Sunobinop

The below scientific publications discuss investigational uses of agents in development and are for informational and educational purposes only. They are 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.

Sunobinop Scientific Publications

Pharmacology

Manuscripts

Date Citation Link
August 2025 In Vitro Pharmacological Evaluation of the Novel NOP Receptor Partial Agonist Sunobinop. Biochem Pharmacol. 2025;238:116972. Camilotto R, Malfacini D, Pola P, et al.
August 2024 Evaluation of Sunobinop for Next-Day Residual Effects in Healthy Participants. Front Pharmacol. 2024;15:1432902. Cipriano A, Kapil RP, Zhou M, et al.
March 2024 Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-Ascending Doses of Sunobinop in Healthy Participants. Clin Pharmacol Drug Dev. 2024;13(7):790-800. Cipriano A, Kapil RP, Zhou M, et al.

Sleep

Manuscripts

Date Citation Link
August 2025 Efficacy and Safety of a Selective Partial Agonist for Nociception/Orphanin-FQ Peptide (NOP) Receptors in Patients with Insomnia Disorder. Br J Clin Pharmacol. Early view online version: 27 August 2025. Whiteside GT, He E, Shet M, Zhou M, Ahmad M, Harris SC.
January 2024 The Nociceptin/Orphanin FQ Receptor Partial Agonist Sunobinop Promotes Non-REM Sleep in Rodents and Patients with Insomnia. J Clin Invest. 2024;134(1):e171172. Whiteside GT, Kyle DJ, Kapil RP, et al.

Abstracts

Date Citation Link
July 2024 Results from a Phase 2, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group Study of Sunobinop in Subjects Who Are Experiencing Insomnia During Recovery from Alcohol Use Disorder. Drug and Alcohol Dependence. 2024;260(S):110455. Sessler N, Harris SC, Zhou M, et al.
May 2020 Safety, Tolerability, and Efficacy of a Novel, Highly Potent and Selective Partial Agonist for Nociceptin/Orphanin-FQ Peptide (NOP) Receptors in Patients with Insomnia Disorder. Sleep. 2020;43(S1):A192. Zhou M, Harris SC, Kapil RP, et al.
May 2020 Evaluation of the Human Abuse Potential of Single Oral Doses of V117957, a Novel, Highly Potent and Selective Partial Agonist for Nociceptin/Orphanin-FQ Peptide (NOP) Receptors. Sleep. 2020;43(S1):A191-A192. Harris SC, Zhou M, Cipriano A, et al.
May 2020 Activation of Nociceptin/Orphanin-FQ Peptide (NOP) Receptors Produces an Increase in Non-REM Sleep in Rats and Constitutes a Novel and Attractive Target for the Treatment of Insomnia. Sleep. 2020;43(S1):A1. Whiteside GT, Hummel M, Knappenberger T, et al.

Urology

Abstracts

Date Citation Link
September 2023 Medical Claims Data Analysis of Comorbidities in Patients with Interstitial Cystitis / Bladder Pain Syndrome. Continence. 2024;7(S1):100823. Pascale V, Yu T, Onyekwere U, Zhao X, Wang S, Mikl J.
April 2023 Effects of Sunobinop (V117957) in a Model of Acute Cystitis Induced by Cyclophosphamide. The Journal of Urology. 2023;209(S4):E152. Whiteside GT, Auge, C, Lluel P.

Alcohol Use Disorder (AUD)

Manuscripts

Date Citation Link
May 2025 Return to Alcohol Use Among Patients Who are in Recovery from Alcohol Use Disorder with Pharmacologically Treated vs Untreated Insomnia. J Stud Alcohol Drugs. Online 27 May 2025. Mikl J, Yu T, Singh S, et al.
June 2020 Current and Potential Pharmacological Treatment Options for Insomnia in Patients with Alcohol Use Disorder in Recovery. Neuropsychopharmacol Rep. 2020;40(3):211-223. Roehrs TA, Auciello J, Tseng J, Whiteside G.

Abstracts

Date Citation Link
May 2020 Psychomotor/Cognitive Effects, Pharmacokinetics and Safety of V117957, a Novel, Highly Potent and Selective Partial Agonist for Nociceptin/Orphanin-FQ Peptide (NOP) Receptors, Administered in Combination with Alcohol in Healthy Subjects. Sleep. 2020;43(S1):A78. Zhou M, Harris, SC, Cipriano, A, et al.