COMP360 Psilocybin Shows Rapid, Durable Effect in TRD, With Steve Levine, MD

Following positive topline results from the phase 3 COMP006 trial, 

 spoke with Steve Levine, MD, chief patient officer of Compass Pathways, to contextualize the clinical relevance of COMP360 (synthetic psilocybin) for treatment-resistant 

“One of the most striking things about the data we've just presented from our 05 and 06 studies is the rapidity of onset,” Levine told 

. “In both cases, we were able to detect a clinically and statistically significant difference in MADRS reduction as of day 2, which is the first day after administration of COMP360. That is a rapidity of effect that we've never seen before.”

Levine said the rapid onset may reflect acute, network-level effects mediated through 5-HT2A receptor agonism. He noted that this mechanism appears distinct from those underlying currently available treatments for TRD.

In COMP006, two 25-mg doses of COMP360 administered 3 weeks apart demonstrated a –3.8-point least squares mean difference in Montgomery-Åsberg Depression Rating Scale (MADRS) score at week 6 compared with a 1-mg control (

 <.001). According to Levine, a 3-point MADRS difference is generally considered clinically meaningful in TRD, placing the 3.8-point separation above the accepted threshold for relevance.

He noted that the magnitude of effect is comparable to that observed in pivotal trials of esketamine (Spravato), currently the only FDA-approved medication specifically indicated for TRD. However, whereas esketamine’s approximately 4-point treatment difference was achieved after multiple administrations over 4 weeks, COMP360 demonstrated a similar effect size 6 weeks after a single administration in COMP005 and after 2 administrations in COMP006.

In Part B of COMP005, participants who achieved ≥ 25% reduction in MADRS at week 6 and received a second treatment demonstrated sustained benefit through week 26. Among those with an initial clinically meaningful response who underwent re-treatment, approximately 40% achieved remission. These findings suggest that 1 or 2 administrations may support symptom improvement lasting up to 6 months in responders.

Furthermore, in COMP005, 25% of participants receiving 25 mg achieved a ≥ 25% MADRS reduction versus placebo. In COMP006, 39% reached this threshold after a second administration.

“This is a level of improvement that is very likely to translate into really meaningful benefit for patients, particularly those who have treatment-resistant depression,” Levine said. “Even modest decreases in symptoms can have an outsized impact on the course of their care and the quality of their life.”

A relevant disclosure for Levine includes Janssen Pharmaceuticals, Inc.

Compass Pathways Successfully Achieves Primary Endpoint in Second Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression. Compass Pathways. Published on February 17, 2026. Accessed on February 19, 2026. 

https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-Successfully-Achieves-Primary-Endpoint-in-Second-Phase-3-Trial-Evaluating-COMP360-Psilocybin-for-Treatment-Resistant-Depression/default.aspx

Derman C. COMP360 Psilocybin Meets Primary Endpoint in Second Phase 3 Trial for TRD. HCPLive. Published on February 19, 2026. Accessed on February 20, 2026. 

https://www.hcplive.com/view/comp360-psilocybin-meets-primary-endpoint-second-phase-3-trial-trd

Videos

Levine breaks down Compass Pathways’ phase 3 data on COMP360, highlighting next-day onset and sustained symptom improvement through 26 weeks.

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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.

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Raja Atreya, MD, is head of the IBD Center at University Hospital

Sustained Remission in Hard-to-Treat Crohn’s: Insights From SEQUENCE

New long-term data from the SEQUENCE program, presented at the 2026 Congress of the European Crohn’s and Colitis Organisation (ECCO), continue to reinforce the clinical impact of risankizumab (Skyrizi) in moderate-to-severe Crohn’s disease, particularly among patients with prior anti-TNF failure.

In discussing the findings, Raja Atreya, MD, head of the IBD Center at University Hospital

of Erlangen, characterized SEQUENCE as a “landmark” trial and emphasized that its design and durability data are directly shaping real-world decision-making.

“This is a head-to-head trial addressing an unmet need that we have in the treatment of our patients with exposure to anti-TNF therapy. This is a common clinical problem that we have,” Atreya explained. “I'm glad that I'm practicing in these times where we have a lot of therapeutic options. In the setting of previous anti TNF failure, where we already know these are hard to treat patients, because failure to anti TNF is like a surrogate marker for severe disease, hard to treat disease, refractory disease. So having these biological options is very nice, but when choosing the second advanced therapy, you have to make the right choice.”

He stressed that the head-to-head comparison of risankizumab and ustekinumab provided critically needed direct comparative data in this hard-to-treat population, something that has historically been lacking in Crohn’s disease.

The analysis included 224 patients who completed part 1 of the SEQUENCE study (week 48) and could receive risankizumab 360mg subcutaneously (SC) every 8 weeks in part 2, the open-label maintenance period of the SEQUENCE trial, starting at week 52.

Results showed patients with moderate-to-severe Crohn’s disease and prior anti-TNF failure, a population generally considered to have more refractory disease, demonstrated durable clinical remission, endoscopic response, endoscopic remission, and mucosal healing through 148 weeks of risankizumab treatment in the SEQUENCE study.

Of note, most patients who achieved clinical remission at week 8 maintained clinical remission throughout later time points, and clinical remission at week 148 was achieved by the majority (98.5% by CDAI; 88.1% by SF/APS) of week 8 clinical remitters.

Investigators additionally observed durability of clinical remission throughout later time points in patients who achieved clinical remission at week 48.

Of patients who achieved endoscopic response, endoscopic remission, or mucosal healing at week 24, 84.7%, 78.2%, and 67.3% of patients, respectively, maintained the corresponding endpoint at week 148. Similar results at week 148 were observed for patients who achieved these endoscopic endpoints at week 48.

Atreya further emphasized that early response appears to be the strongest predictor of long-term success. While molecular predictors remain elusive, he noted that patients who achieve early clinical and endoscopic remission are most likely to sustain benefit over time.

“With the amazing treatment results that we see in the SEQUENCE study and the sustained effectiveness seen in the open label extension studies, this is really something that helps us to position risankizumab high up in my personal therapeutic algorithm,” Atreya said.

Editors’ Note: Atreya reports relevant disclosures with AbbVie, Abivax, AlfaSigma, Astra-Zeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion Healthcare, Gilead, GlaxoSmithKline, Johnson & Johnson, Lilly, Merck Sharpe & Dohme, Pfizer, Roche Pharma, Takeda Pharma, and others.

R Atreya, J Lindsay, M Ferrante, B Siegmund, Q Cao, S Van Haaren, J Crowley, T Anschutz, A Garrison, X Huang, M C Dubinsky, DOP004 Durable Efficacy of Risankizumab Through Week 148 in Patients With Moderate-to-Severe Crohn’s Disease: A Post Hoc Analysis of Part 2 of the SEQUENCE Study, 

, Volume 20, Issue Supplement_1, January 2026, jjaf231.041, 

https://doi.org/10.1093/ecco-jcc/jjaf231.041

Brooks A. Marla Dubinsky, MD: Clinical Outcomes with Risankizumab Versus Ustekinumab in SEQUENCE. HCPLive. February 24, 2024. Accessed February 20, 2026. 

https://www.hcplive.com/view/marla-dubinsky-md-clinical-outcomes-risankizumab-ustekinumab-sequence

SEQUENCE trial data highlight sustained 3-year clinical and endoscopic remission with risankizumab in anti-TNF–exposed Crohn’s patients.

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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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How Head-to-Head SEQUENCE Data Shape Crohn’s Disease Treatment Decisions, With Raja Atreya, MD

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

chronic obstructive pulmonary disease (COPD) 

has undergone a quiet but profound reassessment. Once viewed as a largely homogeneous condition managed primarily with inhaled bronchodilators and corticosteroids, COPD is now increasingly understood as a biologically diverse disease with multiple inflammatory drivers. This evolving perspective has challenged long-standing assumptions about treatment limitations and opened the door to more individualized approaches.

Recent years have marked a pivotal shift, with biologic therapies—long established in asthma—beginning to demonstrate meaningful benefits in carefully selected COPD populations. Approvals such as dupilumab and mepolizumab have helped redefine what is possible for patients with persistent exacerbations and inflammatory phenotypes, signaling that disease biology, rather than diagnosis alone, may guide future therapy choices.

 These advances have reframed COPD not as a therapeutic dead end, but as a condition ripe for precision medicine.

convened a clinical forum led by Sarah Tomashefski, MSN, AGNP-C, FCCP, Lead Outpatient Pulmonary Advanced Practice Provider, and Director of the Pulmonary APP Fellowship program, Prisma Health, Greenville, South Carolina, focusing on how advanced practice providers (APP) and clinicians are now navigating how to translate emerging data into real-world practice. Questions around patient selection, biomarkers, safety, access, and guideline integration are shaping day-to-day decision-making. The clinical forum captured that moment of transition, reflecting a field actively recalibrating its approach to one of pulmonary medicine’s most challenging diseases.

“[The growing recognition of type 2 inflammation in COPD] opens the door past just the inhalers for a lot of us, where before it's like you get to a point with them and then they're just exacerbating. You're putting them on steroids. And it's like, well, now what do we do? We can see you again, treat you again. But you hit a limit with their treatment. So having the different biologics has definitely opened the door,” Alyssa Minute, DNP, APRN, FNP-C, Upstate Lung & Critical Care Specialists, said during the forum.

The forum explores how improved understanding of COPD heterogeneity has enabled more targeted therapeutic strategies, particularly through biologics aimed at type 2 inflammation. Participants detailed the importance of combining biomarkers such as eosinophil counts with clinical indicators like exacerbation history to identify patients most likely to benefit, while cautioning against indiscriminate use.

In addition to reviewing efficacy and safety considerations, the discussion highlighted practical challenges including reimbursement, workflow integration, and clinician education. Throughout, the conversation reinforced a central theme: the future of COPD management lies not in replacing existing therapies, but in layering precision-based options onto a foundation of optimized standard care.

“I know that there's this big push now for precision medicine. And I feel like just having biomarkers available to help kind of dictate the right tool for the right job is helpful and kind of meeting those new standards for a patient to - obviously, everyone should have individualized care, but it just helps kind of hone in even further [to find the] right tool for a job,” another attendee said.

Dupixent® (dupilumab) Approved in the U.S. as the First-ever Biologic Medicine for Patients with COPD. Regeneron Pharmaceuticals, Inc. September 27, 2024. https://www.globenewswire.com/news-release/2024/09/27/2954552/0/en/Dupixent-dupilumab-Approved-in-the-U-S-as-the-First-ever-Biologic-Medicine-for-Patients-with-COPD.html.

Johnson V. FDA Approves Mepolizumab for Eosinophilic COPD. News release. Article. HCPLive. https://www.hcplive.com/view/personalized-copd-treatment-lessons-biologic-trials-clinical-practice

Articles

Chronic obstructive pulmonary disease is increasingly recognized as a heterogeneous, biologically driven syndrome rather than a uniform airflow-limitation entity, creating momentum for precision-based escalation beyond inhaled therapies. Biologics long used in asthma are now demonstrating benefit in defined COPD subsets, with dupilumab and mepolizumab supporting a type 2 inflammation paradigm in patients with persistent exacerbations. Implementation hinges on rigorous patient selection using biomarkers (eg, blood eosinophils) plus exacerbation history, while addressing safety, reimbursement, workflow integration, and clinician education to layer targeted therapy onto optimized standard care.

COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

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Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

Frontline COPD Care in the Biologic Era: Practical Insights From APPs

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Janani Rangaswami, MD, FAHA, a nephrologist with expertise in cardiovascular- kidney medicine; Professor of Medicine, George Washington University, Washington DC; Co-chair, Scientific Advisory Group of the AHA's presidential advisory on CKM Health.

Holly Kramer, MD, is a nephrologist at Loyola University Medical Center and the editor in chief of 

Vlado Perkovic is Dean and Scientia Professor of Medicine at UNSW Sydney. He is also a Professorial Fellow at The George Institute and a Staff Specialist in Nephrology at the Royal North Shore Hospital in Sydney.

Just 1 year ago, semaglutide (Ozempic) was approved by the 

This approval marked an important milestone as the first GLP-1 receptor agonist to reduce the risk of worsening kidney disease, kidney failure, and death due to cardiovascular disease in these patient populations.

Semaglutide, initially developed by Novo Nordisk, received its first approval from the FDA under the name Ozempic on December 5, 2017. Its first indication was as an injection of 0.5 mg or 1 mg once weekly for glycemic control in patients with type 2 diabetes (T2D) – as an adjunct to diet and exercise.

Since then, semaglutide has exploded into nearly every related field. Glucagon-like peptide-1(GLP-1) receptors were discovered everywhere from the pancreas and the gastrointestinal tract to the heart, kidney, and liver. GLP-1 receptor agonists were quickly introduced into nephrology and cardiology, expanding their indications over the years to meet need in a variety of organs. Semaglutide has been at the forefront of this expansion due to its comparatively superior reductions of A1c, glucose, and overall weight.

In 2020, semaglutide received approval for the reduction of cardiovascular risk in patients with T2D, marking its entry into the cardiology sphere. In January of 2025, semaglutide became the first GLP-1 receptor agonist approved for worsening kidney disease, kidney failure, and death due to cardiovascular disease in patients with T2D and chronic kidney disease (CKD). This approval marked semaglutide’s entry into the full cardio-kidney-metabolic (CKM) disease spectrum, addressing mortality and worsening outcomes for major contributing diseases.

Now, just over a year after semaglutide’s approval for CKD, the editorial team at 

 has gathered insights from key clinicians across the CKM spectrum to discuss how this revolutionary drug overhauled the treatment landscape for kidney disease from all sides.

Semaglutide’s revolutionary impact on the endocrinology field cannot be understated. Despite not being the first, for years, this GLP-1 RA was the best method of reducing 3 major contributing factors to mortality in T2D. A1c reduction, glucose management, and weight loss saw substantial improvements as a result of the drug’s approval. However, semaglutide’s efficacy now extends far beyond T2D.

“I think that, sometimes, there’s hesitancy around starting a new therapy because the clinicians don’t know if other specialties will be on board,” Diana Isaacs, PharmD,

the director of Education and Training in Diabetes Technology and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and a member of 

 in an interview. “Now, we’re seeing through notes that nephrology is saying, ‘Why don’t you consider using semaglutide?’ And when they come to me as part of endocrinology, I see that, and I’m encouraged to use it. I think semaglutide really has enhanced team-based care in that we’re all on board.”

Isaacs went on to describe how semaglutide’s CKD approval provided a major paradigm shift for the American Diabetes Association’s standards of care.

“By showing its positive outcomes, particularly in people with kidney disease, semaglutide was paradigm-changing for the ADA Standards of Care and for our guidelines in that, previously, SGLT2 inhibitors were preferred for people with T2D and CKD,” Isaacs said. “Now, it’s either SGLT2 inhibitors or GLP-1 therapy – in practice, we’re now utilizing both of them.”

The Cardio-Kidney-Metabolic Landscape of Semaglutide

On October 9, 2023, the American Heart Association (AHA) released a presidential advisory regarding CKM syndrome, highlighting the interplay between metabolic risk factors, the cardiovascular system, and CKD. This syndrome has a significant impact on morbidity and mortality – poor CKM health, which is prominent among the American population, is associated with increased incidence of cardiovascular disease events.

“CKM syndrome encompasses the entire spectrum of risk, starting from people who have no risk factors or cardiovascular disease, going all the way through 

, vascular risk factors, subclinical disease, and clinical cardiovascular disease,” Janani Rangaswami, MD, professor of medicine at George Washington University and co-chair of the Scientific Advisory Group of the AHA’s presidential advisory on CKM Health, told 

 in an exclusive interview. “In any healthcare setting, the interplay between cardiology, nephrology, and endocrinology is the bulk of practice. In my practice, when I see individuals with kidney disease, diabetes alone is responsible for close to 50% of the cause of that kidney disease. When you add in obesity, metabolic dysfunction, and hypertension, all of these come together very heavily.”

Semaglutide’s approval for CKD effectively provided a bridge between all 3 specialties. When coupled with its initial diabetes indications and its cardioprotective effect, the drug was approved to tackle CKM syndrome on all fronts. Additionally, semaglutide’s efficacy when combined with SGLT2 inhibitors and RAAS blockade in patients with both CKD and high cardiovascular risk made it an effective tool for bolstering the protective effects of existing therapies. In this collaborative space between cardiology and nephrology, semaglutide became something of a miracle drug.

“While GLPs like semaglutide are very effective for A1c management and weight management, the FLOW trial really showed that this therapy saved lives, hearts, and kidneys,” Rangaswami said. “So now these therapies do multiple things; they’re addressing everything from improving lifespan to improving health outcomes, heart and kidney, and even beyond.”

The Bilateral Relationship Of CKD and Obesity

CKD remains one of the most common and serious complications of T2D, with obesity increasingly shaping disease trajectory, transplant eligibility, and therapeutic decision-making.

As global rates of obesity and CKD continue to climb, clinicians are paying closer attention to how excess adiposity directly affects renal physiology, independent of diabetes and hypertension.

“In obesity, metabolic demands increase, so the kidneys have to increase glomerular filtration rate and renal plasma flow to meet those demands. If nephron number is already reduced, the remaining nephrons have to work even harder. That leads to increased pressure inside each nephron, which causes barotrauma, scarring, and increased urine protein excretion,” explained Holly Kramer, MD, a nephrologist at Loyola University Medical Center and editor in chief of 

. “Severe obesity can also directly contribute to nephron loss through inflammatory effects. Often, obesity is accompanied by diabetes and hypertension, which further accelerate kidney disease progression.”

At BMI levels >40, systemic inflammation rises, adipokine signaling alters renal hemodynamics, and insulin resistance further increases glomerular stress. These processes frequently coexist with hypertension and T2D, amplifying cumulative kidney injury.

Despite this convergence of risk factors, CKD is often managed reactively rather than proactively. By the time patients reach end-stage kidney disease (ESKD) and require maintenance dialysis, obesity can create additional barriers to transplantation because of higher perioperative and postoperative complication risks. Increasingly, clinicians are focused on intervening earlier in the disease course.

In this landscape, GLP-1 agonists have emerged as a treatment strategy for patients with CKD and T2D, especially as a anti-imflammatory marker.

Subsequent research has shown an association of persistent low‑grade inflammation with worsened clinical outcomes in CKD, including faster eGFR decline, higher cardiovascular risk, and increased all‑cause mortality. Additionally, inflammation is a driving factor in the development and progression of T2D and its complications.

The reduction of inflammatory markers, such as CRP, has been highlighted as a potential clinical strategy to protect kidney function. In turn, semaglutide has been associated with reductions in CRP and other inflammatory markers independent of glycemic effects.

“GLP-1 receptor agonists have become another pillar we can use for people with chronic kidney disease. I see them being used as an adjunct to other medications, such as SGLT2 inhibitors and nonsteroidal mineralocorticoid receptor antagonists. Especially when used in conjunction with those therapies, I think they have kidney benefits,” said Kramer. “They reduce urine albumin-to-creatinine ratios. If patients lose weight, we improve blood pressure control. If they have type 2 diabetes, glucose control improves. All of those factors help slow kidney disease progression, so I think GLP-1 receptor agonists are a great addition to our existing armamentarium.”

Where Obesity, CKD, and T2D Intersect with Semaglutide: The FLOW Trial

The approval for semaglutide for patients with T2D and CKD was based on data from FLOW, a phase 3b, multinational, parallel-group, double-blind, randomized, placebo-controlled trial investigating the effects of 1.0 mg once weekly semaglutide, a once-weekly GLP-1RA, on kidney outcomes in participants with CKD and T2D.

“I think it has largely removed the uncertainty that once existed around the effects of GLP-1 receptor agonists on kidney function and has clearly demonstrated that these agents are kidney-protective,” FLOW study investigator, Vlado Perkovic, MBBS, PhD, and provost at the University of New South Wales, told 

 “That, in turn, has informed guideline updates and helped the clinical community accept GLP-1 receptor agonists as a fourth pillar of care for people with diabetic kidney disease. That is a major advance.”

FLOW included 3533 participants with T2D and CKD, with the composite primary endpoint being time to first kidney failure, defined as persistent eGFR <15 ml/min/1.73 m2 or initiation of chronic kidney replacement therapy, persistent ≥50% reduction in eGFR, or death from kidney or cardiovascular causes.

Over a median follow-up of 3.4 years, semaglutide reduced the risk of a primary outcome event by 24% compared with placebo (331 vs 410 first events; HR, 0.76; 95% CI, 0.66-0.88; P = .0003). Similar reductions were observed for the kidney-specific composite (HR, 0.79; 95% CI, 0.66-0.94) and cardiovascular death (HR, 0.71; 95% CI, 0.56-0.89).

All confirmatory secondary outcomes favored semaglutide, including a slower annual decline in eGFR (difference, 1.16 mL/min/1.73 m²; P <.001), an 18% reduction in major cardiovascular events (HR, 0.82; 95% CI, 0.68-0.98; P = .029), and a 20% lower risk of all-cause mortality (HR, 0.80; 95% CI, 0.67-0.95; P = .01). Serious adverse events occurred in 49.6% of the semaglutide group versus 53.8% with placebo.

Beyond Weight Loss: Inflammation and Future Directions of Semaglutide

Perkovic emphasized that FLOW was not intended to be a weight-loss trial, with a broad range of BMIs among participants, including 25% with BMI <27. While GLP-1 receptor agonists, especially semaglutide and emerging combination therapies, present efficacy regarding weight loss, FLOW indicated semaglutide’s specific kidney benefits not simply attributable to obesity treatment.

However, Perkovic also remarked on patterns from the FLOW trial’s participant population, where the mean BMI was 32. Additionally, in the CREDENCE trial, which also evaluated patients with T2D and CKD, the mean BMI was 31. This highlights obesity as a prevalent, rather than incidental, comorbidity in contemporary CKD populations. Taken together, these findings underscore the importance of considering body weight as a core component of CKD risk assessment, rather than a secondary concern.

“What that tells us is that people with diabetes and kidney disease are, on average, significantly overweight and often fall into the obese category. Many of these patients are therefore likely to benefit from weight loss as well,” explained Perkovic. “These therapies address multiple, parallel pathologies that commonly coexist in our patients, which makes them particularly exciting. It also raises the question of whether more potent agents that induce greater weight loss might confer additional kidney benefits, something that still needs to be tested.”

As obesity, T2D, and CKD increasingly converge in clinical practice, therapies capable of targeting overlapping metabolic, hemodynamic, and inflammatory pathways may redefine standard care. For clinicians managing complex kidney disease populations, GLP-1 receptor agonists now represent not simply a metabolic adjunct, but a foundational component of comprehensive CKD risk reduction.

Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others.

Rangaswami reports relevant disclosures with the Veterans Health Administration, Boehringer Ingelheim, Bayer, Procyrion, and the American Heart Association.

Kramer reports relevant disclosures with Bayer, Alexion, American Journal of Kidney Disease, National Kidney Foundation, and others.

Perkovic reports relevant disclosures with AstraZeneca, Bayer, Boehringer Ingelheim, and others.

Novo Nordisk. Novo Nordisk Receives FDA Approval of OZEMPIC (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes. 

. December 5, 2017. Accessed February 19, 2026. 

https://www.prnewswire.com/news-releases/novo-nordisk-receives-fda-approval-of-ozempic-semaglutide-injection-for-the-treatment-of-adults-with-type-2-diabetes-300567052.html

Knudsen LB, Lau J. The Discovery and Development of Liraglutide and Semaglutide. 

Novo Nordisk. FDA approves Ozempic for cardiovascular risk reduction in adults with type 2 diabetes and known heart disease, updates Rybelsus label. 

. January 16, 2020. Accessed February 19, 2026. 

https://www.prnewswire.com/news-releases/fda-approves-ozempic-for-cardiovascular-risk-reduction-in-adults-with-type-2-diabetes-and-known-heart-disease-updates-rybelsus-label-300988672.html

Anderer S. FDA approves semaglutide to reduce risk of kidney disease progression. 

Ndumele CE, Rangaswami J, Chow SL, et al. Cardiovascular-kidney-metabolic health: A presidential advisory from the American Heart Association. 

Furth SL, Colhoun HM, Kanbay M, et al. The relationship between obesity and chronic kidney disease: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. 

. Published online September 2025:S0085-2538(25)007744. doi:

https://doi.org/10.1016/j.kint.2025.09.019

Good PI, Li L, Hurst HA, et al. Low nephron endowment increases susceptibility to renal stress and chronic kidney disease. 

https://doi.org/10.1172/jci.insight.161316

Wang H, Fan K, Ning Y, et al. Hypertension and BMI as Mediators of Type 2 Diabetes-Induced CKD: Insights from an Integrative Multi-Database Study. 

Perkovic V. Inflammation Emerges as Promising CKD Treatment Target, With Vlado Perkovic, MBBS, PhD. HCPLive. Published February 9, 2026. Accessed February 20, 2026. 

https://www.hcplive.com/view/inflammation-emerges-as-promising-ckd-treatment-target

Rossing P, Baeres FMM, Bakris G, et al. The rationale, design and baseline data of FLOW, a kidney outcomes trial with once-weekly semaglutide in people with type 2 diabetes and chronic kidney disease. 

Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. 

Pruijm M, Belmar N, Bjornstad P, et al. REMODELing mechanistic trials for kidney disease: a multimodal, tissue-centered approach to understand the renal mechanism of action of semaglutide. 

https://doi.org/10.1016/j.kint.2025.10.005

Semaglutide has expanded from a T2D glycemic agent to a cardio-kidney-metabolic therapy, culminating in FDA approval for reducing CKD progression, kidney failure, and CV death in T2D with CKD. Cross-specialty adoption is accelerating, reshaping guideline positioning alongside SGLT2 inhibitors and enabling combination strategies with RAAS blockade and nsMRAs. Obesity is increasingly recognized as a direct mediator of renal injury via hyperfiltration, inflammation, and nephron stress, influencing progression and transplant candidacy. FLOW established kidney and survival benefits beyond weight loss.

1 year into real-world use, 4 clinicians discuss how semaglutide is transforming the endocrinology, nephrology, and cardiology landscape.


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...

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Chronic Kidney Disease

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Type 2 Diabetes

Strategic Alliance Partnership

1 Year After CKD Approval, Semaglutide Transforms Diabetes, Kidney, and Heart Care

Ron Vender, MD, is a dermatologist in Hamilton, Ontario, and is the founder and director of Dermatrials Research Incorporated and Venderm Consulting Inc. He is also an associate clinical professor at McMaster University in the Department of Medicine, Division of Dermatology.

3-Year Patient-Reported Psoriasis Outcomes for Bimekizumab, With Ron Vender, MD

 emphasizing that its design reflects the types of patients dermatologists see in everyday clinical practice.

In this interview, Vender noted that the study’s head-to-head comparison of bimekizumab, a dual interleukin (IL)-17A and IL-17F inhibitor, with secukinumab, an established IL-17A inhibitor, provides meaningful informtion beyond traditional efficacy endpoints.

“This paper in particular was looking at patient reported outcomes in that and not necessarily efficacy in terms of [body surface area] or [Psoriasis Area and Severity Index], but we, of course, we did look at that as well,” Vender explained.

While PASI and body surface area (BSA) outcomes remain important, Vender stressed that the most compelling aspect of this analysis was its focus on patient-reported outcomes (PROs). According to Vender, rapid relief of symptoms is critical in psoriasis management. He pointed to data showing improvements in itch, skin pain, and scaling as early as the 4-week mark with bimekizumab use.

Vender underscored early attainment of PASI 0 alongside a Dermatology Life Quality Index (DLQI) score of 0 or 1 reflects not just clearance of skin, but meaningful quality-of-life improvement. At a single year and extending through 3 years, Vender emphasized the durability of patients’ responses. He acknowledged clinicians often express concern about loss of efficacy over time with biologic therapies, but the sustained symptom resolution and maintained low DLQI scores observed with continued bimekizumab therapy address that concern.

Importantly, he also discussed the subgroup of patients who switched from secukinumab to bimekizumab during the open-label extension. These patients experienced additional improvements after switching, suggesting that dual IL-17A/F inhibition may provide incremental benefit for certain individuals. However, Vender was careful to note that secukinumab remains an effective and widely used therapy; the findings represent comparative gains rather than shortcomings.

Overall, Vender framed the data as reinforcing the importance of considering both rapidity and durability of patient-centered outcomes when selecting biologic therapy for moderate to severe plaque psoriasis.

The quotes used in this summary were edited for clarity.

Vender reported support from AbbVie, Alumis, Amgen, Arcutis, Bausch, Bristol Myers Squibb, Celltrion, JAMP, Janssen, Leo, Lilly, Meiji, Novartis, Organon, Orka, Sandoz, Sun, Takeda, and UCB.

Augustin M, Feldman SR, Warren RB, et al. Three-Year Patient-Reported Outcomes From Bimekizumab for Plaque Psoriasis: The BE RADIANT Randomized Clinical Trial With Open-Label Extension. JAMA Dermatol. Published online February 18, 2026. 

Smith T. BE RADIANT Trial: Bimekizumab Effective for Psoriasis After 3 Years of Use. HCPLive. February 19, 2026. Accessed February 20, 2026. 

https://www.hcplive.com/view/be-radiant-trial-bimekizumab-effective-psoriasis-after-3-years-use

This interview with Vender highlights recent findings on patient-reported outcomes (PROs) in patients in the BE RADIANT trial with psoriasis.

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Chelsie Derman is an associate editor for 

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