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49 News |  |
- | retosiban (GSK-221,149-A) / GSK
Journal: Crystal structure of the human oxytocin receptor. (Pubmed Central) - Apr 12, 2022
Here, we report the crystal structure of human OTR in complex with retosiban, a nonpeptidic antagonist developed as an oral drug for the prevention of preterm labor...Furthermore, our structure in combination with experimental data allows the identification of a conserved neurohypophyseal receptor-specific coordination site for Mg that acts as potent, positive allosteric modulator for agonist binding. Together, these results further our molecular understanding of the oxytocin/vasopressin receptor family and will facilitate structure-guided development of new therapeutics.
- || retosiban (GSK-221,149-A) / GSK
Clinical, Journal: Randomized Trials of Retosiban Versus Placebo or Atosiban in Spontaneous Preterm Labor. (Pubmed Central) - Jan 4, 2022
Key factors negatively affecting participation were patient and physician resistance to use of a placebo comparator, lack of investigator consensus on diagnostic criteria and acceptance of protocol procedures, and ethics committee decisions. Meaningful cooperation between pharmaceutical companies, regulatory authorities, and the obstetric community is essential for future development of drugs to treat sPTL.
- || nolasiban (OBE001) / ObsEva, retosiban (GSK-221,149-A) / GSK
Review, Journal: Oxytocin antagonists for assisted reproduction. (Pubmed Central) - Nov 29, 2021
This conclusion is based on a phased study comprising three trials that provided low- to high-certainty evidence. Further large, well-designed RCTs, reporting on live births and adverse clinical outcomes, should focus on identifying the subgroups of women who are likely to benefit from this intervention.
- || retosiban (GSK-221,149-A) / GSK
Clinical, Retrospective data, Review, Journal: Novel oxytocin receptor antagonists for tocolysis: a systematic review and meta-analysis of the available data on the efficacy, safety, and tolerability of retosiban. (Pubmed Central) - Oct 20, 2021
With the limited high quality evidence available, retosiban demonstrates no clear benefit over placebo in the management of preterm labor. Nevertheless, its favorable safety profile, oral bioavailability, and novel mechanism of action and the limited number of studies available for review warrant further analysis.
- || retosiban (GSK-221,149-A) / GSK
Clinical, Journal: Safety and Outcomes in Infants Born to Mothers Participating in Retosiban Treatment Trials: ARIOS Follow-Up Study. (Pubmed Central) - Aug 6, 2021
· There were no safety concerns with retosiban treatment. · Slow recruitment led to termination of the Phase 3 trials.
- || retosiban (GSK-221,149-A) / GSK
Clinical, Journal: Erratum: Randomized Trials of Retosiban versus Placebo or Atosiban in Spontaneous Preterm Labor. (Pubmed Central) - Jul 9, 2021
· Slow recruitment led to termination of the Phase 3 trials. No abstract available
- | retosiban (GSK-221,149-A) / GSK
Journal: Functionally selective inhibition of the oxytocin receptor by retosiban in human myometrial smooth muscle. (Pubmed Central) - Jul 18, 2020
Retosiban and epelsiban demonstrate distinct pharmacology when compared to atosiban in human myometrial smooth muscle. Atosiban displays agonist activity at micromolar concentrations leading to stimulation of prostaglandin production.
- | retosiban (GSK-221,149-A) / GSK
Trial completion, Enrollment change: ARIOS: Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies (clinicaltrials.gov) - Sep 25, 2019
P3, N=99, Completed, Sponsor: GlaxoSmithKline
Atosiban displays agonist activity at micromolar concentrations leading to stimulation of prostaglandin production. Active, not recruiting --> Completed | N=2100 --> 99
- ||||| retosiban (GSK-221,149-A) / GSK
Enrollment closed, Phase classification, Trial completion date, Trial primary completion date: ARIOS: Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies (clinicaltrials.gov) - Jun 13, 2019
P3, N=2100, Active, not recruiting, Sponsor: GlaxoSmithKline
Active, not recruiting --> Completed | N=2100 --> 99 Phase classification: P2/3 --> P3 | Trial completion date: Jul 2022 --> Jul 2019 | Trial primary completion date: Jul 2022 --> Jul 2019 | Recruiting --> Active, not recruiting
- | retosiban (GSK-221,149-A) / GSK
Clinical, P1 data, PK/PD data, Journal: A Phase 1 Randomized, Placebo-Controlled Study Assessing the Pharmacokinetics, Safety, and Tolerability of Retosiban in Healthy, Nonpregnant Japanese Subjects. (Pubmed Central) - Mar 29, 2019
The 2 doses of retosiban were well tolerated across both populations, and no ethnic difference was observed in the safety profile. Given the results of this study and the known safety profile and dosing flexibility in the phase 3 trials, ethnic-specific dose adjustment of retosiban is not considered necessary for the Japanese and general Asian population.
- | retosiban (GSK-221,149-A) / GSK
Enrollment open, Phase classification: ARIOS: Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies (clinicaltrials.gov) - Nov 15, 2018
P2/3, N=2100, Recruiting, Sponsor: GlaxoSmithKline
Given the results of this study and the known safety profile and dosing flexibility in the phase 3 trials, ethnic-specific dose adjustment of retosiban is not considered necessary for the Japanese and general Asian population. Active, not recruiting --> Recruiting | Phase classification: P3 --> P2/3
- ||| retosiban (GSK-221,149-A) / GSK
Enrollment change: The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor (clinicaltrials.gov) - Dec 13, 2017
P2, N=93, Completed, Sponsor: GlaxoSmithKline
Active, not recruiting --> Recruiting | Phase classification: P3 --> P2/3 N=75 --> 93
- retosiban (GSK-221,149-A) / GSK
Enrollment change: NEWBORN-1: A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor (clinicaltrials.gov) - Nov 1, 2017
P3, N=24, Terminated, Sponsor: GlaxoSmithKline
N=75 --> 93 N=19 --> 24
- | retosiban (GSK-221,149-A) / GSK
Enrollment change, Trial termination: A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour (clinicaltrials.gov) - Oct 10, 2017
P3, N=99, Terminated, Sponsor: GlaxoSmithKline
N=19 --> 24 N=330 --> 99 | Active, not recruiting --> Terminated; The study was stopped due to the feasibility of recruiting the study in a timely manner
- ||||| retosiban (GSK-221,149-A) / GSK
Enrollment closed: ARIOS: Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies (clinicaltrials.gov) - Sep 7, 2017
P3, N=2100, Active, not recruiting, Sponsor: GlaxoSmithKline
N=330 --> 99 | Active, not recruiting --> Terminated; The study was stopped due to the feasibility of recruiting the study in a timely manner Recruiting --> Active, not recruiting
- retosiban (GSK-221,149-A) / GSK
Trial primary completion date: NEWBORN-1: A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor (clinicaltrials.gov) - Jul 12, 2017
P3, N=19, Terminated, Sponsor: GlaxoSmithKline
Recruiting --> Active, not recruiting Trial primary completion date: Nov 2017 --> Jul 2017
- retosiban (GSK-221,149-A) / GSK
Enrollment change, Trial termination, Trial primary completion date: NEWBORN-1: A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor (clinicaltrials.gov) - Jun 16, 2017
P3, N=19, Terminated, Sponsor: GlaxoSmithKline
Trial primary completion date: Nov 2017 --> Jul 2017 N=900 --> 19 | Recruiting --> Terminated | Trial primary completion date: Jan 2019 --> Nov 2017; Asset terminated by PIB
- ||||| retosiban (GSK-221,149-A) / GSK
Enrollment closed: A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour (clinicaltrials.gov) - May 10, 2017
P3, N=330, Active, not recruiting, Sponsor: GlaxoSmithKline
N=900 --> 19 | Recruiting --> Terminated | Trial primary completion date: Jan 2019 --> Nov 2017; Asset terminated by PIB Recruiting --> Active, not recruiting
- |||| retosiban (GSK-221,149-A) / GSK
Trial primary completion date: ARIOS: Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies (clinicaltrials.gov) - May 9, 2017
P3, N=2100, Recruiting, Sponsor: GlaxoSmithKline
Recruiting --> Active, not recruiting Trial primary completion date: Mar 2024 --> Jul 2022
- |||||| retosiban (GSK-221,149-A) / GSK
Enrollment open: NEWBORN-1: A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor (clinicaltrials.gov) - Apr 13, 2016
P3, N=900, Recruiting, Sponsor: GlaxoSmithKline
Trial primary completion date: Mar 2024 --> Jul 2022 Not yet recruiting --> Recruiting
- |||| retosiban (GSK-221,149-A) / GSK
Trial primary completion date: A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour (clinicaltrials.gov) - Jan 20, 2016
P3, N=330, Recruiting, Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting Trial primary completion date: Jun 2016 --> Aug 2017
- |||| retosiban (GSK-221,149-A) / GSK
Trial primary completion date: NEWBORN-1: A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor (clinicaltrials.gov) - Nov 9, 2015
P3, N=900, Not yet recruiting, Sponsor: GlaxoSmithKline
Trial primary completion date: Jun 2016 --> Aug 2017 Trial primary completion date: Feb 2018 --> Nov 2018
- |||| retosiban (GSK-221,149-A) / GSK
Phase classification, Trial primary completion date: ARIOS: Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies (clinicaltrials.gov) - Aug 24, 2015
P3, N=2100, Recruiting, Sponsor: GlaxoSmithKline
Trial primary completion date: Feb 2018 --> Nov 2018 Phase classification: P=N/A --> P3 | Trial primary completion date: Oct 2021 --> Mar 2024
- ||||| retosiban (GSK-221,149-A) / GSK
Trial initiation date, Trial primary completion date: NEWBORN-1: A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor (clinicaltrials.gov) - Jul 20, 2015
P3, N=900, Not yet recruiting, Sponsor: GlaxoSmithKline
Phase classification: P=N/A --> P3 | Trial primary completion date: Oct 2021 --> Mar 2024 Initiation date: Jul 2015 --> Nov 2015 | Trial primary completion date: Jul 2017 --> Feb 2018
- ||| retosiban (GSK-221,149-A) / GSK
Enrollment open: ARIOS: Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies (clinicaltrials.gov) - Jun 15, 2015
P=N/A, N=2100, Recruiting, Sponsor: GlaxoSmithKline
Initiation date: Jul 2015 --> Nov 2015 | Trial primary completion date: Jul 2017 --> Feb 2018 Not yet recruiting --> Recruiting
- | retosiban (GSK-221,149-A) / GSK
Trial completion, Enrollment change: Study to Investigate the Pharmacokinetics (PK), Safety and Tolerability of Retosiban in Healthy Japanese Women (clinicaltrials.gov) - Jun 6, 2015
P1, N=32, Completed, Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting Recruiting --> Completed | N=24 --> 32
- ||||| retosiban (GSK-221,149-A) / GSK
Trial initiation date: NEWBORN-1: A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor (clinicaltrials.gov) - Apr 22, 2015
P3, N=900, Not yet recruiting, Sponsor: GlaxoSmithKline
Recruiting --> Completed | N=24 --> 32 Initiation date: Apr 2015 --> Jul 2015
- |||||| retosiban (GSK-221,149-A) / GSK
Enrollment open: A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour (clinicaltrials.gov) - Apr 22, 2015
P3, N=330, Recruiting, Sponsor: GlaxoSmithKline
Initiation date: Apr 2015 --> Jul 2015 Not yet recruiting --> Recruiting
- retosiban (GSK-221,149-A) / GSK
Enrollment open: Study to Investigate the Pharmacokinetics (PK), Safety and Tolerability of Retosiban in Healthy Japanese Women (clinicaltrials.gov) - Apr 2, 2015
P1, N=24, Recruiting, Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| retosiban (GSK-221,149-A) / GSK
New P3 trial: NEWBORN-1: A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor (clinicaltrials.gov) - Mar 3, 2015
P3, N=900, Not yet recruiting, Sponsor: GlaxoSmithKline
- | retosiban (GSK-221,149-A) / GSK
New P1 trial: Study to Investigate the Pharmacokinetics (PK), Safety and Tolerability of Retosiban in Healthy Japanese Women (clinicaltrials.gov) - Mar 3, 2015
P1, N=24, Not yet recruiting, Sponsor: GlaxoSmithKline
- ||| retosiban (GSK-221,149-A) / GSK
Clinical: ARIOS: Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies (clinicaltrials.gov) - Nov 17, 2014
P=N/A, N=2100, Not yet recruiting, Sponsor: GlaxoSmithKline
- |||||||||| retosiban (GSK-221,149-A) / GSK
New P3 trial: A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour (clinicaltrials.gov) - Nov 17, 2014
P3, N=330, Not yet recruiting, Sponsor: GlaxoSmithKline
- retosiban (GSK-221,149-A) / GSK
Enrollment change: A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) When Dosed With Efavirenz (EFZ) (clinicaltrials.gov) - Jan 8, 2014
P1, N=18, Completed, Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting N=13 --> 18
- | retosiban (GSK-221,149-A) / GSK
Trial completion: A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) When Dosed With Efavirenz (EFZ) (clinicaltrials.gov) - Oct 3, 2013
P1, N=18, Completed, Sponsor: GlaxoSmithKline
N=13 --> 18 Active, not recruiting --> Completed
- | retosiban (GSK-221,149-A) / GSK
New P1 trial: A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) When Dosed With Efavirenz (EFZ) (clinicaltrials.gov) - Jun 2, 2013
P1, N=18, Completed, Sponsor: GlaxoSmithKline
- || retosiban (GSK-221,149-A) / GSK
Enrollment change: This Study Will Investigate the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers. (clinicaltrials.gov) - Feb 27, 2013
P1, N=52, Completed, Sponsor: GlaxoSmithKline
Active, not recruiting --> Completed N=25 --> 52
- ||| retosiban (GSK-221,149-A) / GSK
Trial completion: This Study Will Investigate the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers. (clinicaltrials.gov) - Feb 27, 2013
P1, N=52, Completed, Sponsor: GlaxoSmithKline
N=25 --> 52 Not yet recruiting --> Completed
- ||| retosiban (GSK-221,149-A) / GSK
New P1 trial: This Study Will Investigate the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers. (clinicaltrials.gov) - Oct 4, 2012
P1, N=52, Completed, Sponsor: GlaxoSmithKline
- | retosiban (GSK-221,149-A) / GSK
New P1 trial: A Two Cohort Study to Look at the Metabolites of GSK221149, the Metabolism of GSK221149 Administered With a High Fat Meal and With Ketoconazole (clinicaltrials.gov) - Jun 24, 2012
P1, N=46, Completed, Sponsor: GlaxoSmithKline
- |||| retosiban (GSK-221,149-A) / GSK
Trial completion: The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor (clinicaltrials.gov) - Oct 13, 2011
P2, N=75, Completed, Sponsor: GlaxoSmithKline
Not yet recruiting --> Completed Recruiting --> Completed