Nancy Reau, MD, is Professor of Internal Medicine, Richard B. Capps Chair of Hepatology, Associate Director of Solid Organ Transplantation, and Section Chief of Hepatology at Rush University Medical Center.

Recognizing, Treating Alcohol as an Additive Risk Factor in MASLD

, hosts Nancy Reau, MD, and Kimberly Brown, MD, focus on one of the most challenging, and often underappreciated, aspects of managing 

metabolic dysfunction-associated steatotic liver disease (MASLD)

: accurately assessing and addressing alcohol use.

Reau highlights data examining patient reluctance to disclose alcohol consumption, using phosphatidylethanol (PEth) testing as an objective biomarker. Even at a relatively low cutoff, PEth identified alcohol use in a substantial proportion of patients who reported little or no drinking during clinic visits. Of note, many patients who stated they abstained entirely showed biochemical evidence of alcohol exposure, reinforcing a reality many clinicians recognize: self-reported alcohol use is often inaccurate, whether due to stigma, reluctance, or misunderstanding of what constitutes meaningful intake.

The conversation then turns to how PEth testing can be integrated into practice. Reau emphasizes transparency, explaining that she routinely tells patients when PEth is being ordered, framing it as a tool to support honest, nonjudgmental conversations about liver health.

Brown contrasts this with a more routine testing strategy, likening PEth to other standard laboratory assessments. For her, she says the value lies in using objective data to educate patients, showing that even amounts they perceive as minimal may still be harmful in the context of MASLD. She also notes the implications for clinical trials, pointing out that many study populations likely include patients with overlapping metabolic disease and alcohol use, given the limitations of self-reporting.

Both experts emphasize the clinical importance of another study discussed in the segment, which demonstrated that even modest alcohol consumption, including levels considered lower risk by public health standards, was associated with increased fibrosis in patients with MASLD. This risk was compounded by the presence of multiple metabolic factors, with alcohol acting as another “layer” of risk that accelerates disease progression.

Reau and Brown agree that for patients with MASLD, particularly younger individuals with decades of disease risk ahead, no amount of alcohol is truly safe, and addressing this openly is essential to long-term outcomes.

Editors’ note: Relevant Disclosures for Reau include AbbVie, Gilead, Salix, Arbutus, and VIR. Relevant disclosures for Brown include Mallinckrodt Pharmaceuticals, Gilead, Salix, Intercept, Ipsen, and Madrigal.

Daugherty T, Roepke E, Caviness D, et al. Real-world use of PEth in a MASLD Clinic. Presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2025. Washington, DC. November 7-11, 2025.

Duseja A, Verma N, De A, et al. Any amount of alcohol intake increases the risk of significant fibrosis and fibrotic MASH in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) - Insights from 7189 patients from Indian Consortium on MASLD (ICOM-D). Presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2025. Washington, DC. November 7-11, 2025.

Videos

Nancy Reau, MD, and Kimberly Brown, MD, discuss the challenges of accurately assessing and addressing alcohol use in patients with MASLD.

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.

Hepatology

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.

Eliezer Katz, MD, is the chief medical officer at Eledeon Pharmaceuticals. 

2-Year Phase 1b Tegoprubart Maintains Kidney Function in Transplant Recipients With Eliezer Katz, MD

2-year phase 1b results from the first adult de novo kidney transplant recipients treated with tegoprubart as the core immunosuppressive agent showed preserved 

, no episodes of acute rejection, and an acceptable safety profile.

The findings were presented at the American Society of Transplant Surgeons (ASTS) Winter Symposium, January 22–25, 2026, in Phoenix, AZ, highlighting the potential for non-calcineurin inhibitor-based immunosuppression.

The current standard of care for kidney transplant immunosuppression in the United States is a calcineurin inhibitor–based regimen with tacrolimus and mycophenolate. Over 90% of patients in the United States are maintained on these two agents, with or without corticosteroids.

Tacrolimus is a potent immunosuppressive drug used primarily to prevent organ rejection in transplant recipients. It acts as a calcineurin inhibitor, binding to FKBP12 to block T-cell activation and IL-2 production. While highly effective, neurotoxic effects are common, including hand tremors, insomnia, and headaches. Long-term tacrolimus use is associated with nephrotoxicity, supporting continued evaluation of noncalcineurin inhibitor–based regimens.

“Calcineurin inhibitors are very effective at preventing rejection, but they come at a significant cost,” said Eliezer Katz, MD, Chief Medical Officer of Eledon Pharmaceuticals. “Beyond nephrotoxicity, calcineurin inhibitors can damage pancreatic islet cells, leading to diabetes, and cause neurologic side effects such as tremor, brain fog, insomnia, and headaches. They are also associated with hypertension and cardiovascular effects. Patients are grateful that their graft is functioning, but many are still suffering from these side effects.”

Tegoprubart, a humanized monoclonal antibody, selectively inhibits CD40 ligand (CD154), a co-stimulatory molecule in T-cell activation. The investigational drug has the potential to enter the treatment landscape as a disease-modifying option.

Katz and colleagues conducted a multicenter, phase 1b, single-arm trial, enrolling adults who were Epstein–Barr virus (EBV)–seropositive, had low levels of panel-reactive antibodies, and had no donor-specific antibodies (DSAs) at screening before receipt of their first kidney transplant from a living or deceased donor.

On the day of transplantation, all patients received induction with rATG ≤6 mg/kg and maintenance therapy with intravenous tegoprubart (20 mg/kg, administered on days 1, 7, 14, 21, and 28 post-transplantation). After this, every 21 days, patients received mycophenolate and corticosteroids.

Primary safety endpoints included the incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs). If a patient experienced more than one adverse event with the same preferred term, they were counted once for that term.

At 12 and 24 months, exploratory endpoints included the incidence of biopsy-proven acute rejection, graft failure, de novo DSA formation, and mean estimated glomerular filtration rate (eGFR). Patients who completed 12 months of treatment were offered enrollment in an open-label extension study.

Overall, 8 patients completed 12 months of treatment and continued into the extension study. The mean (standard deviation [SD]) treatment duration with tegoprubart was 29.50 (5.42) months, with seven of the eight patients completing at least 24 months of treatment.

“Tegoprubart has a different mechanism of action. It offers the possibility of achieving effective immunosuppression without many of these side effects, as we demonstrated in a phase 2 study that we recently presented at Kidney Week in Houston in early November,” explained Katz. “The fundamental difference is specificity. Tacrolimus is a small molecule taken orally, and its effects are distributed throughout the body. Because calcineurin plays a role in many cellular processes, inhibiting it affects virtually every organ system, which explains the wide range of side effects.”

Over 24 months, tegoprubart had an acceptable safety profile. All patients experienced ≥1 TEAE, while SAEs were reported for 3 patients, and AESIs were reported for 7 patients. No cases of biopsy-proven acute rejection, de novo DSA, delayed graft function, or graft loss were reported.

Investigators observed functional eGFR levels were restored within 1 month after transplantation and generally maintained over 24 months. At 12 and 24 months, mean (SD) eGFRs were 67.0 (19.85) mL/min/1.73 m² and 74.2 (24.91) mL/min/1.73 m², respectively.

E. Katz, T. Coates, J. Gill2, et al. Long-Term Outcomes of a Phase 1, Single-Arm Cohort of De Novo Kidney Transplant Recipients Treated with Tegoprubart, an Anti-CD40L Antibody, as the Core Immunosuppression Regimen. Poster presented at: American Society of Transplant Surgeons (ASTS) Winter Symposium. January 22-25, 2026; Phoenix, AZ.

Araya AA, Tasnif Y. Tacrolimus. PubMed. Published May 29, 2023. https://www.ncbi.nlm.nih.gov/books/NBK544318/

Laskow DA, Neylan JF, Shapiro RS, Pirsch JD, Vergne-Marini PJ, Tomlanovich SJ. The role of tacrolimus in adult kidney transplantation: a review. 

. 1998;12(6):489-503. https://pubmed.ncbi.nlm.nih.gov/9850440/

Investigational anti-CD40L therapy tegoprubart highlights the potential for non-calcineurin inhibitor–based immunosuppression in adult de novo kidney transplant patients. 

Nephrology

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

Stone is professor of medicine at Harvard Medical School and the Edward A Fox Chair in Medicine at the Massachusetts General Hospital. He has treated IgG4-related disease (IgG4-RD) since its emergence in recent years and is passionate about educating patients and fellow healthcare providers (HCPs) about the indolent and systemic nature of this disease.

Hope on the Horizon: The Future of GCA Treatment

This video covers the following questions:

Let’s close this series by discussing the future of GCA management. How can clinicians continue to close the gaps in diagnosis and management, and what do you hope is on the horizon for GCA treatment? 

Thank you again to our panel, and thanks to our audience for watching. We hope you found this 

Peer Exchange to be useful and informative.

Video Series

Reflecting on Trial Limitations in GCA: Painting a Future for IL-17A Targeting Therapies

Do these phase 3 results reflect the limitations of IL‑17A as a therapeutic target in GCA, or might issues in trial design, patient selection, or taper regimen explain the discrepancy between Phase II and Phase III outcomes? What role do you see for secukinumab in future GCA treatment?

Reflecting on Trial Limitations in GCA: Painting a Future for IL-17A Targeting Therapies 

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.

The US Food and Drug Administration (FDA) has accepted Unicycive Therapeutics’ NDA for oxylanthanum carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

As described in a January 29, 2026, release from the Company, the Agency has deemed the OLC resubmission to be a Class II complete response which has a 6-month review period from the date of resubmission and set a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2026.

“We are pleased that the agency has promptly accepted the resubmission of our NDA for OLC,” Shalabh Gupta, MD, Chief Executive Officer of Unicycive, said in a statement.

“We are advancing our commercial preparation activities in anticipation of a potential launch of OLC later this year, to help provide an important treatment option to patients with CKD on dialysis who continue to struggle with hyperphosphatemia.”

OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with CKD on dialysis.

In April 2025, Unicycive announced patient-reported outcomes data from its phase 2 study of oxylanthanum carbonate for hyperphosphatemia in patients with CKD on dialysis as well as findings from a survey on top barriers to phosphate binder adherence among patients undergoing dialysis. The data were presented during poster sessions at the National Kidney Foundation (NKF) Spring Clinical Meetings and highlighted patients’ satisfaction with oxylanthanum carbonate compared to their prior phosphate lowering therapy as well as patient perspectives on the barriers phosphate binder pill size and count pose to consistent medication use.

Later, in June 2025, the FDA issued a Complete Response Letter to Unicycive Therapeutics’ NDA for OLC, citing deficiencies previously identified at a third-party manufacturing vendor unrelated to OLC. Of note, no other concerns were stated, including pre-clinical, clinical, or safety data.

As part of its overall manufacturing strategy, the Company had previously identified a back-up third-party manufacturing vendor to build redundancy into its supply chain. According to Unicycive, the second vendor has a long history of successful FDA and international regulatory inspections and has already produced OLC drug product, which could also be used to support the resolution of the CMC issues identified in the CRL.

The resubmission of the NDA is supported by data from 3 clinical studies, including a phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers and a tolerability study of OLC in CKD patients on dialysis, as well as multiple preclinical studies and chemistry, manufacturing and controls (CMC) data.

A decision on its approval is expected on June 27, 2026, nearly a year after the 2025 CRL.

Unicycive Therapeutics. Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission. January 29, 2026. Accessed January 29, 2026. 

https://www.globenewswire.com/news-release/2026/01/29/3228435/0/en/Unicycive-Therapeutics-Announces-FDA-Acceptance-of-Oxylanthanum-Carbonate-OLC-New-Drug-Application-NDA-Resubmission.html

Brooks A. FDA Issues CRL to Oxylanthanum Carbonate for Hyperphosphatemia in CKD, Dialysis. HCPLive. June 30, 2025. Accessed January 29, 2026. 

https://www.hcplive.com/view/fda-issues-crl-oxylanthanum-carbonate-hyperphosphatemia-ckd-dialysis

Brooks A. Oxylanthanum Carbonate May Offer Desirable Alternative to Current Phosphate Binders. HCPLive. April 10, 2025. Accessed January 29, 2026. 

https://www.hcplive.com/view/oxylanthanum-carbonate-may-offer-desirable-alternative-current-phosphate-binders

Articles

The FDA has accepted Unicycive Therapeutics' NDA for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in CKD patients on dialysis, with a PDUFA target date of June 27, 2026. OLC, an investigational oral phosphate binder, uses nanoparticle technology to enhance phosphate binding potency, reducing pill burden. The NDA resubmission follows a 2025 Complete Response Letter due to third-party manufacturing issues, now resolved with a backup vendor. The resubmission is supported by data from three clinical studies and multiple preclinical studies, with a decision expected nearly a year after the CRL.

With the acceptance, the FDA has assigned the oral phosphate binder a Prescription Drug User Fee Act target action date of June 27, 2026.

Chronic Kidney Disease

FDA News

FDA Accepts Oxylanthanum Carbonate NDA Resubmission for Hyperphosphatemia in CKD, Dialysis

Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

The FDA approval is based on a pair of phase 3 trials, including the larfest and longest safety study of presbyopia eye drops. 

Ophthalmology

Ophthalmology page, resources on the topics of medical news and expert insight into ophthalmic disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on eye disease research, treatment, and drug development.

FDA Approves First Dual-Agent Eye Drop for Near Vision Loss

Dawn Eichenfield, MD, PhD, is a dermatologist at Rady Children's Hospital-San Diego and an assistant clinical professor of dermatology at UC San Diego School of Medicine.

This Q&A interview with Dawn Eichenfield, MD, PhD, highlights notable takeaways from her session at Maui Derm Hawaii titled ‘Pediatric Dermatology 2026.’

Plaque Psoriasis

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

Conference

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

Spotlighting Pediatric Dermatology Updates for 2026, With Dawn Eichenfield, MD, PhD

Linda Stein Gold, MD, is a dermatologist at Henry Ford Health. 

This interview with Stein Gold continues her discussion of new and emerging psoriasis therapies in 2026.

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.

Emerging Psoriasis, PsA Drugs and Future Developments in Dermatology, With Linda Stein Gold, MD

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

ASH’s multidisciplinary panel provides a standardized diagnostic pathway emphasizing early laboratory testing and surrogate biopsies.

Hematology

ASH Releases New Clinical Practice Guidelines for Diagnosing AL Amyloidosis

Mazen Noureddin, MD, MHSc, is a professor of medicine and a transplant hepatologist at Houston Methodist and director of the Houston Research Institute.

Noureddin recaps recent progress in MASH therapeutic development and looks ahead to what 2026 and beyond may offer.

MASH Pipeline Developments and Emerging Therapies to Watch in 2026, With Mazen Noureddin, MD, MHSc

This interview at the 2026 Maui Derm Hawaii meeting features a discussion of new and emerging therapies in psoriasis, including icotrokinra.

Discussing Icotrokinra for Adolescents, Other Emerging Psoriasis Drugs, With Linda Stein Gold, MD

Podcasts

Reau and Brown discuss new data on MASH/MASLD, including awareness, referral patterns, discussions around alcohol, and emerging pharmacotherapies.

Liver Lineup: Updates & Unfiltered Insights

Introducing Liver Lineup: Updates & Unfiltered Insights — an exciting new podcast delivering timely, candid perspectives on the most pressing topics in the fast-moving world of hepatology. Created by Nancy Reau, MD, and Kimberly Brown, MD, and hosted by HCPLive, this series dives into the cutting edge of liver disease research, clinical care, and real-world practice.

Liver Lineup: Managing MASLD and MASH Amid Limited Awareness, Overlapping Risk Factors

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.

The new approval allows for repeat administration of iDose TR, modifying the existing single-administration label.

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...

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.

FDA Approves Labeling Update for iDose TR for Open-Angle Glaucoma and Ocular Hypertension

In a 31-center phase 2 trial in 10 countries, apecotrep BI 764198 reduced proteinuria in patients with primary focal segmental glomerulosclerosis.  


Focal Segmental Glomerulosclerosis

The HCPLive focal segmental glomerulosclerosis page is a resource for medical news and expert insights on FSGS. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in FSGS, and more. 

Apecotrep Delivers 40% Proteinuria Reduction in Phase 2 FSGS Trial

Ruth Frikke-Schmidt, MD, PhD, is a professor and chief physician at Copenhagen University Hospital.

Frikke-Schmidt discusses the newfound genetic correlation between vascular-related dementia and an increased BMI, partially mediated by high blood pressure.

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

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.

Geriatrics

Geriatric medicine condition center page is a comprehensive resource for clinical news and insights on frequent geriatric-related diseases and conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for sleep disorder, dementia, Alzheimer's disease, and more.

Dementia and Alzheimer Disease

Alzheimer Disease condition center page, resources on the topics of medical news and expert insight into Alzheimer's can be found. Content includes articles, interviews, videos, podcasts, and breaking news on dementa and Alzheimer disease research, treatment, and drug development.

Latest News

Recognizing, Treating Alcohol as an Additive Risk Factor in MASLD

2-Year Phase 1b Tegoprubart Maintains Kidney Function in Transplant Recipients With Eliezer Katz, MD

Hope on the Horizon: The Future of GCA Treatment

Reflecting on Trial Limitations in GCA: Painting a Future for IL-17A Targeting Therapies

FDA Accepts Oxylanthanum Carbonate NDA Resubmission for Hyperphosphatemia in CKD, Dialysis