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- lumicitabine (JNJ-64041575) / J&J
Phase classification: A Phase 2a Study to Evaluate Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus (clinicaltrials.gov) - Feb 4, 2025
P2, N=9, Completed, Sponsor: Alios Biopharma Inc.
Phase classification: P2a --> P2
- || PC786 / Pulmocide
Review, Journal: Systematic Review of the Efficacy and Safety of RSV-Specific Monoclonal Antibodies and Antivirals in Development. (Pubmed Central) - Sep 1, 2024
Moving forward, passive immunisation and treatment options for RSV infection will play a significant role in reducing the health burden of RSV, complementing recent advancements in vaccine development. TRIAL REGISTRATION: PROSPERO registration: CRD42022376633.
- || lumicitabine (JNJ-64041575) / J&J
PK/PD data, Journal: Lumicitabine, an orally administered nucleoside analog, in infants hospitalized with respiratory syncytial virus (RSV) infection: Safety, efficacy, and pharmacokinetic results. (Pubmed Central) - Jul 23, 2023
P1, P2
This contrasts with the findings of the previous RSV-A adult challenge study where significant antiviral activity was noted, without incidence of neutropenia. Trial registration ClinicalTrials.gov Identifier: NCT02202356 (phase 1b); NCT03333317 (phase 2b).
- || bemnifosbuvir (AT-527) / Atea Pharma, lumicitabine (JNJ-64041575) / J&J, Lagevrio (molnupiravir) / Ridgeback Biotherap, Merck (MSD)
Review, Journal: Nucleoside analogs for management of respiratory virus infections: mechanism of action and clinical efficacy. (Pubmed Central) - Nov 22, 2022
Besides, we outline how nucleoside analogs interact with the polymerases of respiratory viruses, to cause lethal virus mutagenesis or disturbance of viral RNA synthesis. In this way, we aim to convey the key findings on this rapidly evolving class of respiratory virus medication.
- | lumicitabine (JNJ-64041575) / J&J
Journal: Nitro-Activated Nucleobase Exchange in the Synthesis of 2'-Fluoro-2'-Deoxyribonucleosides. (Pubmed Central) - Jul 20, 2022
Under Vorbrüggen conditions, 5-nitrouracil serves as the leaving nucleobase and enables exchange with pyrimidine and purine nucleobases to anomeric 2'-fluoro-2'-deoxyribonucleosides in favor of β-anomers generally. The strategy is also applied in the isotopic labeling of 2'-fluoro-2'-deoxyuridines.
- | Journal: 4'-Modified Nucleosides for Antiviral Drug Discovery: Achievements and Perspectives. (Pubmed Central) - Feb 19, 2022
P=N/A, P3
FNC cured the COVID-19 disease in almost all patients and showed better therapeutic efficacy than remdesivir. In this Account, we provide an overview of 4'-modified nucleoside analogs in clinical stages for antiviral therapies, highlighting the drug discovery strategies, structure-activity relationship studies, and preclinical/clinical studies and also give our perspectives on nucleoside-based antiviral drug discovery.
- | Preclinical, Journal: Evaluation of Small Molecule Combinations against Respiratory Syncytial Virus In Vitro. (Pubmed Central) - May 25, 2021
On the other hand, all combinations between fusion inhibitors showed antagonistic effects against RSV in vitro, with volume of antagonism ranging from -50 µM % to -176 µM % at 95% confidence interval. Over all, our results suggest the potentially therapeutic combinations in combating RSV in vitro could be considered for further animal and clinical evaluations.
- lumicitabine (JNJ-64041575) / J&J
[VIRTUAL] Expedient synthesis of nucleoside analogues by activation and replacement of pyrimidine nucleobases: Application for synthesis of radio-labeled lumicitabine via Vorbrüggen transglycosylation () - Mar 28, 2021 - Abstract #ACSSp2021ACS-Sp_7135;
This synthetic method was applied to the production of radioisotope-labeled Lumicitabine (ALS-8176, 4) by activation of a pyrimidine nucleobase via substitution of the electron-withdrawing group at the 5-position of the uracil ring of the 2-deoxyuridine analogues, followed by replacement of the activated uracil with a 14C-labeled uracil (Vorbrüggen reaction with BSA/TMSOTf), producing a high specific activity 14C tracer in respectable radiochemical yield, thus demonstrating the utility of the method for the production of a complex nucleoside analogues. The results will be presented.
- | lumicitabine (JNJ-64041575) / J&J
Preclinical, Journal: Potent in vitro activity of β-D-4'-chloromethyl-2'-deoxy-2'-fluorocytidine against Nipah virus. (Pubmed Central) - Dec 18, 2020
However, further cytotoxicity testing in primary cells and bone marrow progenitor cells indicated cytotoxicity at higher concentrations of ALS-8112. Our results warrant the evaluation of lumicitabine against NiV infection in relevant animal models.
- | Review, Journal: Advances in respiratory virus therapeutics - A meeting report from the 6th isirv Antiviral Group conference. (Pubmed Central) - May 17, 2020
Other topics included considerations of novel endpoints such as ordinal scales and patient reported outcomes (PRO), and study design issues, and other regulatory considerations for antiviral drug development. The aim of this report is to provide a summary of the presentations given at this meeting.
- | lumicitabine (JNJ-64041575) / J&J
Trial completion: A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection (clinicaltrials.gov) - May 13, 2020
P2, N=7, Completed, Sponsor: Janssen Research & Development, LLC
The aim of this report is to provide a summary of the presentations given at this meeting. Active, not recruiting --> Completed
- | lumicitabine (JNJ-64041575) / J&J
Journal: Respiratory syncytial virus-A dynamics and the effects of lumicitabine, a nucleoside viral replication inhibitor, in experimentally infected humans. (Pubmed Central) - May 9, 2020
The semi-mechanistic model characterizes RSV kinetics and the antiviral effectiveness of lumicitabine in an adult challenge population. This model is applicable to guide dose selection in adult and paediatric patients.
- |||| lumicitabine (JNJ-64041575) / J&J
Clinical data, New P2 trial: A Study of ALS-008176 in Infants and Children Hospitalized with RSV (EUDRACT) - Apr 4, 2019
P2, N=120, , Sponsor: Janssen-Cilag International NV
- | lumicitabine (JNJ-64041575) / J&J
Trial completion date, Trial primary completion date: A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection (clinicaltrials.gov) - Dec 5, 2018
P2, N=7, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
This model is applicable to guide dose selection in adult and paediatric patients. Trial completion date: Apr 2021 --> Apr 2020 | Trial primary completion date: Apr 2021 --> Apr 2020
- | lumicitabine (JNJ-64041575) / J&J
Enrollment change, Trial withdrawal: STEP: Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Oral Lumicitabine Regimens in Hospitalized Adult Participants Infected With Human Metapneumovirus (clinicaltrials.gov) - Nov 15, 2018
P2b, N=0, Withdrawn, Sponsor: Janssen Research & Development, LLC
Trial completion date: Apr 2021 --> Apr 2020 | Trial primary completion date: Apr 2021 --> Apr 2020 N=90 --> 0 | Not yet recruiting --> Withdrawn
- | lumicitabine (JNJ-64041575) / J&J
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus (clinicaltrials.gov) - Nov 14, 2018
P2, N=7, Terminated, Sponsor: Janssen Research & Development, LLC
N=90 --> 0 | Not yet recruiting --> Withdrawn N=180 --> 7 | Trial completion date: Apr 2019 --> Mar 2018 | Suspended --> Terminated | Trial primary completion date: Apr 2019 --> Mar 2018; Sponsor Decision
- | lumicitabine (JNJ-64041575) / J&J
Enrollment closed, Enrollment change: A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection (clinicaltrials.gov) - Nov 7, 2018
P2, N=7, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
N=180 --> 7 | Trial completion date: Apr 2019 --> Mar 2018 | Suspended --> Terminated | Trial primary completion date: Apr 2019 --> Mar 2018; Sponsor Decision Recruiting --> Active, not recruiting | N=70 --> 7
- | lumicitabine (JNJ-64041575) / J&J
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus (clinicaltrials.gov) - Nov 7, 2018
P2b, N=49, Terminated, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting | N=70 --> 7 N=128 --> 49 | Trial completion date: Mar 2019 --> Jul 2018 | Suspended --> Terminated | Trial primary completion date: Mar 2019 --> Jul 2018; sponsor decision
- | lumicitabine (JNJ-64041575) / J&J
Trial completion date: STEP: Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Oral Lumicitabine Regimens in Hospitalized Adult Participants Infected With Human Metapneumovirus (clinicaltrials.gov) - Aug 8, 2018
P2b, N=90, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
N=128 --> 49 | Trial completion date: Mar 2019 --> Jul 2018 | Suspended --> Terminated | Trial primary completion date: Mar 2019 --> Jul 2018; sponsor decision Trial completion date: Nov 2019 --> Oct 2020
- | lumicitabine (JNJ-64041575) / J&J
Trial suspension: Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus (clinicaltrials.gov) - Jul 23, 2018
P2b, N=128, Suspended, Sponsor: Janssen Research & Development, LLC
Trial completion date: Nov 2019 --> Oct 2020 Recruiting --> Suspended
- | lumicitabine (JNJ-64041575) / J&J
Enrollment change, Trial termination: A Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Participants (clinicaltrials.gov) - Jul 23, 2018
P1, N=18, Terminated, Sponsor: Janssen Research & Development, LLC
Recruiting --> Suspended N=36 --> 18 | Recruiting --> Terminated; The study has been terminated due to pending data analysis
- | lumicitabine (JNJ-64041575) / J&J
New P1 trial: A Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Participants (clinicaltrials.gov) - Jul 23, 2018
P1, N=18, Terminated, Sponsor: Janssen Research & Development, LLC
- || lumicitabine (JNJ-64041575) / J&J
Trial primary completion date: Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus (clinicaltrials.gov) - Jun 8, 2018
P2b, N=126, Recruiting, Sponsor: Janssen Research & Development, LLC
N=36 --> 18 | Recruiting --> Terminated; The study has been terminated due to pending data analysis Trial primary completion date: Apr 2018 --> Mar 2019
- || lumicitabine (JNJ-64041575) / J&J
Trial completion: A Crossover Study to Assess the Effect of Intravenous Infusion of Piperacillin/Tazobactam on the Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) in Healthy Adult Participants (clinicaltrials.gov) - Jun 7, 2018
P1, N=18, Completed, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Apr 2018 --> Mar 2019 Active, not recruiting --> Completed
- lumicitabine (JNJ-64041575) / J&J
Enrollment closed: A Crossover Study to Assess the Effect of Intravenous Infusion of Piperacillin/Tazobactam on the Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) in Healthy Adult Participants (clinicaltrials.gov) - Apr 25, 2018
P1, N=18, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||||| lumicitabine (JNJ-64041575) / J&J
New P2b trial: STEP: Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Oral Lumicitabine Regimens in Hospitalized Adult Participants Infected With Human Metapneumovirus (clinicaltrials.gov) - Apr 18, 2018
P2b, N=90, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- | lumicitabine (JNJ-64041575) / J&J
Trial completion: A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants With Various Degrees of Renal Function (clinicaltrials.gov) - Apr 17, 2018
P1, N=38, Completed, Sponsor: Janssen Pharmaceutica N.V., Belgium
Recruiting --> Active, not recruiting Recruiting --> Completed
- ||| lumicitabine (JNJ-64041575) / J&J
Trial completion, Enrollment change: A Study of ALS-008176 in Infants Hospitalized With RSV (clinicaltrials.gov) - Mar 30, 2018
P1, N=183, Completed, Sponsor: Alios Biopharma Inc.
Recruiting --> Completed Recruiting --> Completed | N=264 --> 183
- | lumicitabine (JNJ-64041575) / J&J
New P1 trial: A Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Participants (clinicaltrials.gov) - Mar 18, 2018
P1, N=36, Recruiting, Sponsor: Janssen Research & Development, LLC
- | lumicitabine (JNJ-64041575) / J&J
Trial suspension: A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus (clinicaltrials.gov) - Mar 9, 2018
P2, N=180, Suspended, Sponsor: Janssen Research & Development, LLC
Recruiting --> Completed | N=264 --> 183 Recruiting --> Suspended
- | lumicitabine (JNJ-64041575) / J&J
New P1 trial: A Crossover Study to Assess the Effect of Intravenous Infusion of Piperacillin/Tazobactam on the Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) in Healthy Adult Participants (clinicaltrials.gov) - Feb 22, 2018
P1, N=18, Recruiting, Sponsor: Janssen Research & Development, LLC
- |||| lumicitabine (JNJ-64041575) / J&J
Enrollment open: A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection (clinicaltrials.gov) - Jan 31, 2018
P2, N=70, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Suspended Not yet recruiting --> Recruiting
- |||| lumicitabine (JNJ-64041575) / J&J
Enrollment open: A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus (clinicaltrials.gov) - Dec 18, 2017
P2, N=180, Recruiting, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| lumicitabine (JNJ-64041575) / J&J
New P2 trial: A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection (clinicaltrials.gov) - Nov 6, 2017
P2, N=70, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- ||||| lumicitabine (JNJ-64041575) / J&J
New P2 trial: A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus (clinicaltrials.gov) - Nov 6, 2017
P2, N=180, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- || Clinical: A Study of ALS-008176 in Infants Hospitalized With RSV (clinicaltrials.gov) - Oct 10, 2017
P1, N=264, Recruiting, Sponsor: Alios Biopharma Inc.
Not yet recruiting --> Recruiting Trial primary completion date: Nov 2017 --> Mar 2018
- lumicitabine (JNJ-64041575) / J&J
Clinical: A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants With Various Degrees of Renal Function (clinicaltrials.gov) - Aug 24, 2017
P1, N=42, Recruiting, Sponsor: Janssen Pharmaceutica N.V., Belgium
Trial primary completion date: Nov 2017 --> Mar 2018 Not yet recruiting --> Recruiting
- | lumicitabine (JNJ-64041575) / J&J
P1 data: A Phase 1 Study to Evaluate the Effect of the Organic Anion Transporter Inhibitor Probenecid on the Pharmacokinetics of JNJ-64041575 in Healthy Adults (clinicaltrials.gov) - Jul 25, 2017
P1, N=18, Completed, Sponsor: Janssen-Cilag International NV
Not yet recruiting --> Recruiting Recruiting --> Completed
- ||| lumicitabine (JNJ-64041575) / J&J
Clinical: Study to Evaluate the Effect of ALS-008176 on Cardiac Repolarization Interval in Healthy Participants (clinicaltrials.gov) - Jul 2, 2017
P1, N=111, Completed, Sponsor: Alios Biopharma Inc.
Recruiting --> Completed Recruiting --> Completed | N=78 --> 111
- | lumicitabine (JNJ-64041575) / J&J
Clinical: A Study to Assess the Relative Bioavailability of JNJ64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations (clinicaltrials.gov) - Jun 23, 2017
P1, N=48, Completed, Sponsor: Janssen Research & Development, LLC
Recruiting --> Completed | N=78 --> 111 Active, not recruiting --> Completed
- | lumicitabine (JNJ-64041575) / J&J
Clinical: A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants With Various Degrees of Renal Function (clinicaltrials.gov) - Jun 16, 2017
P1, N=42, Not yet recruiting, Sponsor: Janssen Pharmaceutica N.V., Belgium
- ||| Clinical: A Study of ALS-008176 in Infants Hospitalized With RSV (clinicaltrials.gov) - Jun 2, 2017
P1, N=264, Recruiting, Sponsor: Alios Biopharma Inc.
Active, not recruiting --> Completed Suspended --> Recruiting
- lumicitabine (JNJ-64041575) / J&J
P1 data: A Phase 1 Study to Evaluate the Effect of the Organic Anion Transporter Inhibitor Probenecid on the Pharmacokinetics of JNJ-64041575 in Healthy Adults (clinicaltrials.gov) - May 9, 2017
P1, N=18, Recruiting, Sponsor: Janssen-Cilag International NV
Suspended --> Recruiting Not yet recruiting --> Recruiting
- || lumicitabine (JNJ-64041575) / J&J
Clinical data: Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus (clinicaltrials.gov) - May 1, 2017
P2b, N=114, Recruiting, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting Trial primary completion date: Apr 2017 --> Apr 2018
- lumicitabine (JNJ-64041575) / J&J
Clinical: A Study to Assess the Relative Bioavailability of JNJ64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations (clinicaltrials.gov) - Apr 12, 2017
P1, N=48, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Apr 2017 --> Apr 2018 Recruiting --> Active, not recruiting
- | lumicitabine (JNJ-64041575) / J&J
P1 data: A Phase 1 Study to Evaluate the Effect of the Organic Anion Transporter Inhibitor Probenecid on the Pharmacokinetics of JNJ-64041575 in Healthy Adults (clinicaltrials.gov) - Apr 10, 2017
P1, N=18, Not yet recruiting, Sponsor: Janssen-Cilag International NV
- |||| lumicitabine (JNJ-64041575) / J&J
Clinical data: Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus (clinicaltrials.gov) - Mar 24, 2017
P2b, N=114, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting Suspended --> Recruiting
- | lumicitabine (JNJ-64041575) / J&J
Clinical data: Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus (clinicaltrials.gov) - Feb 27, 2017
P2b, N=114, Suspended, Sponsor: Janssen Research & Development, LLC
Suspended --> Recruiting N=90 --> 114
- lumicitabine (JNJ-64041575) / J&J
Clinical: A Study to Assess the Relative Bioavailability of JNJ64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations (clinicaltrials.gov) - Feb 24, 2017
P1, N=48, Recruiting, Sponsor: Janssen Research & Development, LLC
N=90 --> 114 Not yet recruiting --> Recruiting
- || lumicitabine (JNJ-64041575) / J&J
Clinical: Study to Evaluate the Effect of ALS-008176 on Cardiac Repolarization Interval in Healthy Participants (clinicaltrials.gov) - Feb 1, 2017
P1, N=78, Recruiting, Sponsor: Alios Biopharma Inc.
Not yet recruiting --> Recruiting Trial primary completion date: Oct 2016 --> Feb 2017