Jennifer Manne-Goehler, MD, is a physician in the division of infectious diseases at Brigham and Women’s Hospital and the department of medicine at Mass General Brigham.

1 in 4 Adults Worldwide Eligible for GLP-1 Treatment for Obesity, With Jennifer Manne-Goehler, MD

More than 1 in 4 adults worldwide are eligible for GLP-1 receptor agonists for 

, of which almost 4 in 5 live in low- or lower-middle-income countries, according to a recent study from Mass General Brigham.

GLP-1 receptor agonists have emerged explosively into every corner of medicine, acting as an effective therapeutic class for obesity management and the prevention of its myriad complications. Global organizations, such as WHO, are actively assembling guidelines and exploring policies for the integration of obesity management medications like GLP-1s. Understanding the possible demand and socioeconomic impacts of GLP-1 receptor agonists is necessary for effectively designing these policies.

To that end, a team of investigators from Mass General Brigham, Washington University School of Medicine, and Emory University’s Rollins School of Public Health analyzed pooled, individual patient data from a series of nationally representative, cross-sectional household health surveys, which had been conducted across 99 countries between 2008 and 2021. Of the surveyed patients, investigators collected a sample comprised of non-pregnant individuals between 25-64 years with an available 

 biomarker, body mass index (BMI) and blood pressure measurement, and complete data on 

“The motivation for this paper is to start quantifying the challenge of scaling and paying for GLP-1s as we think about models of care that work best,” said Jennifer Manne-Goehler, MD, a physician in the division of infectious diseases at Brigham and Women’s Hospital and the department of medicine at Mass General Brigham, in an exclusive interview with 

. “What are the sustainable ways to do this? How do you take a new tool, build a system around it, and make it available to millions of people?”

Patients were defined as eligible for GLP-1 receptor agonists for weight management if they had a BMI ≥30 kg/m2 or a BMI of ≥27 kg/m2 with hypertension, diabetes, or both. Hypertension was defined based on measured blood pressure, while diabetes was defined based on glycemic markers included HbA1c and plasma glucose. Notably, obesity-related comorbidities like sleep apnea or cardiovascular disease were not considered.

The pooled sample included a total of 810,635 patients from 99 countries. Of the utilized surveys, 15 were conducted in low-income countries, 34 in lower-middle-income countries, 30 upper-middle-income countries, and 20 in high-income countries. The median response rate was 87%, and the mean age of included respondents was 38 years (Standard Deviation [SD], 9.7). Of these respondents, 617,915 were women.

Investigators found that roughly 27% of the pooled sample were eligible to receive GLP-1 RAs (95% CI, 26.2-27.8); when incorporating age-stratified UN 2020 population size estimates, this equates to roughly 799 million individuals. When divided by country income, eligibility was 11.7% (95% CI, 10.9-12.5) in low-income countries, 25.2% (23.6-26.8) in lower-middle-income countries, 26.2% (25-27.4) in upper-middle-income countries, and 41.8% (40.5-43.2) in high-income countries.

Eligibility varied substantially across world regions, with the highest in Europe and North America (42.8%; 95% CI, 41.4-44.2) and the Pacific Islands (41%; 39-43.1). Although 23.1% of patients were eligible in south, east, and southeast Asia, the largest absolute number of eligible patients were located here. Additionally, women were more likely to be eligible (28.5%; 95% CI, 27.6-29.5) than men (25.5%; 95% CI, 24.6-26.4). Eligibility also increased with age, ranging from 17.9% (17-18.8) among patients 25-34 years to 38.3% (36.8-39.7) among patients aged 54-64 years.

“With health policymaking bodies and medical societies, I think there’s an increasing focus on obesity and people with high-risk diseases under their BMI,” Manne-Goehler said. “These are the people we need to figure out how to better select from our patient panels and start offering it to them, because those are the patients with the potential for the best health benefits of using these medicines.”

Editor’s Note: Manne-Goehler reports support from the US National Heart, Lung, and Blood Institute.

Mass General Brigham. Study finds more than a quarter of adults worldwide could benefit from GLP-1 medications for weight loss. 

 January 8, 2026. Accessed January 13, 2026. 

https://www.eurekalert.org/news-releases/1111834

Yoo SG, Teufel F, Theilmann M, et al. GLP-1 receptor agonists for obesity: Eligibility across 99 countries. The Lancet Diabetes &amp; Endocrinology. 2026;14(2):105-108. 

Videos

Manne-Goehler discusses a recent study highlighting the scope and scale at which GLP-1 receptor agonists can reduce obesity and its associated risks.

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Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

A recent meta-analysis shows upadacitinib’s short term efficacy may be preferential for short-term efficacy versus 4 other oral Janus Kinase (JAK) inhibitors for 

, although direct comparison studies are still warranted.

These findings on JAK inhibitor use resulted from a study conducted to compare oral upadacitinib therapy to 4 other JAK inhibitors, or JAKis: abrocitinib (100 or 200 mg), baricitinib (2 or 4 mg), and ivarmacitinib (4 or 8 mg).

Investigator Najib Babul, PharmD, MBA, a drug development consultant from Cinergen, and colleagues described indirect comparisons made via Bayesian network meta-analysis (BNMA) as helpful for comparisons of medication efficacy. However, previous studies had chiefly focused on biologics and others had information gaps due to a general exclusion of various data on different atopic dermatitis drugs.

“To address these gaps, we conducted a Bayesian network meta-analysis (BNMA) evaluating the short-term efficacy of four JAK inhibitors (abrocitinib, upadacitinib, baricitinib, and ivarmacitinib) as monotherapy for moderate-to-severe AD,” Babul and colleagues wrote.

 “The study aimed to rank their comparative efficacy, identify the most effective regimen across EASI-75, IGA-AD 0/1, and Itch NRS ≥ 4 endpoints, and inform evidence-based clinical decision-making.”

The investigators, in accordance with PRISMA 2020 guidelines, conducted a systematic review conducted and registered in PROSPERO evidence drawn from various phase 2 and phase 3 randomized, double-blind, placebo-controlled trials. These studies would be evaluating oral JAK inhibitors for the treatment of moderate-to-severe atopic dermatitis, and the investigators’ searches involved the Embase, PubMed, Cochrane Library, and ScienceDirect databases.

In the early portion of their study, through August 2025, they conducted their search for trials. This was also supplemented by a manual screening of reference lists along with relevant congress abstracts, with Babul and coauthors seeking to ensure inclusion of all eligible research. In their review, they looked at data on baricitinib at doses of 2 mg and 4 mg, abrocitinib at 100 mg and 200 mg, upadacitinib at 15 mg and 30 mg, and ivarmacitinib at 4 mg and 8 mg. Age eligibility criteria were noted by the investigators as consistent with criteria implemented in the pivotal clinical development programs for each of these drugs.

Research related to abrocitinib included the JADE MONO-1 study (NCT03349060), JADE MONO-2 (NCT03575871), and a phase 2b analysis (NCT02780167), with patients evaluated being aged 12 years and older. Data on upadacitinib’s use were derived from MEASURE UP-1 (NCT03569293) and MEASURE UP-2 (NCT03607422). These 2 studies included participants between the ages of 12 - 75 years.

The BREEZE-AD1 (NCT03334396), BREEZE-AD2 (NCT03334422), and BREEZE-AD5 (NCT03435081) studies were used to look at baricitinib, and all of these trials were limited to adults aged 18 years or older. For ivarmacitinib, Babul et al used a phase 3 study (NCT04875169) that enrolled adolescents and adults between 12 - 75 years of age. In terms of primary efficacy outcomes, they looked for patient attainment of at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) at 12 - 16 weeks.

Additionally, they looked at participants’ Investigator’s Global Assessment scores of clear or almost clear (IGA-AD 0/1). They also looked for a reduction of at least 4 points on the itch numeric rating scale, also known as the Itch NRS. Effects of therapies were estimated by the investigators via Bayesian hierarchical models, with odds ratios (ORs) being generated with corresponding 95% credible intervals (CrIs). Comparative ranking across these 4 drugs was determined through the use of surface under the cumulative ranking curve (SUCRA) probabilities.

In total, there were 9 randomized controlled trials. These studies were made up of 4261 individuals who had met the criteria for involvement. Across all endpoints examined by Babul and colleagues, upadacitinib 30 mg consistently had the strongest level of efficacy in those with atopic dermatitis. In their assessment of EASI 75 scores, the OR was 12.3 (95% CrI, 7.9–18.7). IGA-AD 0/1 response, on the other hand, yielded an OR of 18.9 (95% CrI, 12.0–29.7). Positive shifts in pruritus severity, defined by a ≥4-point reduction in trial participants’ Itch NRS scores, was also shown to be the greatest with upadacitinib 30 mg treatment, with an OR of 11.1 (95% CrI, 7.2–17.5).

This dose was followed in overall efficacy by upadacitinib 15 mg. Then, Babul and coauthors found abrocitinib 200 mg had the next best efficacy, followed by ivarmacitinib 8 mg. In contrast, they found baricitinib at both the 2 mg and 4 mg doses had been consistently in the lowest treatment ranking positions. They reinforced such data via SUCRA analyses. Upadacitinib 30 mg attained probabilities ranging from 97% - 98%, which the investigators note suggests an increased likelihood of being the most effective option across the different endpoints.

Overall, the investigative team concluded upadacitinib, especially at the 30 mg dose and followed by the 15 mg dose, allows for the most robust short-term improvements in both patients’ level of skin clearance and their level of itch among these 4 oral JAKis.

“These findings support a provisional efficacy preference for upadacitinib in managing moderate-to-severe [atopic dermatitis] unresponsive to biologic or topical therapies,” they wrote.

A variety of limitations were also noted in this analysis, with the team citing the lack of head-to-head trials among the 4 aforementioned medications, requiring reliance on indirect, placebo-controlled comparisons. They also noted variability in baseline characteristics. Examples of baseline severity differences include IGA-AD and EASI scores.

For trials such as Measure Up 1, IGA-AD severity among 3 cohorts at baseline ranged from 125-131, whereas in JADE MONO-1, for example, baseline severity among 3 cohorts involved ranged from 31-64. Other baseline characteristic differences were referenced such as patients' ages between studies as well as different geographic locations, background use of topicals, and washout rules among those evaluated.

Outcome timing across studies was also highlighted, along with additional constraints such as the inability to assess publication bias, baseline severity differences, the short-term only focus on efficacy, and the lack of quality-of-life outcomes included due to inconsistent reporting and measurement. Overall, the investigators acknowledgements underscored the need for longer-term and more standardized future research.

Babul A, Mehta D, Babul N, et al. Upadacitinib Leads in Efficacy: A Bayesian Network Meta-Analysis of Four JAK Inhibitors in Moderate-To-Severe Atopic Dermatitis. Int J Dermatol. 2026 Jan 5. 

Zhao Y, Gooderham M, Zhang J. Ivarmacitinib for Moderate to Severe Atopic Dermatitis in Adults and Adolescents: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2025 Jul 1;161(7):688-697. doi: 10.1001/jamadermatol.2025.0982. PMID: 40305055; PMCID: PMC12044538.

Articles

A recent meta-analysis indicates that upadacitinib may offer superior short-term efficacy compared to other oral JAK inhibitors for atopic dermatitis, though direct comparison studies are needed. The study utilized Bayesian network meta-analysis to evaluate the efficacy of upadacitinib, abrocitinib, baricitinib, and ivarmacitinib. Upadacitinib, particularly at a 30 mg dose, showed the highest efficacy across various endpoints, including EASI-75 and IGA-AD 0/1. Limitations include the absence of direct head-to-head trials and variability in baseline characteristics, emphasizing the need for more standardized research.

Investigators ranked the short-term effectiveness of 4 oral JAKis, upadacitinib, abrocitinib, baricitinib, and ivarmacitinib in moderate-to-severe atopic dermatitis.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

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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.

Upadacitinib Outperforms 4 JAK Inhibitors in Atopic Dermatitis Meta-Analysis

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

Clarametyx Biosciences reported positive topline results from a phase 1b/2a study of its immune-enabling antibody CMTX-101 in people with 

, showing the therapy was safe and well-tolerated while producing clinically meaningful reductions in inflammatory biomarkers and pulmonary 

“These highly encouraging results support the potential for CMTX-101 to play a significant role in the treatment of CF and other chronic biofilm-driven respiratory diseases,” said lead investigator Jerry Nick, MD, professor of medicine in the division of pulmonary, critical care, and sleep medicine at National Jewish Health, in a “This well-conducted, early-stage trial demonstrated meaningful and sustained improvements in inflammatory biomarkers, pulmonary function, and microbiological burden, illustrating its promise to address persistent unmet needs of the CF population, even in the era of highly effective CFTR modulators.”

CMTX-101 is an investigational immune-enabling antibody therapy designed to treat chronic respiratory disease by selectively and rapidly dismantling the shared structural components of bacterial biofilms.

 By weakening extracellular bacterial defenses, the approach enhances immune and antibiotic activity to reduce exacerbations, resolve inflammation, and improve patient outcomes across multiple indications, including nontuberculous mycobacterial lung disease, non-cystic fibrosis bronchiectasis, and chronic obstructive pulmonary disease. The 

 has previously granted Clarametyx a fast-track designation for CMTX-101 to treat cystic fibrosis following a positive interim analysis, announced on August 4, 2025.

Nick and colleagues conducted a randomized, double-blind, placebo-controlled phase 1/b/2a clinical study to assess the safety and tolerability of a single intravenous dose of CMTX-101 in 42 patients aged ≥ 18 years with cystic fibrosis infected with 

Along with assessing the safety, investigators sought to characterize the pharmacokinetic profile of a single dose and assess whether treatment induced the development of anti-drug and neutralizing antibodies.

Patients all received standard of care, including stable regimens of cystic fibrosis transmembrane conductance regulator (CFTR) modulators or inhaled antibiotics for ≥ 3 months. CFTR modulators included Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), Trikafta (elexacaftor/tezacaftor/ivacaftor), Symdeko (tezacaftor/ivacaftor), Orkambi (lumacaftor/ivacaftor), or Kalydeco (ivacaftor).

Inhaled antibiotics include aztreonam inhalation solution (Cayston), Tobramycin inhalation solution (TOBI, Bethkis, Kitabis Pak, or generic), Tobramycin inhalation powder (TOBI Podhaler), and an inhaled form of amikacin.

The trial met its primary endpoint, demonstrating the safety and tolerability of CMTX-101. Patients on 5 mg/kg of CMTX had a clinically meaningful 77% reduction of neutrophil elastase at day 28 compared to standard of care. Patients receiving CMTX-101 also had meaningful reductions in additional inflammatory biomarkers, including IL-1 beta, IL-8, and calprotectin.

CMTX-101 also preserved pulmonary function, measured by forced expiratory volume (FEV1) from baseline compared to standard of care. Additionally, CMTX-101 reduced 

 burden, with 13 out of 17 participants achieving > 70% reduction in colony-forming unit (CFU) count on day 28.

The analysis showed CMTX-101 was generally well-tolerated, with no detection of neutralizing antibodies.

“These encouraging findings support exploring future development of CMTX-101 in bronchiectasis,” said David V. Richards, chief executive officer of Clarametyx. “We are deeply grateful to the patients and their families, as well as the investigators and clinical site teams, whose participation and tireless efforts were essential to the successful completion of this study.”

The company plans to engage with global regulatory authorities in the first half of 2026 to advance a phase 2 study of CMTX-101 in bronchiectasis, a condition with only 1 approved therapy and disease physiology similar to cystic fibrosis.

Clarametyx Biosciences Announces Positive Topline Data From Phase 2a Study Evaluating CMTX-101 in Cystic Fibrosis. BusinessWire. Published on January 9, 2026. Accessed on January 13, 2026. 

https://www.businesswire.com/news/home/20260109419506/en/Clarametyx-Biosciences-Announces-Positive-Topline-Data-From-Phase-2a-Study-Evaluating-CMTX-101-in-Cystic-Fibrosis

Clarametyx Biosciences Announces FDA Grant of Fast Track and Qualified Infectious Disease Product Designations for CMTX-101. Published on August 4, 2025. Accessed on January 13, 2026. 

https://www.businesswire.com/news/home/20250804750253/en/Clarametyx-Biosciences-Announces-FDA-Grant-of-Fast-Track-and-Qualified-Infectious-Disease-Product-Designations-for-CMTX-101

A Study To Evaluate The Safety Of CMTX-101 In People With Cystic Fibrosis. ClinicalTrials.gov. Published on November 21, 2025. Accessed on January 13, 2026. 

https://www.clinicaltrials.gov/study/NCT06159725

CFTR Modulator Therapies. Cystic Fibrosis Foundation. Accessed on January 13, 2026. 

https://www.cff.org/managing-cf/cftr-modulator-therapies

Antibiotics. Cystic Fibrosis Foundation. Accessed on January 13, 2026. 

https://www.cff.org/managing-cf/antibiotics

Clarametyx Biosciences' phase 1b/2a study of CMTX-101 in cystic fibrosis patients demonstrated safety, tolerability, and significant reductions in inflammatory biomarkers and Pseudomonas aeruginosa burden. The investigational antibody therapy dismantles bacterial biofilms, enhancing immune and antibiotic efficacy. The trial met its primary endpoint, showing a 77% reduction in neutrophil elastase and improvements in pulmonary function. CMTX-101 was well-tolerated with no neutralizing antibodies detected. Clarametyx plans to advance to a phase 2 study in bronchiectasis, engaging with global regulatory authorities in 2026.

CMTX-101 met safety endpoints in a phase 1b/2a cystic fibrosis study, with meaningful reductions in inflammatory biomarkers and pulmonary Pseudomonas aeruginosa burden.

Rheumatology

Rheumatology condition center page is a comprehensive resource for clinical news and insights on rheumatologic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for arthritis, gout, nr-AxSpA, and more.

Pulmonary Fibrosis

CMTX-101 Shows Safety and Bacterial Reductions in Cystic Fibrosis Trial

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.

 announced the extension of the review timeline for the supplemental New Drug Application (sNDA) of sparsentan (Filspari) for 

focal segmental glomerulosclerosis (FSGS)

In a press release, Travere Therapeutics, Inc. announced the FDA has moved the Prescription Drug User Fee Act (PDUFA) target action date, which was expected on January 13, 2026, to April 13, 2026. Otherwise, no additional information relating to the safety or manufacturing of the drug has been requested.

“We believe in the potential of [sparsentan] to make a meaningful difference in the lives of people living with FSGS and are encouraged by the productive engagement with the FDA,” said Eric Dube, PhD, the president and chief executive officer of Travere Therapeutics, in a company statement. “We remain focused on the goal of bringing [sparsentan] to the patients who urgently need an effective medicine for this devastating and rapidly progressing disease and remain committed to working with the Agency during the extension period. In parallel, our commercial preparations continue to ensure a successful launch, if approved.”

The announcement comes after the FDA had requested further characterization of the clinical benefit of sparsentan. Upon submission of responses, the FDA determined they constituted a Major Amendment to the sNDA, and extended the PDUFA action date accordingly.

Sparsentan is the only non-immunosuppressive, oral medication designed to directly target podocyte injury by optimally blocking the endothelin A receptor and the angiotensin II subtype 1 receptor.

 for slowing kidney function decline in adults with IgA nephropathy (IgAN) in September 2024, based on 2-year confirmatory results from the phase 3 PROTECT study. In May 2025, the therapeutic’s 

 for the treatment of adults with FSGS. Additionally, the FDA

 for the therapeutic’s sNDA in September 2025, after the Agency had initially said it would require one.

The sNDA for the use of sparsentan in FSGS was supported by findings from the phase 3 DUPLEX Study and the phase 2 DUET Study.

The phase 3 DUPEX study was the largest interventional study in FSGS, as well as the only one against a maximally dosed active comparator. 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. The 2-year results from the study were published in the 

 and showed that sparsentan delivered clinically meaningful benefit at 108 weeks with significant proteinuria reduction, higher rates of partial and complete remission, and a lower rate of end-stage kidney disease compared to the active control.

In concurrence, the phase 2 DUET study met the primary efficacy endpoint for the combined treatment group, demonstrating a > 2-fold reduction in proteinuria compared to irbesartan. Its safety profile was consistent across all clinical trials and comparable to the maximally dosed active control.

If approved, sparsentan would be the first medication indicated for the treatment of adults with FSGS.

Travere Therapeutics Announces FDA Extends Review of sNDA for FILSPARI® (sparsentan) in FSGS. Travere.com. Published 2025. Accessed January 13, 2026. 

https://ir.travere.com/press-releases/news-details/2026/Travere-Therapeutics-Announces-FDA-Extends-Review-of-sNDA-for-FILSPARI-sparsentan-in-FSGS/default.aspx

Travere Therapeutics Announces FDA Acceptance of sNDA for FILSPARI® (sparsentan) in FSGS. Travere.com. Published 2025. Accessed January 5, 2026. 

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

The FDA has extended the review timeline for sparsentan's supplemental New Drug Application for focal segmental glomerulosclerosis (FSGS) to April 13, 2026. This extension follows the submission of additional data, deemed a Major Amendment, to further characterize the drug's clinical benefits. Sparsentan, a non-immunosuppressive oral medication, targets podocyte injury and has shown promising results in reducing proteinuria in FSGS patients. If approved, it would be the first treatment specifically indicated for adults with FSGS, offering a significant advancement in managing this progressive kidney disease.

The FDA has extended its review of the sNDA, delaying the previous January 13, 2026, PDUFA date, to April 13, 2026.



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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.

Focal Segmental Glomerulosclerosis

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

FDA News

FDA Extends Sparsentan (Filspari) sNDA Review for Focal Segmental Glomerulosclerosis

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

The US Food and Drug Administration (FDA) has requested the removal of information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that currently include such language.

As described in a January 13, 2026, release from the Agency, affected products include liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Zepbound). The action follows a comprehensive FDA review that found no increased risk of SI/B associated with the use of GLP-1 RA medications.

Liraglutide, semaglutide, and tirzepatide are each approved for weight reduction in individuals with obesity or overweight. At the time of their original FDA approvals, the labeling for each of these products included information in the 

 section about the potential risk of SI/B. Of note, similar information about SI/B is also included in the labeling of other types of weight loss medicines and is based on reports of such events observed with a variety of older medicines used or studied for weight loss.

Labeling for GLP-1 RA medications that are approved to improve glycemic (blood sugar) control or other complications in patients with type 2 diabetes mellitus does not currently include information on the risk of SI/B.

The FDA approved the first GLP-1 receptor agonist in 2005 as adjunctive therapy to improve glycemic control in type 2 diabetes, a milestone that has since reshaped multiple areas of medicine. What began as a diabetes therapy has rapidly evolved into one of the most influential drug classes in modern clinical practice, with expanding indications across endocrinology, cardiology, nephrology, and hepatology. Today, several GLP-1 receptor agonists are available, and their transformative clinical impact, coupled with unprecedented patient and provider demand, has driven sustained nationwide shortages from 2023-2025, underscoring their central role in contemporary care.

In July 2023, after receiving postmarketing reports of SI/B in patients taking GLP-1 RA medications, the FDA initiated further investigation of the potential risk of SI/B for GLP-1 RA medications. Findings from a preliminary review of clinical trial and postmarketing data, including observational studies and case reports, were publicly reported by the FDA in its January 2024 Drug Safety Communication.

The initial review of GLP-1 RA clinical trial data did not find an association between the use of GLP-1 RAs and the occurrence of SI/B. However, because of the small number of cases of SI/B observed in individual trials, the Agency cited considerable uncertainty in the risk estimate.

To address this concern, the FDA performed a comprehensive meta-analysis of clinical trials across GLP-1 RA drug development programs to improve the precision of the risk estimate. The meta-analysis assessed the risk of SI/B comparing GLP-1 RA medications to placebo in 91 placebo-controlled GLP-1 RA medication trials enrolling 107,910 patients, including 60,338 treated with a GLP-1 RA and 47,572 treated with placebo. Of note, results did not show an increased risk for SI/B or for other relevant psychiatric adverse events such as anxiety, depression, irritability, or psychosis.

The FDA additionally conducted a retrospective cohort study using administrative healthcare claims data from the FDA Sentinel System to compare the risk of intentional self-harm between new users of GLP-1 RAs and sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with type 2 diabetes mellitus. The study population included 2,243,138 users (1,161,983 initiated on a GLP-1 RA and 1,081,155 initiated on a SGLT2i) from 10 data partners between October 2015 and September 2023.

After controlling for baseline confounders in the study, the FDA did not find an increased risk of intentional self-harm in GLP-1 RA users compared to SGLT2i users. Similarly, the FDA did not find an increased risk in the subgroup of patients with both type 2 diabetes mellitus and obesity.

The FDA also reviewed published observational and pooled studies evaluating the relationship between GLP-1 RAs and SI/B, and related outcomes. The Agency’s review concluded that the totality of these studies does not support a causal relationship between the use of GLP-1 RAs and the occurrence of SI/B.

Consistent with these findings, the Agency is requesting that application holders remove information regarding the risk of SI/B from the labeling of GLP-1 RA medications that currently include such language.

US Food and Drug Administration. FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications. January 13, 2026. Accessed January 13, 2026. 

https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-suicidal-behavior-and-ideation-warning-glucagon-peptide-1-receptor-agonist-glp?utm_medium=email&utm_source=govdelivery

US Food and Drug Administration.Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity. January 11, 2024. Accessed January 13, 2026. 

https://www.fda.gov/drugs/drug-safety-and-availability/update-fdas-ongoing-evaluation-reports-suicidal-thoughts-or-actions-patients-taking-certain-type

The FDA has requested the removal of warnings about suicidal ideation and behavior (SI/B) from the labeling of GLP-1 receptor agonist medications, including liraglutide, semaglutide, and tirzepatide. This decision follows a comprehensive review that found no increased risk of SI/B associated with these drugs. The review included a meta-analysis of clinical trials and a retrospective cohort study, both of which showed no significant association between GLP-1 RAs and SI/B. Consequently, the FDA concluded that the warnings are not supported by current evidence.

An FDA review found no increased risk of SI/B associated with the use of GLP-1 RA medications, including liraglutide, semaglutide, and tirzepatide.

FDA Requests Removal of Suicidal Ideation and Behavior Warning From GLP-1 RA Therapies

Open-label RCT findings suggest a short-term, calorie-restrictive diet may be an effective intervention for mild and moderate Crohn’s 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.

Fasting-Mimicking Diet Elicits Clinical, Biochemical Response in Mild Crohn’s Disease

Angel S. Byrd, MD, PhD, is an associate professor at Howard University College of Medicine.

This episode of Skin of Color Savvy was filmed on-site at the Skin of Color Society's 'Meeting the Challenge Summit' in Washington, DC.

Skin of Color Savvy: The Art and Science of Treating Patients of Color

Hosted by Skin of Color Society and produced by HCPLive, 

 delves into the latest research, clinical insights, and culturally intelligent care practices in dermatology with leading experts. 

Whether it’s groundbreaking research, practice-changing insights, or highlights from the SOCS community, this twice-monthly program provides dermatologists and care providers with expert perspectives on treating patients with skin of color.

Podcasts

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

Skin of Color Savvy: On-Site Interviews at the Meeting the Challenge Summit

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

The KAI 12L program is now cleared to determine short PR interval, atrial bigeminy, ventricular bigeminy, left axis deviation, and right axis deviation.

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...

Arrhythmia

FDA Clears AI Program Powering Kardia 12L Electrogram for 5 New Cardiac Determinations

These recommendations simultaneously emphasize the efficacy of weight loss drugs and encourage incorporating lifestyle therapy on top of medication.

ADA’s Obesity Association Releases Guidelines for Use of Obesity Medications

A new national database study suggests malnutrition reverses the obesity survival benefit in hospitalized ESKD patients undergoing dialysis


Chronic Kidney Disease

Malnutrition Reverses Obesity Survival Advantage in Hospitalized Patients With End Stage Kidney Disease

Neurolief’s physician-directed therapy brings supervised, noninvasive brain stimulation into the home for adults with MDD who have not responded to ≥ 1 antidepressant.

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.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

FDA Approves ProlivRx, First At-Home Neuromodulation Device for MDD

Investigators assessed the 72-week effectiveness of tralokinumab on 4 anatomical regions among patients with atopic dermatitis in real-world clinical practice.

Tralokinumab Consistently Effective for Eczema Regardless of Anatomical Site

Sonalika Khachikian, MD, is an endocrinologist at Monument Health.

Management of thyroid eye disease (TED) may require adjunctive medical therapies and surgical intervention, particularly in patients with severe, refractory, or high-risk disease features. 


Video Series

Adjunctive Therapies, Surgery, and Special Populations in TED

The report details the disease burden, mortality, and quality of care trends for 5 major risk factors and the 5 leading causes of CVD death.

JACC Inaugural Cardiovascular Studies Report Highlights Progress and Potential for Growth

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

An audio recap of the top 5 stories in healthcare news from the week of 01/04-01/10.

Type 1 Diabetes

Schizophrenia

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

Dementia and Alzheimer Disease

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

Geriatrics

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

Latest News

1 in 4 Adults Worldwide Eligible for GLP-1 Treatment for Obesity, With Jennifer Manne-Goehler, MD

Upadacitinib Outperforms 4 JAK Inhibitors in Atopic Dermatitis Meta-Analysis

CMTX-101 Shows Safety and Bacterial Reductions in Cystic Fibrosis Trial

FDA Extends Sparsentan (Filspari) sNDA Review for Focal Segmental Glomerulosclerosis

FDA Requests Removal of Suicidal Ideation and Behavior Warning From GLP-1 RA Therapies