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0 Diseases |  |
2 Trials |
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2 Trials |  |
46 News |  |
- || volixibat (SAR 548304) / Mirum Pharma
Trial completion date, Trial primary completion date: VANTAGE: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis (clinicaltrials.gov) - Jan 1, 2024
P2, N=180, Recruiting, Sponsor: Mirum Pharmaceuticals, Inc.
- ||| volixibat (SAR 548304) / Mirum Pharma
Enrollment change: VANTAGE: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis (clinicaltrials.gov) - Nov 14, 2023
P2, N=180, Recruiting, Sponsor: Mirum Pharmaceuticals, Inc.
N=260 --> 180
- | volixibat (SAR 548304) / Mirum Pharma
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA) (clinicaltrials.gov) - Feb 8, 2023
P2a/2b, N=4, Terminated, Sponsor: Mirum Pharmaceuticals, Inc.
N=260 --> 180 N=280 --> 4 | Trial completion date: Jan 2024 --> Dec 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2024 --> Dec 2022; Due to company's assessment of enrollment feasibility.
- ||| volixibat (SAR 548304) / Mirum Pharma
Enrollment closed: A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA) (clinicaltrials.gov) - Dec 13, 2022
P2a/2b, N=280, Active, not recruiting, Sponsor: Mirum Pharmaceuticals, Inc.
N=280 --> 4 | Trial completion date: Jan 2024 --> Dec 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2024 --> Dec 2022; Due to company's assessment of enrollment feasibility. Recruiting --> Active, not recruiting
- || volixibat (SAR 548304) / Mirum Pharma
$MIRM discontinue the OHANA study of Volixibat in intrahepatic cholestasis of pregnancy (ICP) due to enrollment feasibility. (Twitter) - Nov 29, 2022
- volixibat (SAR 548304) / Mirum Pharma, Livmarli (maralixibat) / Mirum Pharma
Dosing ileal bile acid transporter inhibitors in the fasted state minimizes gastrointestinal adverse effects while maintaining pharmacodynamic effect (Poster Area) - Mar 16, 2022 - Abstract #EASLILC2022EASL_ILC_1152;
These data demonstrate that GI tolerability is improved when dosing an IBATi in the fasted state, versus dosing at mealtime or immediately after food intake. Animal data show that PD effect is maintained regardless of dosing time relative to mealtime, suggesting that efficacy can be maintained while minimizing GI events.
- || volixibat (SAR 548304) / Mirum Pharma
Trial primary completion date: VISTAS: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) (clinicaltrials.gov) - Nov 14, 2021
P2, N=200, Recruiting, Sponsor: Mirum Pharmaceuticals, Inc.
Animal data show that PD effect is maintained regardless of dosing time relative to mealtime, suggesting that efficacy can be maintained while minimizing GI events. Trial primary completion date: Dec 2022 --> Sep 2024
- || volixibat (SAR 548304) / Mirum Pharma
Clinical, P2 data, Journal: Volixibat in adults with non-alcoholic steatohepatitis: 24-week interim analysis from a randomized, phase II study. (Pubmed Central) - Nov 5, 2021
P2
Increased serum C4 and decreased serum cholesterol levels provide evidence of target engagement. However, there was no therapeutic benefit of ASBT inhibition with volixibat on the liver in adults with NASH (ClinicalTrials.gov identifier: NCT02787304).
- |||| volixibat (SAR 548304) / Mirum Pharma
Enrollment open: VANTAGE: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis (clinicaltrials.gov) - Nov 3, 2021
P2, N=260, Recruiting, Sponsor: Mirum Pharmaceuticals, Inc.
However, there was no therapeutic benefit of ASBT inhibition with volixibat on the liver in adults with NASH (ClinicalTrials.gov identifier: NCT02787304). Not yet recruiting --> Recruiting
- ||||| volixibat (SAR 548304) / Mirum Pharma
New P2 trial: VANTAGE: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis (clinicaltrials.gov) - Sep 19, 2021
P2, N=260, Not yet recruiting, Sponsor: Mirum Pharmaceuticals, Inc.
- ||| volixibat (SAR 548304) / Mirum Pharma
Enrollment open: VISTAS: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) (clinicaltrials.gov) - Jan 5, 2021
P2, N=200, Recruiting, Sponsor: Mirum Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||| volixibat (SAR 548304) / Mirum Pharma
New P2 trial: VISTAS: A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) (clinicaltrials.gov) - Dec 11, 2020
P2, N=200, Not yet recruiting, Sponsor: Mirum Pharmaceuticals, Inc.
- || Review, Journal: The inhibitors of the apical sodium-dependent bile acid transporter (ASBT) as promising drugs (Pubmed Central) - Nov 2, 2020
All of them are at different stages of clinical trials, which confirm the high efficacy and good tolerance of these inhibitors. Current trends in this field also include directed chemical synthesis of ASBT inhibitors, as well as their search among substances of plant origin.
- volixibat (SAR 548304) / Mirum Pharma
[VIRTUAL] A PHASE 1 DOSE-RANGING STUDY ASSESSING FECAL BILE ACID EXCRETION BY VOLIXIBAT, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR, AND COADMINISTRATION WITH LOPERAMIDE () - Oct 11, 2020 - Abstract #AASLD2020AASLD_1221;
BID dosing appears to increase fBA excretion vs QD, and higher doses appear to increase bile acid synthesis. LOP mitigates transient diarrhea expected with ASBT inhibition.
- A3384 / Albireo, elobixibat (A3309) / Albireo, Ajinomoto, Ferring
[VIRTUAL] EFFICACY OF COMBINATION THERAPY WITH ELOBIXIBAT AND COLESTYRAMINE FOR NON-ALCOHOLIC STEATOHEPATITIS MODEL MICE TO PREVENT ARTERIOSCLEROSIS. () - Oct 11, 2020 - Abstract #AASLD2020AASLD_527;
Our findings clearly suggest ASBT inhibition in combination with BAS provide the promising therapeutic strategy for NASH with higher reduction of serum bile acid and tolerability compared to ASBT inhibitor monotherapy. In addition, it was found that a preventive effect on arteriosclerosis can be expected.
- A3384 / Albireo, elobixibat (A3309) / Albireo, Ajinomoto, Ferring
[VIRTUAL] Efficacy and safety of combination therapy with elobixibat and colestyramine for non-alcoholic steatohepatitis model mice (Poster Area) - May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-1455;
The phase 2 study of volixibat, an inhibitor of the apical sodium-dependent bile acid transporter (ASBT), for NASH was conducted but resulted in early termination due to lack of efficacy and occurrence of adverse events. Our findings clearly suggest ASBT inhibition in combination with BAS provide the promising therapeutic strategy for NASH with higher reduction of serum bile acid and tolerability compared to ASBT inhibitor monotherapy.
- | volixibat (SAR 548304) / Mirum Pharma
Preclinical, Journal: Apical sodium-dependent bile acid transporter inhibition with volixibat improves metabolic aspects and components of non-alcoholic steatohepatitis in Ldlr-/-.Leiden mice. (Pubmed Central) - Feb 22, 2020
Gene profiling showed that volixibat reversed the inhibitory effect of the HFD on metabolic master regulators, including peroxisome proliferator-activated receptor-γ coactivator-1β, insulin receptor, and sterol regulatory element-binding transcription factor 2. Volixibat may have beneficial effects on physiological and metabolic aspects of NASH pathophysiology.
- volixibat (SAR 548304) / Takeda, maralixibat (SHP625) / Takeda
DOSE-DEPENDENT FECAL BILE ACID EXCRETION WITH APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITORS MARALIXIBAT AND VOLIXIBAT IN A DOSE-RANGING PHASE 1 STUDY IN OVERWEIGHT AND OBESE ADULTS (Hynes Convention Center, Hall B) - Sep 29, 2019 - Abstract #AASLD2019AASLD_2483;
Safety outcomes were similar across tested dose ranges and between compounds. The pharmacodynamic profiles of MRX and VXB support further clinical development in cholestatic liver disease up to the maximum tested dose.
- | volixibat (SAR 548304) / Takeda
Clinical, P1 data, PK/PD data, Journal: A randomised, double-blind, placebo-controlled phase 1 study of the safety, tolerability and pharmacodynamics of volixibat in overweight and obese but otherwise healthy adults: implications for treatment of non-alcoholic steatohepatitis. (Pubmed Central) - Mar 29, 2019
P1
This study indicates that maximal inhibition of bile acid reabsorption, as assessed by FBA excretion, occurs at volixibat doses of ≥20 mg/day in obese and overweight adults, without appreciable change in gastrointestinal tolerability. These findings guided dose selection for an ongoing phase 2 study in patients with non-alcoholic steatohepatitis.
- ||||| volixibat (SAR 548304) / Mirum Pharma
Trial completion date, Trial termination, Trial primary completion date: Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Aug 14, 2018
P2, N=197, Terminated, Sponsor: Shire
These findings guided dose selection for an ongoing phase 2 study in patients with non-alcoholic steatohepatitis. Trial completion date: Jan 2020 --> Jul 2018 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2020 --> Jul 2018
- ||| volixibat (SAR 548304) / Mirum Pharma
Enrollment closed, Enrollment change: Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Jun 15, 2018
P2, N=197, Active, not recruiting, Sponsor: Shire
Trial completion date: Jan 2020 --> Jul 2018 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2020 --> Jul 2018 Recruiting --> Active, not recruiting | N=292 --> 197
- || volixibat (SAR 548304) / Mirum Pharma
Trial primary completion date: Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - May 2, 2017
P2, N=266, Recruiting, Sponsor: Shire
Recruiting --> Active, not recruiting | N=292 --> 197 Trial primary completion date: Jun 2019 --> Jul 2020
- |||| volixibat (SAR 548304) / Mirum Pharma
Enrollment open: Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Aug 1, 2016
P2, N=266, Recruiting, Sponsor: Shire
Trial primary completion date: Jun 2019 --> Jul 2020 Not yet recruiting --> Recruiting
- ||||| volixibat (SAR 548304) / Mirum Pharma
New P2 trial: Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Jun 1, 2016
P2, N=266, Not yet recruiting, Sponsor: Shire
- ||| volixibat (SAR 548304) / Mirum Pharma, Livmarli (maralixibat) / Mirum Pharma, Takeda
Trial completion: Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and Obese Adults as Assessed by Fecal Bile Acid Excretion (clinicaltrials.gov) - Mar 22, 2016
P1, N=84, Completed, Sponsor: Shire
Not yet recruiting --> Recruiting Recruiting --> Completed
- volixibat (SAR 548304) / Mirum Pharma
Trial completion: A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose (clinicaltrials.gov) - Mar 15, 2016
P1, N=8, Completed, Sponsor: Shire
Recruiting --> Completed Recruiting --> Completed
- || volixibat (SAR 548304) / Mirum Pharma, Livmarli (maralixibat) / Mirum Pharma, Takeda
Enrollment change, Trial primary completion date: Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and Obese Adults as Assessed by Fecal Bile Acid Excretion (clinicaltrials.gov) - Oct 28, 2015
P1, N=84, Recruiting, Sponsor: Shire
Recruiting --> Completed N=48 --> 84 | Trial primary completion date: Jun 2015 --> Dec 2015
- volixibat (SAR 548304) / Mirum Pharma
New P1 trial: A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose (clinicaltrials.gov) - Oct 22, 2015
P1, N=8, Recruiting, Sponsor: Shire
- ||| volixibat (SAR 548304) / Mirum Pharma
Trial completion, Enrollment change: Safety and Tolerability Study of SHP626 in Overweight and Obese Adults (clinicaltrials.gov) - Jul 21, 2015
P1, N=84, Completed, Sponsor: Shire
N=48 --> 84 | Trial primary completion date: Jun 2015 --> Dec 2015 Recruiting --> Completed | N=108 --> 84
- | volixibat (SAR 548304) / Mirum Pharma, Livmarli (maralixibat) / Mirum Pharma, Takeda
New P1 trial: Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and Obese Adults as Assessed by Fecal Bile Acid Excretion (clinicaltrials.gov) - Jun 18, 2015
P1, N=48, Recruiting, Sponsor: Shire
- ||| volixibat (SAR 548304) / Mirum Pharma
Enrollment open: Safety and Tolerability Study of SHP626 in Overweight and Obese Adults (clinicaltrials.gov) - Mar 12, 2015
P1, N=108, Recruiting, Sponsor: Shire
Recruiting --> Completed | N=108 --> 84 Not yet recruiting --> Recruiting
- ||| volixibat (SAR 548304) / Mirum Pharma
New P1 trial: Safety and Tolerability Study of SHP626 in Overweight and Obese Adults (clinicaltrials.gov) - Nov 12, 2014
P1, N=108, Not yet recruiting, Sponsor: Shire