A Double-blind, Randomized, Placebo-controlled, Multicenter Phase III Clinical Trial to Examine the Clinical Efficacy and Safety of Ranquilon, 1 mg Tablets in Patients With Anxiety in Neurasthenia and Adjustment Disorders

The primary objective of the study is to evaluate the efficacy of Ranquilon, 1 mg tablets, at a dose of 6 mg/day compared to placebo for the treatment of patients with anxiety in neurasthenia and adjustment disorder.
An additional study objective was to evaluate the safety of Ranquilon, 1 mg tablets, at a dose of 6 mg/day compared to placebo in patients with anxiety in neurasthenia and adjustment disorder.

Start Date12 Oct 2022

Sponsor / Collaborator

Valenta Pharmaceuticals JSC

100 Clinical Results associated with Ranquilon

100 Translational Medicine associated with Ranquilon

100 Patents (Medical) associated with Ranquilon

Literatures (Medical) associated with Ranquilon

01 Jun 2023·Doklady. Biochemistry and biophysics

The Effect of the Agonist Cholecystokinin-4 D-GB-115 On the Character of Motor Activity of Paramecium caudatum.

Article

Author: Gruzdev, G A ; Soboleva, L V ; Kamensky, A A

The study investigated the effect of GABA in various concentrations and D-GB-115 at a concentration of 10^-7 M on the behavior of Paramecium caudatum. It was shown that GABA increases motor activity and changes the movement strategy of these protozoans, and the dose-effect relationship is domed, which can be explained by the presence of two types of GABA receptors in the outer membrane of paramecia: GABA-A and GABA-B. The active concentrations of GABA range from 10^-3 to 10^-13 M. The effect of pharmacological agents interacting with the GABA system on the behavior of ciliates (nembutal and D-GB-115) was studied.

01 Jan 2019·Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova

Results of a clinical study of a new anxiolytic, a blocker of central cholecystokinin receptors

Article

Author: Seredenin, S B ; Neznamov, G G ; Martyanov, V A ; Minaev, S V ; Dorofeeva, O A ; Syunyakov, T S ; Ivashkina, N Yu ; Metlina, M V

AIMTo evaluate anxiolytic action of GB-115, a low-affinity blocker of central cholecystokinin receptors, used in tablets in a dose of 1 mg for the treatment of patients with anxiety disorders in order to determine effective dose, safety, tolerability and efficacy in clinical settings.MATERIAL AND METHODSThe study included 31 patients (22 women, 9 men) diagnosed with generalized anxiety disorder (GAD, F41.1 according to ICD-10), aged from 22 to 53 years. The duration of treatment was 21 days. The Hamilton Anxiety Rating scale, Psychopathologic symptoms severity evaluation scale (PSSES), Spilberger State-Anxiety Inventory, Multidimensional Fatigue Inventory (MFI), Clinical Global Impression scale (CGI), computerized battery for evaluation of cognitive functions ('NS-Psychotest') were used.RESULTS AND CONCLUSIONThe effective dose of GB-115 was determined at 6 mg per day. Drug action is characterized by fast onset of anxiolytic effect with stimulating properties and beneficial effect on sleep disturbances and autonomic symptoms. GB-115 treatment was associated with favorable changes in attention parameters, reaction time and overall performance. In contrast to first-line drugs for GAD treatment (SSRIs and SNRIs), GB-115 does not induce initial overactivation, anxiety and sleep disturbances. GB-115 is safe and has a good tolerability.

14 Nov 2018·Current Pharmaceutical DesignQ4 · MEDICINE

Novel Technologies for Dipeptide Drugs Design and their Implantation

Q4 · MEDICINE

Review

Author: Ostrovskaya, Rita U. ; Gudasheva, Tatiana A. ; Seredenin, Sergey B.

The article is an overview of author’s data obtained in the framework of the project “The Creation of dipeptide preparations” at the V.V. Zakusov Institute of Pharmacology, Moscow, Russia. Advantages of dipeptides over longer peptides consist in that they are orally active owing to higher stability and ability to penetrate biological barriers due to the presence of specific ATP–dependent transporters in enterocytes and blood-brain barrier. Two original approaches for dipeptide drugs design have been developed. Both of them are based on the idea of a leading role of central dipeptide fragment of the peptide chain beta-turn in the peptide-receptor interaction. The first approach, named "peptide drug-based design" represents the transformation of known nonpeptide drug into its dipeptide topological analog. The latter usually corresponds to a beta-turn of some regulatory peptide. The second approach represents the design of tripeptoide mimetic of the beta-turn of regulatory peptide or protein. The results of the studies, which led to the discovery of endogenous prototypes of the known non-peptide drugs piracetam and sulpiride, are presented herein. The paper discusses the process, based on the abovementioned principles, that was used in designing of nontoxic, orally available, highly effective dipeptide drugs: nootropic noopept, dipeptide analog of piracetam; antipsychotic dilept, neurotensin tripeptoid analog; selective anxiolytic GB-115, tripeptoid analog of CCK-4, and potential neuroprotector GK-2, homodimeric dipeptide analog of NGF.

100 Deals associated with Ranquilon

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Indication	Highest Phase	Country/Location	Organization	Date
Adjustment disorders	Phase 3	RU	Valenta Pharmaceuticals JSC	12 Oct 2022
Anxiety Disorders	Phase 3	RU	Valenta Pharmaceuticals JSC	12 Oct 2022
Neurasthenia	Phase 3	RU	Valenta Pharmaceuticals JSC	12 Oct 2022

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