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
April 2026
A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Interactions Between Alcohol and Sunobinop in Healthy Participants.
J Clin Psychopharmacol. 2026;April 3.
Harris S, Shet M, Cipriano A, et al.
March 2026
Human Abuse Potential of Single Oral Doses of Sunobinop, a Novel, Highly Potent, and Selective Partial Agonist for Nociceptin/Orphanin-FQ Peptide (NOP) Receptors.
J Clin Psychopharmacol.2026;46(3):297-310.
Harris SC, Cipriano A, Whiteside GT, et al.
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. 2026;92(1):172-185.
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
Pharmacologic Treatment of Insomnia Reduces Risk of Return to Alcohol Use in Patients in Recovery From Alcohol Use Disorder.
J Stud Alcohol Drugs. 2026;87(2):314–322.
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.
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