Ron Blankstein, MD, is the associate director of the cardiovascular imaging program, director of cardiac computed tomography, and co-director of the cardiovascular imaging training program at Brigham and Women’s Hospital, as well as a professor of medicine at Harvard Medical School.

Total Plaque Volume Indicates Patients With 0 CAC May Still Be at Risk

 score of 0, symptomatic patients can remain at significant risk from non-calcified plaque that cannot be detected with standard calcium scoring, according to a recent substudy of the DECIDE registry.

This analysis was presented at the 21st Annual Scientific Meeting of the Society of Cardiovascular Computed Tomography (SCCT) in San Diego, California, by Ron Blankstein, MD, the associate director of the cardiovascular imaging program, director of cardiac computed tomography, and co-director of the cardiovascular imaging training program at Brigham and Women’s Hospital, as well as a professor of medicine at Harvard Medical School.

“Of course, when you look at total plaque volume, we’re now looking at the overall amount of plaque, not just calcified plaque,” Blankstein told 

 in an exclusive interview. “A particular patient may have a small amount of calcified plaque, but when you consider the overall amount, they move to a higher risk category, and that could have implications about treating that patient more aggressively.”

The DECIDE registry, initially conducted by HeartFlow, aimed to collate observational data regarding the management of patients before and after HeartFlow Artificial Intelligence-Quantitative Coronary Plaque Analysis (AI-QCPA). The registry itself is a post-market, multi-center, data collection study assessing the change in management of clinically stable patients with plaque detected after coronary computed tomography angiography (CCTA).

Investigators for the DECIDE registry collected data immediately after the CCTA was completed, with analyses conducted 90 days, 180 days, and 365 days post-scan. Patient data were organized into 6 groups, the details of which are as follows:

Group 1: No AI-QCPA – symptomatic patients who were scanned with plaque detected and no prior revascularization

Group 2: Delayed AI-QCPA – previously scanned, symptomatic patients with plaque detected and no prior revascularization. AI-QCPA provided 90 days after CCTA

Group 3: Stress Test Only – symptomatic patients with prior non-invasive stress testing without CCTA and no prior revascularization

Group 4: Prospective AI-QCPA, symptomatic with no prior revascularization – newly scanned symptomatic patients with plaque

Group 5: Prospective AI-QCPA, prior PCI – newly scanned patients with plaque, asymptomatic or symptomatic, with prior PCI in 1 vessel territory

Group 6: Prospective AI-QCPA, asymptomatic without prior revascularization – newly scanned, asymptomatic patients with plaque and no current symptoms or prior revascularization.

The primary endpoint of the registry was change in medical management after AI-QCPA at 90 days versus following CCTA alone. This endpoint was only assessed in group 2 patients. Secondary outcomes included changes in LDL-C, HbA1c, non-HDL-C, HDL-C, and triglyceride levels across all groups, among others.

The present analysis included 11,792 symptomatic patients of the roughly 20,000 enrolled in the DECIDE registry. After analysis and accounting for total plaque volume, investigators found that 50% of all patients with a CAC score of 0 were reclassified into higher-risk categories, as were 30% of those with CAC scores 1-99 or 100-299. Conversely, patients with high calcium but modest total plaque volume were reclassified downwards.

These data reflect existing publications indicating that HeartFlow Plaque Staging substantially changed management in >50% of patients. The current analysis of this dataset effectively provides a model for the intensification of preventive therapy in patients with high total plaque volume despite a CAC score of 0, as well as for deescalating in patients with high CAC but lower total plaque volume.

“Perhaps some patients’ risk is not very high based on a calcium score, and if we had the overall plaque burden, that might reclassify them into a higher risk group, and we may treat them a little differently,” Blankstein said. “I think that’s what this latest study is trying to get at – after all, most of that reclassification occurred in patients who had a mild amount of plaque.”

Editors’ Note: Blankstein reports disclosures with Amgen, Heartflow, Nanox AI, Novartis, Caristo Diagnostics, Siemens, and others.

HeartFlow. New Data at SCCT 2026 Reinforce Heartflow Plaque Analysis as the Standard for AI-Powered Coronary Artery Disease Management. 

https://www.globenewswire.com/fr/news-release/2026/07/09/3324747/0/en/index.html

HeartFlow. AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management (DECIDE). ClinicalTrials.gov Identifier: NCT06376851. Updated October 14, 2025. Accessed July 20, 2026. 

https://clinicaltrials.gov/study/NCT06376851

Videos

Ron Blankstein, MD, discusses a secondary analysis of HeartFlow’s DECIDE registry, indicating undetected cardiovascular risk in patients previously labeled safe.

News

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

Clinical

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

Cardiology

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

Atherosclerotic Cardiovascular Disease

Total Plaque Volume Indicates Patients With 0 CAC May Still be at Risk

Most Penicillin Allergy Labels Are Wrong, Blumenthal Says

label are not actually allergic, and clinicians should treat that label as a diagnosis in need of revisiting rather than a permanent fixture in the chart, according to Kimberly Blumenthal, MD, MSc, professor of medicine at Mayo Clinic College of Medicine and Science.¹ In an interview with

, Blumenthal said the label itself carries measurable harm, including greater rates of 

 infection, MRSA, and surgical site infections within 5 years of documentation.

Blumenthal said the strength of the recommendation for testing or delabeling depends heavily on how recently the reaction occurred. Patients reporting a reaction within the past few years may warrant confirmatory testing. Those citing a childhood reaction relayed secondhand, often decades old, are typically strong candidates for direct delabeling with little to no testing.

“We're talking 50, 60, 70 years ago,” Blumenthal said. “With all of that time that has passed, the likelihood of them being allergic is quite low.”

Risk Stratification Now Drives the Testing Pathway

The approach to confirming or removing a penicillin allergy label has shifted substantially since the 2009 FDA approval of the major determinant skin test reagent, Blumenthal said. Early widespread skin testing revealed that the test performs poorly in low-risk patients, generating false positives, while emerging safety data showed that direct drug challenges work well in that same low-risk group. Pooled data across thousands of pediatric challenges have shown reaction rates of roughly 3.5% to 6%, supporting direct challenge as the preferred pathway for lower-risk patients while reserving skin testing for higher-risk cases.

“If you are a lower-risk patient, direct drug challenge is the most effective way of getting that penicillin allergy label safely removed,” Blumenthal said. “If you're a higher-risk person, you should be focusing on skin testing.”

That shift toward direct oral challenge in low-risk patients is reflected in a 2024 systematic review and meta-analysis, which pooled 12 studies and found that direct drug challenge safely delabeled 97.13% of previously labeled patients, with no critical adverse events.

 Only 10 of 1070 participants developed mild immediate reactions.

Some Labels Stay in Modified Form, Even After Negative Testing

Blumenthal said a negative workup does not always mean the allergy label disappears entirely. When patients report symptoms like isolated itching or a headache without objective signs of an allergic reaction, she often revises the label to specify the milder concern rather than removing it outright.

“I would feel comfortable removing the allergy, but the patient doesn't,” she said. “In those cases, I revise the allergy label to say itching only—not a full contraindication to taking this medication again. I tried to specify in the comments to communicate to future doctors that I wasn't concerned that this patient was going to have a significant reaction.”

Check out parts 1 and 2 of our interview with Blumenthal here: 

What's Behind Perioperative Anaphylaxis? Cefazolin Tops the List

Hidden Operating Room Allergens: Dyes, Implants, Chlorhexidine Overwash

Blumenthal KG, et al. Penicillin allergy delabeling: a multidisciplinary opportunity. 

https://pmc.ncbi.nlm.nih.gov/articles/PMC8019188/

Blumenthal KG, Smith LR, Mann JTS, et al. Reaction Risk to Direct Penicillin Challenges: A Systematic Review and Meta-Analysis. 

Safe penicillin allergy delabeling in primary care: a systematic review and meta-analysis. 

https://www.jaci-inpractice.org/article/S2213-2198(24)00640-8/abstract

Kimberly Blumenthal, MD, discusses who qualifies for de-labeling and how risk stratification guides testing.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Anaphylaxis

The HCPLive anaphylaxis page is a comprehensive resource for clinical news and insights on acute allergic reactions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for preventing anaphylaxis, and more.

Richard Lafayette, MD, is a professor of medicine and director of the Glomerular Disease Center at Stanford University Medical Center.

Atacicept Approval Brings BAFF/APRIL Targeting to IgAN With Richard Lafayette, MD

 has granted accelerated approval to atacicept (Trutakna) for adults with primary

 at risk for disease progression, introducing the first BAFF and APRIL inhibitor designed to target upstream immune pathways driving disease.

The FDA based the approval on data from the phase 3 ORIGIN 3 trial, an ongoing randomized study evaluating atacicept in adults with IgAN. Richard Lafayette, MD, FACP, professor of medicine in nephrology and director of the Glomerular Disease Center at Stanford University Medical Center and a principal investigator in the ORIGIN clinical program, said the findings reinforce the role of B-cell dysregulation in IgAN and highlight the potential of targeting disease biology earlier in the disease process.

FDA Approves Atacicept (Trutakna) for IgA Nephropathy

Atacicept inhibits B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), 2 cytokines involved in B-cell survival, activation, and antibody production. By targeting these pathways, the therapy reduces production of galactose-deficient IgA1 (Gd-IgA1), a key component of IgAN pathogenesis.

“I think this is really an amazing event,” Lafayette told 

. “Patients really now have access to medication that can completely retarget their disease course and can actually give them the promise of not slowing but completely preserving their kidney function.”

Although long-term kidney outcomes remain under evaluation, Lafayette said the improvements observed with atacicept in proteinuria, hematuria, and Gd-IgA1 provide optimism that the therapy may meaningfully alter disease progression.

ORIGIN 3 Demonstrates Significant Proteinuria Reduction With Atacicept

The phase 3 ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating atacicept in adults with primary IgAN.

The trial enrolled 431 adults with IgAN who were randomized in a 1:1 ratio to receive atacicept 150 mg once weekly through subcutaneous injection or placebo.

Among the first 203 participants included in the prespecified interim analysis, atacicept reduced 24-hour urine protein-to-creatinine ratio (UPCR) by 46% from baseline, with a statistically significant 42% reduction compared with placebo at 36 weeks (

The proteinuria reduction was consistent across prespecified subgroups, including age, sex, race, geographic region, baseline proteinuria, baseline estimated glomerular filtration rate (eGFR), and baseline sodium-glucose cotransporter-2 inhibitor use.

Participants treated with atacicept also experienced a 68% reduction in Gd-IgA1, although this secondary endpoint was considered observational because it was not adjusted for multiplicity.

The safety profile of atacicept was comparable with placebo, with adverse events occurring in 59.3% of patients receiving atacicept compared with 50.0% of patients receiving placebo.

BAFF/APRIL Inhibition Highlights Role of B-Cell Dysregulation in IgAN

The approval of atacicept provides clinical evidence supporting a growing understanding of IgAN as a disease driven by abnormal immune regulation.

IgAN develops through a multistep process in which immune dysregulation leads to production of Gd-IgA1, formation of pathogenic immune complexes, and subsequent kidney injury.

For years, treatment strategies have focused primarily on reducing downstream consequences of disease, including proteinuria and kidney function decline. However, recent advances have shifted attention toward therapies that target the immune pathways responsible for generating pathogenic IgA.

“The fact that a BAFF plus APRIL inhibitor is being so effective at managing these biomarkers of IgA nephropathy really lends credence to this being a disease of B-cell misregulation or dysregulation, and that both BAFF and APRIL have key elements in controlling the disease,” Lafayette said.

He added that atacicept provides an opportunity to directly address the source of abnormal IgA production.

“This really gives us the first opportunity to really control the source of the galactose-deficient IgA production and do it effectively,” Lafayette said.

Where Atacicept Fits in the Expanding IgAN Treatment Landscape

Atacicept enters an increasingly expanding IgAN treatment landscape, with therapies now targeting multiple components of disease progression, including immune activation, complement pathways, and downstream kidney injury.

For clinicians incorporating new therapies into practice, Lafayette emphasized the importance of achieving rapid and effective disease control among patients who remain at risk for progression.

“We have very clear goals from KDIGO and other treatment guidelines to get the patient’s disease activity under control rapidly and effectively,” Lafayette said.

Patients who fail to achieve adequate disease control with supportive therapy may represent those most likely to benefit from targeted immune intervention.

“If patients are not already near goal where they can be simply modified with supportive therapy, atacicept really represents a true way forward that’s targeted, effective, well tolerated, and really should be a tool that we reach for in the vast majority of patients who have the need for intervention,” Lafayette said.

ORIGIN 3 Will Determine Long-Term Kidney Impact

Although proteinuria reduction and biomarker improvements demonstrate atacicept’s biological activity, investigators must still determine whether these changes translate into long-term preservation of kidney function.

The ongoing ORIGIN 3 trial will continue evaluating kidney outcomes, including changes in eGFR over 2 years, as part of the confirmatory requirements following accelerated approval.

Lafayette said those data will ultimately determine whether atacicept can alter the trajectory of kidney decline in IgAN.

“We certainly have to wait for the GFR data for ORIGIN 3,” Lafayette said. “Again, I’m confident that it will look similar to the phase 2b study, but seeing it is believing, and actually getting to that data will be really important.”

Beyond efficacy, continued follow-up will provide additional information regarding the long-term safety and tolerability of once-weekly BAFF/APRIL inhibition, including whether the therapy maintains its safety profile without increased infection risk.

Editor’s Note: Relevant disclosures for Lafayette include Aurinia, Callidatas, Complexa, Mallinckrodt, Omeros, Pfizer, Vera Therapeutics, and others.

Vera Therapeutics Receives FDA Accelerated Approval for TRUTAKNA™ for Adult Patients with Primary IgA Nephropathy.

Lafayette R, Barbour SJ, Brenner RM, et al. 

A Phase 3 Trial of Atacicept in Patients with IgA Nephropathy.

 Published online November 6, 2025. doi:10.1056/nejmoa2510198

ORIGIN 3 investigator brings atacicept approval to BAFF/APRIL targeting to IgAN 

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.

IgA Nephropathy

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

FDA News

Abigail Brooks is a strategic content lead overseeing 

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.

 has published detailed efficacy and safety findings from the phase 2b RELIEVE UCCD trial evaluating duvakitug, an investigational anti-TL1A monoclonal antibody co-developed by Teva and Sanofi, in adults with moderate to severely active 

ulcerative colitis (UC) and Crohn disease (CD)

Results showed that at week 14, clinical remission rates in UC reached 36% and 48% across the 2 duvakitug dose groups compared with 20% for placebo, and endoscopic response rates in CD reached 26% and 48% compared with 13% for placebo.

The publications arrive as Sanofi and Teva advance duvakitug into phase 3 development for both indications. Anti-TL1A agents have become a closely watched drug class in inflammatory bowel disease (IBD), with Merck's tulisokibart and Roche's afimkibart also progressing through phase 3 testing in UC and CD.³ Duvakitug's high-dose response rates rank among the strongest posterior remission and response findings reported for the anti-TL1A class to date.

Assessing Duvakitug in UC and CD: RELIEVE UCCD

RELIEVE UCCD was a multicenter, randomized, double-blind, placebo-controlled phase 2b study enrolling adults 18-75 years of age with moderately to severely active UC or CD, including patients with inadequate response, loss of response, or intolerance to prior conventional or advanced therapies.

Participants were randomly assigned in a 1:1:1 ratio to a 2250 mg subcutaneous loading dose of duvakitug followed by 450 mg or 900 mg every 2 weeks, or matching placebo.

In the UC cohort, investigators screened 260 patients and randomized 137 to the modified intention-to-treat population (47 to 450 mg, 46 to 900 mg, and 44 to placebo). A total of 17 of 47 patients (36%) in the 450 mg group and 22 of 46 (48%) in the 900 mg group achieved clinical remission by modified Mayo score at week 14, compared with 9 of 44 (20%) on placebo. Posterior mean response differences versus placebo were 15% (95% CrI, −3 to 33) for the 450 mg dose and 26% (95% CrI, 8 to 44) for the 900 mg dose, with posterior probabilities of superiority of 0.95 and greater than 0.99, respectively.

In the CD cohort, 139 of 275 screened patients were randomized (46 to 450 mg, 47 to 900 mg, and 46 to placebo); 1 patient in the 900 mg group did not receive study drug, leaving 46 patients per group in the modified intention-to-treat population. 12 of 46 patients (26%) in the 450 mg group and 22 of 46 (48%) in the 900 mg group achieved endoscopic response at week 14, defined as at least a 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease, versus 6 of 46 (13%) on placebo. Posterior probabilities of superiority reached 0.94 for the 450 mg dose and greater than 0.99 for the 900 mg dose.

Patients in the UC cohort had a mean age of 41.0 years (SD, 13.1), and 31% had previous exposure to an approved advanced therapy. Patients in the CD cohort skewed slightly younger (mean age, 39.5 years; SD, 14.7), and 57% had prior advanced therapy exposure, reflecting a more treatment-experienced population entering the CD arm.

Duvakitug Safety Profile in the RELIEVE UCCD Trials

Overall adverse event rates in the UC cohort were similar across arms: 23 of 47 patients (49%) in the 450 mg group, 20 of 46 (43%) in the 900 mg group, and 23 of 44 (52%) on placebo. Anaemia occurred in 1 patient on 450 mg, 1 on 900 mg, and 3 on placebo, while upper respiratory tract infection occurred in 3 patients on 450 mg, 1 on 900 mg, and 1 on placebo. A single serious adverse event occurred in the 900 mg group, non-infective oophoritis, and 1 occurred in the placebo group, intracranial haemorrhage.

In the CD cohort, adverse events were more frequent in the 450 mg group (31 of 46 patients, 67%) than in the 900 mg group (20 of 46, 43%) or placebo (22 of 46, 48%). Nasopharyngitis affected 2 patients on 450 mg, 3 on 900 mg, and 3 on placebo, and headache affected 4 patients on 450 mg, 1 on 900 mg, and 1 on placebo. Serious adverse events occurred in 6 patients (13%) on 450 mg, 1 patient (2%) on 900 mg, and 5 patients (11%) on placebo, with investigators reporting no new safety signals in either cohort.

Positive results from the RELIEVE UCCD long-term extension (LTE) study were announced on February 17, 2026, and showed durable clinical and endoscopic efficacy maintained over 44 weeks in patients with UC and CD that initially responded to the induction phase, reinforcing the efficacy from the RELIEVE UCCD phase 2b induction study.

“One of the persistent challenges in treating ulcerative colitis and Crohn’s disease isn’t just achieving an initial response, but sustaining it,” Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, Teva, said in a statement at the time of the LTE data announcement.

 “These phase 2b results further reinforce TL1A as a compelling target and clearly strengthen the case that duvakitug has the potential to be a best-in-class therapy.”

Duvakitug is now being evaluated in ongoing phase 3 studies for UC and CD under the Teva-Sanofi collaboration, with Sanofi leading clinical development and the companies sharing global development costs and profits. The program advances alongside Merck's tulisokibart and Roche's afimkibart, both competing anti-TL1A candidates in late-stage UC and CD development.

Efficacy and safety of duvakitug in patients with ulcerative colitis (RELIEVE UCCD): a phase 2b, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. Published online 2026. doi:

Efficacy and safety of duvakitug in patients with Crohn's disease (RELIEVE UCCD): a phase 2b, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. Published online 2026. doi:

Hillenbrand A. Tulisokibart Meets Phase 3 Endpoints in Ulcerative Colitis, First for Anti-TL1A. HCPLive. June 22, 2026. Accessed July 20, 2026. 

https://www.hcplive.com/view/tulisokibart-phase-3-endpoints-ulcerative-colitis-anti-tl1a

Danese S, Allegretti JR, Schreiber S, et al. Anti-TL1A antibody, afimkibart, in moderately-to-severely active ulcerative colitis (TUSCANY-2): a multicentre, double-blind, treat-through, multi-dose, randomised, placebo-controlled, phase 2b trial. 

. 2025;10(10):882-895. doi:10.1016/S2468-1253(25)00129-3

Sanofi. Sanofi and Teva's duvakitug phase 2b maintenance data demonstrated clinically meaningful durable efficacy in ulcerative colitis and Crohn's disease. Published February 17, 2026. Accessed July 20, 2026. 

https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-17-11-00-00-3239014

Articles

Phase 2b RELIEVE UCCD evaluated duvakitug, an anti‑TL1A monoclonal antibody, in moderate-to-severe ulcerative colitis and Crohn disease, including treatment-experienced patients. At week 14, ulcerative colitis clinical remission reached 36% and 48% with 450 mg and 900 mg q2w dosing versus 20% placebo, while Crohn disease endoscopic response was 26% and 48% versus 13%. Bayesian posterior probabilities supported superiority, particularly at 900 mg. Safety was broadly comparable to placebo with no new signals. Long‑term extension data suggested durability through 44 weeks, supporting phase 3 advancement.

Newly published phase 2b RELIEVE UCCD data show strong 14 week results for duvakitug in ulcerative colitis and Crohn disease.

Gastroenterology

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

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

Inflammatory Bowel Disease

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

Ulcerative Colitis

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

TL1A Antibody Duvakitug Boosts Clinical Remission in UC, Response in CD

Ashish Rana, MD, is the internal medicine program director and associate chair of academic medicine at Crozer Health, as well as a member of Sermo’s advisory board.

Survey Shows Peptide Misinformation, Misuse Rising in US

The 45th Sermo Barometer survey has revealed the full extent to which unregulated 

 use has infiltrated US clinics and exam rooms.

Conducted from May 8-12, 2026, the survey included 507 US-based healthcare providers. These physicians were from a variety of specialties including cardiology, dermatology, endocrinology, neurology, internal medicine, and orthopedic surgery.

“The concern is over prescribing medications that potentially may be helpful, but may not be necessary for the particular patient,” Ashish Rana, MD, internal medicine program director and associate chair of academic medicine at Crozer Health, as well as a member of Sermo’s advisory board, told 

in an exclusive interview. “So, physicians are put in awkward positions where patients want something, but we don’t necessarily think it’s necessary for them at that moment, which creates a conflict immediately.”

The Sermo survey focused on gathering information regarding emerging peptide therapies in patient conversations. Among those surveyed, 48% reported that patients have disclosed using peptides that have not received approval from the US Food and Drug Administration (FDA) in the past 12 months. These drugs are typically accessed via medspas, compounding pharmacies, and online “research” products.

According to the survey, 69% of patients report seeking out peptides for weight loss, while 57% report taking the drugs as an anti-aging treatment, 55% report using them for muscle gain, and 41% for longevity. Additionally, these patients are not learning about these peptides from their clinicians – 84% of survey responders said that patients typically cite social media, influencers, podcasts, or online forums as their source of peptide information.

The survey also indicated physicians’ increasing discomfort with patients’ access to and self-prescription of peptides. Approximately 66% responded to the survey expressing moderate or extreme concern regarding patients accessing and taking investigational peptides outside of supervised clinical pathways. 81% of responders said a clear approval or review pathway from the FDA is crucial or extremely important to how they counsel patients on the safety of emerging therapies.

Patients having so much exposure to GLP-1s without any clinical guidance also results in a significant amount of misinformation regarding results. 33% of surveyed clinicians reported unrealistic patient expectations in the clinic, citing them as the biggest challenge of peptide conversations. 21% reported feeling pressure to recommend unapproved treatments – clinicians are more often spending visit time recalibrating expectations instead of discussing evidence-based therapy options.

As further GLP-1-based therapies advance towards regulatory approval, including triple agonists like retatrutide, physicians have also expressed concern that these drugs will enter a market overly influenced by social channels. Among relevant specialists surveyed, 69% said they anticipate strong patient interest following these therapies’ potential approval, with 24% reporting patients already questioning them about triple agonists.

The FDA has scheduled an advisory committee meeting for July 2026, during which it will discuss regulatory considerations for compounding certain peptide-based therapies. Speculation has suggested that the organization may potentially loosen existing restrictions.

“If a patient is manifesting symptoms of a GI problem, don’t necessarily attribute it only to gastroenteritis or colitis or something – explore deeper,” Rana said. “Is there a non-prescribed medication involved? Ask that question directly, because when you do, patients are more obliged to then answer correctly and truthfully.”

Editors’ Note: Rana reports no relevant disclosures.

Sermo. Sermo Barometer Finds Nearly Half of Physicians Report Patients are Using Non-FDA Regulated Peptides. June 4, 2026. Accessed July 17, 2026. 

https://www.sermo.com/press-releases/sermo-barometer-finds-nearly-half-of-physicians-report-patients-are-using-non-fda-regulated-peptides/

Sermo. The Peptide Frontier: What 500+ Physicians Are Seeing Before Regulators Act. June 12, 2026. Accessed July 17, 2026. 

https://www.sermo.com/barometer-reports/the-peptide-frontier-what-500-physicians-are-seeing-before-regulators-act/

Ashish Rana, MD, discusses Sermo’s recent clinician survey, which highlighted patients’ use of unapproved and compounded GLP-1 medications.

Endocrinology

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

This page also hosts content previously published by EndocrinologyNetwork. 


Kimberly Blumenthal, MD, MSc, explains how surgical dyes, antibiotic-coated implants, and more can trigger perioperative anaphylaxis without appearing in the chart.

Sanjay Rajagopalan, MD, is the chief academic and scientific officer at University Hospitals Case Medical Center.

Sanjay Rajagopalan, MD, discusses the need for more patient-specific air pollution warnings to optimize accessibility for all individuals.

Improving Air Quality Indices for Personalized Health Warnings from Pollution Exposure

Marc Richards, MD is a nephrologist at Florida Kidney Physicians, LLC and Director of the FKP Glomerulonephritis Center of Excellence in Boca Raton, Florida.

Marc Richards, MD, discusses how new therapies and combination treatment strategies are transforming evidence-based care for chronic kidney disease.


Chronic Kidney Disease

Strategic Alliance Partnership

Expanding Era of Evidence-Based CKD Care, With Marc Richards, MD

Giovanni Leone, MD, from Israelite Hospital.

Erythema was less frequent with combination therapy than with phototherapy alone, according to Giovanni Leone, MD.

Dermatology

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

Vitiligo

Vitiligo condition center page is a comprehensive resource for clinical news and insights on the dermatologic condition. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for the affected skin of vitiligo patients.

Oral GP-SOD for Vitiligo: Safety Profile, Dosing, and What's Next

Ann Marie Navar, MD, PhD, is an associate professor of cardiology at the University of Texas Southwestern Medical Center.

Ann Marie Navar, MD, PhD, discusses the groundbreaking approval of the first oral PCSK9 inhibitor and what it means for patients managing their LDL-C levels.

Dyslipidemia

Enlicitide Receives FDA Approval for Hypercholesterolemia Following CORALreef Trials

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

FDA accepted Camurus’ resubmitted CAM2029 application for acromegaly, with a target action date of December 18, 2026.

Hormonal Disorders

FDA Accepts Resubmitted CAM2029 NDA for Acromegaly

Michael Richards, MD, discusses aldosterone's role in CKD pathophysiology and why targeting this pathway may reshape kidney disease treatment.

Why Aldosterone Has Become a Key Target in CKD Care, With Marc Richards, MD

Alex Hillenbrand is an assistant editor for 

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

The FDA granted traditional approval to Novartis’ iptacopan (Fabhalta) for adults with primary IgA nephropathy, supported by phase 3 APPLAUSE-IgAN data showing slowed kidney function decline and sustained proteinuria reductions.

FDA Grants Full Approval to Iptacopan (Fabhalta) in IgAN

Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

New secondary endpoint analyses from Phase 3 LATITUDE PsO 3001 and 3002 reveal high rates of clearance on high-impact areas.

Latest News

Total Plaque Volume Indicates Patients With 0 CAC May Still be at Risk

Most Penicillin Allergy Labels Are Wrong, Blumenthal Says

Atacicept Approval Brings BAFF/APRIL Targeting to IgAN With Richard Lafayette, MD

TL1A Antibody Duvakitug Boosts Clinical Remission in UC, Response in CD

Survey Shows Peptide Misinformation, Misuse Rising in US