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

Continuous ketone monitoring (CKM) is emerging as a companion to continuous glucose monitoring (CGM), offering clinicians real-time insight into a complication long feared with sodium-glucose cotransporter 2 (SGLT2) inhibitor therapy: euglycemic diabetic ketoacidosis (DKA). The technology could reshape how the drug class is used in 

, where kidney-protective benefits have been weighed against ketoacidosis risk.

Continuous Ketone Monitoring May Guide SGLT2i Use in T1D

, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discussed early clinical experience with CKM technology, drawing on patient cases presented at an interactive Medscape education program the month prior.

Watch the full episode, featuring tech, screening, and care updates from ADCES 2026,

One case involved a patient with new-onset T1D, believed to be latent autoimmune diabetes in adults, who was managed on an SGLT2 inhibitor without insulin. Ketone testing showed moderate elevation, prompting discussion of when to initiate insulin or discontinue the SGLT2 inhibitor rather than waiting for symptoms to emerge. The case illustrated the diagnostic gap CKM is designed to close, since intermittent point-of-care ketone checks can miss the gradual rise associated with euglycemic DKA.

Clinicians are increasingly interested in extending SGLT2 inhibitor therapy, even at reduced doses, to patients with T1D for its cardiorenal protective effects, particularly in those who cannot tolerate metformin or a GLP-1 receptor agonist. The barrier remains the elevated euglycemic DKA risk unique to T1D. Continuous ketone data could allow clinicians to identify early metabolic drift and intervene before ketoacidosis develops, potentially expanding safe access to the drug class.

A second case centered on a pregnant patient carrying twins and using a connected insulin pen, where ketone monitoring supported decisions around nutritional adequacy and DKA prevention during a period of heightened metabolic risk. The discussion underscored how CKM may extend beyond T1D management to support other high-risk populations.

Both speakers acknowledged clinicians have limited experience interpreting continuous, rather than intermittent, ketone data, and said real-world device use will help define appropriate thresholds and interventions. As CKM systems reach wider clinical availability, the technology is positioned to refine risk stratification for SGLT2 inhibitor therapy in T1D and other high-risk metabolic states.

Editors’ 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.

Fernando K, Akturk H. Present and Future of Continuous Ketone Monitoring: Risky or Rewarding? 

. July 10, 2026. Accessed August 12, 2026. 

https://www.medscape.com/viewarticle/present-and-future-continuous-ketone-monitoring-risky-or-2026a1000mym

Videos

In this segment from the latest episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the promise of continuous ketone monitoring in T1D.

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This page also hosts content previously published by EndocrinologyNetwork. 


Type 1 Diabetes

Arvid Harder, PhD candidate of Karolinska Institutet, Stockholm, Sweden.

A genome-wide association meta-analysis with > 460,000 participants has identified 2 genetically distinct subtypes of 

: AERS+ (hypersomnia with increased appetite and weight gain) and AERS− (insomnia with appetite and weight loss). These subtypes diverge in heritability, polygenicity, and metabolic genetic correlations.¹

Current MDD diagnostic criteria treat opposite-direction neurovegetative symptoms, weight gain versus weight loss, and hypersomnia versus insomnia as clinically interchangeable.¹ The investigators, working within the Psychiatric Genomics Consortium's MDD working group, stratified individuals meeting MDD criteria into AERS+, AERS−, and an uncategorized group before running subtype-specific genome-wide association analyses.¹ The approach builds on the research team's earlier coverage of the AERS framework's genetic architecture.²

"We know if you're at a higher BMI, your subsequent risk of depression increases, and vice versa," said Arvid Harder, lead study author. "We are unable to make any claims about the [causal architecture]. We just show they co-occur together, but we don't know exactly [how]."

Metabolic Traits Differentiate AERS+, AERS− MDD Subtypes, With Arvid Harder

AERS+ and AERS− Subtypes Show Distinct GWAS Architecture

The meta-analysis pooled data across cohorts to reach effective sample sizes of 47,858 for AERS+, 156,624 for AERS−, and 215,828 for the uncategorized group. Across the 3 groups, the investigators identified 27 genome-wide significant loci, including 4 for AERS+, 10 for AERS−, and 13 for the uncategorized group.¹

AERS+ showed a greater SNP-based heritability (10.9%) than AERS− (7.9%) or the uncategorized group (8.6%), despite its smaller sample size. AERS+ also showed lower polygenicity, with associated variants covering an estimated 1.7% of SNPs compared with 2.9% for AERS− and 5.3% for the uncategorized group, and larger effect sizes at its associated loci. AERS+ and AERS− were moderately genetically correlated (rg = 0.64; SE = 0.04), indicating overlapping but distinguishable genetic architecture between the 2 symptom-direction subtypes.¹

Metabolic Genetic Correlations Distinguish MDD Subtypes

Metabolic traits emerged as the primary axis separating the subtypes. AERS+ correlated positively with BMI, metabolic syndrome, and related metabolic traits, while AERS− correlated weakly in the opposite direction.¹

What is the difference between AERS+ and AERS− depression subtypes?


AERS+ describes MDD with hypersomnia and weight gain, while AERS− describes MDD with insomnia and weight loss; the 2 subtypes differ in heritability, polygenicity, and metabolic genetic correlations.

How many genetic loci were identified across the MDD subtypes?


The meta-analysis identified 27 genome-wide significant loci in total, 4 for AERS+, 10 for AERS−, and 13 for the uncategorized group.

What clinical implication does the research suggest for depression assessment?


The investigators suggest retaining the direction of neurovegetative symptoms, such as weight gain versus weight loss, in diagnostic instruments rather than treating opposite-direction symptoms as equivalent.

Harder said the pattern may reflect how genetic studies of clinical traits also capture biomarkers shaped by a person's current body weight rather than depression biology alone. AERS−, marked by weight loss during a depressive episode, showed a genetic link to anorexia nervosa alongside more favorable metabolic markers, a pattern Harder attributed partly to weight-related masking of the underlying depression signal.

The findings identify metabolic biology as a central axis differentiating MDD subtypes beyond mood symptoms alone. Harder said continuous assessment of symptom directionality, rather than a single unified depression score, could eventually guide treatment selection if subgroup-specific treatment response is confirmed in future trials.

“It's very nice to kind of have this dialogue between clinicians and researchers on how we should continuously develop these instruments and which questions we ask,” Harder said.

Harder A, Wang R, Bergstedt J, et al. Atypical energy-related symptoms define biologically distinct subtypes of major depressive disorder. medRxiv. Preprint posted July 2, 2026. 

AERS subtypes show distinct genetic architecture in MDD. 

https://www.hcplive.com/view/aers-subtypes-major-depression-genetics

. Published August 12, 2026. Accessed August 12, 2026.

Articles

A large genome-wide meta-analysis (>460,000 participants) supports 2 genetically distinguishable MDD subtypes defined by atypical energy-related symptom directionality: AERS+ (hypersomnia, hyperphagia, weight gain) and AERS− (insomnia, reduced appetite, weight loss). Despite smaller effective sample size, AERS+ showed higher SNP-heritability, lower polygenicity, and larger locus effects. The subtypes were moderately genetically correlated, indicating partial overlap with separable architecture. Metabolic genetics most clearly differentiated them, with AERS+ aligning with adverse metabolic traits and AERS− showing opposing correlations.

New genome-wide data show AERS+ and AERS− subtypes of major depressive disorder diverge in heritability and metabolic genetic correlations.

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.

Systemic treatment options for pediatric 

 are expanding rapidly below age 12, where dupilumab has long stood as the only biologic approved in most of the world. In a phase 3 open-label extension study, 79.3% of children aged 6 months to 5 years reached at least a 75% improvement in disease severity after 1 year of treatment.¹ Another 58.6% reached a 90% improvement, with investigators reporting a favorable long-term safety profile in this younger age group.¹

Newer agents targeting the interleukin (IL)-13 and IL-31 pathways are now generating pediatric data of their own. Lebrikizumab met its primary and key secondary endpoints in the phase 3 ADorable-1 trial, with 63% of children aged 6 months to 17 years achieving a 75% reduction in Eczema Area and Severity Index (EASI) score.² Nemolizumab has separately shown clinically meaningful reductions in lesions and itch through week 16, sustained to 1 year, in an open-label study of children aged 2 - 11 years.³

These results raise practical questions for clinicians managing young children with limited topical options. As differently targeted biologics reach younger age groups, dosing intervals, injection frequency, and effects on comorbidity development will help determine how each agent fits alongside dupilumab in practice.

Lawrence Eichenfield, MD, is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and vice chair of the department of dermatology at the University of California, San Diego. He reviewed this expanding pipeline during a recent 2026 Maui Derm conference session on atopic dermatitis. In the following interview, Eichenfield discusses which advances he sees as most impactful and where unmet needs remain for the youngest patients:

: Which of these agents do you feel has the most potential to be impactful, whether from new data or recent approvals?

What's most impactful is that we now have a choice of non-steroids. Families come in so concerned about topical steroid use that they're often underutilizing it; there's so much penetration of the idea of steroid addiction, even though it's very uncommon with judicious topical steroid use.

The real takeaway is having an option, depending on choices, access, and the clinical situation, and now we have a broader ability to get those options across different ages. I'm especially excited to have a potentially useful drug under age 2, since there are so few options in that group, which I think is really important in the topical space.

: What are the remaining unmet needs in the topical space for children under 2?

 We have very few topical corticosteroids approved under age 2, but we use them with limitations, in a non-continuous manner, generally at lower strengths. Our first nonsteroidals, historically tacrolimus and pimecrolimus, never got approval for younger ages in the U.S. There's a fair amount of studies, especially with pimecrolimus, so sometimes they're covered and sometimes they're not from an access standpoint, but they also just haven't been well studied.

People still get concerned about the boxed warning even though we're reassuring about that. Topical crisaborole has been approved and is a very safe product, though it can cause stinging and burning. So we're trying to bring a new agent into this younger age group that shows safety in a broad population, with tolerance meaning not a lot of stinging and burning, or essentially none, and very few side effects in the PDE4 class, which is where roflumilast sits. I think that could be very useful, especially in long-term disease control models, as we're learning that if we can control disease earlier, whether with topicals or systemics, we may decrease the whole impact of the disease on a child and the family over time.

: Are there any other treatments on the horizon for pediatric patients, whether new drugs or new data?

 The systemic space is really heating up. We have extended experience and data sets on dupilumab in younger children, with multi-year data showing decreased development of comorbidities in patients treated with the drug. From an approval standpoint, around the world dupilumab is essentially the only biologic approved under age 12, though in some parts of the world patients may have access to an oral JAK inhibitor.

Part of what I reviewed was new data presented in the last few months: nemolizumab had data not just in the adolescents included in its core study, but in open-label studies in 2- to 11-year-olds, used alongside topical agents, showing some nice efficacy. Lebrikizumab has also completed placebo-controlled trials in children as young as 6 months up to 17 years of age, including a cohort of 6-month- to 2-year-olds, showing very good utility in that population.

It could be very interesting over time to see how a differently directed agent, a specific IL-13 or IL-31 agent, will be used in younger children the way we've used dupilumab, and whether there are advantages or disadvantages in terms of impact on developing comorbidities or frequency of injections. These are issues we haven't dealt with yet, especially in younger kids with pediatric atopic dermatitis, but within the next year or two that's going to be what we're figuring out in practice.

Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools.

Paller AS, Siegfried EC, Simpson EL, et al. Dupilumab safety and efficacy up to 1 year in children aged 6 months to 5 years with atopic dermatitis: results from a phase 3 open-label extension study. Am J Clin Dermatol. 2024;25(4):655-668. doi:10.1007/s40257-024-00859-y.

Eli Lilly and Company. Lilly's EBGLYSS (lebrikizumab-lbkz) is the first and only selective IL-13 inhibitor to deliver positive Phase 3 outcomes in patients aged six months to 18 years with moderate-to-severe atopic dermatitis. Published March 16, 2026. Accessed August 11, 2026. 

https://investor.lilly.com/news-releases/news-release-details/lillys-ebglyss-lebrikizumab-lbkz-first-and-only-selective-il-13

Galderma. AAD 2026: Late-breaking nemolizumab data demonstrate clinically meaningful benefits for children aged 2 to 11 with moderate-to-severe atopic dermatitis. Published March 28, 2026. Accessed August 11, 2026. 

https://www.galderma.com/news/aad-2026-late-breaking-data-atopic-dermatitis

Systemic therapy for pediatric atopic dermatitis is broadening rapidly in patients younger than 12 years, with dupilumab supported by 1-year open-label extension data showing high EASI-75 and EASI-90 response rates and reassuring safety in ages 6 months to 5 years. Emerging pediatric programs for pathway-selective biologics include IL-13 inhibition with lebrikizumab and IL-31 blockade with nemolizumab, both demonstrating meaningful efficacy signals. Practical differentiation will likely hinge on access, injection burden, dosing intervals, and potential effects on comorbidity trajectories.

In this discussion, Eichenfield discusses which advances in eczema he sees as most impactful and where unmet needs remain for pediatric patients.

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.

Q&A: Where the Pediatric Atopic Dermatitis Systemic Pipeline Stands

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.

BEL512 (CM512 in Greater China), an investigational bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and interleukin-13 (IL-13), met its primary endpoint and all secondary endpoints in a phase 2 trial in adults with inadequately controlled 

 (CRSwNP), according to Belenos Biosciences.

The double-blind, placebo-controlled trial (NCT06930612) was conducted in China by Belenos' partner, Keymed Biosciences, and enrolled 120 patients with a Nasal Polyp Score (NPS) of 5 or higher, at least 2 polyps per nostril, and a Nasal Congestion Score of 2 to 3 at baseline.

 Patients were randomized to subcutaneous BEL512 300 mg every 12 weeks, 300 mg every 24 weeks, 600 mg every 24 weeks, or placebo, each added to daily intranasal mometasone furoate 200 μg, over 24 weeks of treatment followed by a 12-week safety follow-up.

“These results provide important clinical validation for simultaneously targeting TSLP and IL-13 in treating CRSwNP,” said Donnie McGrath, MD, chief executive officer of Belenos Biosciences. “The magnitude, speed of onset and durability of improvement across objective measures of nasal polyp disease and the symptoms that matter most to patients, in conjunction with infrequent dosing indicate that BEL512 may offer patients an attractive treatment option.”

The primary endpoint, change from baseline in NPS at week 24, was met with statistically significant improvement across all BEL512 dosing groups versus placebo.

 All secondary endpoints were also met, including Nasal Congestion Score, Loss of Smell Score, Total Symptom Score, sinus CT Lund-Mackay score, and the 22-item Sino-Nasal Outcome Test (SNOT-22).

 Improvements were observed as early as week 4 and remained durable through the treatment and follow-up periods, including in the every-24-week dosing groups.

Type 2 inflammation is a key driver of CRSwNP, with TSLP acting as an upstream epithelial alarmin that initiates and amplifies inflammatory responses and IL-13 acting as a downstream effector cytokine linked to mucus production, tissue inflammation, and remodeling.

 BEL512 is designed to inhibit both pathways within a single molecule.

 CRS affects an estimated 10.9% to 13.4% of the Western population, with the more severe CRSwNP subtype accounting for approximately 18% to 20% of CRS cases.

Did BEL512 meet its endpoints in the phase 2 CRSwNP trial?

Yes. BEL512 met its primary endpoint (change in Nasal Polyp Score at week 24) and all secondary endpoints versus placebo.

BEL512 is a bispecific antibody that inhibits both thymic stromal lymphopoietin (TSLP), an upstream epithelial alarmin, and interleukin-13 (IL-13), a downstream effector cytokine, targeting type 2 inflammation in a single molecule.

What are the next steps for BEL512 in CRSwNP?

Keymed Biosciences plans to initiate a phase 3 trial in China, and Belenos plans to initiate a phase 3 trial outside China in the first half of 2027. BEL512 has also received Breakthrough Therapy Designation in China for CRSwNP.

What was BEL512’s safety profile and what are next steps?

BEL512 was well tolerated across all dosing groups, with overall treatment-emergent adverse event (TEAE) rates similar to placebo.

 There were no severe TEAEs, no discontinuations in the treatment groups, no serious AEs, and minimal anti-drug antibody formation.

 Based on these results, China's National Medical Products Administration Center for Drug Evaluation recently included BEL512 in its Breakthrough Therapy program for CRSwNP.

Keymed Biosciences plans to initiate a phase 3 trial of BEL512 in CRSwNP in China in the near future, while Belenos plans to initiate a phase 3 trial outside China in the first half of 2027.

 Detailed results are expected to be presented at a scientific meeting and submitted for publication in a peer-reviewed journal.

“Patients with CRSwNP experience a significant and profound impact on their quality of life, struggling to breathe through their nose, smell, and sleep normally,” said Stella Lee, MD, associate professor of otolaryngology-head and neck surgery at Harvard Medical School and director of the Sinus Center at Brigham and Women's Hospital, who was not involved in the study. “The marked improvements observed across nasal polyp burden, congestion, and sense of smell may translate into meaningful improvements in health-related quality of life, strongly supporting continued development of BEL512 for CRSwNP.”

BEL512 is also in development for asthma, chronic obstructive pulmonary disease, and atopic dermatitis, conditions the company characterizes as sharing epithelial-immune dysregulation with CRSwNP.

Belenos Biosciences. Belenos Biosciences Announces Positive Topline Results from a Phase 2 Clinical Trial of BEL512 in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Published August 11, 2026. Accessed August 11, 2026. 

https://www.businesswire.com/news/home/20260811141838/en/Belenos-Biosciences-Announces-Positive-Topline-Results-from-a-Phase-2-Clinical-Trial-of-BEL512-in-Chronic-Rhinosinusitis-with-Nasal-Polyps-CRSwNP

Laidlaw TM, Mullol J, Woessner KM, Amin N, Mannent LP. Chronic Rhinosinusitis With Nasal Polyps and Asthma. 

BEL512 (CM512) is an investigational TSLP/IL-13 bispecific antibody that achieved statistically significant improvement in nasal polyp burden at week 24 versus placebo in a 120-patient, double-blind phase 2 CRSwNP trial in China, while meeting all key symptom, imaging, and quality-of-life endpoints. Benefits emerged by week 4 and persisted through treatment and follow-up, including with every-24-week dosing. Safety was comparable to placebo, with no serious or severe TEAEs, no discontinuations, and minimal immunogenicity. Phase 3 programs are planned in China and globally.

The bispecific TSLP/IL-13 inhibitor BEL512 met its primary endpoint and all secondary endpoints in adults with chronic rhinosinusitis with nasal polyps.

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.

BEL512 Improves CRSwNP and Symptoms in Phase 2 trial

Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. 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.

Definium Therapeutics has announced positive topline results from the phase 3 Voyage trial of DT120 (lysergide) orally disintegrating tablet (ODT) 100 µg, showing a statistically significant placebo-adjusted reduction of 5.4 points on the Hamilton Anxiety Rating Scale (HAM-A) at week 12 in adults with 

The result marks Definium's second positive phase 3 readout for DT120 ODT, following the positive Emerge trial results in major depressive disorder (MDD) announced in June 2026.¹ The US Food & Drug Administration (FDA) has granted DT120 Breakthrough Therapy designation for GAD.¹ Voyage is 1 of 2 pivotal phase 3 trials in the program, with topline results from the second trial, Panorama, expected in September.¹

GAD remains one of psychiatry's most undertreated conditions, with limited additional treatment options since 2007.

Yet approximately 26 million adults in the US live with GAD.

"Despite the burden of the disorder, the last new FDA-approved treatment for this condition was nearly 2 decades ago, and many of the patients I see have not found relief despite trying multiple therapies," said Brian Barnett, MD, vice chair of psychiatry, Cleveland Clinic, and a Voyage principal investigator, in a statement.

“A single-dose treatment option delivering meaningful benefits for 12 weeks is a promising step forward not found in today’s therapies.”

DT120 ODT Efficacy in the Phase 3 Voyage Trial

Voyage is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluating a single 100 µg dose of DT120 ODT versus placebo in adults with GAD.¹ The trial enrolled 214 participants aged 18 to 74 years across approximately 35 US sites, with a DSM-5-confirmed GAD diagnosis and a baseline HAM-A score of ≥ 20.¹

Mean baseline HAM-A scores were 28.4 in the DT120 ODT group (n = 107) and 27.4 in the placebo group (n = 107).¹ The double-blind Part A spans 12 weeks and is followed by a 40-week open-label extension, Part B, during which participants may receive up to 4 additional doses based on symptom severity.¹

For the primary endpoint, the least squares (LS) mean change from baseline in HAM-A score at week 12 was -11.6 with DT120 ODT compared with -6.2 with placebo (LS mean difference of -5.4 points, 

 <.0001; Cohen's d = 0.81).¹ Key secondary endpoints also reached significance: CGI-S LS mean change at week 12 was -1.0 versus -0.4 (difference, -0.6; 

 <.0001), HAM-A LS mean change at week 1 was -11.9 versus -4.2 (difference, -7.7; 

 <.0001), and CGI-S change at day 2 was -1.0 versus -0.2 (difference, -0.8; 

 <.0001).¹ Definium reported efficacy emerged as early as day 2 and was sustained across all post-baseline timepoints in Part A.¹

"The unprecedented efficacy demonstrated in Voyage should raise the bar for what patients and clinicians expect from GAD treatments," said Rob Barrow, chief executive officer, Definium Therapeutics, in a statement.¹

DT120 ODT Safety and Secondary Endpoints in GAD

What did the Voyage trial show for DT120 ODT in GAD?


Voyage met its primary endpoint, with DT120 ODT 100 µg producing a placebo-adjusted 5.4-point reduction in HAM-A score at week 12 (


DT120 ODT is a single 100 µg orally disintegrating tablet formulation of lysergide (LSD), built on Catalent's Zydis fast-dissolve technology, with additional doses available during the open-label extension based on symptom severity.

Is DT120 ODT associated with a suicidality risk in GAD?


Definium reported no new safety signals in Voyage, including no suicidality signal or suicidal behavior, with treatment-emergent adverse events mild to moderate and largely confined to the dosing day.

Additional secondary analyses favored DT120 ODT across response and remission measures.¹ HAM-A response rate (≥ 50% reduction) at week 12 was 43% with DT120 ODT versus 16% with placebo (difference, 27%; 

 <.0001), remission rate (HAM-A ≤ 7) was 14% versus 4% (difference, 10%; 

 =.0222), and the proportion reaching mild severity or better (HAM-A < 16) was 51% versus 23% (difference, 28%; 

DT120 ODT was generally well tolerated, with treatment-emergent adverse events mild to moderate in severity, transient, and predominantly occurring on the day of dosing.¹ The company reported no new safety signals and no suicidality signal or suicidal behavior.¹ Using an hourly end-of-session checklist (EoSC) beginning at hour 5 post-dose, the average time to meeting EoSC criteria was 6.4 hours, with a median of 6.1 hours and 92% of participants meeting criteria by hour 8.¹

Definium's second Phase 3 GAD trial, Panorama, adds a low-dose 50 µg arm to the same design, with participants randomized 2:1:2 to DT120 ODT 100 µg, DT120 ODT 50 µg, or placebo.¹ The company stated the low-dose arm is intended to confound participants' ability to accurately identify their randomized dose, building on phase 2b data the company believes demonstrated DT120's clinical activity is not attributable to functional unblinding.¹ Definium is also developing DT120 ODT for PTSD.¹

Definium Therapeutics announces positive topline results from Phase 3 Voyage study of DT120 ODT in generalized anxiety disorder. Definium Therapeutics. Published August 12, 2026. Accessed August 12, 2026. 

https://www.businesswire.com/news/home/20260812579720/en/Definium-Therapeutics-Announces-Positive-Topline-Results-from-Phase-3-Voyage-Study-of-DT120-ODT-in-Generalized-Anxiety-Disorder

De Berardis D, Serroni N, Carano A, et al. The role of duloxetine in the treatment of anxiety disorders. 

Definium Therapeutics reported positive phase 3 results for DT120 (lysergide) ODT 100 µg as a single-dose intervention for adults with DSM-5 generalized anxiety disorder. In Voyage (n=214), DT120 achieved a placebo-adjusted HAM-A reduction of 5.4 points at week 12 (P<.0001; d=0.81), with improvements evident by day 2 and sustained through 12 weeks. Key secondary endpoints (CGI-S, early HAM-A change) were significant. Tolerability was favorable, with mainly transient, day-of-dose adverse events and no suicidality signal.

DT120 ODT produced a 5.4-point placebo-adjusted HAM-A reduction at week 12 in the phase 3 Voyage trial for generalized anxiety disorder.

Voyage: DT120 ODT Reduces Anxiety in Phase 3 GAD Trial

Brad Rovin, MD, discusses persistent gaps in IgA nephropathy diagnosis and treatment, from RAS inhibition limits to the promise of B-cell-targeted therapies.

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.

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.

What's Still Missing in IgA Nephropathy Care, With Brad Rovin, MD

In this segment from the latest episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss new insulin pump technology presented at ADCES 2026.

Type 2 Diabetes

New Patch Pump Options Highlighted at ADCES 2026

Jay Lieberman, MD, from University of Tennessee

New reviews outline barriers to epinephrine use and support age-specific anaphylaxis recognition criteria in infants and toddlers, says Jay Lieberman, MD.

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.

Age-Specific Criteria Improve Anaphylaxis Detection in Infants

Rima Rachid, MD, from Boston Children’s Hospital.

Rima Rachid, MD, discussed why antibiotic pretreatment before fecal microbiota transplantation may improve peanut allergy response rates.

Food Allergy

Antibiotic Pretreatment Improves FMT Response in Peanut Allergy

This Q&A highlights recent data and FDA approvals described in the pediatric atopic dermatitis space by Lawrence Eichenfield, MD.

Q&A: First Pediatric Eczema Guidelines and New Topical Options Down to Age 2

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.

A pair of clinical forums examined new CKM staging, SGLT2 and MRA trial data, and the barriers delaying heart failure treatment.

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...

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

Heart Failure Staging and Prevention: Perspectives From Clinical Forums

In this interview, Lawrence Eichenfield, MD, reviews new data on topical and systemic treatments such as tapinarof and ruxolitinib in atopic dermatitis.

New Nonsteroidal Options Expand for Pediatric Atopic Dermatitis

Sonelokimab hit its primary ACR50 endpoint and all key secondary endpoints in biologic-naive patients with psoriatic arthritis in the phase 3 IZAR-1 trial.

Plaque Psoriasis

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

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.

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.

IZAR-1: Sonelokimab Meets Phase 3 End Points for PsA

Brad Rovin, MD, discusses gaps in IgA nephropathy care, biopsy's expanding role, and how new B cell therapies are reshaping treatment.

Closing Gaps in IgA Nephropathy Diagnosis and Treatment, With Brad Rovin, MD

Podcasts

Once-weekly insulin icodec hits US pharmacies, simplifying basal dosing for type 2 diabetes with new titration rules and promising A1c results.

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

Diabetes Dialogue

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

Latest News

Continuous Ketone Monitoring May Guide SGLT2i Use in T1D

Metabolic Traits Differentiate AERS+, AERS− MDD Subtypes, With Arvid Harder

Q&A: Where the Pediatric Atopic Dermatitis Systemic Pipeline Stands

BEL512 Improves CRSwNP and Symptoms in Phase 2 trial

Voyage: DT120 ODT Reduces Anxiety in Phase 3 GAD Trial