niclosamide novel solution / Bayer - LARVOL DELTA

Clinical safety and pharmacokinetics of a novel oral niclosamide formulation compared with marketed niclosamide chewing tablets in healthy volunteers: A three-part randomized, double-blind, placebo-controlled trial. (PubMed, PLoS One) - P1 | "Overall safety and tolerability observed in healthy subjects were benign. This is also true for individuals with high absorption (Cmax > 2µg/ml), encouraging further research into niclosamide as a potential therapeutic agent. Galenic optimization, however, will remain challenging as evident from the observed exposure variability and non-linear PK. Non-linearity, if confirmed by additional data, might make niclosamide more suitable for multi-dose rather than high single dose regimens. The observed food effect should also be considered when further investigating systemic niclosamide exposures."

Clinical • Journal • PK/PD data • Gastrointestinal Disorder • Infectious Disease • Oncology

Nano-Dry-Melting: A Novel Technology for Manufacturing of Pharmaceutical Amorphous Solid Dispersions. (PubMed, Pharmaceutics) - "Feasibility studies were performed with indomethacin and PVP. Furthermore, a "proof-of-concept" study was conducted with niclosamide. The experiments successfully led to amorphous samples at temperatures of about 50 K below the melting point within seconds of heat exposition. With this novel, solvent-free and therefore "green" production technology it is feasible to manufacture ASDs even with those drug candidates that cannot be processed by conventional process technologies."

Journal

NICCAM: Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat (clinicaltrials.gov) - P2; N=4; Terminated; Sponsor: Charité Research Organisation GmbH; N=40 ➔ 4; Suspended ➔ Terminated; sub-therapeutic plasma levels of active substance

Clinical • Enrollment change • Trial termination • Infectious Disease • Novel Coronavirus Disease

NIC-002: Safety and Pharmacokinetics of a Novel Niclosamide Solution in Combination With Camostat (clinicaltrials.gov) - P1; N=28; Completed; Sponsor: Charité Research Organisation GmbH; Recruiting ➔ Completed

Clinical • Combination therapy • Trial completion • Infectious Disease • Novel Coronavirus Disease

NICCAM: Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat (clinicaltrials.gov) - P2; N=40; Suspended; Sponsor: Charité Research Organisation GmbH; Trial completion date: Jun 2021 ➔ Dec 2021; Recruiting ➔ Suspended; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Trial suspension • Infectious Disease • Novel Coronavirus Disease

NICCAM: Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Charité Research Organisation GmbH; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

NICCAM: Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat (clinicaltrials.gov) - P2; N=40; Not yet recruiting; Sponsor: Charité Research Organisation GmbH

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease

NIC-002: Safety and Pharmacokinetics of a Novel Niclosamide Solution in Combination With Camostat (clinicaltrials.gov) - P1; N=28; Recruiting; Sponsor: Charité Research Organisation GmbH

Clinical • Combination therapy • New P1 trial • Infectious Disease • Novel Coronavirus Disease