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Revolutionizing Atopic Dermatitis

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.

Alan Y. Hsu, MD | Image Credit: Google Scholar

A recent retrospective cohort study conducted in Taiwan indicated a connection between semaglutide treatment and nonarteritic anterior ischemic optic neuropathy (NAION) risk in patients with diabetes.

“Because NAION is a potentially debilitating 

 condition, gaining a clearer understanding of its incidence and the factors influencing its occurrence would enhance care for those considering the use of these medications,” wrote Alan Y. Hsu, MD, department of ophthalmology, China Medical University, and colleagues.

Hsu and colleagues indicated that the study was initially proposed due to a lack of research surrounding semaglutide’s potential risk of NAION incidence. Studies such as one conducted by Hathaway et al

 were able to draw a connection between semaglutide treatment and NAION but were likewise unable to indicate a causal relationship.

The team collected its data from the TriNetX analytics platform. The study focused on patients with diabetes ≥12 years of age who were treated with either semaglutide or non-glucagonlike peptide 1 (non-GLP-1) receptor agonists (RAs) between 2019 and 2023.

The initial number of patient records collected was 3,344,205; after excluding those with a history of semaglutide usage, optic neuritis, giant cell arteritis, and NAION diagnoses before first prescription, the total was reduced to 349,168 patients with diabetes. Of this number, 174,584 patients had received a form of semaglutide and 174,584 had received non-GLP-1 RA medications.

The team discovered no increased risk in semaglutide recipients at the 1-month (hazard ratio [HR], 2.99; 95% CI, .21-28.75; 

 = .26), 3-month (HR, 1.33; 95% CI, .30-5.93; 

 = .23), 6-month (HR, 1.79; 95% CI, .60-5.35; 

 = .37), and 1-year time points (HR, 1.94; 95% CI, .93-4.02; 

 = .26) compared to non-GLP-1 RA medication recipients.

Increased risk was discovered, however, at the 2-year (HR, 2.39; 95% CI, 1.37-4.18; 

 = .11), 3-year (HR, 2.44; 95% CI, 1.44-4.12; 

 = .21), and 4-year (HR, 2.05; 95% CI, 1.26-3.34; 

 = .71) periods compared to non-GLP-1 RA recipients. Cumulatively, an increased NAION risk was associated with semaglutide use among patients with diabetes (HR, 2.22; 95% CI, 1.37-3.60; 

Subgroup analysis indicated that female patients and those within the 40-64 age range had a greater risk of NAION when prescribed semaglutide (HR, 3.31; 95% CI, 1.68-6.53) than other non-GLP-1 RAs. Interestingly, patients with hypertensive disease had an increased risk (HR, 2.42; 95% CI, 1.19-4.92), while those with obesity, concomitant lipoprotein disorder, sleep apnea, ischemic heart disease, and hypothyroidism showed no increased risk for NAION compared to recipients of non-GLP-1 RAs.

Additionally, subgroups of different semaglutide brands exhibited different levels of NAION incidence. Patients with diabetes who were prescribed Ozempic (HR, 6.27; 95% CI, 2.92-13.47) or had a history of usage (HR, 2.47; 95% CI, 1.50-4.09) exhibited an increased risk, while those using Rybelsus (HR, 1.31; 95% CI, 0.34-5.10) or Wegovy (HR, 2.13; 95% CI, 0.11-41.43) or who had a history of using Rybelsus (HR, 1.56; 95% CI, 0.54-4.52) or Wegovy (HR, 7.52; 95% CI, 0.44-128.80) had no increased risk when compared to non-GLP-1 RA recipients.

Semaglutide is the only GLP-1 RA currently available in oral form. The team suggests that its safety profile is insufficiently investigated, particularly in relation to NAION risk. NAION’s prevalence and the sudden unilateral vision loss it can cause, the team argues, requires further study of potential triggers, such as semaglutide.

“This study’s retrospective design can only infer associations rather than establish causality, and other limitations warrant future, carefully designed observational studies to explore this association further,” wrote Hsu and colleagues.

Hsu AY, Kuo H-T, Wang Y-H, et al. Semaglutide and nonarteritic anterior ischemic optic neuropathy risk among patients with diabetes. 

. Published online March 27, 2025. doi:10.1001/jamaophthalmol.2025.0349

Hathaway JT, Shah MP, Hathaway DB, et al. Risk of nonarteritic anterior ischemic optic neuropathy in patients prescribed SEMAGLUTIDE. 

. 2024;142(8):732. doi:10.1001/jamaophthalmol.2024.2296

Articles

A retrospective cohort study in Taiwan explored the association between semaglutide treatment and nonarteritic anterior ischemic optic neuropathy (NAION) risk in diabetic patients. The study analyzed data from 349,168 patients, revealing no increased NAION risk within the first year of semaglutide use. However, a heightened risk was observed at 2-4 years, particularly in females and those aged 40-64. Subgroup analysis showed varying risk levels among different semaglutide brands. The study highlights the need for further research to understand semaglutide's safety profile and its potential link to NAION.

Study draws correlative connection between semaglutide and nonarteritic anterior ischemic optic neuropathy, more data required to show causation.

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Semaglutide May Increase Nonarteritic Anterior Ischemic Optic Neuropathy Risk

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

​In March, the pulmonology field saw notable advancements in treatments and diagnostic insights. The FDA accepted Liquidia Corporation's resubmission for treprostinil inhalation powder (YUTREPIA), aiming for final approval to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). ​

A study comparing pneumococcal vaccines in patients with chronic obstructive pulmonary disease (COPD) found that the 13-valent pneumococcal conjugate vaccine (PCV13) provided longer-lasting protection against pneumonia than the 23-valent pneumococcal polysaccharide vaccine (PPV23). ​

Research indicated that bronchodilator responsiveness tests in asthma patients yield more reliable results when conducted in the morning, suggesting a potential shift in clinical practice to optimize diagnostic accuracy. The accuracy of pulse oximeters in individuals with darker skin pigmentation has also been called into question, highlighting the need for more inclusive calibration standards to ensure equitable respiratory care. ​

At the AAAAI/WAO Joint Congress, experts provided insights into personalized asthma treatments and environmental health disparities. Flavia Hoyte, MD, discussed the roles of interleukin-5 (IL-5) and interleukin-13 (IL-13) in tezepelumab response, emphasizing the importance of targeted therapies in asthma management, while Sarah Chambliss, PhD, explored the impact of pollution sources on asthma morbidity in communities of color, underscoring the necessity for addressing environmental determinants in respiratory health.

Pulmonary Tests Demonstrated Varying Accuracy

Skin Pigmentation May Impact Capability of Pulse Oximeters


Concerns have been raised about the accuracy of pulse oximeters in individuals with darker skin pigmentation, as these devices may overestimate oxygen saturation levels in non-White patients. The findings highlight the need for more inclusive calibration standards to ensure equitable and accurate respiratory monitoring.

Asthma Bronchodilator Tests May be More Reliable in the Morning

New research indicated that bronchodilator responsiveness testing in asthma is more reliable when performed in the morning, due to variations in airway physiology throughout the day. The findings could influence clinical practice by optimizing the timing of diagnostic assessments for improved accuracy.

Expert Insights from AAAAI/WAO Joint Congress

Investigating IL-5, IL-13, and Tezepelumab Response, with Flavia Hoyte, MD


At the AAAAI/WAO Joint Congress, Flavia Hoyte, MD, discussed the roles of IL-5 and IL-13 in modulating response to tezepelumab, a biologic used for severe asthma. Her findings reinforce the need for personalized approaches in asthma management, leveraging biomarkers to optimize treatment efficacy.

Investigating Pollution Sources and Asthma Morbidity in Communities of Color, with Sarah Chambliss, PhD


Sarah Chambliss, PhD, explored how pollution sources contribute to asthma disparities in communities of color, emphasizing the disproportionate burden of environmental exposures. Her discussion underscored the importance of addressing social determinants of health in respiratory disease management and advocacy efforts.

FDA Accepts Treprostinil Resubmission for PAH, PH-ILD Final Approval


The FDA accepted Liquidia Corporation’s resubmission for treprostinil inhalation powder (YUTREPIA) for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), positioning it for final approval after the expiration of Tyvaso DPI’s market exclusivity in May 2025. The decision marks a significant regulatory step toward expanding treatment options for these progressive and life-threatening conditions.

PCV13 Pneumonia Vaccine Shows Longer Durability Over PPV23 in People With COPD


A study comparing pneumococcal vaccines in patients with COPD found that PCV13 provided longer-lasting protection against pneumonia than PPV23, with a sustained immune response over time. These findings suggest PCV13 may offer superior durability in preventing pneumococcal infections in this high-risk population.

February saw significant advancements in respiratory care, including new treatments and regulatory developments. A survey revealed the need for better integration of inhaled triple therapy in asthma management. The FDA granted Priority Review to a DPP1 inhibitor for non-cystic fibrosis bronchiectasis and accepted a BLA for a novel treatment for recurrent respiratory papillomatosis. Dupilumab showed promise in reducing COPD exacerbations and improving small airway dysfunction in type 2 asthma. Environmental concerns, particularly the impact of wildfires on air quality, were also highlighted in a pulmonology podcast.

This March 2025 month in review covers key pulmonology updates, including new findings on pulmonary function tests and expert insights from the AAAAI/WAO Joint Congress.

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Pulmonology Month in Review: March 2025

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

 who have a family history of inflammatory conditions are more likely to present with Hurley stage 2 or 3 versus stage 1, new findings suggest, highlighting the value of evaluating family history in those living with HS.

These findings connecting the shared inflammatory pathways between various autoinflammatory conditions and HS resulted from a recent retrospective analysis. Defne Özkoca, from the Koç University School of Medicine Department of Dermatology and Venerology in Istanbul, led a team of investigators in this study.

“In this retrospective study, we analyzed 248 HS patients admitted to Koç University Hospital between January 2019 and July 2024,” Özkoca and colleagues wrote.

 “Routine clinical assessments included detailed medical and family histories, specifically concerning Behçet's disease, psoriasis, IBD, and rheumatologic diseases.”

Some of these diseases had previously been shown to be linked to HS.

 The investigative team looked at 248 individuals for the purposes of their retrospective study, with each of these subjects having been admitted to Koç University Hospital between January 2019 - July 2024 and each subject living with HS.

The team would determine participants' severity level in their HS through the use of the Hurley staging system for classification. They included comprehensive histories of medical needs and family background, placing their focus on 

, Behçet’s disease, inflammatory bowel disease (IBD), and rheumatologic conditions, in their routine clinical evaluations of subjects.

The investigators conducted the necessary statistical analyses through the use of SPSS version 21, employing chi-square and Fisher’s exact tests. Given the need for comparisons in their analysis, the team created a control group of 70 age- and gender-matched subjects without HS. A 

-value of < .05 was decided by the investigators to be statistically significant.

Among the 248 HS patients, the mean age at disease onset was 28.4 years, and 60.1% of the cohort was male. The majority were categorized as Hurley stage 1 (42.7%) or stage 2 (39.9%), while 17.3% were classified as stage 3.

Higher rates than those of the control arm were identified by the research team among those with HS for arthralgia, metabolic syndrome, ankylosing spondylitis, and follicular occlusion tetrad. The team additionally found that a family history of HS, Behçet’s disease (P = .023), and rheumatologic conditions (

 < .01) were shown to have been more frequently seen among those in the HS arm of the analysis.

A familial history of inflammatory diseases among those presenting with Hurley stage 2 or 3 was identified as more likely, rather than stage 1 (

 = .047). Overall, the investigators' results highlight the notable and impactful role of family history in severity of HS. 

Recent analyses the investigative team highlighted in addition had pointed to mutations in the MEFV gene, which encodes pyrin, as having been detected in those with HS.

 Such data could indicate overlapping inflammatory pathways with other autoinflammatory conditions, and the team noted that such a genetic connection would support the involvement of key inflammatory mechanisms. These mechanisms could include interleukin (IL)-1 and TNF-α signaling.

In their description of the study's primary limitations, the investigators noted that its retrospective design and single-center scope would be examples. Despite this acknowledgement, they added that their research provide some valuable insights into the link between HS severity and inflammatory conditions with a strong familial component.

The team also highlighted prior findings linked vitamin D levels to HS severity, as vitamin D deficiency was shown to be more prevalent among individuals with HS who did not demonstrate any comorbid inflammatory conditions (

 = .028). Despite such conclusions, additional research with larger cohorts may be required to clarify the clinical significance of vitamin D deficiency in those with HS.

The accumulation of data identified in the investigators' analysis suggest that early identification and management of familial risk factors could aid in the optimizing of HS management, as could the shared genetic framework between HS and other inflammatory diseases.

“Further multicenter prospective studies are needed to clarify the underlying molecular mechanisms linking familial inflammatory disease history and HS disease course, potentially leading to more targeted therapeutic approaches,” they concluded.

Özkoca, D., Özcanlı, A., Er Gülbezer, E., Salıcı, N.S., Yaylı, S. and Vural, S. (2025), Association Between Familial Inflammatory Diseases and Hidradenitis Suppurativa Severity: A Single-Center Study. Int J Dermatol. 

T. V. Nguyen, G. Damiani, L. A. V. Orenstein, I. Hamzavi, and G. B. Jemec, “Hidradenitis Suppurativa: An Update on Epidemiology, Phenotypes, Diagnosis, Pathogenesis, Comorbidities and Quality of Life,” Journal of the European Academy of Dermatology and Venereology 35, no. 1 (2021): 50–61.

J. W. Frew, “Unravelling the Complex Pathogenesis of Hidradenitis Suppurativa,” British Journal of Dermatology 192, no. Supplement_1 (2025): i3–i14.

A retrospective study analyzed 248 patients with hidradenitis suppurativa (HS) to explore the link between family history of inflammatory conditions and HS severity. The study found that individuals with a familial history of inflammatory diseases were more likely to present with advanced Hurley stages 2 or 3. The research highlighted the potential shared inflammatory pathways between HS and other autoinflammatory conditions, suggesting that genetic factors, such as MEFV gene mutations, may play a role. The study emphasized the importance of considering family history in HS management and called for further research.

These data highlight the susceptibility loci shared between HS and other inflammatory diseases among those with this condition.

Hidradenitis Suppurativa

Hidradenitis Suppurativa 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 dermatology research, treatment, and drug development.

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.

Family History Plays Significant Role in Severity of Hidradenitis Suppurativa

Leandro Boer, MD, PhD, vice president of general medicines at Amgen

Preliminary results from the VESALIUS-REAL study highlight a significant burden of 

 in real-world settings, revealing gaps in lipid-lowering management among more than 277,000 individuals in the U.S. with elevated low-density lipoprotein cholesterol (LDL-C).

The analysis found that most high-risk patients aged ≥50 years with atherosclerotic cardiovascular disease (ASCVD)—including coronary artery disease (CAD), peripheral artery disease (PAD), cerebrovascular disease (CeVD), or high-risk diabetes—who had no prior history of myocardial infarction or stroke were neither adequately tested for LDL-C nor treated with lipid-lowering therapy (LLT).

Among 277,808 patients, only 37.6% received statin therapy, while more than half (62.4%) had no background LLT. One year after the index date, 87.6% of patients had an LDL-C level above 70 mg/dL, yet only 22.4% intensified their treatment, and fewer than 2% initiated a nonstatin LLT.

American College of Cardiology (ACC) 2025 Annual Scientific Sessions

, Leandro Boer, MD, PhD, vice president of general medicines at Amgen, discussed the study’s findings, emphasizing the urgent need for improved LDL-C management strategies to reduce cardiovascular risk in high-risk patient populations.

This transcript has been edited for clarity.

: What do these results inform about the current state of cardiovascular disease risk management in US patients?

These results are part of a whole cohort of patients in the VESALIUS-REAL study, comprising 277,000 patients in the US, alongside 11 other countries. This just focuses on the presentation of the US data. Who are these patients? These patients are patients with a very high risk of cardiovascular events. They have CVD, but have never had a stroke or myocardial infarction before. We are focused on what happened with them once they are in that situation.

We found very startling findings in the US, which may not be different from the rest of the world, showing 70% of these patients are not starting any therapy for LDL reduction, which is the most modifiable risk factor. In 88% of patients, if they start on a medication, they don’t have their medication intensified to the next level so they can achieve their goals. The level of patients not achieving this goal is high and that’s what we show in this poster.

: When we consider this issue, do we see it more as a provider-driven issue, a patient adherence challenge, or a systemic health care obstacle?

It’s a systemic health care gap. I like to say there is no silver bullet for this problem, but we also should not be looking at the gap and say ‘it is what it is.’ Since I started practicing, I prescribed my first statin prescription more than 20 years ago. We haven’t seen much happening and have seen a lot of inertia. These results and outcomes in the US population are not acceptable.

I believe there is a problem that we need to tackle. We need to be together, hand in hand, with insurers; they need to do their part. The manufacturers need to do their part and the patient needs to do their part. And the HCP needs to do their part. I think it’s missing the element of empowerment of the patient and the HCP binary, we need to help them take control of their destiny and their treatments.

: Despite the need for more intensive therapy, these data indicate <2% of patients initiated a nonstatin lipid-lowering therapy (LLT). What are the barriers that might be impacting the greater adoption of those agents?

In the US, we have some statistics. For example, one-third of the population does not have any insurance or is poorly insured. The second thing, a lot of cardiologists often come from cities, but 50% of counties in the country do not have a single cardiologist. We have a compounding effect of many things happening culminating with a patient not being intensified or therapy not achieving their goals. So, we have systemic barriers.

Even the possibility of a patient talking about their disease with their doctor, given the short duration of time, it often feels like patients spend more time asking questions with ChatGPT than their doctors. Is this the ideal thing? Maybe it’s an indication of how to use technology in the future, but we need to put the trust back in the relationship. Approximately three out of four patients in the US trust their primary care, so I think it’s an untapped opportunity.

We should not only focus on cardiology, we need to go to primary care, so they can also achieve their goals. This is not rocket science. We talk about lipids, the most modifiable risk factor. It’s accessible and really for everyone. It’s not complicated, so I think all primary care should have these goals and help their patients achieve those goals.

: How can recent guideline recommendations from organizations like the ACC and the American Heart Association (AHA) help address this issue?

Every time they go with the guidelines in a simple way, they can make it clear that what they’re recommending can be translated into clinical practice. Even when the guideline is not clear, we have a gap of 17 years between what is published and actual clinical practice. That’s why we need implementation science that’s been around with the National Institutes of Health (NIH) for the last 20 years. They help, by not only being a beacon and source of knowledge, but also helping us be partners for implementation initiatives. What works best to have those patients achieve their goals?

HCPLive: Do you have any final thoughts on these treatment

I would say just the importance of testing. In the country right now, we’re seeing dramatically low levels of testing. People are not testing for LDL, and when they do test, they don’t initiate the treatment. Something is going on there that we need to crack the code of, particularly what’s going on between the testing not being performed and why testing is not generating the urgency to do something.

It’s accessible to everyone and affordable, so why is someone not doing it? Testing is very important, because that’s the best way to put someone on a patient care pathway, so they can achieve their goals. The second thing is to continue mass education of both patients and also HCPs so they know the goal, know your number, and understand getting there is not so complicated.

Disclosures: Boer is an employee of Amgen.

Sakhuja S, Chan Q, Ochs A et al. Lipid Lowering Therapy Use in High-Risk ASCVD Patients Without Prior MI or Stroke - Preliminary Data from VESALIUS-Real, US. Presented at: American College of Cardiology (ACC.25) Annual Scientific Session. March 29 – 31, 2025. Chicago, Il.

The VESALIUS-REAL study reveals significant gaps in lipid-lowering management among over 277,000 U.S. patients with elevated LDL-C, highlighting a systemic healthcare issue. Despite being at high risk for cardiovascular events, many patients with ASCVD are inadequately tested and treated for LDL-C. Only 37.6% received statin therapy, and a mere 22.4% intensified treatment after a year. Barriers include lack of insurance, limited access to cardiologists, and insufficient patient-provider communication. Recent guidelines and implementation science are crucial for improving LDL-C management and reducing cardiovascular risk.

At ACC.25, Boer highlights treatment gaps in the US for lipid control in a high-risk ASCVD population.

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Atherosclerotic Cardiovascular Disease

Dyslipidemia

VESALIUS-REAL Reveals Lipid Control Gaps in US with Leandro Boer, MD, PhD

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.

 Q1/Q2 Psychiatry Updates, with Steve Levine, MD

With the first quarter of the year coming to an end, 

spoke with Steve Levine, MD, from Compass Pathways, for a brief recap of developments in 

 this year and a look ahead at what is coming in quarter 2.

Levine said aside from psychedelics, the pipeline is relatively dry, with several cases of failures and discontinuations. Looking ahead to quarter 2, topline results for several treatments in treatment-resistant depression are expected to be announced.

“Because there are multiple data readouts coming up...clinicians should just be paying attention and reading these studies in detail—or at least to the extent that you know it may be sort of top line results, press release, as opposed to published peer review data,” Levine said.

J&J’s Monotherapy Indication for SPRAVATO

The US Food and Drug Administration (FDA) approved esketamine (SPRAVATO) CIII nasal spray as the first monotherapy for adults with treatment-resistant depression (TRD), announced by Johnson & Johnson on January 21, 2025. The approval of this supplemental new drug application (NDA) was based on a phase 4 randomized, double-blind, multicenter, placebo-controlled study which found esketamine brought a rapid and superior improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 4 weeks compared with placebo; 22.5% on esketamine vs 7.6% on placebo reached remission (MADRS ≤ 12) at week 4.

Otsuka and Lundbeck’s NDA for Brexpiprazole 

The FDA accepted the sNDA for brexpiprazole alongside sertraline to treat adult PTSD, Otsuka and Lundbeck announced in June 2024. Since then, a phase 3 trial showed brexpiprazole with sertraline significantly reduced PTSD symptoms in 10 days, and Otsuka announced FDA announced plans to host an advisory committee meeting to discuss this decision. The FDA has yet to set a meeting date, but it is anticipated to occur during the first half of 2025. This has pushed back brexpiprazole with sertraline’s original PDUFA target date of February 8, 2025.

Neumora’s Kappa Opioid Receptor, Navacaprant 

Neumora’s kappa opioid antagonist, navacaprant, failed to show efficacy in the phase 3 KOASTAL-1 trial for major depressive disorder. Navacaprant demonstrated no significant difference from placebo in reducing depressive symptoms after 6 weeks of treatment and even led the company’s shares to drop by > 80%.

Discontinued VENTURA Program on Anticaprant for MDD

J&J decided to discontinue their phase 3 VENTURA program after the kappa opioid receptor anticaprant failed to show significant improvements in MDD. However, the company said aticaprant could have potential in other therapeutic areas.

Transcend Therapeutics announced on March 31, 2025, that methylone (TSND-201) signficantly improved PTSD symptoms in the phase 2 IMPACT-1 trial, thus meeting its primary endpoint of significant change from baseline to day 64 in the Clinician-Administered PTSD Scale for DSM05 (CAPS-5) score. This randomized, double-blind, placebo-controlled trial demonstrated patients on methylone had an average CAPS-5 improvement of – 9.64 points on day 64 compared with placebo (-23.28 points vs -13.64 points; P = .0011), with improvement evident on day 10.

COMP360 for Treatment-Resistant Depression

Levine said Compass Pathways will be reporting topline primary endpoint data on COMP360 psilocybin treatment for treatment-resistant depression during the second quarter. The company’s phase 2b trial, conducted across 22 sites in 10 countries across Europe and North America, assessed the safety and efficacy of COMP360 in 3 doses: 1 mg, 10 mg, and 25 mg. Previous findings demonstrated that a single 25 mg dose of COMP360, in combination with psychological support, was linked to a significantly greater reduction in depressive symptoms after 3 weeks (P < .001), with a rapid, durable response for 12 weeks.

Beckley Psytech’s Intranasal 5-MeO-DMT for Treatment-Resistant Depression 

Beckley Psytech, developing a novel formulation of intranasal 5-MeO-DMT for treatment-resistant depression, also anticipates announcing topline results in the second quarter.

Last year, the company announced positive initial data from their open-label phase 2a study of 5-MeO-DMT formulation BPL-003 for treatment-resistant depression, finding that a single dose provides a rapid antidepressant response in 55% of patients the day after dosing. More than half (55%) achieved remission from depression at day 29 and 45% at day 85.

Derman, C. FDA Approves Esketamine as First Monotherapy for Treatment-Resistant Depression. HCPLive. January 21, 2025. 

https://www.hcplive.com/view/fda-approves-esketamine-first-monotherapy-treatment-resistant-depression

Derman, C. Brexpiprazole with Sertraline Significantly Reduces PTSD Symptoms in 10 Days. HCPLive. December 19, 2024. 

https://www.hcplive.com/view/brexpiprazole-sertraline-significantly-reduces-ptsd-symptoms-10-days

Derman, C. FDA Accepts sNDA for Brexpiprazole in Combination with Sertraline for Adult PTSD. HCPLive. June 25, 2025. 

https://www.hcplive.com/view/fda-accepts-snda-for-brexpiprazole-in-combination-with-sertraline-for-adult-ptsd

Otsuka Announces FDA Plans to Host an Advisory Committee Meeting to Discuss the sNDA for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD). Otsuka. January 10, 2025. 

https://www.otsuka-us.com/news/otsuka-announces-fda-plans-host-advisory-committee-meeting-discuss-snda-brexpiprazole

Derman, C. Phase 3 KOASTAL-1 Trial Fails to Show Navacaprant Significantly Improves MDD. HCPLive. January 2, 2025. 

https://www.hcplive.com/view/phase-3-koastal-1-trial-fails-show-navacaprant-significantly-improves-mdd

J&J Axes Late-Stage Depression Trial After Underwhelming Efficacy. BioSpace. March 7, 2025. 

https://www.biospace.com/drug-development/j-j-axes-late-stage-depression-trial-after-underwhelming-efficacy

Derman, C. Methylone Shows Rapid PTSD Symptom Improvement in Phase 2 IMPACT-1 Trial. HCPLive. March 31, 2025. 

https://www.hcplive.com/view/methylone-shows-rapid-ptsd-symptom-improvement-in-phase-2-impact-1-trial

https://compasspathways.com/our-work/comp360-psilocybin-treatment-in-trd/

Beckley Psytech announces positive initial data from Phase IIa study of novel 5-MeO-DMT formulation BPL-003 for Treatment Resistant Depression. Beckley Psytech. March 26, 2024. 

https://www.beckleypsytech.com/posts/beckley-psytech-announces-positive-initial-data-from-phase-iia-study-of-bpl-003-for-treatment-resistant-depression

The first quarter of 2025 in psychiatry saw significant developments, including the FDA's approval of esketamine as a monotherapy for treatment-resistant depression and promising results for brexpiprazole with sertraline in PTSD. However, some trials, like Neumora's navacaprant, failed to show efficacy. Looking ahead, the second quarter anticipates key data releases for treatment-resistant depression, including Compass Pathways' COMP360 psilocybin and Beckley Psytech's intranasal 5-MeO-DMT. These upcoming results could influence future treatment strategies and clinical practices in psychiatry.

HCPLive spoke with Levine about what is moving in the psychiatry pipeline and what is to come.

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.

Q1 and Q2 Psychiatry Updates, with Steve Levine, MD

Ahmad Masri, MD, MS, is the director of the Hypertrophic Cardiomyopathy Center at Oregon Health and Science University. 

Videos

Ahmad Masri, MD, MS, discusses how new options change the historic approach to the treatment of newly diagnosed ATTR-CM.  

Cardiomyopathy

Navigating Treatment in ATTR-CM's New Era, with Ahmad Masri, MD, MS

Abigail Brooks is an assistant 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.

Study findings suggest COVID-19 is linked to a greater risk of long-term kidney dysfunction and new-onset advanced CKD than influenza.

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.

Chronic Kidney Disease

COVID-19 Infection Increases Risk of Advanced CKD, Long-Term Renal Dysfunction

Daniel P. Judge, MD, is the Edwin W. and Teresa H. Rogers Endowed Chair for Cardiovascular Research at the Medical University of South Carolina.

Daniel Judge, MD, discusses data from a prespecified analysis of ATTRibute-CM examining the effects of acoramidis with and without concomitant tafamidis use.

Acoramidis, ATTR-CM, & Tafamidis: ATTRibute-CM Insights, with Daniel Judge, MD

Research presents a correlation between the index and age-related macular degeneration and suggests a causal relationship.

Age-Related Macular Degeneration

age-related macular degeneration condition center page is a comprehensive resource for clinical news and insights on retina disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for patients with AMD.

Systemic Inflammatory Response Index Predicts Macular Degeneration

The first quarter of 2025 saw approvals in diabetes, depression, kidney disease, and pain, among others. Read more about high-impact approvals of Q1 now.

Latest News

Semaglutide May Increase Nonarteritic Anterior Ischemic Optic Neuropathy Risk

Pulmonology Month in Review: March 2025

Family History Plays Significant Role in Severity of Hidradenitis Suppurativa

VESALIUS-REAL Reveals Lipid Control Gaps in US with Leandro Boer, MD, PhD

Q1 and Q2 Psychiatry Updates, with Steve Levine, MD