Maria Hordinsky, MD, is an R.W. Goltz Professor of the Department of Dermatology at the University of Minnesota.

Credit: National Alopecia Areata Foundation

In April, Cosmo Pharmaceuticals released 

 on clascoterone 5% topical solution in male patients living with mild-to-moderate androgenetic alopecia (AGA), with sustained efficacy being observed with continued use in the program.

The study, involving 1465 patients across 51 sites in the US and Europe, was the largest phase 3 clinical analysis effort to date for a topical drug in male patients with AGA. In light of the lack of newly-approved drugs for AGA in more than 3 decades, 

 spoke in an interview with Maria Hordinsky, MD, an R.W. Goltz Professor of Dermatology at the University of Minnesota and a lead investigator in the trial program, who spoke about the clinical and patient-centered implications of these data.

The following Q&A transcript summarizes Hordinsky’s responses to 

’s inquiries about the new data on clascoterone 5% topical solution for patients with hair loss in the form of AGA:

What were the most important takeaways from this phase 3 study of clascoterone 5% topical solution for patients with androgenetic alopecia (AGA)?

 I'll think about this from the perspective of a patient in the clinic, and think about what patients are looking for. There hasn't been a new FDA treatment, a medical treatment, for over 30 years. It's been a long time since something has come to this point with the current medication. So, we now have the opportunity to really use a topical agent that targets the androgen receptor, one of the key players in androgenetic alopecia. Patients in this particular study, phase 2 and phase 3, have done very, very well. It looks like we're going to very soon have a new tool in our toolbox that will be able to offer male patients with androgenetic alopecia. It's actually very exciting.

We also wanted to go explore some of the findings. The data show continued hair growth from Month 6 to Month 12. How clinically meaningful is that sustained response for patients?

That is very clinically relevant. What I would love to see…but again, the FDA did not require this. I think it'd be great, and we'll get it in real-world data, [but I’d love us] to be able to see the durability over years of use. But the fact that the durability was there at the 12-month mark and also was showing, at that time, continued improvement is, again, something very exciting.

Can you explain the significance of the 239% relative improvement in target area hair count and how that translates into real-world outcomes?

 Patients with pattern hair loss, if you talk to them about hair counts in a circle, it probably doesn't mean very much to people. You might have X number of fibers, and then you double it or triple it, and then you'll see something there. But from the patient's perspective, they're looking at the global picture, the big picture. So, the patient's perspective is really, really important. Then, when you go to that target area, you see this increase in hair counts to this particular significant number. That is really important, because that is visible and it's real.

What does the comparison between patients who stayed on treatment versus those who switched to vehicle tell us about the importance of continuous therapy?

 I think all these studies were done very well. I think it's always important to have a group of people who are treated, and then at some point in time, in a randomized manner, are switched to the placebo group, because you can see the improvement, and then you can see the decline. I think, like with most hair conditions when we treat [them], the decline is not like jumping off a cliff. It's gradual. So, in all likelihood, down the road and in the future, one will actually be able to capture that, because people sometimes get sick. You know, things happen in life. You're going to come off the medication for a bit of period of time, and I think people just have to recognize from this data that, yes, you might go backwards a little bit, but you can probably catch up.

Based on these findings, how do you see clascoterone solution fitting into the current treatment landscape for hair loss?

Well, I think hair is hot right now in so many ways. There are so many things that are being looked at from so many different perspectives for the treatment of pattern, hair loss, this particular product, product, and tool is here at the right time, because many of the other tools are still very early in development. From a patient's perspective, there are those who just want to do something topically. They don't want to take a pill. They want something very conservative. And then some want to do everything possible and add PRP and everything to the mix of what they're doing. It will be a great tool to use for people who have pattern hair loss, who are either very conservative or want to do everything that they can.

But the other place where this really fits is that the vehicle and the delivery system are very, very nice. It's easy to use and it's something that, if you think about your 18-year-old male who's going to college, sometimes that type of person wants to take a pill by mouth, but at other times, the person, again, just wants something straightforward and simple. This is going to be something that will fit the lifestyle of that particular person. It will also be a tool for many patients who really do not want to be taking any type of anti-androgen or medication currently on the market that can affect libido or sex drive, because right now, we know with this medicine, even though it is an androgen blocking agent, a receptor blocking agent, no such side effects were detected in the clinical trials. I think that's really important.

The quotes used in the above summary were edited for the purposes of clarity.

Hordinsky has served on an advisory board for AbbVie (fees) and as an investigator receiving grants or research funding from Arcutis Biotherapeutics, Cassiopea, Concert Pharmaceuticals, Eli Lilly and Company, National Alopecia Areata Foundation, RegenLab, and Sun Pharmaceuticals. She has also received fees for other work with UpToDate, Inc.

Phase III 12-Month Data for Clascoterone 5% Topical Solution Confirm Positive Safety for Chronic Use and Continued Hair Growth, both of which Are Statistically Significant. Cosmo Pharmaceuticals. April 15, 2026. Accessed April 30, 2026. 

https://www.cosmohealthconfidence.com/news/98958067-clascoterone-12-month-safety-results-ende

Hordinsky M. Phase 3 SCALP Study on Clascoterone for Androgenetic Alopecia, With Maria Hordinsky, MD. HCPLive. December 18, 2025. Accessed April 30, 2026. 

https://www.hcplive.com/view/phase-3-scalp-study-clascoterone-androgenetic-alopecia-maria-hordinsky-md

Articles

Phase 3 SCALP program evaluated clascoterone 5% topical solution, an androgen-receptor antagonist, in 1465 men with mild-to-moderate androgenetic alopecia across 51 US/European sites. Twelve-month data showed statistically significant, sustained and incremental gains from Month 6 to 12, supporting chronic use. A 239% relative improvement in target-area hair count suggests visible density changes, while patient-perceived global improvement remains central. Randomized withdrawal to vehicle indicated gradual regression off therapy, implying maintenance dosing and potential regain after interruptions. Favorable tolerability without libido/sexual adverse signals may broaden uptake.

In this Q&A interview, Hordinsky was asked about recent 1-year data on clascoterone solution 5% in androgenetic alopecia (AGA).

Alopecia

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Q&A: 1-Year Efficacy Data on Clascoterone 5% in Androgenetic Alopecia, With Maria Hordinsky, MD

Archana Sadhu, MD, is the director of transplant endocrinology, pancreas transplantation, and the system diabetes program at Houston Methodist.

Advances and Shortcomings in Cell Therapy for Type 1 Diabetes, With Archana Sadhu, MD

Although their widespread clinical use is still some distance away, cell therapy for 

 has made great strides in the last few years and continues to grow in promising directions.

American Association of Clinical Endocrinology (AACE) Annual Meeting 2026

 in Las Vegas, NV, by Aaron Kowalski, PhD, chief executive officer at Breakthrough T1D, and moderated by Archana Sadhu, MD, director of transplant endocrinology, pancreas transplantation, and the system diabetes program at Houston Methodist. In an exclusive interview with 

, Sadhu discusses the timeliness of this presentation and the need for education on the future of gene-based T1D therapies.

“We already have islet cell transplant available, but now we’re embarking on new stem cell-derived islets that should be a clinical option very, very soon,” Sadhu told 

. “We want to educate all of our endocrinologists and the endocrine care team on which patients would qualify for these therapies, where you go to offer them for your patients, and an overview of how far we’ve come. And we’ve come a long way.”

Donor-derived islet cells are still the primary source of available therapy for T1D; however, their efficacy is limited in that several donor pancreases are often needed for a single transplant. Although it works on an individual basis, this process is not scalable due to an ongoing shortage of donor organs. To this end, most cell therapies are limited to patients with unstable blood sugar management and severe hypoglycemia.

To this end, stem cell transplant is a growing focus of the therapeutic industry. The process involves injecting lab-grown pancreatic beta cells into patients, enabling restoration of the body’s insulin production. If administered early in T1D development, stem cell transplant could potentially cease insulin dependency outright.

In 2025, the first successful stem cell therapy was completed in a patient with T1D. In a publication in 

, the investigative team reported the patient’s complete insulin independence in 3 months after receiving autologous iPSC-derived islet-like cells. Though this success is only preliminary and requires further research to validate its mechanics and confirm that this insulin independence is maintained, the trial marks a substantial step forward in 1 of the more promising avenues for cell therapy in T1D.

However, the shortcomings and roadblocks of islet cell therapy are also applicable in stem cell transplants, limiting their practical application. Foremost among these issues is immune system modulation – T1D is characterized by the immune system directly attacking the body’s beta cells. Given that stem cell transplantation relies on replacing these cells, any successful procedure will need to account for this autoimmune angle, either by protecting the administered cells or by altering the immune response. Various techniques have been suggested and tested towards this end, but currently, cell therapy still largely relies on in-depth patient selection.

“The biggest thing we’ve learned is that patient selection is important – each of these therapies have different risks and different benefits, and choosing the right patient is key,” Sadhu said. “You need to select someone who can follow the tight protocols after transplant to comply with a tedious medication regimen to a T, to make sure that there’s no rejection and other complications. But when you have that patient, they’re going to get the best solution in terms of diabetes treatments.”

Editors’ Note: Sadhu reports disclosures with the Houston Methodist Academic Institute, Weill Cornell Medicine, and Texas A&M Health Sciences.

Kowalski A. Cell Therapies in T1D: Are we close to cures? Presented at the American Association of Clinical Endocrinology Annual Meeting 2026, Las Vegas, NV. April 22-24, 2026.

Kumar D, Tanwar R, Gupta V. First-ever stem cell therapy restores insulin independence in type 1 diabetes: A medical milestone. 

Videos

Sadhu provides an update on the state of the stem cell and islet cell therapy landscapes, highlighting encouraging developments in insulin independence.

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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.

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Pranav Garimella, MBBS, MPH, is chief medical officer of the American Kidney Fund.

For decades, a significant proportion of 

 in Black patients has been attributed to hypertension. This mislabeling may have obscured a distinct and underrecognized genetic driver, variants in the 

APOL1-mediated kidney disease (AMKD) affects an estimated 6 million African Americans who carry a high-risk genotype,¹ with approximately 13% of the self-identified African American population carrying two risk alleles that confer substantially elevated kidney disease risk.² Yet AMKD remains largely absent from routine clinical practice.

In recognition of the third annual AMKD Awareness Day, HCPLive spoke with Pranav Garimella, MD, Chief Medical Officer of the American Kidney Fund, about the scope of the misclassification problem embedded in the "hypertensive nephrosclerosis" diagnosis, the systemic and patient-level barriers slowing genetic testing uptake, and what nephrologists outside major academic centers should be doing differently — right now — for patients who carry two high-risk APOL1 variants.

The American Kidney Fund has described APOL1-mediated kidney disease as historically underdiagnosed, with many cases likely labeled as hypertension-associated kidney disease. How significant is that misclassification problem in practice, and how should nephrologists be rethinking patients currently labeled with 'hypertensive nephrosclerosis'?

The misclassification problem is real and clinically important. Hypertensive nephrosclerosis is often a diagnosis of exclusion, so some patients labeled that way actually have APOL1-associated kidney disease, FSGS, glomerulonephritis, or another primary kidney disorder. One biopsy-based study found that current clinical criteria for nephrosclerosis had very low sensitivity, 0.13, and even an optimized algorithm only rose to 0.19, while 40% of test-positive cases had other treatable diagnoses such as glomerulonephritis or interstitial nephritis.

In practice, that means nephrologists should be more skeptical of the label, especially in younger patients, those with proteinuria, hematuria, rapid eGFR decline, or an atypical course. Rather than accepting hypertension as the full explanation, we should rethink those cases as 'kidney disease with hypertension' and consider whether biopsy, genetic testing, or a broader workup is warranted.

Genetic testing for APOL1 is becoming more available, but uptake in clinical practice remains limited. What are the biggest barriers—clinical, systemic, or patient-level—to broader testing in high-risk populations, and where does responsibility for closing that gap ultimately fall?

Despite increasing availability of genetic testing, several barriers continue to limit its broader uptake in clinical practice. At the clinical level, many health care professionals remain uncertain about how to act on results, particularly if the downstream implications for treatment and monitoring are not clearly defined in guidelines. In addition, genetic testing is still not well integrated into routine clinical workflows.

At the patient level, awareness of APOL1 variants remains relatively low, even among high-risk populations. Concerns about genetic privacy, potential discrimination and mistrust of the healthcare system can further reduce uptake, particularly in communities that have historically been underserved or marginalized.

Addressing these gaps will require shared responsibility across stakeholders. Professional societies and researchers must develop consensus guidelines on monitoring, including incorporating genetic counseling services. To make meaningful progress, there needs to be equitable access, coverage for genetic counseling services, and an infrastructure. At the same time, community engagement and patient education are essential to building trust and awareness, requiring coordinated efforts across the care continuum.

The third annual APOL1-mediated kidney disease Awareness Day just passed. When you talk about 'awareness,' who is the primary target—patients, clinicians, or both? And what does meaningful awareness look like in practice versus awareness that doesn't change clinical care?

Both patients and clinicians. The American Kidney Fund is working to reach all of these audiences. Given how relatively recent the link between APOL1 and kidney disease was identified, we know that awareness among patients is low, and it's fair to say that health care professionals outside of nephrology likely have not received specialized education about AMKD.

For patients, awareness means understanding that APOL1 can be relevant to kidney disease risk and knowing when to ask questions or seek testing. For clinicians, especially outside nephrology, it means recognizing when APOL1 or AMKD should be part of the differential and when a "hypertensive nephrosclerosis" label deserves a second look. The new ICD code for AMKD is a big step forward as it gives clinicians a formal way to name APOL1-mediated kidney disease instead of forcing patients into nonspecific labels like hypertensive nephrosclerosis. In practice, that should improve recognition, data capture, family counseling, and trial referral.

Awareness only matters if it changes decisions such as diagnosis, counseling, testing, referral, or follow-up — not if it just increases familiarity with the term. Actionable awareness is the goal with the American Kidney Fund's efforts surrounding AMKD awareness.

With APOL1-targeted therapies in clinical trials, what should nephrologists outside of major academic centers be doing right now for a patient with two high-risk APOL1 variants—if anything differently today compared to standard chronic kidney disease management?

Nephrologists should treat the CKD phenotype, not just the genotype, using standard measures that slow progression: RAAS blockade when indicated, SGLT2 inhibitors when appropriate, BP control, statins when indicated, nephrotoxin avoidance, and sick-day counseling.

They should monitor closely if the patient is high risk. A two-risk-variant APOL1 genotype raises concern for progressive disease, so you should be more alert to rising albuminuria, falling eGFR, and faster-than-expected progression, but the treatment backbone remains standard CKD care.

Nephrologists should also discuss family member testing to identify other high-risk carriers who may need close monitoring as well, and refer to a clinical trial if eligible and if access exists.

Lastly, use shared decision-making. If discussing APOL1 results, explain that many people with two risk variants never develop kidney disease, so genotype is risk information, not an outcome. Partner with a clinical genetic counselor for better patient understanding.

Editor’s Note; Garimella reported no relevant financial disclosures.

Srinivasan V, So PN, Kwakyi EPK, Lerma EV, Wiegley N. APOL1 mediated kidney disease: a review and look toward the future. 

Pollak MR, Friedman DJ. APOL1 and APOL1-associated kidney disease: a common disease, an unusual disease gene — proceedings of the Henry Shavelle Professorship. 

APOL1 high-risk genotypes—present in ~13% of self-identified African Americans—may underlie kidney disease long attributed to hypertension, leaving millions with unrecognized AMKD. “Hypertensive nephrosclerosis” often functions as a low-specificity diagnosis of exclusion; biopsy data show poor clinical sensitivity and frequent alternative, treatable pathology. Broader APOL1 testing is slowed by unclear actionability, workflow gaps, limited counseling access, and privacy/mistrust concerns. A dedicated ICD code can improve recognition, data capture, counseling, and trial referral. Management remains phenotype-driven CKD care with intensified monitoring and shared decision-making.

Garimella, MBBS, unpacks what clinicians need to know about APOL1-mediated kidney disease, including misclassification, testing barriers, and management gaps. 

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.

Beyond Hypertensive Nephrosclerosis: A Closer Look at APOL1-Mediated Kidney Disease

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.

 remains one of the most common, but complex, gastrointestinal disorders in clinical practice. Defined by abdominal pain and altered bowel habits, IBS has historically been difficult to characterize, treat, and even explain to patients.

In recent years, the field has undergone a meaningful shift, with advances in understanding the gut-brain axis, microbiome, and underlying pathophysiology reshaping how clinicians approach diagnosis and management. At the same time, new therapies and evolving treatment strategies are expanding options for patients.

: clinical assistant professor at Rosalind Franklin University Chicago Medical School and director of the IBD program at Sinai Health System Chicago

: medical director of the GI Motility Program at Cedars-Sinai

: gastroenterologist with Baptist Health South Florida

As IBS Awareness Month highlights both progress and ongoing needs, experts emphasize a dual reality: care is improving, but major gaps remain.

For decades, IBS was categorized as a “functional” disorder, a label that often reflected uncertainty around its biological basis. Today, that framework is rapidly evolving.

“Our understanding of IBS has expanded significantly, leading to meaningful changes in how we approach disease management,” said 

 advisory board member Adelina Hung, MD. “It is increasingly recognized as a complex disorder of the gut-brain-microbiome rather than the traditional ‘functional’ condition.”

This shift reflects growing recognition that IBS arises from multiple interacting mechanisms, including dysregulation of the gut-brain axis, microbial imbalance, altered motility, immune activation, and visceral hypersensitivity. Rather than a single disease entity, IBS is now widely viewed as a spectrum of related conditions with overlapping features.

That complexity has important implications for care. Because the condition is highly heterogeneous with symptoms that vary widely between patients, standardized treatment approaches are inherently limited.

From Symptom Control to Targeted Management

Historically, IBS management focused on symptom relief, including antidiarrheals for IBS-D, laxatives for IBS-C, and general dietary advice. While these strategies remain important and still play an important role in care, they are no longer seen as sufficient as standalone approaches.

, Ali Rezaie, MD, noted that the field has moved away from purely empirical treatment toward more tailored strategies informed by underlying mechanisms.

“20 or 30 years ago, we would empirically treat patients, mostly just targeting symptoms,” he explained. “Now, we recognize that IBS has multiple underlying pathophysiologies, and depending on the patient, we can tailor therapy more precisely.”

For more from Rezaie on our evolving understanding of IBS treatment, check out 

Modern care begins with a thorough evaluation to exclude alarm features and conditions that may mimic IBS, such as 

 or malignancy. From there, clinicians can build a layered treatment approach that integrates lifestyle changes, pharmacotherapy, and targeted interventions based on symptom patterns and suspected drivers.

Dietary modification remains a cornerstone, but its effectiveness is often limited, with many patients ultimately requiring pharmacologic therapy and treatment selection guided by predominant symptoms such as constipation, diarrhea, or bloating.

Although several US Food and Drug Administration (FDA)-approved medications are now available, most continue to focus on symptom control rather than addressing root causes, a limitation that underscores the need for continued therapeutic innovation.

Recent years have brought important developments in IBS therapeutics, reflecting both incremental progress and broader shifts in treatment philosophy.

New investigational agents are exploring novel mechanisms across IBS subtypes, one of the most recent being EnteroBiotix Limited’s EBX-102-02, a next-generation oral full-spectrum microbiome therapeutic for IBS-C and IBS-D. In the phase 2a TrIuMPH trial, EBX-102-02 demonstrated clinically meaningful improvements in the IBS symptom severity score versus placebo, with clear separation from placebo observed as early as week 1 and sustained throughout the 6-week follow up period in both the IBS-C and IBS-D cohorts.

At the same time, regulatory milestones like the FDA approval of linaclotide (Linzess) for pediatric IBS-C are expanding access to care for younger patients. In November 2025, the guanylate cyclase C agonist from Ironwood Pharmaceuticals was approved for pediatric patients ≥ 7 years of age with IBS-C, making it the first treatment approved for IBS-C in this patient population.

Growing attention is also being paid to microbiome-directed therapies. Research suggests that, for some patients, alterations in the gut microbiome may play a central role in symptom development.

“There is no doubt that a subgroup of IBS patients has disease driven by the gut microbiome,” Rezaie said.

This recognition has supported the use of targeted interventions such as antibiotics, dietary strategies, and other microbiome-modulating approaches in select patients. However, identifying which patients will benefit most remains an ongoing challenge.

The Rise of Multimodal, Patient-Centered Care

As understanding of IBS has evolved, so has the approach to treatment. Care is increasingly being defined not by a single intervention, but by a combination of strategies tailored to the individual.

“Treatment involves a combination of diet, medications, lifestyle changes, and adjunctive therapy like CBT, hypnosis, acupuncture, and yoga,” Caroline Soyka, DO, told 

This multimodal framework reflects the interconnected nature of IBS pathophysiology, particularly the role of the gut-brain axis. Behavioral therapies, in particular, are gaining recognition for their ability to address symptom perception, stress response, and central processing of pain.

Rather than prioritizing one modality over another, Soyka said she approaches treatment as a collaborative process shaped by patient preferences, disease severity, and response to prior therapies. In a condition where no single treatment works universally, this flexibility is critical.

One of the defining features of IBS is its chronicity. Many patients are diagnosed in early adulthood and require long-term management, often with periods of symptom fluctuation.

“A lot of patients are diagnosed in their 20s, 30s, or 40s,” Rezaie said. “If you start them on a medication, this is not necessarily a curable disease, so they might be on that medication for years or decades.”

This reality makes expectation-setting a key component of care. Clinicians must balance the goal of symptom improvement with the understanding that complete resolution is often unrealistic.

Soyka emphasized the importance of reframing success for patients, particularly those with persistent or refractory symptoms.

“I remind [my patients] that we are not always aiming for perfection, but rather improvement each time,” she said.

This approach can help patients remain engaged in care while navigating the trial-and-error process that often accompanies IBS management.

Despite advances in understanding and treatment, IBS care often remains inconsistent in practice. One major challenge is the condition’s lack of a clear, algorithmic treatment pathway.

IBS requires individualized care, extensive patient education, and often ongoing adjustments to therapy, all of which are factors that can be difficult to accommodate in routine clinical settings. As a result, care may vary significantly depending on provider experience and available resources.

Soyka noted that many clinicians receive limited formal training in IBS, particularly in areas such as the gut-brain axis and microbiome-targeted therapies. This gap can contribute to variability in care and underutilization of certain treatment modalities. Access also remains a barrier, especially for non-pharmacologic interventions like cognitive behavioral therapy and complementary therapies, which are not always covered by insurance.

At the same time, real-world data suggest that these gaps continue to have a measurable impact on patients’ daily lives. Findings from the 2024 IBS in America survey indicate that IBS symptoms interfere with work productivity for nearly 11 days each month, while also disrupting personal and social activities for approximately 8 days monthly. Absenteeism has increased compared with prior years, and fewer than one-third of patients report being able to reliably predict when symptoms will occur, underscoring the persistent unpredictability of the condition.

Taken together, these data highlight a disconnect between advances in clinical knowledge and the lived experience of patients. While therapeutic options have expanded and understanding of IBS pathophysiology has deepened, many patients continue to face significant functional impairment and reduced quality of life.

Meanwhile, the underlying heterogeneity of IBS continues to complicate both diagnosis and treatment selection, reinforcing the need for more precise tools and biomarkers to guide care.

Looking Ahead: Precision Medicine and the Microbiome

The future of IBS care will likely be shaped by continued advances in microbiome science and precision medicine. Researchers are working to better characterize the diverse biological pathways involved in IBS and to identify targeted interventions for specific patient subgroups.

“The fecal microbiome holds so much of the key,” Soyka said.

However, translating this promise into clinical practice will require overcoming significant challenges. The microbiome is highly individualized and dynamic, making it difficult to define universal targets or standardized interventions.

Still, the broader trajectory of IBS research is clear: toward more personalized, mechanism-based care that moves beyond symptom management alone. As IBS Awareness Month underscores, the progress is real, but so is the work that remains.

NIDDK. Irritable Bowel Syndrome (IBS). November 2017. Accessed April 30, 2026. 

https://www.niddk.nih.gov/health-information/digestive-diseases/irritable-bowel-syndrome/definition-facts

Brooks A. EBX-102-02 Shows Benefit for IBS-C and IBS-D in Phase 2a TrIuMPH Trial. HCPLive. January 28, 2026. Accessed April 30, 2026. 

https://www.hcplive.com/view/ebx-102-02-shows-benefit-for-ibs-c-and-ibs-d-in-phase-2a-triumph-trial

Brooks A. FDA Approves Linaclotide (Linzess) Capsules for Pediatric IBS-C. HCPLive. November 5, 2025. Accessed April 30, 2026. 

https://www.hcplive.com/view/fda-approves-linaclotide-linzess-capsules-for-pediatric-ibs-c

Rezaie A. Rethinking IBS Management: The Shift Toward Precision Care, With Ali Rezaie, MD. HCPLive. April 13, 2026. Accessed April 30, 2026. 

https://www.hcplive.com/view/rethinking-ibs-management-the-shift-toward-precision-care-with-ali-rezaie-md

Brooks A. Positive Psychological Gut-Brain Behavior Therapy Shows Early Benefit for IBS. HCPLive. August 29, 2025. Accessed April 30, 2026. 

https://www.hcplive.com/view/positive-psychological-gut-brain-behavior-therapy-shows-early-benefit-for-ibs

AGA. IBS in America: Despite advances, IBS remains a burden for many millions. August 7, 2025. Accessed April 30, 2026. 

https://gastro.org/press-releases/ibs-in-america-despite-advances-ibs-remains-a-burden-for-many-millions/

AGA. Landmark Survey Reveals Physical and Emotional Challenges Faced by Patients Living with IBS. April 12, 2016. Accessed April 30, 2026. 

https://gastro.org/press-releases/landmark-survey-reveals-physical-and-emotional-challenges-faced-by-patients-living-with-ibs/

Irritable bowel syndrome is increasingly viewed as a heterogeneous gut–brain–microbiome disorder driven by interacting mechanisms including dysbiosis, motility disturbances, immune activation, and visceral hypersensitivity. Management is shifting from empiric symptom suppression to mechanism-informed, layered care after exclusion of alarm features and mimicking disease. Therapeutic options are expanding, spanning FDA-approved agents (including pediatric linaclotide) and investigational microbiome therapeutics such as EBX-102-02. Multimodal strategies incorporating dietary, pharmacologic, and behavioral interventions are emphasized, yet real-world care remains variable, burdensome, and in need of biomarkers to enable precision treatment.

IBS care is evolving with personalized, multimodal strategies, but gaps in access, education, and real-world outcomes continue to impact patients’ lives

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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.

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

Navigating Progress, Personalization, and Persistent Gaps in IBS Care

IL-23 or IL-17 for Preventing Psoriasis Progression into PsA, With Andrew Blauvelt, MD, MBA

The longstanding debate over IL-23 versus IL-17 inhibitors in moderate to severe plaque psoriasis has largely been framed around skin clearance — a competition that most experts characterize as effectively too close to call. At the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado, that debate extended to a more clinically consequential and mechanistically charged question: whether biologic class selection in psoriasis patients without current joint involvement might determine who goes on to develop psoriatic arthritis.

Andrew Blauvelt, MD, MBA, owner of Blauvelt Consulting, in Annapolis, Maryland, and a principal investigator on the ONWARD program, argued the affirmative in a formal debate at the meeting, with Richard Langley, MD, professor of dermatology at Dalhousie University in Halifax, Nova Scotia, taking the opposing view. The debate drew on an emerging body of observational evidence suggesting that treatment with IL-23 pathway inhibitors — agents targeting the IL-23p19 subunit such as guselkumab, risankizumab, and iltaekizumab — may reduce the rate of PsA development in patients with psoriasis who do not yet have joint disease.

The clinical context for the debate is well established. Up to 30% of patients with psoriasis develop PsA over their disease course, with a lag of 5 to 7 years on average between skin and joint onset — a window that, in principle, creates an opportunity for preventive intervention. IL-17 inhibitors are currently regarded by most experts as the preferred biologic for patients who already have established PsA, given their more robust joint outcome data from controlled trials. The more provocative and contested question is whether IL-23 inhibitors might have a distinct preventive role upstream of PsA onset — a hypothesis Blauvelt characterized as biologically coherent in a conversation with 

IL-23 is an orchestrator cytokine sitting proximal to multiple downstream inflammatory cascades, including the IL-17 axis; inhibiting it theoretically disrupts the upstream regulatory signal before it can drive synovio-entheseal inflammation, rather than blocking the downstream effector cytokine once the inflammatory cascade is already established.

Several observational analyses have provided preliminary support for this hypothesis. Real-world studies of patients with psoriasis and early musculoskeletal symptoms treated with IL-23 inhibitors have reported lower rates of PsA progression compared with historical rates and with patients on other biologic classes. The ongoing PAMPA (Preventing Arthritis in a Multicentre Psoriasis At-Risk cohort) trial, a randomized, double-blind, placebo-controlled phase 4 study, is directly testing this hypothesis prospectively, with guselkumab versus placebo in psoriasis patients at elevated PsA risk; co-primary endpoints include a power Doppler ultrasound musculoskeletal score at week 24 and the proportion of patients with new PsA at week 96. PAMPA data are not yet mature.

The central methodological objection to the existing observational evidence — and the core of Langley's opposing argument — is selection bias. In routine practice, patients with any musculoskeletal symptoms are more likely to be placed on IL-17 inhibitors, which have established joint efficacy, while patients without joint involvement are more likely to receive IL-23 inhibitors. If this prescribing pattern holds across the observational datasets, then the apparently lower PsA incidence in IL-23-treated cohorts may simply reflect the fact that those patients were less predisposed to joint disease at baseline — not that the drug prevented it. Conversely, IL-17-treated cohorts may appear to have higher PsA rates because they were enriched for patients already on a joint disease trajectory. Blauvelt acknowledged this confounding risk directly, framing it as the critical limitation of the current literature and the reason prospective randomized data from PAMPA and similar trials are needed to settle the question.

The debate did not yield a consensus — nor was it designed to — but it distilled the clinical decision point that will face dermatologists as the evidence base matures: whether, for a psoriasis patient without current joint symptoms but with risk factors for PsA progression such as nail disease, scalp involvement, high body mass index, or a family history of PsA, IL-23 inhibition should be considered not only for skin control but as a strategy to delay or prevent joint disease onset. Blauvelt's position is that the mechanistic rationale is compelling and the emerging observational data are hypothesis-generating enough to take seriously, even before prospective confirmation. Langley's counterpoint is that prescribing decisions of this magnitude require randomized evidence that does not yet exist, and that acting on biologically plausible but methodologically compromised data risks systematically misallocating treatment in a disease where IL-17 inhibitors offer established and proven joint protection.

“Anybody with any kind of musculoskeletal disease may have preferentially been put on 17 blocker, and then they may be more predisposed to develop PsA. So that's the controversy. I'm taking the stance that 23 blockers do indeed have the potential to block PsA,” Blauvelt said.

Langley RG, Blauvelt A. Debate: IL-23 versus IL-17 inhibitors — does biologic class prevent psoriatic arthritis development? Presented at: AAD Annual Meeting; Denver, Colorado; March 27-31, 2026.

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