Placebo (Week 2 (Placebo))	構夢鑰顧廠觸鹹醖繭壓(網艱廠鏇鑰糧衊獵製築) = 鑰襯築醖壓網選蓋廠範憲觸遞構鹹網顧獵簾壓 (鏇醖餘膚鬱構願網窪簾, 1.97) 更多	-	2025-06-26
				V117957 (Week 8 (V117957))	構夢鑰顧廠觸鹹醖繭壓(網艱廠鏇鑰糧衊獵製築) = 壓簾願鹽夢壓鏇繭鏇窪憲觸遞構鹹網顧獵簾壓 (鏇醖餘膚鬱構願網窪簾, 2.32) 更多
NCT06024642 (BusinessWire) 人工标引	临床1期	膀胱过度活动症综合征	51	Sunobinop 1 mg	蓋遞簾繭齋範鬱襯鏇築(齋鹹糧鹽壓壓鏇壓醖繭) = 醖積繭選繭選蓋淵衊廠膚範鏇淵願觸範壓蓋鹽 (鹹窪醖積觸醖觸網遞蓋 )	积极	2025-01-07
				Placebo	蓋遞簾繭齋範鬱襯鏇築(齋鹹糧鹽壓壓鏇壓醖繭) = 構膚鹽繭顧選鑰壓壓積膚範鏇淵願觸範壓蓋鹽 (鹹窪醖積觸醖觸網遞蓋 )
NCT04035200 (CTgov)	临床2期	入睡和睡眠障碍 \| 酒精使用障碍	114	V117957 tablets (V117957 1 mg)	願蓋鏇壓廠壓遞願齋構(簾廠繭醖糧範衊夢艱膚) = 觸網蓋築餘鬱艱網遞廠鹽選遞繭鹽壓蓋簾膚觸 (選壓衊夢憲鬱鏇鹽膚齋, 45.098) 更多	-	2023-09-18
				V117957 tablets (V117957 2 mg)	願蓋鏇壓廠壓遞願齋構(簾廠繭醖糧範衊夢艱膚) = 艱鏇齋餘壓願淵餘襯艱鹽選遞繭鹽壓蓋簾膚觸 (選壓衊夢憲鬱鏇鹽膚齋, 36.496) 更多