Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Despite a relatively quiet month from the 

, the American College of Cardiology (ACC) Scientific Sessions 2026 more than made up for the lack of regulatory news with a continued series of key trial updates. From 

obstructive hypertrophic cardiomyopathy (oHCM)

, all aspects of cardiology saw significant forward movement during this conference. Additionally, updates to the ABCs of Cardiology and other guidelines in April continued the paradigm shift towards prevention that cardiology has embraced in recent months.

With so many trials reaching their endpoints, the editorial team at 

 has collected 7 of the most impactful headlines from the last 30 days below:


SCOUT-HCM: Mavacamten Outperforms Placebo in Adolescents With HCM, With Joseph Rossano, MD, MS


Presented by Joseph Rossano, MD, MS, co-director of the Cardiac Center and chief of the division of cardiology at the Children’s Hospital of Philadelphia, new data from the SCOUT-HCM trial have proven mavacamten’s efficacy in reducing left ventricular outflow in adolescent patients with oHCM compared with placebo. Additionally, of the 65 enrolled patients, adverse events occurred in only 18 in the mavacamten arm and 17 in the placebo arm, with only 2 serious adverse events in each group.

CORALreef AddOn: Enlicitide Outperforms Standard Hypercholesterolemia Drugs, With Ann Marie Navar, MD, PhD


The CORALreef AddOn trial has demonstrated enlicitide’s superior reduction of low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia. The trial compared enlicitide to bempedoic acid, ezetimibe, and a combination thereof – among patients with 

atherosclerotic cardiovascular disease (ASCVD)

, enlicitide saw a substantially higher LDL-C reduction than all 3 comparators. Ann Marie Navar, MD, PhD, discusses the results and their implication for an expected New Drug Application.


Self-Administered Etripamil for PSVT Has Minimal Blood Pressure, Heart Rate Effects, With Narendra Singh, MD


Etripamil nasal spray, recently approved for paroxysmal supraventricular tachycardia (PSVT), has minimal effects on blood pressure, despite a long history of calcium channel blockers leading to hypotension. Parts 1-3 of the NODE-301 trial, assessing heart rate and blood pressure changes in patients treated with a test dose of etripamil, revealed significantly lower blood pressure changes than other CCBs. Narendra Singh, MD, assistant professor at Mercer University Atlanta Campus, director of clinical research at NSC Cardiology, and co-author of NODE-301, spoke on the reassurance that this trial provides for clinicians prescribing etripamil.


Reviewing the Updated ABCs of Cardiovascular Disease Prevention, With Aaron Troy, MD, MPH


The ABCs of Cardiovascular Disease Prevention has recently undergone a major update, highlighting the PREVENT equations and Life’s Essential 8. Additionally, the document now includes 

, largely considered disease-focused areas rather than preventable conditions. Aaron Troy, MD, MPH, clinical research fellow at Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center, discusses the value of a more prevention-focused mindset in cardiovascular disease.

CADENCE: Sotatercept Reduces PVR in CpcPH-HFpEF, With Mardi Gomberg-Maitland, MD, MSc


Based on data presented at ACC 2026 by Mardi Gomberg-Maitland, MD, MSc, director of the pulmonary 

 program, chief clinical research officer at the Office of Clinical Research SMHS, and professor of medicine at George Washington University, sotatercept has successfully reduced pulmonary vascular resistance (PVR) in combined post- and pre-capillary pulmonary hypertension (CpcPH) heart failure with preserved ejection fraction (HFpEF). The ongoing CADENCE trial has already shown substantially greater PVR reductions compared to placebo at week 24.


Tonlamarsen Lowers Angiotensinogen, Mixed Results for Blood Pressure, With Luke Laffin, MD


An update from the Kardinal study, provided by Luke Laffin, MD, co-director of the Center for Blood Pressure Disorders and associate professor of medicine at the Cleveland Clinic, has shown that monthly tonlamarsen successfully lowered plasma angiotensinogen in patients with uncontrolled hypertension compared to a single dose. However, it led to no additional blood pressure reduction, indicating the need for further placebo-controlled trials to determine its efficacy in single doses or a multi-dose regimen.

Obicetrapib is Safe and Well-Tolerated in HeFH and ASCVD, With Stephen Nicholls, MD


A pooled safety analysis of the BROADWAY and BROOKLYN phase 3 trials has revealed the safety and tolerability of obicetrapib in patients with heterozygous familial hypercholesterolemia (HeFH) and ASCVD. Presented at ACC 2026 by Stephen Nicholls, MD, director of the Monash Victorian Heart Institute at Monash Health, these data indicated less new-onset diabetes, fewer adverse events, and less incidence of hypertension in patients treated with obicetrapib.

Videos

April 2026 saw further updates from ACC.26, plus key trial results, guideline updates, and more.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Strategic Alliance Partnership

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

Hypertension

The HCPLive hypertension page is a resource for medical news and expert insights on high blood pressure. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for hypertension, and more.

Cardiomyopathy

Atherosclerotic Cardiovascular Disease

7 Cardiology Headlines You Missed in April 2026

Gil Melmed, MD, is affiliated with Cedars-Sinai Inflammatory Bowel Disease Center.

Which Biologic Lasts Longest for Crohn's Disease? Real-World Switch Rate Data Explained

With a growing roster of advanced therapies available for Crohn's disease (CD), treatment sequencing has become one of the most consequential decisions a gastroenterologist makes. While clinical trial data inform efficacy and safety, they do not capture what happens over the years a patient spends on a given drug in the real world.

A new claims-based analysis presented at Digestive Disease Week (DDW) 2026 in Chicago, IL, offers a different lens, taking a closer look at real-world switch rates. Gil Melmed, MD, a gastroenterologist at Cedars-Sinai, presented data from the US-payer claims database analysis examining real-world switching rates over 24 months among patients with CD initiating risankizumab, adalimumab, infliximab, ustekinumab, or vedolizumab.

“Switch rates are important when we think about therapies for Crohn's disease. It really gives us a sense of what is the anticipated persistence of a drug,” Melmed told 

. “When we offer chronic therapy to a patient with a chronic condition, there's only so much that we can tell from clinical trials, because clinical trials don't tell the whole story.”

The analysis drew on the Merative Marketscan database, identifying 5434 patients ≥ 18 years of age with ≥ 1 inpatient or 2 outpatient claims for CD who initiated a new biologic between January 2022 and July 2025. All patients had a minimum of 6 months of follow-up.

Nonswitching rates, defined as no claim for another advanced therapy, were assessed using Kaplan-Meier analysis over 24 months across the full population and the biologic-naïve subgroup. A Cox proportional hazards model adjusted for baseline differences including age, comorbidity burden, prior surgery, and prior biologic exposure.

At 24 months, risankizumab demonstrated the lowest estimated switch rate of any biologic assessed (14.0% across all patients, 13.4% in the biologic-naïve subgroup). Ustekinumab followed at 21.1% and 19.3%, respectively, with vedolizumab, infliximab, and adalimumab trailing further behind, the latter reaching a switch rate of 36.0% in the overall population.

Of note, the advantage of risankizumab was most pronounced in biologic-naïve patients, consistent with the broader principle that first-line advanced therapy offers the best opportunity for durable response. However, the advantage still persisted even among patients with prior biologic exposure.

“For risankizumab, that switch rate of the persistence of the drug requiring to go on to a different therapy is lowest in risankizumab, meaning that switch rate is lower than it is with other drugs,” Melmed explained. “This effect is more pronounced in patients who are naive to other therapies, as opposed to patients who have previously been on other therapies. And we see that with risankizumab being the lowest switch rate, even in patients who have also been on prior advanced therapies.”

Melmed emphasized that real-world persistence data capture the aggregate effect of efficacy, tolerability, and patient experience over time, something clinical trials cannot. A patient who stops a drug for any reason shows up in switch rate data, making it a composite reflection of how a therapy performs outside of protocol-driven conditions.

The findings are also consistent with switch rate data for risankizumab in other immune-mediated conditions, including psoriasis and psoriatic arthritis, suggesting a durable treatment profile that may extend across indications.

Melmed noted that the claims data did not capture the reasons behind individual switching decisions, an acknowledged limitation that future analyses should aim to address.

Editor's note: Melmed reports relevant disclosures with AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Genentech, Gilead, Janssen, Medtronic, Merck, Prometheus Labs, Pfizer, Takeda, and others.

Melmed G, Ungaro RC, Griffith J, et al. Real-World Switching Rates Among Patients With Crohn's Disease Treated With Biologics in the United States. Presented at Digestive Disease Week (DDW) 2026; Chicago, IL; May 2–5, 2026.

Teeple A, Sah J, Mallampati R, et al. Persistence, Dosing, and Other Treatment Patterns Among Crohn's Disease Patients Initiating Biologics in United States. 

. 2021;3(4):otab076. Published 2021 Nov 5. doi:10.1093/crocol/otab076

Gil Melmed, MD, breaks down real-world data showing risankizumab has the lowest switch rates in Crohn’s over 24 months, highlighting strong persistence vs other biologics.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Inflammatory Bowel Disease

On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Real-World Data Favor Risankizumab for Long-Term Persistence in Crohn's Disease

Anat Shoshani, PhD, professor at Reichman University and chief psychologist at Kai.ai.

A conversational AI intervention reduced 

 more than group therapy and a waiting list control, with similar

 outcomes, in a randomized trial of 995 university students with psychological distress.

At 12 weeks, the AI intervention reduced anxiety more than group therapy (MD, −2.17; 95% CI, −2.67 to −1.67) and control (MD, −2.15; 95% CI, −2.65 to −1.65) and improved well-being versus group therapy (MD, 5.72; 95% CI, 2.71 to 8.73). Among those with baseline clinical anxiety, 57.9% in the AI group remitted to nonclinical levels versus 14.4% with group therapy and 9.8% with control (

Participants used the intervention a mean of 3 days per week; 61% remained engaged at 12 weeks. A perceived digital therapeutic alliance was associated with greater engagement and symptom improvement (

Depression improved versus control (MD, −1.99; 95% CI, −2.63 to −1.35) but did not differ from group therapy after adjustment. PTSD symptoms did not differ across groups, highlighting potential limits of AI-based care for trauma-related conditions.

Anat Shoshani, PhD, professor at Reichman University and chief psychologist at Kai.ai, discussed the clinical implications of these findings, including the integration of conversational AI across levels of care and the alignment of intervention intensity with patient needs.

What do you see as the most clinically meaningful takeaway from this trial comparing the conversational AI intervention with group therapy and a waiting list control?

 The biggest takeaway is that mental health support no longer has to exist only inside clinic walls. Traditional psychotherapy is incredibly valuable, but it… happens in scheduled weekly sessions. Human suffering is not episodic. Panic attacks happen at midnight. Students spiral before exams. People relapse after treatment ends. Many struggle while sitting on waiting lists for months.

What our study suggests is that when AI is designed responsibly and grounded in real psychological frameworks, it can help fill those vulnerable “in-between moments” where traditional care is often absent. The AI intervention led to reductions in anxiety and depression and improvements in well-being and life satisfaction compared with the waiting list group.

The most important implication is not that AI replaces therapy. It’s that mental health care may be shifting from episodic support to more continuous support.

That means helping people before therapy begins, between sessions, and after treatment ends.

The AI platform showed greater reductions in anxiety than face-to-face group therapy. How should clinicians interpret that result in terms of real-world effectiveness?

 I would interpret this finding cautiously… Anxiety is often highly situational. It spikes late at night, before social situations, during academic stress, or in moments when people feel completely alone with racing thoughts. A weekly group therapy model can be very valuable, but it may not always reach people when anxiety is actually happening.

Kai offered continuous access, personalized responses, memory across conversations, and repeated opportunities to practice coping skills in real time. That may be particularly helpful for anxiety because regulation often depends on what happens in the moment.

There’s also an important contextual factor. This trial took place during a prolonged period of stress and uncertainty in Israel. One possible interpretation is that during prolonged real-world stress, a weekly group format may not have been sufficient for some participants, who needed more individualized and ongoing support. I would not frame this as AI being “better than therapy.” I would frame it as continuity and immediacy potentially mattering enormously for anxiety care.

Depression outcomes were more similar between AI and group therapy after adjustment, while PTSD symptoms did not improve. What does this pattern suggest about where conversational AI is most and least useful?

 Conversational AI appears particularly promising for mild-to-moderate anxiety, depressive symptoms, stress management, emotional regulation, and day-to-day well-being support.

PTSD is different. Trauma symptoms are often more complex and may require trauma-focused interventions, deeper clinical judgment, careful pacing, and sometimes exposure-based work. The platform was not originally designed as a trauma-specific treatment model.

I actually see the PTSD finding as a strength of the study because it reminds the field that responsible AI requires humility. We need to understand not only where these tools work but where human care remains essential.

Your study highlights “digital therapeutic alliance” as a key driver of engagement and symptom change. How do you define alliance in an AI context, and how should clinicians conceptualize it?

 This was one of the most fascinating findings in the study. In psychotherapy, alliance typically refers to trust, emotional connection, and the belief that someone understands you and can help you. We found that people can experience something functionally similar to AI.

Users rated Kai similarly to human group therapists on warmth and competence. Alliance predicted engagement, and engagement predicted symptom improvement.

I think of Kai as a transitional bridge. It’s not a therapist. It’s not human attachment. But it can help people feel less alone in vulnerable moments, contain distress temporarily, and create enough emotional stability to reconnect with real human relationships and clinicians.

That’s very different from replacement. It’s augmentation.

Engagement was strongly associated with symptom improvement. What design features appeared most important for sustaining engagement over 12 weeks?

 This was actually one of the findings I found most meaningful because engagement is the Achilles’ heel of digital mental health. Many people download mental health apps with good intentions and abandon them very quickly because the experience feels clinical, burdensome, or disconnected from real life.

Participants engaged around 3 days per week, and 61% were still active at week 12, which is unusually high for this field.

Kai was designed to fit into the natural rhythm of emotional life rather than asking users to step outside of it. Distress often happens in small, ordinary moments. Before an exam. After an argument. During a lonely evening. On the way to work. People are rarely willing to open a separate platform and complete a 40-minute mental health module in those moments.

Kai lives inside familiar messaging platforms, so support feels immediate and accessible. It can proactively check in during difficult periods rather than waiting passively for someone to return. When people are overwhelmed, it offers interventions that feel manageable, like a 2-minute breathing exercise, a quick reframing prompt, or a short grounding practice.

The platform was also designed to go beyond symptom reduction. Mental health is not only about reducing anxiety. It’s also about building resilience, meaning, connection, and positive emotions. Users may move between discussing distress and engaging in exercises related to gratitude, strengths, relationships, or purpose.

One of the most underestimated factors is memory. Kai remembers prior conversations, recurring triggers, emotional patterns, and important life events. That continuity creates something powerful. People don’t feel like they are restarting from 0 every time they open the conversation. It begins to feel less like using an app and more like returning to a space that already knows where you’ve been.

What are the most important next steps for testing AI interventions in real-world psychiatric or primary care settings?

 The field is entering a much more interesting phase. The question is no longer simply whether conversational AI can reduce symptoms in controlled trials. We now have growing evidence that it can help certain populations. The bigger question is whether it can help solve structural problems in mental health care.

One major opportunity is using AI to support those vulnerable in-between periods: while someone is waiting for treatment, between therapy sessions when real-life triggers happen, and after treatment ends when relapse risk increases.

There’s also a much broader opportunity. Many people never enter therapy at all. Some live in areas with severe clinician shortages. Others cannot afford treatment. Some avoid care because of stigma, cultural barriers, or fear of being judged. Scalable AI could provide immediate, low-barrier emotional support and preventive mental health tools before distress escalates into crisis.

Where do you see conversational AI fitting into stepped care models for mental health going forward?

 Conversational AI could fundamentally reshape how we think about stepped care. Traditionally, mental health care has often been binary. You’re either receiving formal therapy, or you’re largely on your own.

Human distress is far more fluid than that. People move in and out of difficult periods. Sometimes they need intensive clinical care. Sometimes they need light support, accountability, coping tools, or simply immediate emotional containment during a hard moment.

For some people, it may function as an early intervention tool before symptoms become severe enough to require formal treatment. For others, it can extend psychotherapy into daily life by helping people practice skills when real triggers actually happen. After treatment ends, it can help people maintain progress and identify early warning signs before a full relapse occurs. For higher-risk cases, it should also help direct people toward human clinicians faster rather than delaying care.

I don’t think the future is AI replacing therapists. I think the future is a much more flexible continuum of care where support becomes responsive to what people actually need in a given moment.

Articles

Shoshani discusses RCT data showing AI reduces anxiety and improves well-being, with outcomes comparable to those of group therapy. 

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

Conversational AI for Anxiety Matches Group Therapy Outcomes, With Anat Shoshani, PhD

Elizabeth A. Kiracofe, MD, is a board-certified dermatologist and the founder of Airia Comprehensive Dermatology, located in downtown Chicago's Fulton Market District, where she practices medical, surgical, and cosmetic dermatology.

How to Get Involved in Community Service in Dermatology, With Elizabeth Kiracofe, MD

, Mona Shahriari, MD, of the Yale School of Medicine, continues her discussion with Elizabeth A. Kiracofe, MD, a board-certified dermatologist and founder of Airia Comprehensive Dermatology, about practical ways physicians can engage in community service without becoming overwhelmed by logistical or time-related barriers.

Kiracofe emphasizes that meaningful involvement does not need to begin with large-scale initiatives, instead pointing to the value of small, actionable steps. Referencing her work with My Block, My Hood, My City, she highlights the organization’s guiding principle, focusing on one simple action each day to improve the lives of others. This philosophy, she explains, reframes community engagement as something accessible and incremental, rather than requiring significant planning or institutional backing. Whether through small acts of service or participation in existing programs, she suggests that consistent, manageable contributions can evolve into more substantial efforts over time.

Kiracofe also underscores that service does not have to be limited to clinical or dermatologic care. She describes her involvement with the The Daisy Foundation, where philanthropic work has included supporting underserved schools through initiatives such as funding essential resources like playgrounds, teacher spaces, and basic household appliances for students in need. Through events like the organization’s “holiday magic” program, Kiracofe and collaborators have built relationships with local schools, which later enabled more targeted dermatologic outreach, including eczema education and screenings for hundreds of students.

A key takeaway from her experience is the importance of relationship-building in facilitating sustainable outreach. Kiracofe notes that earlier attempts to engage directly with school systems were met with skepticism, but partnerships developed through community organizations created trust and opened doors for ongoing programming. These efforts ultimately allowed her to integrate dermatologic education into broader community initiatives, demonstrating how nonclinical entry points can lead to meaningful health interventions.

The discussion also addresses barriers that often prevent dermatologists from participating in traditional free clinics, including administrative complexity, unfamiliar electronic medical records, and limited clinical infrastructure. In response, Kiracofe outlines a vision for simplifying participation through a “clinic-in-a-box” model, enabling physicians to deliver care directly in community settings such as shelters with minimal logistical burden. By bringing essential tools and support staff to patients, rather than relying on centralized systems, she suggests more clinicians could realistically engage in outreach.

Ultimately, Kiracofe frames the challenge not as a lack of willingness among physicians, but as a need to reduce friction. She and Shahriari emphasize that creating accessible pathways to service, much like simplifying patient adherence strategies in clinical practice, can empower more clinicians to contribute. The conversation reinforces that impactful community involvement begins with small, intentional actions and grows through connection, adaptability, and a focus on practicality.

Editor’s note: This segment was summarized with the help of AI tools.

Shahriari M, Kiracofe E. The Medical Sisterhood: Exposure is Power-Women in Medicine Creating Opportunity, With Elizabeth Kiracofe, MD. April 30, 2026. Accessed May 4, 2026. 

https://www.hcplive.com/view/the-medical-sisterhood-exposure-is-power-women-medicine-creating-opportunity-elizabeth-kiracofe-md

In this segment from the April episode of The Medical Sisterhood podcast, the speakers discussed simple ways for physicians to get involved in community service without feeling overwhelmed.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Podcasts

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Mirum Pharmaceuticals reported volixibat met the primary endpoint in the phase 2b VISTAS trial in adults with primary sclerosing 

 (PSC) and cholestatic pruritus, a symptom with limited treatment options and no approved PSC-specific therapies in the US.

The company said the investigational ileal bile acid transporter (IBAT) inhibitor produced a statistically significant placebo-adjusted reduction in itch severity over 28 weeks, in their May 4, 2026 announcement.

“In PSC, a disease that has been historically difficult to study and treat, volixibat delivered statistically significant and clinically meaningful reductions in cholestatic pruritus,” Joanne Quan, MD, chief medical officer at Mirum, said in the company’s announcement.

 The topline readout is likely to draw attention because pruritus is a major driver of impaired quality of life in PSC, a chronic cholestatic liver disease that can progress to cirrhosis, liver failure, cholangiocarcinoma, and transplantation.

According to the press release, VISTAS was a global, randomized, double-blind, placebo-controlled phase 2b study enrolling 158 patients with PSC.

Patients were stratified into a primary analysis cohort with moderate to severe itch at baseline (n = 111) and a secondary cohort with mild itch (n = 47), based on Adult Itch Reported Outcome (ItchRO) scores. The prespecified primary endpoint was assessed in the moderate-to-severe pruritus cohort.

In that cohort, patients assigned to volixibat 20 mg twice daily had a least squares mean change in Adult ItchRO score of −2.72 vs −1.08 with placebo, for a placebo-adjusted difference of −1.64 (

 Mirum also reported that 55.6% of volixibat-treated patients achieved at least a 2-point reduction in Adult ItchRO score compared with 26.3% in the placebo group (

Serum bile acids also decreased relative to placebo, with a least squares mean difference of −35.8 (

 The company said improvements in pruritus were observed within 2 weeks, although full data have not yet been presented publicly.

Safety findings were described as generally consistent with IBAT inhibition.

Across the primary and secondary cohorts, treatment-emergent adverse events occurred in 93.5% of patients receiving volixibat and 84.0% receiving placebo; grade 3 or higher events occurred in 13.0% and 11.1%, respectively.

Serious treatment-emergent adverse events were reported in 10.4% vs 6.2%, and study discontinuation due to adverse events occurred in 9.1% vs 2.5%.

 Diarrhea-related discontinuation was reported in 3.9% of volixibat-treated patients and 1.2% of placebo recipients.

 The company also noted elevations in alanine aminotransferase and bilirubin.

PSC remains an area of substantial unmet need. Major liver society guidance notes that no medical therapy has been conclusively shown to alter long-term disease course, and management is largely supportive, addressing dominant strictures, inflammatory bowel disease, surveillance for hepatobiliary malignancy, and symptom control.

Pruritus is commonly managed with off-label approaches such as bile acid sequestrants, rifampin, opioid antagonists, and selective serotonin reuptake inhibitors, but tolerability and efficacy are variable.

Volixibat belongs to the same broad drug class as maralixibat and odevixibat, IBAT inhibitors already approved for pruritus in certain pediatric cholestatic disorders.

 By reducing enterohepatic bile acid recirculation, these agents may lessen systemic bile acid exposure and cholestatic itch. Whether this mechanism will translate into a favorable benefit-risk profile in PSC, where liver biochemistry fluctuations and disease heterogeneity complicate interpretation, will depend on fuller disclosure of trial details.

For clinicians, the main significance of the VISTAS readout is symptomatic rather than disease-modifying. The reported effect size on ItchRO appears potentially relevant for patients with burdensome itch, but the absence of peer-reviewed data, subgroup analyses, and detailed laboratory outcomes limits interpretation. It also remains unclear how regulators will weigh a pruritus endpoint in PSC, especially in the setting of liver test elevations and higher discontinuation rates.

Mirum said a pre–new drug application meeting with the FDA is planned for summer 2026, with a possible submission in the second half of the year.

 Full results are expected at the European Association for the Study of the Liver International Liver Congress on May 30, 2026.

Those data should help clarify durability of response, safety over time, and whether any patient subgroups derived greater benefit.

Class: ileal bile acid transporter inhibitor  

Safety: GI AEs, ALT/bilirubin elevations  

Mirum Pharmaceuticals. Mirum Pharmaceuticals announces primary endpoint met in VISTAS study of volixibat in patients with primary sclerosing cholangitis. Business Wire. May 4, 2026. Accessed May 4, 2026. 

https://www.businesswire.com/news/home/20260504069726/en/Mirum-Pharmaceuticals-Announces-Primary-Endpoint-Met-in-VISTAS-Study-of-Volixibat-in-Patients-with-Primary-Sclerosing-Cholangitis

Bowlus CL, Lim JK, Lindor KD. AGA clinical practice update on surveillance for hepatobiliary cancers in primary sclerosing cholangitis: expert review. 

Chapman R, Fevery J, Kalloo A, et al. Diagnosis and management of primary sclerosing cholangitis. 

Gunaydin M, Bozkurt Y, Demirci H, et al. Ileal bile acid transporter inhibitors in cholestatic pruritus and cholestatic liver disease: current evidence and future directions. 

Volixibat, an investigational IBAT inhibitor, achieved statistically significant, clinically meaningful reductions in cholestatic pruritus in adults with PSC in the global phase 2b VISTAS trial. In the moderate-to-severe itch cohort (n=111), Adult ItchRO improved −2.72 vs −1.08 with placebo (difference −1.64; P<.0001), with responses emerging by week 2 and bile acids declining. Adverse events were common, with diarrhea-related discontinuations and ALT/bilirubin elevations. With no approved PSC-specific therapies, the signal is symptomatic pending full EASL data and FDA discussions in 2026.

Volixibat reduced cholestatic pruritus in phase 2b primary sclerosing cholangitis data, with diarrhea and liver test elevations reported.

Hepatology

Cholangitis

cholangitis page, resources on the topics of medical news and expert insight into cholangitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on research, treatment, and drug development in PBC, PSC, and more!

Volixibat Improves Pruritus in Phase 2b PSC Trial, With GI and Liver Safety Signals

Ariann Chelli, LCSW, LCADC, MBA, is the clinical director at Desert Hope Treatment Center, an American Addiction Centers facility.

Without FDA-approved medications or standardized detox protocols, clinicians face unique challenges treating methamphetamine addiction.

Addiction

Addiction medicine condition center page, resources on the topics of medical news and expert insight into clinical addiction can be found. Content includes articles, interviews, videos, podcasts, and breaking news on addiction therapy research, treatment, and drug development.

Treating Methamphetamine Use Disorder Without FDA-Approved Medications

Joseph Murray, MD, is a gastroenterologist at Mayo Clinic.

Murray breaks down what gastroenterologists need to know about celiac disease diagnosis and management.

Confronting Unmet Needs in Celiac Disease, With Joseph Murray, MD

Marla Dubinsky, MD, is chief of the division of pediatric gastroenterology and nutrition and co-director of the Susan and Leonard Feinstein IBD Clinical Center, Mount Sinai Kravis Children's Hospital, Icahn School of Medicine.

Marla Dubinsky, MD, explains LIBERTY post hoc data showing SC infliximab 240 mg recaptured clinical response within 8 weeks in CD and UC patients following a drug holiday.

Ulcerative Colitis

Ulcerative Colitis condition center page, resources on the topics of medical news and expert insight into colitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on UC research, treatment, and drug development.

Subcutaneous Infliximab Recaptures Disease Control After Treatment Interruption in IBD

Laurie Keefer, PhD, is a clinical health psychologist and professor of medicine at Icahn School of Medicine at Mount Sinai.

Laurie Keefer, PhD, makes the case for integrating mental health, social determinants, and brain-gut behavior therapies into routine GI care.

Rethinking Gut Health: Social Determinants, Mental Health, and Brain-Gut Therapies

Anjali Byale, MD, is a fellow at West Virginia University School of Medicine.

Anjali Byale, MD, reviews data supporting EUS-guided procedures as first-line options for high-risk patients with cholecystitis or malignant gastric outlet obstruction.

EUS-Guided Procedures Outperform Traditional Interventions for High-Risk GI Patients

Sobia Laique, MD, is a gastroenterologist and transplant hepatologist at Cleveland Clinic.

New paired biopsy data show histologic regression after metabolic bariatric surgery in compensated MASH patients, challenging the irreversibility of cirrhosis.

MASH / MASLD

The HCPLive MASH & MASLD page is a comprehensive resource for clinical news and insights on metabolic dysfunction-associated steatotic liver disease and steatohepatitis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for fatty liver disease, steatohepatitis, and more.

Histologic Evidence of MASH Cirrhosis Regression After Metabolic Bariatric Surgery, With Sobia Laique, MD

Allison Wu, MD, MPH, is a general pediatric gastroenterologist at Boston Children’s Hospital and an assistant professor of pediatrics at Harvard Medical School.

Wu describes her research linking low food access and food insecurity to higher childhood obesity risk, highlighting the need for early, multilevel prevention strategies.

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

Latest News

7 Cardiology Headlines You Missed in April 2026

Real-World Data Favor Risankizumab for Long-Term Persistence in Crohn's Disease

Conversational AI for Anxiety Matches Group Therapy Outcomes, With Anat Shoshani, PhD

How to Get Involved in Community Service in Dermatology, With Elizabeth Kiracofe, MD

Volixibat Improves Pruritus in Phase 2b PSC Trial, With GI and Liver Safety Signals