histamine glutarimide (XC-8) / Eurrus Biotech, Valenta Pharm - LARVOL DELTA

Superionic Transition in Mixed Conducting Graphite Intercalation Compounds CsC8 and RbC8. (PubMed, J Phys Chem B) - "Here, we investigate the ionic diffusion behavior of graphite intercalation compounds XC8 (X = Cs, Rb) through first-principles calculations combined with ab initio molecular dynamics simulations...Additionally, both compounds show good thermal stability and mechanical properties. These findings offer new insights into the design of high-performance MIEC materials."

Journal

A novel partitivirus with four dsRNA segments causing no obvious symptoms in Aspergillus flavus. (PubMed, Arch Virol) - "MZ600060.1 and MZ600061.1). Infection by AfPV2 isolate XC-8 did not cause any obvious significant phenotypic changes in A. flavus."

Journal • Infectious Disease

Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections (clinicaltrials.gov) - P3 | N=252 | Recruiting | Sponsor: Valenta Pharm JSC

New P3 trial • Cough • Infectious Disease • Respiratory Diseases

Pharmacokinetics and Bioequivalence of XC8 10 mg and 40 mg Tablets in Fasted Volunteers (clinicaltrials.gov) - P=N/A | N=24 | Completed | Sponsor: Valenta Pharm JSC | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Dec 2022 | Trial primary completion date: Dec 2023 ➔ Nov 2022

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

Efficacy and Safety of XC8, Film-coated Tablets, 40 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection (clinicaltrials.gov) - P3 | N=250 | Completed | Sponsor: Valenta Pharm JSC | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Jul 2022

Trial completion • Trial completion date • Cough • Infectious Disease • Influenza • Respiratory Diseases

Study of the Effect of Food Intake on the Bioavailability of XC8 10 mg Film-coated Tablets (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Valenta Pharm JSC | Recruiting ➔ Completed | N=46 ➔ 24

Enrollment change • Trial completion

System dynamics monitoring using PIC micro-controller-based PLSE. (PubMed, Chaos) - "The PLSE algorithm is optimized to fit the program and data memory of low-end processors using the XC8 compiler and the MPLAB X IDE...The effectiveness of the developed tool is validated by considering an electrical circuit of the Duffing oscillator that can generate both periodic and chaotic dynamics. By comparing the PLSE values with the phase portraits and previous results on the Duffing oscillator circuit, the developed tool efficiently allows one to monitor the behavior of dynamical systems."

Journal

Pharmacokinetics and Bioequivalence of XC8 10 mg and 40 mg Tablets in Fasted Volunteers (clinicaltrials.gov) - P=N/A | N=24 | Recruiting | Sponsor: Valenta Pharm JSC

New trial • Infectious Disease • Influenza • Respiratory Diseases

Efficacy and Safety of XC8, Film-coated Tablets, 40 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection (clinicaltrials.gov) - P3 | N=250 | Recruiting | Sponsor: Valenta Pharm JSC | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Enrollment open • Trial completion date • Trial primary completion date • Cough • Infectious Disease • Respiratory Diseases

Study of the Effect of Food Intake on the Bioavailability of XC8 10 mg Film-coated Tablets (clinicaltrials.gov) - P1 | N=46 | Recruiting | Sponsor: Valenta Pharm JSC

New P1 trial

Efficacy and Safety of XC8, Film-coated Tablets, 10 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection (clinicaltrials.gov) - P2 | N=160 | Completed | Sponsor: Valenta Pharm JSC

New P2 trial • Cough • Infectious Disease • Respiratory Diseases

Efficacy and Safety of XC8, Film-coated Tablets, 40 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection (clinicaltrials.gov) - P3 | N=250 | Not yet recruiting | Sponsor: Valenta Pharm JSC

New P3 trial • Cough • Infectious Disease • Respiratory Diseases

The Effect of Anti-Chemokine Oral Drug XC8 on Cough Triggered by The Agonists of TRPA1 But Not TRPV1 Channels in Guinea Pigs. (PubMed, Pulm Ther) - "XC8 acts against cough evoked by the activation of TRPA1 (citric acid/cinnamaldehyde) but not TRPV1 (capsaicin) channels. XC8 inhibits the cough reflex and suppresses the cough potentiation by IFN-γ. XC8 might be of significant therapeutic value for patients suffering from chronic cough associated with inflammation."

Journal • Asthma • Chronic Cough • Cough • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • IFNG

XC8 in the Treatment of Patients With the Eosinophilic Phenotype of Bronchial Asthma (clinicaltrials.gov) - P2; N=70; Completed; Sponsor: Chemlmmune Therapeutics LLC; Recruiting ➔ Completed

Clinical • Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

XC8 in the Treatment of Patients With the Eosinophilic Phenotype of Bronchial Asthma (clinicaltrials.gov) - P2; N=70; Recruiting; Sponsor: Chemlmmune Therapeutics LLC; Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Respiratory Diseases

XC8 in the Treatment of Patients With the Eosinophilic Phenotype of Bronchial Asthma (clinicaltrials.gov) - P2; N=70; Not yet recruiting; Sponsor: Chemlmmune Therapeutics LLC

Clinical • New P2 trial • Asthma • Immunology • Respiratory Diseases

New Anti-Chemokine Oral Drug XC8 in the Treatment of Asthma Patients with Poor Response to Corticosteroids: Results of a Phase 2A Randomized Controlled Clinical Trial. (PubMed, Pulm Ther) - P2 | "Given the high safety, oral route of administration, and efficacy, XC8 may provide a promising treatment option for patients with mild-to-moderate asthma."

Clinical • Journal • P2a data • Asthma • Respiratory Diseases • CCL2 • CXCL10 • IFNG

Safety, pharmacokinetics and pharmacodynamics of a novel anti-asthmatic drug, XC8, in healthy probands. (PubMed, Pulm Pharmacol Ther) - P1 | "XC8 was safe and well tolerated. A phase 2 study is being performed to further evaluate the potential role of XC8 in asthma treatment."

Clinical • Journal • PK/PD data • Asthma • Respiratory Diseases