Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!

Diabetes Dialogue: FDA Approves Novo Nordisk’s Insulin Icodec-abae (Awiqli) for T2D

 approved Novo Nordisk’s insulin icodec-abae under the name Awiqli for patients with 

In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, highlight the FDA approval of once-weekly insulin icodec, emphasizing its significance as a major advancement in insulin therapy. They begin by addressing practical considerations, including its high concentration (U-700) and the implications for dosing, noting that weekly administration necessitates substantially higher unit doses compared with daily basal insulin.

The discussion focuses on dosing strategy, particularly the need to scale weekly doses approximately sevenfold relative to daily regimens, as well as the rationale for an initial loading dose of 1.5 times the calculated weekly requirement to more rapidly achieve steady state. Isaacs underscores the pharmacokinetic basis for this approach, given the drug’s long half-life and delayed time to steady state, while also noting the constraints of dosing in 10-unit increments.

Bellini and Isaacs explore the clinical implications of once-weekly insulin, with particular attention to adherence and treatment burden. Bellini emphasizes the potential benefit for insulin-naive patients and those struggling with daily injection adherence, framing weekly insulin as a means to significantly reduce injection frequency and improve consistency. Isaacs expands on this, arguing that reduced dosing frequency may mitigate missed doses and glycemic variability, especially in patients with irregular routines. Both highlight the flexibility afforded by the long half-life, allowing for minor deviations in dosing timing without substantial impact on glycemic control.

The conversation also addresses potential risks, including delayed titration and the possibility of over-basalization, particularly in patients with fluctuating nutritional intake or socioeconomic instability. They stress the importance of careful patient selection and monitoring, given the longer interval required to adjust doses.

Reviewing clinical trial data from the ONWARDS phase 3 program, the hosts note that once-weekly insulin demonstrated modestly greater A1C reduction compared with daily basal insulin in treat-to-target trials, reinforcing the hypothesis that improved adherence may translate into better glycemic outcomes.

They further discuss implementation considerations across care settings, highlighting potential advantages for older adults, caregivers, and patients in long-term care, where reduced injection burden may improve safety, independence, and medication management. The episode also touches on current regulatory limitations, noting that while approval is presently limited to type 2 diabetes in the United States, ongoing studies may expand its indication to type 1 diabetes, with off-label use anticipated in select cases.

The hosts conclude by situating weekly insulin within the broader therapeutic landscape, emphasizing renewed innovation in insulin development alongside incretin-based therapies. They note that additional agents in development may soon expand options within this class, signaling a meaningful shift in the management of diabetes toward more patient-centered, lower-burden treatment paradigms.

Editor’s Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

Novo Nordisk. Awiqli approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes. March 26, 2026. Accessed April 3, 2026. 

https://ml-eu.globenewswire.com/Resource/Download/cb9dda59-1286-4718-a7e5-4256e2397b0c

Kunzmann K. FDA Approves Insulin Icodec (Awiqli) as First Once-Weekly Basal Insulin for Type 2 Diabetes. 

. March 26, 2026. Accessed April 3, 2026. 

https://www.hcplive.com/view/fda-approves-awiqli-insulin-icodec-first-once-weekly-basal-insulin-for-type-2-diabetes

Podcasts

This episode covers the March 26th approval of Awiqli for T2D, highlighting its high concentration and once-weekly administration.

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

Sotatercept has reduced pulmonary vascular resistance (PVR) in combined post- and pre-capillary pulmonary hypertension (CpcPH) 

heart failure with preserved ejection fraction (HFpEF)

, improving both pulmonary vascular and cardiac end points, according to data from the CADENCE trial.

American College of Cardiology (ACC) Scientific Sessions 2026

 in New Orleans, Louisiana, by Mardi Gomberg-Maitland, MD, MSc, director of the pulmonary hypertension program, chief clinical research officer at the Office of Clinical Research SMHS, and professor of medicine at George Washington University.

“Here we have a drug for a disease that we’ve never had therapy for, one that has high morbidity and mortality, and now we have potential,” Gomberg-Maitland told 

 in an exclusive interview. “We’re seeing good effects – now it’s time that we move to the next phase, to phase 3.”

CADENCE is an ongoing phase 2, multicenter, double-blind, randomized trial investigating the efficacy, safety, and tolerability of sotatercept in patients with CpcPH-HFpEF. The trial consisted of a 24-week placebo-controlled treatment period and an active-drug extension period. Gomberg-Maitland and colleagues reported the placebo-controlled period, during which patients were randomly assigned in a 1:1:1 ratio to receive subcutaneous sotatercept at 0.3 mg/kg (before potential escalation to 0.7 mg/kg after 3 dosing visits) or placebo every 3 weeks.

Eligible patients were aged 18-85 years with symptomatic CpcPH-HFpEF diagnosed via an assessment of hemodynamics through right heart catheterization. Patients were excluded if they were diagnosed with another form of pulmonary hypertension, clinically significant lung disease, severe hepatic impairment, and/or cirrhosis, among other criteria.

CADENCE’s primary efficacy endpoint was the change from baseline in PVR at week 24. The key secondary efficacy endpoint was the change from baseline in 6-meter walk distance at week 24. Other secondary endpoints included time to clinical worsening, which was defined as the time from the first dose date to the first occurrence of all-cause death or non-elective hospitalization for cardiopulmonary indications related to pulmonary hypertension and/or heart failure, and change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, NYHA functional class, and hemodynamic or echocardiographic parameters.

A total of 164 patients were randomized, with 54 assigned to sotatercept 0.3 mg/kg, 55 assigned to 0.7 mg/kg escalated from 0.3, and 55 assigned to placebo. The median duration of follow-up during this period was 5.6 months (interquartile range [IQR], 5.5-5.7) in the 0.3 mg/kg group, 5.6 months (IQR, 5.5-5.8) in the 0.7 mg/kg group, and 5.6 months (IQR, 5.5-5.8) in the placebo group.

By week 24, sotatercept treatment resulted in substantially greater reductions in PVR versus placebo. The median change from baseline was -0.67 Wood units in the 0.3 mg/kg group, -0.33 Wood units in the 0.7 mg/kg group, and 0.26 Wood units in the placebo group. The Hodges-Lehmann shift estimate was -1.02 Wood units (95% CI, -1.81 to -0.23; 

 = .004) for the 0.3 mg/kg group and -0.75 Wood units (95% CI, -1.52 to 0.03; 

 = .024) for the 0.7 mg/kg group compared to placebo. These results were consistent across subgroups, including the degree of PVR elevation at baseline.

Mean pulmonary arterial pressure saw a mean reduction of -9.19 mmHg (95% CI, -13 to -5.38) and -9.22 (95% CI, -12.97 to -5.46) in the 0.3 mg/kg and 0.7 mg/kg groups, respectively. Changes in 6-minute walk distance were 20.3 meters (95% CI, 1.5 to 39.1) for the 0.3 mg/kg group and 5.8 meters (95% CI, -17.3 to 28.9) for the 0.7 mg/kg group.

Ultimately, Gomberg-Maitland and colleagues noted that these findings provide an effective proof of concept for improved pulmonary vascular and cardiac hemodynamics following activin signaling inhibition with sotatercept in patients with CpcPH-HFpEF.

“As for how it can impact therapy, we’re going to continue into our phase 3 trials to really look at these echo parameters over time and see if this is perhaps a way that we can follow patients,” Gomberg said. “Ultimately, you don’t want to be doing right heart casts on everybody to see how they’re doing. We need other assessments that are more functional.”

Editors’ Note: Gomberg-Maitland reports disclosures with Merck, Catalys Pacific, Gossamer, Janssen Pharmaceuticals, Medtronic, Novartis, and others.

Gomberg-Maitland M, Tedford R, Langleben D, et al. Efficacy and Safety of Sotatercept in Combined Post- and Pre-capillary Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction: results from the Phase 2 Cadence Trial. Abstract presented at the American College of Cardiology Scientific Sessions 2026, New Orleans, Louisiana. March 28-30, 2026.

Gomberg-Maitland M, Tedford RJ, Langleben D, et al. Sotatercept for combined post- and pre-capillary pulmonary hypertension associated with heart failure: Results from the phase 2, randomized, placebo-controlled Cadence Study. 

Videos

Gomberg-Maitland addresses sotatercept’s capacity to improve pulmonary vascular and cardiac endpoints in patients with CpcPH-HFpEF.

New Therapeutic Options Raise More Questions for IgA Nephropathy Treatment, With Sayna Norouzi, MD

Evidence shows a continually and rapidly expanding therapeutic landscape for patients with IgA nephropathy (IgAN). Due to the heterogeneity of the disease, clinicians remain undecided about how to approach these options with the IgAN’s complex, individualized presentation.

“It's getting more and more complicated with having more options out there, and we still have ongoing clinical trials, and we recruit for these trials as well. We have to keep in mind that we don't have a cure for IgAN yet, and we're not done with this field,” Norouzi siad. “I think the next step for a lot of our colleagues who are not spending a lot of time with IgAN patients would be a referral to a glomerular disease clinic or center of excellence.”

At WCN, a plethora of data supporting positive progress in IgAN was presented. In a

, Norouzi highlighted the emergence of targeted agents, including targeted-release budesonide, endothelin receptor antagonists like sparsentan and atrasentan, complement inhibitors such as iptacopan, and newer APRIL-targeting therapies. Together, these agents provide clinicians with multiple avenues to reduce proteinuria and preserve kidney function.

“When I go back from every conference that I attend to my clinic, my patients are excited. Sometimes I share with them that I'm going to a conference, and they know when I come back, I'm going to have more data, and they might have more options for their disease. And it's not just about IgAN. We're getting more options for C3G, lupus nephritis,” she concluded. “It's an exciting time to be a nephrologist.”

Norouzi reports relevant disclosures with Calliditas, Travere, Apellis and others.

Norouzi discussed the remaining challenges that come with having evolving treatment options and a robust patient population in IgAN.

 ushered in a new wave of groundbreaking research into 

, and more. With hundreds of experts presenting hundreds of new studies and analyses, every aspect of cardiology received its fair share of updates.

With such a deluge of information, updates, and trial results, the 

 editorial team has collected 5 of the most impactful Phase 2 and 3 trials that should be on every clinician’s radar. Catch up on the biggest news from ACC.26 below:


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


KARDINAL was a randomized, placebo-controlled phase 2 trial of tonlamarsen in patients with uncontrolled hypertension, aiming to evaluate its efficacy in reducing plasma angiotensinogen and blood pressure. Presented by Luke Laffin, MD, co-director of the Center for Blood Pressure Disorders at Cleveland Clinic, these data showed a substantially greater percentage reduction in angiotensinogen among patients receiving monthly doses, with a least-squares mean percent change of -67.2%. However, tonlamarsen displayed no meaningful difference in blood pressure reduction between monthly doses and a single dose followed by placebo.


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


The SCOUT-HCM phase 3 trial is still ongoing, but at ACC.26, Joseph Rossano, MD, MS, co-director of the Cardiac Center at the Children’s Hospital of Philadelphia, presented data on mavacamten’s efficacy in reducing left ventricular outflow in adolescents with 

obstructive hypertrophic cardiomyopathy (HCM)

 compared to placebo. The analysis included 44 patients; of these, the 23 assigned to receive mavacamten saw dramatic reductions in mean Valsalva left ventricular outflow tract gradient compared to placebo recipients.


Evolocumab Reduces CV Risk in Non-Atherosclerotic Patients With Diabetes, With Nicholas Marston, MD, MPH


This secondary analysis of the VESALIUS-CV trial, presented by Nicholas Marston, MD, MPH, a preventive cardiologist at Brigham and Women’s Hospital, highlighted oral PCSK9 inhibitor evolocumab’s capacity to lower 

 in high-risk patients without a history of major cardiovascular events and with diabetes. A composite endpoint including coronary heart disease death, myocardial infarction, or ischemic stroke – as well as a 4-part endpoint including ischemia-driven arterial revascularization – occurred far less among patients treated with evolocumab compared to those receiving placebo.


MOMENTUM: Hypercortisolism Present in 1-in-4 with Resistant Hypertension


Presented by Deepak Bhatt, MD, MPH, MBA, director of Mount Sinai Fuster Heart Hospital, the MOMENTUM trial revealed that the prevalence of endogenous hypercortisolism may be significantly higher among patients with resistant hypertension than previously thought. Investigators identified the condition in more than 1 in 4 patients of the 1086 screened, evaluating each patient via a 1-mg overnight dexamethasone suppression test. Bhatt and colleagues hope the results will support increased screening for hypercortisolism moving forward.


CHAMPION-AF: Left Atrial Appendage Closure Noninferior to NOACs


Device-based left atrial appendage closure was noninferior to non-vitamin K antagonist oral anticoagulant therapy (NOAC) for preventing adverse events in patients with atrial fibrillation, according to data from the CHAMPION-AF trial. Presented by Saibal Kar, MD, program director of the cardiovascular disease fellowship at Los Robles Regional Medical Center in California, this trial enrolled 3000 patients with non-valvular atrial fibrillation, assigning them to either the Watchman Fix device or an approved NOAC. At 3 years, a composite endpoint of cardiovascular death, stroke, or systemic embolism occurred in 81 patients in the device group and 65 in the NOAC group, while non-procedure-related bleeding occurred in 10.9% of the device group and 19% of NOAC patients.

Catch up on the most impactful trial readouts to come out of ACC 2026.

ACC 2026: Phase 2/3 Trials to Know

 as a disease state commanded a notable share of the late-breaking data presented at the 

2026 American Academy of Dermatology (AAD) Annual Meeting

 in Denver, Colorado, with research spanning a broad and rapidly evolving therapeutic landscape, from established biologics accumulating long-term comparative and extension data to emerging oral medications designed to meaningfully shift how psoriasis is managed in the years to come.

Several themes ran through much of the psoriasis program, including the growing momentum behind oral targeted treatments and the continued push to validate sustained skin clearance well beyond the 16-week primary endpoints known to have historically defined the field. Nail psoriasis and generalized pustular psoriasis (GPP) also featured in the data released at the meeting, reflecting a broader effort to address the full clinical spectrum of psoriatic disease. The following 6 updates from AAD represent key trials clinicians managing psoriasis should know:

ONWARD: Oral Envudeucitinib Demonstrates High PASI Responses in Phase 3, With Andrew Blauvelt, MD

One set of trials from AAD was ONWARD1 and 2, highlighting new phase 3 data for envudeucitinib. This drug, a next-generation, highly selective oral TYK2 inhibitor, demonstrating robust skin clearance in moderate-to-severe plaque psoriasis, was discussed by Andrew Blauvelt, MD, MBA, owner of Blauvelt Consulting, LLC, and principal investigator on the ONWARD program. Both ONWARD1 and ONWARD2 together enrolled more than 1700 adult patients living with moderate-to-severe plaque psoriasis.

Sustained PASI Responses Observed Through Week 60 with Zasocitinib, With Melinda Gooderham, MD

The LATITUDE trial program, highlighted during the AAD late-breaking data sessions, suggests zasocitinib could help to reshape the oral treatment landscape for moderate-to-severe plaque psoriasis. The drug was shown to have a high level of skin clearance, a result typically seen with biologics. Melinda Gooderham, MD, medical director of the SKiN Centre for Dermatology in Ontario, Canada, spoke about these key findings from the pair of pivotal phase 3 studies evaluating zasocitinib against both placebo and an active comparator, apremilast.

Risankizumab Outperforms Deucravacitinib on Psoriasis Clearance Across Patient Subgroups in Phase 4 Head-to-Head Trial

Risankizumab was another drug with new data presented during AAD, with findings demonstrating significantly greater skin clearance than deucravacitinib at the 16-week mark across an array of patient subgroups among adults with biologic-naïve moderate plaque psoriasis. These new data resulted from a subgroup analysis of the phase 4 IMMpactful trial, with the findings highlighting subgroup populations defined by race, sex, age, smoking status, baseline disease severity, body mass index (BMI), and presence of psoriatic arthritis (PsA).

ICONIC-LEAD: 1 Year Icotrokinra Data Confirm Durable Psoriasis Clearance, PRO Improvements in Adults, Adolescents, With Jennifer Soung, MD

Icotrokinra was another drug spotlighted during AAD, with 1-year data from the phase 3 ICONIC-LEAD trial confirming icotrokinra delivered durable skin clearance and meaningful patient-reported improvements among adults and adolescents with moderate-to-severe plaque psoriasis. ICONIC-LEAD investigators also identified no new safety signals through the 52-week mark. This medication became the first and only targeted oral peptide blocking the interleukin (IL)-23 receptor after being approved by the United States Food and Drug Administration (FDA) on March 18, 2026, for psoriasis.

Tildrakizumab Sustains Nail Psoriasis Efficacy Through 52 Weeks in Phase 3b Extension Data

New 52-week results also released during AAD showcased a phase 3b trial of tildrakizumab treatment of moderate-to-severe nail psoriasis, with these data demonstrating continued improvement in the level of nail clearance and sustained response seen among early responders, extending results first reported at last year’s AAD. Thia analysis is the first dedicated phase 3b trial of an IL-23 inhibitor in nail psoriasis.

EFFISAYIL ON: New Long-Term Data Released on Spesolimab Injection for GPP

Results from an ongoing open-label extension analysis were released by LEO Pharma at AAD regarding spesolimab-sbzo in adults with GPP. The EFFISAYIL ON analysis is an open-label extension trial lasting 5 years, designed to examine the long-term efficacy, safety, and tolerability of subcutaneous (SC) spesolimab in those who had previously partaken in either the EFFISAYIL 1 or EFFISAYIL 2 pivotal trials. These findings provide encouraging data suggesting this biologic agent can meaningfully diminish patients’ GPP flare burden over several years of treatment.

Articles

Psoriasis late-breaking data at AAD 2026 emphasized durable clearance beyond traditional 16-week endpoints and accelerating adoption of targeted oral therapies with biologic-like efficacy. Phase 3 programs for selective TYK2 inhibitors envudeucitinib and zasocitinib showed high PASI responses, including sustained outcomes through week 60. Head-to-head phase 4 data favored risankizumab over deucravacitinib across multiple biologic-naïve subgroups. One-year ICONIC-LEAD results supported sustained efficacy and PRO gains with icotrokinra, an FDA-approved oral IL-23R–blocking peptide. Additional updates addressed nail psoriasis with tildrakizumab and long-term GPP control with subcutaneous spesolimab.

This review of new data on psoriasis treatments from AAD 2026 highlights several key trials.

AAD 2026: 6 Psoriasis Trials to Know

March encompassed a number of key updates in the nephrology landscape, including revised clinical practice guidelines from Kidney Disease: Improving Global Outcomes (KDIGO), phase 3 clinical trial data on emerging therapies for 

, and featured content examining the International Society of Glomerular Disease (ISGD)'s latest research advances alongside a deep dive into how neighborhood disadvantage drives kidney disease risk and progression.

In this edition, KDIGO announces a focused update to its 2024 CKD guideline, spotlighting newer pharmacologic agents in the management of CKD progression, including the nonsteroidal mineralocorticoid receptor antagonist finerenone, which has now demonstrated statistically significant eGFR slope improvement in nondiabetic CKD populations in the phase 3 FIND-CKD trial. In IgAN, povetacicept achieved a 52% reduction in urine protein-to-creatinine ratio (UPCR) versus baseline in the RAINIER trial's 36-week interim analysis, reinforcing the therapeutic potential of BAFF/APRIL dual inhibition.

 examines the intersection of social determinants of health and CKD risk, specifically how neighborhood disadvantage may drive disease burden in ways that biomarkers alone cannot capture, alongside a special report from the International Society of Glomerular Disease (ISGD) on the transformative scientific advances reshaping our biological understanding of glomerulonephritis and related conditions over the past five years.

KDIGO Launches Focused Update to 2024 CKD Guideline on Emerging Therapies

KDIGO announced a formal update to the 2024 Clinical Practice Guideline for the Evaluation and Management of CKD, one of the most widely used global resources for CKD evaluation and management. The update will focus on Chapter 3, "Delaying CKD progression and managing its complications," with particular emphasis on medical management using newer therapies in light of the evolving therapeutic landscape.

Finerenone Proves CKD Benefit Extends Beyond Diabetes in FIND-CKD

Bayer announced the phase 3 FIND-CKD trial evaluating finerenone (Kerendia) in adult patients with nondiabetic CKD met its primary endpoint, demonstrating a statistically significant improvement in eGFR slope versus placebo over 32 months. The company indicated it planned to submit the data to the US Food and Drug Administration (FDA) to seek a label expansion into this patient population, which would represent the broadest application of the agent to date across a CKD program spanning more than 20,000 patients in phase 3 trials.

RAINIER: Povetacicept Reduces Proteinuria By 52.0%

Povetacicept met its primary and secondary endpoints in RAINIER, an ongoing phase 3 trial evaluating adults with IgA nephropathy (IgAN), according to a 36-week interim analysis. Vertex Pharmaceuticals announced positive results where povetacicept showed a 52.0% reduction in urine protein to creatinine ratio (UPCR) compared to baseline, with a statistically significant and clinically meaningful 49.8% UPCR reduction compared to placebo (

Crisis Point: The Cause and Calamity, Neighborhood Disadvantage and Kidney Disease

Clinicians often thought of healthcare as having a problem and a solution, but this Crisis Point examined what was going on underneath the surface. With the rising threat of chronic kidney disease, more was at stake than the values measurable in a lab, this piece focused on the detrimental problem of neighborhood disadvantage as both the cause and the calamity of kidney disease.

ISGD and the Fastest 5 Years in Glomerular Disease

For experts from ISGD, the last 5 years were the fastest and most dynamic period in glomerular disease. In this special report, Barbara Gillespie, MD, an adult nephrologist at the University of North Carolina and Chief Medical and Strategy Officer at ISGD, and Toby Huber, MD, head of Internal Medicine at Hamburg-Eppendorf in Germany and founding president of ISGD, broke down the scientific advances and how they revolutionized biological understanding of glomerular diseases.

March’s nephrology updates centered on guideline refinement, late-stage trial readouts, and broader determinants of CKD burden. KDIGO is issuing a focused update to Chapter 3 of its 2024 CKD guideline to incorporate newer agents aimed at slowing progression and managing complications. Phase 3 FIND-CKD data showed finerenone significantly improved eGFR slope versus placebo over 32 months in nondiabetic CKD, supporting a potential FDA label expansion. In IgA nephropathy, interim phase 3 RAINIER results showed povetacicept reduced proteinuria via BAFF/APRIL dual inhibition. Social disadvantage and recent glomerular science advances were also emphasized.

Catch up on the guideline updates, trial news, and featured content from March 2026. 


5 Nephrology Headlines You Missed in March 2026

Diabetes Dialogue: 2026 AACE Guidelines for Type 2 Diabetes

On March 17, 2026, the American Association of Clinical Endocrinology (AACE) released a consensus statement, which features an algorithm for the management of 

In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, review the newly released 2026 American Association of Clinical Endocrinology (AACE) type 2 diabetes treatment algorithm, positioning it as an evolution of the 2023 update that integrates a growing body of clinical trial evidence into a more comprehensive, complications-focused framework. They emphasize a paradigm shift away from glucose-centric management alone, highlighting the importance of addressing comorbidities, including 

metabolic dysfunction–associated steatotic liver disease (MASLD)

The discussion outlines the guideline’s structure, including its 10 guiding principles, which reinforce lifestyle intervention as foundational, promote individualized glycemic targets (with a preference for A1c ≤6.5% when safely achievable), and strongly encourage early use of continuous glucose monitoring (CGM). The hosts underscore the emphasis on avoiding therapeutic inertia, minimizing hypoglycemia risk, and managing cardiometabolic comorbidities alongside glycemia as part of routine care.

A key highlight is the introduction of a diabetes classification algorithm aimed at reducing misdiagnosis, particularly distinguishing type 1 from type 2 diabetes and identifying less common etiologies. Within this framework, the guidelines newly prioritize screening for hypercortisolism, informed by findings from the CATALYST trial, which demonstrated a higher-than-expected prevalence among patients with difficult-to-control diabetes. Isaacs and Bellini note that recognizing and treating underlying hypercortisolism may significantly improve glycemic control and, in some cases, reduce the need for diabetes-specific therapies.

The episode further reviews updated algorithms for cardiovascular risk reduction, dyslipidemia, and hypertension, emphasizing aggressive, individualized targets and the continued central role of lifestyle modification. Pharmacologic recommendations reflect robust recent evidence, prioritizing SGLT2 inhibitors and GLP-1 receptor agonists (including dual GIP/GLP-1 agents) for patients with cardiorenal or metabolic comorbidities, while also incorporating emerging indications such as heart failure with preserved ejection fraction and MASLD.

Isaacs and Bellini also discuss the guideline’s glucose-centric algorithm for patients without major comorbidities, highlighting patient-centered decision-making based on factors such as hypoglycemia risk, weight considerations, and cost/access. They reinforce recommendations for early combination therapy when A1c is significantly above target and appropriate use of insulin, including guidance on avoiding overbasalization and incorporating prandial strategies.

The conversation concludes with commentary on the guideline’s practical strengths, including clear visual algorithms, concise format, and detailed pharmacotherapy tables summarizing efficacy, safety, and organ-specific benefits. The hosts emphasize that the updated AACE algorithm provides clinicians with an actionable, evidence-based roadmap for delivering holistic, individualized diabetes care that extends beyond glycemic control to address the full spectrum of cardiometabolic risk.

Samson SL, Vellanki P, Blonde L, et al. American Association of Clinical Endocrinology Consensus Statement: Algorithm for Management of Adults With Type 2 Diabetes - 2026 Update. 

This episode discusses the recently released algorithm for T2D from the American Association of Clinical Endocrinology.

The first quarter of 2026 established a brisk regulatory pace that Q2 shows no signs of slowing. In the span of 3 months, the 

United States Food and Drug Administration

 (US FDA) cleared deucravacitinib for psoriatic arthritis (PsA) — the first TYK2 inhibitor approved for the indication — navepegritide for achondroplasia, and sublingual epinephrine film as the first needle-free epinephrine option for anaphylaxis. The Commissioner's National Priority Voucher program continued to make headlines, most recently with the fastest New Molecular Entity (NME) approval since 2002 in early April.

Q2 now arrives with a calendar that spans nephrology, endocrinology, cardiology, pulmonology, and dermatology — and that carries several decisions with genuine first-in-class or first-in-indication stakes. April brings what could be a long-awaited milestone for the rare kidney disease community, with a ruling expected on sparsentan in focal segmental glomerulosclerosis, a condition affecting more than 40,000 patients in the US for which no approved pharmacologic therapy currently exists. May narrows to a single high-profile call on whether to approve inhaled insulin for children and adolescents ages 4–17 — a decision that, if favorable, would represent the first needle-free insulin option for pediatric patients in over a century of insulin therapy. June closes the quarter with 3 decisions clustered near month's end: cytisinicline's potential to become the first new smoking cessation pharmacotherapy in nearly 20 years, a pediatric label expansion for roflumilast cream, and a pair of cardiometabolic rulings on olezarsen and baxdrostat that could introduce first-in-class mechanisms to severe hypertriglyceridemia and treatment-resistant hypertension, respectively. 

Here are the 6 FDA decisions to watch in Q2 2026, listed chronologically by expected decision date.

 Focal segmental glomerulosclerosis (FSGS) in adults

 The FDA extended the review timeline for the supplemental New Drug Application (sNDA) of sparsentan (Filspari) for focal segmental glomerulosclerosis, pushing the PDUFA date from January 13, 2026, to April 13, 2026, following Travere's submission of additional data requested by the FDA to further characterize the drug's clinical benefit — with no safety or manufacturing concerns raised. Sparsentan is a non-immunosuppressive, oral medication that directly targets podocyte injury by selectively blocking the endothelin A receptor and the angiotensin II subtype 1 receptor, with the sNDA supported by the phase 3 DUPLEX and phase 2 DUET studies. While DUPLEX achieved its pre-specified interim FSGS partial remission of proteinuria endpoint with statistical significance at 36 weeks, it did not achieve the primary efficacy eGFR slope endpoint over 108 weeks of treatment. Two-year DUPLEX data published in the 

 showed significant proteinuria reduction, higher remission rates, and a lower rate of end-stage kidney disease compared to active control irbesartan.

2. Insulin Human Inhalation Powder (Afrezza) 

 Type 1 or type 2 diabetes in children and adolescents aged 4–17 years

 MannKind's sBLA for Afrezza in pediatric patients is supported by phase 3 INHALE-1 study results, which compared Afrezza in combination with a basal insulin against multiple daily injections in children and adolescents with type 1 or type 2 diabetes. Notably, the INHALE-1 study did not meet its primary endpoint of noninferiority with respect to HbA1c, but investigators reported greater treatment satisfaction and reduced weight gain in the Afrezza arm — points the FDA will weigh in its benefit-risk assessment. If approved, Afrezza would offer young children and teenagers with diabetes a potential alternative to multiple daily injections or an insulin pump system — representing the first needle-free insulin option for pediatric patients since insulin therapy was first developed over a century ago.

 Nicotine dependence for smoking cessation in adults

 The NDA for cytisinicline is supported by data from more than 2,000 participants in the phase 3 ORCA-2 and ORCA-3 trials, where cytisinicline demonstrated significantly higher smoking abstinence rates compared to placebo. Cytisinicline is a plant-derived alkaloid that acts on nicotinic acetylcholine receptors, reducing nicotine craving and the rewarding properties of tobacco use. Its receptor selectivity profile has been associated with a lower rate of nausea than older agents, a tolerability advantage the company has emphasized ahead of the review. The drug carries Breakthrough Therapy designation for the separate indication of e-cigarette or vaping cessation. If approved for smoking cessation, cytisinicline has the potential to become the first new FDA-approved treatment option in nearly 20 years — entering a market still anchored by varenicline and nicotine replacement therapy.

 Hard-to-control hypertension as add-on to antihypertensive therapy in adults

 The BaxHTN trial demonstrated a −14.5 to −15.7 mmHg change in systolic blood pressure with baxdrostat compared to −5.8 mmHg with placebo, and AstraZeneca expects the FDA to act on the NDA during Q2 2026 following Priority Review acceptance and the use of a Priority Review voucher. Baxdrostat selectively inhibits aldosterone synthase (CYP11B2), reducing aldosterone production without meaningfully affecting cortisol — a mechanistic specificity that distinguishes it from older antihypertensive classes. The phase 3 BaxHTN results, published simultaneously in the 

 and presented at the European Society of Cardiology 2025, met the primary and all secondary endpoints. If approved, baxdrostat would become the first aldosterone synthase inhibitor authorized for clinical use.

 Severe hypertriglyceridemia (sHTG; triglycerides ≥500 mg/dL) in adults

 The sNDA for olezarsen in severe hypertriglyceridemia was granted Priority Review by the FDA on the strength of phase 3 CORE and CORE2 data, which across 1,061 patients demonstrated a placebo-adjusted mean reduction in triglycerides of up to 72.2% at 6 months and an 85% relative reduction in acute pancreatitis events — results published in the 

 and accompanied by the FDA's Breakthrough Therapy designation in November 2025. Olezarsen is an antisense oligonucleotide targeting apolipoprotein C-III, dosed once monthly by subcutaneous injection. The drug is already approved as Tryngolza for the rarer indication of familial chylomicronemia syndrome; the sHTG sNDA represents a meaningful expansion into a larger patient population.

 Plaque psoriasis in children aged 2 to 5 years

 The FDA accepted Arcutis's sNDA for roflumilast (Zoryve) cream 0.3% to expand the plaque psoriasis (PsO) indication to children aged 2–5 years, assigning a PDUFA date of June 29, 2026. Roflumilast cream 0.3% is currently approved for plaque psoriasis in adults and children down to age 6. The sNDA is supported by a 4-week Maximal Usage Systemic Exposure study in children aged 2–5 demonstrating minimal-to-no systemic absorption, as well as long-term open-label data showing sustained efficacy and tolerability across age groups. Plaque psoriasis in this younger age group commonly affects sensitive areas including the face and intertriginous regions, where steroid use is particularly challenging. If approved, roflumilast cream 0.3% would be the first topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2, adding to a portfolio that already includes approvals in atopic dermatitis (ages 2+) and seborrheic dermatitis.

Travere Therapeutics. Travere Therapeutics announces FDA acceptance of sNDA for FILSPARI® (sparsentan) in FSGS. Business Wire. May 2025. 

https://ir.travere.com/press-releases/news-details/2025/Travere-Therapeutics-Announces-FDA-Acceptance-of-sNDA-for-FILSPARI-sparsentan-in-FSGS/default.aspx

US Food and Drug Administration. FDA approves first new molecular entity under National Priority Voucher program. FDA.gov. April 1, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program

Q2 2026 features six high-impact FDA decision points across nephrology, endocrinology, cardiometabolic disease, smoking cessation, and dermatology, following a rapid Q1 cadence. Key actions include a long-anticipated FSGS sNDA for sparsentan despite mixed eGFR outcomes, a potential pediatric expansion of inhaled insulin with HbA1c noninferiority questions, and a first-in-decades smoking-cessation entrant in cytisinicline. Late-quarter decisions may introduce first-in-class aldosterone synthase inhibition for resistant hypertension and apoC-III antisense therapy for severe hypertriglyceridemia, plus a younger pediatric psoriasis label for topical roflumilast.

Check out 6 FDA decisions to watch in Q2 2026, listed chronologically by expected decision date.

Q2 2026 Preview: 6 FDA Decisions to Watch

Monthly tonlamarsen successfully reduced plasma angiotensinogen compared with a single tonlamarsen dose in patients with uncontrolled 

, but led to no additional blood pressure reduction, according to data from the Kardinal study.

 in New Orleans, Louisiana, by Luke Laffin, MD, co-director of the Center for Blood Pressure Disorders, medical director of cardiac rehabilitation, and associate professor of medicine at Cleveland Clinic.

“It begs the question of whether you need that sustained angiotensinogen reduction to actually impact the pharmacodynamic marker of blood pressure long-term,” Laffin told 

 in an exclusive interview. “So how do we explain the changes in the angiotensinogen levels and the blood pressure levels in the study, which was not strictly placebo-controlled? We’ll have to establish that in future studies.”

Kardinal was a randomized, placebo-controlled trial investigating the safety and efficacy of 90 mg tonlamarsen delivered subcutaneously once a month for 5 months compared to a single dose of tonlamarsen and subsequent placebo. Patients were eligible for inclusion if they exhibited a systolic blood pressure >135 mmHg and were receiving 2-5 antihypertensive medications. Patients were excluded if they exhibited secondary causes of hypertension, an estimated glomerular filtration rate of <30 mL/min/1.73m2, or a serum potassium >5.1 mmol/L. The study included 2 primary endpoints – the between-group differences in change from baseline to week 20 in plasma angiotensinogen and in-office systolic blood pressure.

The study consisted of a 4-week placebo lead-in, a 4-week active run-in with 1 dose of tonlamarsen, and subsequent randomization to 4 further doses of either tonlamarsen or matching placebo for 16 weeks. Following enrollment, 270 patients received placebo lead-in, 206 received 90mg of tonlamarsen during an active run-in period, and 198 were eventually randomized to receive either placebo or continuous tonlamarsen doses. Mean blood pressure among these randomized participants before and after lead-in was 147/90 mmHg and 147/89 mmHg, respectively.

In the 20 weeks after the first dose of tonlamarsen, least squares (LS) mean percent change in plasma angiotensinogen levels were -23% (95% CI, -27.8 to 18.2) with a single dose and -67.2% (95% CI, -71.9 to -62.4) in patients receiving monthly doses, with a LS mean difference of -44.1% (97.5% CI, -51.9 to -36.4; 

 <.0001). LS mean changes in office systolic blood pressure were -6.7 mmHg (95% CI, -9.8 to -3.5) for patients receiving a single dose of tonlamarsen and subsequent placebo versus -6.7 mmHg (95% CI, -9.8 to -3.6) for those receiving monthly tonlamarsen, with a LS mean difference of -0.1 mmHg (95% CI, -4.5 to -4.4; 

Ultimately, despite the successful angiotensinogen reductions, Laffin and colleagues also observed negligible differences in office systolic blood pressure between treatment arms. The team determined that further placebo-controlled trials are necessary to determine the efficacy of tonlamarsen, assessing either single or multi-dose tonlamarsen regimens.

“The reason why new therapies for hypertension are so important is because, based on current guideline recommendations, less than 30% of Americans have their hypertension controlled,” Laffin said. “It’s great that we have a lot of generic options, but they’re not working for us right now. I think we need to think about different strategies, and I really believe that targeting angiotensinogen upstream is one such strategy that could be effective.”

Editors’ Note: Laffin reports disclosures with Medtronic, Novartis, Eli Lilly, Mineralys, Crispr Therapeutics, Idorsia, and others.

Laffin L, Sarraju A, Sclaich M, et al. Kardinal: A Phase 2 Study of Tonlamarsen for the Treatment of Uncontrolled Hypertension. Abstract presented at the American College of Cardiology Scientific Sessions 2026, New Orleans, LA. March 28-30, 2026.

Laffin L, Wang Q, Sarraju A, et al. Efficacy of Tonlamarsen in Patients with Uncontrolled Hypertension: The KARDINAL Phase 2 Randomized Clinical Trial. 

https://doi.org/10.1016/j.jacc.2026.03.034

Laffin discusses results from the Kardinal study, which investigated a single dose of tonlamarsen followed by placebo against monthly tonlamarsen treatment in hypertension.

Discussing Future of Amlitelimab, OX40/OX40L Treatment, With Eingun James Song, MD

This interview with Eingun James Song, MD, the director of clinical research for Frontier Dermatology, highlights Song’s views on the OX40/OX40 ligand pathway and OX-40-targeted therapies such as amlitelimab.

 in Denver, Song was asked how he views the potential benefit of Sanofi's amlitelimab, for which they are moving ahead with regulatory submissions, in light of discontinuing rocatinlimab due to sarcoma cases.

“Everything that we have right now in atopic dermatitis is working on more downstream cytokines that are being released by these Th2 cells, by and large,” Song said. “...They are effective, but what oftentimes happens is when you stop the medication, the disease comes back relatively quickly.”

Song discusses OX-40-targeted therapies as a newer approach, intervening at the place at which the antigen-presenting cells interact with T cells. The idea, Song expressed, is if one could block the process at this stage, then a more durable remission could take place even when patients discontinue a treatment. Song reiterated his view on this type of therapy as a novel approach.

“There's potential for at least amlitelimab, which is an OX40-ligand inhibitor, that you can dose these patients every four or even every twelve weeks,” Song explained. “...Now that being said, it's important to note that there are two drugs that work on this pathway. One is called rocatinlimab, which is an OX40 receptor blocker, but it's also a depleter. It depletes those T cells. And that could maybe explain some of the adverse events that we've seen with rocatinlimab.”

Overall, Song expressed optimism on amletilimab’s having a role in dermatology care. Its implementation in treatment sequencing remains to be seen, Song suggested, but he noted his cautious optimism for this drug’s benefits for the right patient.

Song has reported serving as an investigator, consultant, and/or speaker for AbbVie, Alphyn Biologics, Amgen, Apogee, Arcutis, Bristol Myers Squibb, Boehringer Ingelheim, Dermavant, DermBiont, Galderma, Incyte, Janssen, LEO Pharma, MoonLake, Novartis, Ortho, Pfizer, Regeneron, Sanofi, Sun Pharmaceutical Industries, Timber Pharmaceuticals, and UCB.

Press Release: Sanofi’s amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic dermatitis. Sanofi.com. Published 2025. Accessed April 3, 2026. 

https://www.sanofi.com/en/media-room/press-releases/2025/2025-09-04-05-00-00-3144170

Kyowa Kirin announces discontinuation of rocatinlimab clinical trials. News release. Kyowa Kirin. March 3, 2026. Accessed April 3, 2026. 

https://www.globenewswire.com/news-release/2026/03/03/3248303/0/en/Kyowa-Kirin-Announces-Discontinuation-of-Rocatinlimab-Clinical-Trials.html

In this AAD interview, Song highlights how he views the potential benefit of amlitelimab in light of discontinuing rocatinlimab.

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