A Phase I, Randomized, Open-label, Single Dose, 2 Period, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Linerixibat Tablets in Healthy Adult Participants

This study will evaluate the effect of food on the Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters of linerixibat administered in fed and fasted states in heathy adult participants

Start Date11 Aug 2022

Sponsor / Collaborator

GSK Plc

NCT05393076

/ CompletedPhase 1

A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Matched Control Participants

This is a phase 1, open-label, single-dose study in adults with moderate hepatic impairment (defined as Child-Pugh B cirrhosis) and matched healthy control participants with normal hepatic function. All participants in both cohorts (moderate hepatic impairment and matched healthy controls) will receive a single dose of the study drug, linerixibat. The purpose of this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) and safety of linerixibat.

Start Date19 Jul 2022

Sponsor / Collaborator

GSK Plc

NCT05133830

/ CompletedPhase 1

A Two-part, Phase 1, Open-label, Randomized, Parallel-arm, Fixed Sequence, Drug-drug Interaction Study to Investigate the Effect of Linerixibat on Plasma Concentrations of Obeticholic Acid and Conjugates in Healthy Adult Participants

This study aims to investigate the effect of linerixibat on plasma concentrations of obeticholic acid (OCA) and its conjugates in healthy adult participants to inform the potential for drug interaction with coadministration of linerixibat and OCA.

Start Date23 Nov 2021

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Linerixibat

100 Translational Medicine associated with Linerixibat

100 Patents (Medical) associated with Linerixibat

Literatures (Medical) associated with Linerixibat

01 Mar 2025·CPT-Pharmacometrics & Systems Pharmacology

Analysis of C4 Concentrations to Predict Impact of Patient‐Reported Diarrhea Associated With the Ileal Bile Acid Transporter Inhibitor Linerixibat

Article

Author: Carreño, Fernando ; Swift, Brandon ; Collins, Jon ; de Souza, Andrea Ribeiro ; Mehta, Rashmi

ABSTRACT:

Linerixibat, an ileal bile acid transporter (IBAT) inhibitor, is being evaluated for the treatment of pruritus in primary biliary cholangitis (PBC). Diarrhea is commonly reported with this drug class as IBAT inhibition redirects bile acids (BA) to the colon. Serum 7‐alpha‐hydroxy‐4‐cholesten‐3‐one (C4) measurement is a validated method to identify BA diarrhea. To inform dose selection, we characterized the relationship between linerixibat dose, C4 levels, and patient‐reported bother on the gastrointestinal symptom rating scale (GSRS) diarrhea question. A kinetic‐pharmacodynamic model was developed using data from five Phase 1/2 trials, to describe the effect of linerixibat dose (1–180 mg) and regimen (once/twice daily) on C4 concentrations over time. GSRS data from patients with PBC and pruritus in the Phase 2b GLIMMER study (NCT02966834) were used to develop a proportional odds model to predict the probability of a score of 1–7 (no–very severe discomfort) to the question “Have you been bothered by diarrhea during the past week?” in relation to linerixibat dose. The two models were linked to describe the linerixibat dose‐C4‐diarrhea bother relationship. Models were validated using graphical and numerical assessment and visual predictive checks. Linerixibat caused dose‐dependent increases in C4 until saturation (~180 mg total daily dose). Increased C4 concentrations trended with increased GSRS diarrhea scores. Simulations demonstrated increases in moderate‐to‐very severe (≥ 4) diarrhea scores with increasing linerixibat dose. Increases in patient‐reported diarrhea scores were linerixibat dose‐dependent. Selecting an optimal dose that maximizes linerixibat's ability to improve pruritus while minimizing patient‐reported diarrhea bother is important to support treatment adherence.

01 Oct 2024·BIOMEDICINE & PHARMACOTHERAPY

Studies on absorption mechanism and pharmacokinetic properties of albendazole-bile acid conjugate: In vivo and in vitro

Article

Author: Tang, Shizhen ; Liu, Jingshuai ; Guo, Zhimei ; Nie, Kaili ; Hu, Chunhui

PURPOSE:

To improve the oral bioavailability of albendazole (ABZ), a series of albendazole-bile acid conjugates (ABCs) were synthesized. ABC's transmembrane transport mechanism and in vivo pharmacokinetic properties were preliminarily studied.

METHODS:

The transmembrane transport mechanism of ABCs was studied using the Caco-2 monolayer cell model and intestinal perfusion model. The concentration of ABCs and ABZ were evaluated using High-Performance Liquid Chromatography (HPLC) and HPLC-Mass Spectrometry (HPLC-MS/MS).

RESULTS:

Compared to ABZ, better permeability was observed for different types and concentrations of ABCs using the Caco-2 monolayer cell model, with ABC-C8 showing the highest permeability. The transmembrane transport of ABCs was affected by ASBT inhibitors, indicating an ASBT-mediated active transport mechanism. Additionally, introducing cholic acid resulted in ABZ no longer being a substrate for P-gp, MRP2, and BCRP, effectively reversing ABZ efflux. In vivo unidirectional intestinal perfusion results in rats showed that ABCs altered the absorption site of ABZ from the jejunum to the ileum. The absorption efficiency of ABCs in each intestinal segment was higher than that of ABZ, and the transmembrane transport efficiency decreased with increasing concentrations of ASBT inhibitors. This further confirmed the presence of both passive diffusion and ASBT-mediated active transport mechanisms in the transport of ABCs. The solubility of ABCs in gastric juice and pharmacokinetics in rats showed that ABZ-C4 exhibited enhanced solubility. Moreover, ABCs significantly increased oral bioavailability compared to ABZ, with ABC-C4 showing an approximately 31-fold increase in bioavailability.

CONCLUSION:

The transmembrane transport mechanism of ABCs involves a combination of ASBT-mediated active transport and passive diffusion. Moreover, the incorporation of BAs successfully reverses the efflux of ABZ by efflux proteins. Among the synthesized conjugates, ABC-C4 demonstrated superior dissolution behavior both in vitro and in vivo.

01 Sep 2024·Liver International

Serum bile acid change correlates with improvement in pruritus in patients with primary biliary cholangitis receiving linerixibat

Article

Author: McLaughlin, Megan M. ; Carreño, Fernando ; Casillas, Linda ; Swift, Brandon ; Karatza, Eleni ; Fettiplace, James ; Kremer, Andreas E. ; Mukherjee, Sumanta ; Lennie, Janelle

Abstract:

Background & Aims:

Total serum bile acid (TSBA) levels are elevated in patients with primary biliary cholangitis (PBC) and may mediate cholestatic pruritus. Linerixibat, an ileal bile acid transporter inhibitor, improved pruritus in patients with PBC. We explored the relationship between linerixibat dose, TSBA concentration, and pruritus.

Methods:

Data from Phase 1/2 trials were used to develop a population kinetic‐pharmacodynamic model to characterize the linerixibat dose–TSBA relationship. Individual Bayesian parameter estimates for participants in the GLIMMER study were used to derive the area under the TSBA concentration curve over 24 h (AUC0–24). Time‐matched post hoc estimates of AUC0–24 were correlated with pruritus reported on a 0–10 numerical rating scale. Baseline TSBA concentration was correlated with change from baseline (ΔBL) in monthly itch score (MIS). ΔBL in model‐estimated TSBA AUC0–24 was correlated with time‐matched ΔBL in weekly itch score (WIS) or MIS.

Results:

Linerixibat dose dependently reduced TSBA AUC0–24, reaching steady state after 5 days. Baseline TSBA levels in GLIMMER did not correlate with ΔBL in MIS. ΔBL in TSBA AUC0–24 correlated with improved WIS over 12 weeks of treatment (r = 0.52, p < 0.0001). Of participants with a ≥30% decrease in TSBA AUC0–24, 60% were pruritus responders (≥2‐point improvement in WIS from baseline).

Conclusions:

Linerixibat treatment leads to rapid, dose‐dependent TSBA reductions. Baseline TSBA levels do not correlate with on‐treatment pruritus change, suggesting they do not predict linerixibat response. Change in TSBA AUC0–24 correlates significantly with, and can be predictive of, pruritus improvement in patients with PBC.

News (Medical) associated with Linerixibat

15 May 2025

·www.prnewswire.com

Cushing's Disease Market Poised for Significant Growth Across the 7MM During the Study Period (2020-2034) with Rising Awareness and Diagnostic Improvements | DelveInsight

The Cushing's disease pipeline possesses some drugs in mid and late-stage development to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including relacorilant, clofutriben, atumelnant, and others. The expected launch of these therapies shall further create a positive impact on the Cushing's disease market. LAS VEGAS, May 15, 2025 /PRNewswire/ -- DelveInsight's Cushing's Disease Market Insights report includes a comprehensive understanding of current treatment practices, Cushing's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Cushing's Disease Market Report According to DelveInsight's analysis, the market size for Cushing's disease was found to be USD 1 billion in the 7MM in 2024. In 2024, among all the current therapies for Cushing's disease, the highest revenue was generated by Mifepristone (KORLYM and generics) in the US. Based on DelveInsight's assessment in 2024, the 7MM had approximately 37K diagnosed prevalent cases of Cushing's disease. These cases are expected to rise due to advancements in diagnostic capabilities and increased awareness about the disease during the forecast period (2025–2034). Leading Cushing's disease companies developing emerging therapies, such as Corcept Therapeutics, Sparrow Pharmaceuticals, Crinetics Pharmaceuticals, H. Lundbeck, Stero Therapeutics, and others, are developing novel Cushing's disease drugs that can be available in the Cushing's disease market in the coming years. The promising Cushing's disease therapies in the pipeline include DUPIXENT (dupilumab), Linerixibat (GSK2330672), NEMLUVIO/MITCHGA (nemolizumab), Volixibat, and others. In March 2025, Corcept Therapeutics announced that the FDA had assigned a PDUFA target action date of December 30, 2025, for relacorilant to treat patients with endogenous hypercortisolism. In February 2025, Crinetics Pharmaceuticals mentioned that the company anticipates beginning enrollment for Atumelnant (CRN04894) in Phase Ib/IIa trials for Cushing's disease in late 2025 or early 2026. In October 2024, Sparrow Pharmaceuticals announced that clofutriben had been granted Orphan Drug Designation (ODD) by the US FDA for the treatment of endogenous Cushing's syndrome. Discover which therapies are expected to grab the major Cushing's disease market share @ Cushing's Disease Market Report Cushing's Disease Overview Cushing's disease is a rare but serious endocrine disorder caused by a pituitary tumor that triggers excessive cortisol production. It presents with a variety of symptoms such as weight gain, fatigue, mood disturbances, high blood pressure, and impaired glucose tolerance. Cushing's syndrome is responsible for 80–85% of hypercortisolism cases, with 75–80% of those linked to ACTH-producing pituitary adenomas. Without treatment, the 5-year survival rate is only about 50%, emphasizing the urgent need for effective therapies. Diagnosing Cushing's disease is especially difficult because it is rare, shares symptoms with other disorders, and presents in various ways. Only 40–60% of patients have a detectable tumor on standard Magnetic Resonance Imaging (MRI), and the diagnosis is often delayed by an average of 7 years. Cushing's Disease Epidemiology Segmentation The Cushing's disease epidemiology section provides insights into the historical and current Cushing's disease patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The Cushing's disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Cushing's Disease Total Diagnosed Prevalent Cases of Cushing's Disease Gender-Specific Diagnosed Prevalent Cases of Cushing's Disease Age-Specific Diagnosed Prevalent Cases of Cushing's Disease Cushing's Disease Treatment Market The primary treatment for Cushing's disease is usually transsphenoidal surgery to remove the pituitary tumor, which often leads to remission. However, some patients may experience a recurrence. When surgery is unsuccessful or not an option, medical therapies are used to control cortisol levels. Various medications are available for managing Cushing's disease, especially in cases where surgery is ineffective or not feasible. One such drug is KORLYM, developed by Corcept Therapeutics, approved for treating hyperglycemia in patients with Cushing's syndrome who also have Type 2 diabetes or glucose intolerance. In 2024, a generic version by Teva Pharmaceuticals entered the market, adding competition, and Corcept itself has released a generic version as well. Other approved options include S IGNIFOR and SIGNIFOR LAR, ISTURISA, and RECORLEV. In addition, off-label drugs like ketoconazole, metyrapone, cabergoline, mitotane, and etomidate are also used in the U.S., with some marketed in Europe by HRA Pharma. SIGNIFOR (pasireotide), developed by Recordati, was the first drug specifically approved for Cushing's disease by the FDA in 2012, and also gained EU approval. Recordati also markets SIGNIFOR LAR, a long-acting injectable version approved by the FDA and Japan's PMDA in 2018. This formulation, administered intramuscularly once every four weeks, shares the same mechanism as SIGNIFOR but offers a different delivery route. Recordati is recognized as a leading player in this therapeutic area. Another key product from the company is ISTURISA (osilodrostat), the first FDA-approved oral drug that inhibits cortisol production by targeting the enzyme 11β-hydroxylase (CYP11B1), which is involved in the final step of cortisol synthesis. Its oral administration makes it more convenient for patients compared to injectable therapies. ISTURISA is also being studied for pediatric use in an ongoing Phase II trial (NCT03708900). RECORLEV, originally developed by Strongbridge Biopharma and later acquired by Xeris Pharmaceuticals, was approved by the FDA in 2021. It is indicated for adults with endogenous Cushing's syndrome who are not surgical candidates or did not achieve a cure through surgery. Unlike ISTURISA, RECORLEV works by inhibiting cortisol production at multiple points in the steroidogenesis pathway, offering a distinct mechanism of action. To know more about Cushing's disease treatment guidelines, visit @ Cushing's Disease Management Cushing's Disease Pipeline Therapies and Key Companies Relacorilant (CORT125134): Corcept Therapeutics Clofutriben (SPI-62): Sparrow Pharmaceuticals Atumelnant (CRN04894): Crinetics Pharmaceuticals Lu AG13909: H. Lundbeck ST-002: Stero Therapeutics Discover more about Cushing's disease drugs in development @ Cushing's Disease Clinical Trials Cushing's Disease Market Dynamics The Cushing's disease market dynamics are expected to change in the coming years. Although Cushing's disease is generally considered a rare condition, growing awareness and recent advances in research suggest that diagnoses may rise in the future; despite a seemingly crowded market, many current hypercortisolism treatments fail to normalize cortisol levels effectively and pose significant side effects highlighting a substantial opportunity for innovation, especially given the limited therapies specifically targeting Cushing's disease and the potential of newer oral alternatives like ISTURISA and RECORLEV to offer greater flexibility compared to SC and intramuscular options such as SIGNIFOR and SIGNIFOR LAR. Furthermore, potential therapies are being investigated for the treatment of Cushing's disease, and it is safe to predict that the treatment space will significantly impact the Cushing's disease market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the Cushing's disease market in the 7MM. However, several factors may impede the growth of the Cushing's disease market. Due to non-specific guidelines and recommendations, patients with Cushing's disease often face suboptimal care, delayed diagnosis, and inconsistent treatment approaches, further compounded by the diagnostic complexity, frequent misdiagnosis, and symptom overlap with more common conditions, which leave many undiagnosed or untreated; while existing therapies such as ketoconazole and metyrapone approved in Europe based on limited retrospective data and used off-label in the US despite high costs are widely trusted and entrenched in clinical practice, posing a significant barrier to the adoption of emerging therapies. Moreover, Cushing's disease treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Cushing's disease market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Cushing's disease market growth. Scope of the Cushing's Disease Market Report Therapeutic Assessment: Cushing's Disease current marketed and emerging therapies Cushing's Disease Market Dynamics: Key Market Forecast Assumptions of Emerging Cushing's Disease Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Cushing's Disease Market Access and Reimbursement Download the report to understand which factors are driving Cushing's disease market trends @ Cushing's Disease Market Trends Table of Contents Related Reports Cushing's Syndrome Market Cushing's Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Cushing's syndrome companies including Corcept Therapeutics, Crinetics Pharmaceuticals, Cyclacel Pharmaceuticals, Sparrow Pharmaceuticals, Stero Therapeutics, among others. Cushing's Syndrome Pipeline Cushing's Syndrome Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Cushing's syndrome companies, including Corcept Therapeutics, Crinetics Pharmaceuticals, Cyclacel Pharmaceuticals, Sparrow Pharmaceuticals, Stero Therapeutics, among others. Endogenous Cushing's Syndrome Market Endogenous Cushing's Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key endogenous Cushing's syndrome companies including Corcept Therapeutics, Crinetics Pharmaceuticals, Sparrow Pharmaceuticals, among others. Endogenous Cushing's Syndrome Pipeline Endogenous Cushing's Syndrome Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key endogenous Cushing's syndrome companies, including Corcept Therapeutics, Crinetics Pharmaceuticals, Sparrow Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalOrphan DrugPhase 2

12 May 2025

·pmlive.com

GSK shares promising phase 3 results for linerixibat in PBC-related itch

GSK has shared promising results from a late-stage study of its investigational oral ileal bile acid transporter inhibitor linerixibat in patients with the rare autoimmune liver disease primary biliary cholangitis (PBC). The phase 3 GLISTEN trial has been evaluating the candidate in adults with PBC and cholestatic pruritus, or relentless itch, a key symptom of the condition that can cause sleep disturbance, fatigue and impaired quality of life. Results presented at this year’s European Association for the Study of the Liver (EASL) Congress demonstrated that linerixibat significantly improved itch compared to placebo over 24 weeks, meeting the trial’s primary endpoint. Patients randomised to receive linerixibat experienced an average placebo-adjusted improvement of 0.72 points on a ten-point rating scale for the worst itch (WI-NRS). Key secondary endpoints were achieved, with significant itch improvements seen as early as week two. GSK’s drug also led to significant benefits in itch-related sleep interference, and 56% of linerixibat-treated patients achieved clinically meaningful itch improvement, defined as at least a three point reduction on the WI-NRS, compared to 43% in the placebo group at week 24. Expected to affect 510,000 people worldwide by 2030, PBC is a life-long condition that leads to irreversible scarring of the liver and the destruction of bile ducts. The disease disproportionately impacts women and is associated with symptoms such as fatigue and joint aches. Pruritus can occur at any stage of the disease and is experienced in varying degrees of severity by up to 90% of patients. Linerixibat is designed to inhibit bile acid re-uptake and has already been granted orphan drug designations by the US Food and Drug Administration and the European Medicines Agency to treat PBC-associated cholestatic pruritus. Kaivan Khavandi, senior vice president, global head, respiratory, immunology and inflammation research and development, GSK, said: “Relentless itch is present in the majority of patients with PBC and is a symptom that affects sleep, mental health and quality of life. “With linerixibat, we are one step closer to addressing the high unmet need of itch and its related sleep interference that are critically important to patients but historically under-treated.”

Clinical ResultOrphan DrugPhase 3Phase 2

08 May 2025

·firstwordpharma.com

GSK makes its case for PBC itch drug linerixibat, with Mirum closing in

With Mirum Pharmaceuticals' rival oral IBAT inhibitor nipping at its heels, GSK released detailed results Thursday from a Phase III trial of its more advanced contender, linerixibat, in treating cholestatic pruritus associated with primary biliary cholangitis (PBC).The UK drugmaker had teased top-line results late last year from the 238-patient GLISTEN trial, which met its primary endpoint of improving monthly itch score over 24 weeks. Full results were presented this week at the European Association for the Study of the Liver (EASL) conference.In the study, participants with moderate-to-severe pruritus who were given linerixibat achieved an average placebo-adjusted drop of 0.72 points on a 10-point numerical rating scale (NRS) for the worst itch (WI-NRS).Regarding secondary endpoints, the significant improvement over placebo was seen as soon as the second week and was sustained throughout the 24-week trial, GSK said. Patients taking linerixibat also achieved a 0.53-point greater improvement in itch-related sleep problems over 24 weeks compared to placebo. Additionally, 56% of patients taking linerixibat saw clinically meaningful itch improvement — defined as a reduction of at least 3 points on WI-NRS — compared to 43% for placebo."With linerixibat, we are one step closer to addressing the high unmet need of itch and its related sleep interference that are critically important to patients, but historically under-treated," said Kaivan Khavandi, GSK's global head of respiratory, immunology and inflammation R&D.Safety-wise, GSK said the main side effect was mild diarrhoea, which led to treatment discontinuation in 4% of linerixibat patients — higher than the placebo group (<1%), but consistent with the mechanism of IBAT inhibition.Commenting on the GLISTEN data, analysts at Morgan Stanley said they see a positive readthrough to Mirum's drug volixibat, which may also hold an edge in terms of efficacy. Previously reported Phase IIb data from the VANTAGE PBC trial showed a placebo-adjusted itch score reduction of 2.3 points — driven by a 3.8-point drop in the volixibat group, versus 1.5 points for placebo — as measured by the ItchRO scale."Overall, we continue to believe volixibat has a competitive profile with more robust placebo-adjusted itch reduction," the analysts said in a recent note. Mirum is expected to unveil more data on volixibat at the EASL meeting this week as well.

Clinical ResultPhase 2Phase 3

100 Deals associated with Linerixibat

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cholestatic pruritus	Phase 3	United States	GSK Plc	14 Jul 2020
Cholestatic pruritus	Phase 3	China	GSK Plc	14 Jul 2020
Cholestatic pruritus	Phase 3	Japan	GSK Plc	14 Jul 2020
Cholestatic pruritus	Phase 3	Argentina	GSK Plc	14 Jul 2020
Cholestatic pruritus	Phase 3	Brazil	GSK Plc	14 Jul 2020
Cholestatic pruritus	Phase 3	Bulgaria	GSK Plc	14 Jul 2020
Cholestatic pruritus	Phase 3	Canada	GSK Plc	14 Jul 2020
Cholestatic pruritus	Phase 3	Czechia	GSK Plc	14 Jul 2020
Cholestatic pruritus	Phase 3	France	GSK Plc	14 Jul 2020
Cholestatic pruritus	Phase 3	Germany	GSK Plc	14 Jul 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04950127 (GLISTEN, Company_Website 1 \| Company_Website 2) Manual	Phase 3	Primary Biliary Cholangitis	238	Linerixibat	iiheoowmiz(ncmhjnknqx): Difference (LS Mean) = -0.72 (95% CI, -1.15 to -0.28), P-Value = 0.001 Met View more	Positive	19 Nov 2024
				Placebo
NCT03992014 (CTgov)	Phase 1	Cholestasis	6	[14C] Linerixibat+Linerixibat (Linerixibat 90 mg Oral Tablets + [14C] Linerixibat 100 μg IV)	eagckvsnmm(xgutzpvtyc) = siundcyhpt nxzxlrebld (pqeqftwtfl, 25.8) View more	-	26 Jun 2020
				[14C]-Linerixibat ([14C]-Linerixibat 90 Milligram Oral Solution)	xrbkvaawgl(ncbokhkykv) = vpcafkifoq niosbmfbtw (gftixvpsol, 95.3) View more
NCT02202161 (CTgov)	Phase 2	Diabetes Mellitus, Type 2	70	placebo+metformin+GSK2330672 (Placebo)	ghijfcnytl(cgoomfqifx) = mdbbjnhbbf otwvdcilkz (dyhpnptvge, 16.357) View more	-	06 Nov 2017
				GSK2330672 (GSK2330672 10 mg BID)	ghijfcnytl(cgoomfqifx) = dhaunnurkz otwvdcilkz (dyhpnptvge, 6.500) View more
NCT01929863 (CTgov)	Phase 2	Diabetes Mellitus, Type 2	16	Metformin+GSK2330672 (Treatment A-GSK2330672 + Metformin)	gpotgtalcf = dyjxzadeth pmrhbadaav (aeuuuqqgzj, onyfojtlbw - zdzniutpvk) View more	-	16 Aug 2017
				Placebo+Metformin (Treatment B-Placebo + Metformin)	gpotgtalcf = wqvdmjrpcb pmrhbadaav (aeuuuqqgzj, zgiqnbefop - fabbdnusxv) View more
NCT01899703 (Pubmed \| Lancet) Manual	Phase 2	Pruritus \| Primary Biliary Cholangitis	22	GSK2330672	mavqoztfei(mninqcyfgw) = Diarrhoea was the most frequent adverse event during treatment with GSK2330672 (seven with GSK2330672 vs one with placebo) and headache was the most frequent adverse event during treatment with placebo (seven with placebo vs six with GSK2330672). ysqothgdmk (emjvmrupsn )	Positive	18 Mar 2017
				Placebo

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