Psilocybin to target persistent concussion symptoms in Australia's first clinical trial

In continuation of my update on psychedelic

Monash University researchers have launched Australia's first clinical trial to test whether the psychedelic drug psilocybin is an effective treatment for persistent post-concussion symptoms.

There are few effective therapies for the debilitating long-term effects of mild traumatic brain injury, more commonly known as concussion.

But researchers now think psilocybin, a psychedelic compound found in some mushrooms, could be the answer.

A recent preclinical study from Monash University indicates that a single macrodose can reduce the symptoms that often appear after brain injury. The research is published in the journal Cell Reports Medicine.

The project will leverage leading-edge capability and a track record in neuroimaging and biomarkers of psychedelics within the Monash Trauma Group, and clinical implementation and assessment within the Clinical Psychedelic Lab.

Why researchers are hopeful

Lead researcher on the trial, Professor Terence O'Brien, head of Monash University's School of Translational Medicine, program director Alfred Brain, and deputy director of research at Bayside Health Alfred, said the clinical trial is a huge step forward and will provide hope for many patients.

"Given the lack of effective treatment options for persistent and debilitating concussion symptoms, we are excited to be studying a promising new approach," O'Brien said.

"In addition to alleviating symptoms, research suggests it can also target the biological effects concussion has on the brain."

Up to 50% of people who sustain a concussion will experience persistent post-concussion symptoms.

These commonly include cognitive and emotional issues, plus other debilitating symptoms such as headache, dizziness, irritability and sleep disturbances.

How the trial will work

The Monash-led trial will take place in Melbourne over three years, beginning in 2026.

It is Australia's first randomized, double-blind, active placebo-controlled clinical trial investigating the efficacy of psilocybin-assisted therapy for persistent post-concussion symptoms in humans.

It will study the effect of the drug on people who have had persistent post-concussion symptoms for at least six months, regardless of the cause of the original concussion.

Professor Sandy Shultz, from the Monash Trauma Group in the School of Translational Medicine, said researchers expect psilocybin will reduce neuroinflammation and enhance the brain's ability to form new neural connections.

"We will also be looking at blood and neuroimaging biomarkers in the brain so we can understand exactly what the drug is doing in the body and how it is helping reduce symptoms," Shultz said.

"These benefits could last for at least six months post-treatment, which would be a game changer, and we will test this in the trial."

Support and broader collaboration

Dr. Josh Allen, a research fellow in the Clinical Psychedelic Lab at Monash's School of Clinical Sciences, said while many think this kind of trial isn't for them, it's worth reaching out if you suffer from persistent post-concussion symptoms.

"Participants are supported every step of the way," he said.

"This includes preparation sessions before, guided care during the psychedelic experience, and integration therapy afterward.

"Our approach will promote safety and maximize benefits for all trial participants."

Dr. Paul Liknaitzky, head of the Clinical Psychedelic Lab, said the research will address a major unmet need for people with persistent post-concussion symptoms.

"We're testing a combined treatment approach that targets both the neurological and psychological drivers of patients' symptoms and functionality," Liknaitzky said.

The project is a collaboration between the university's Department of Neuroscience and Department of Psychiatry. Also part of the research team are Dr. Georgia Symons, Dr. Jennifer Makovec Knight, Dr. Zhibin Chen and Dr. Andrew Gibbons, all from Monash University, as well as Professor Karen Caeyenberghs from Deakin University, Professor Joshua Byrnes from the University of Queensland, Professor Karen Barlow from the University of Queensland, and Naomi Fuller from Connectivity Traumatic Brain Injury Australia.

Ref: https://en.wikipedia.org/wiki/Psilocybin

Psilocybin to target persistent concussion symptoms in Australia's first clinical trial

Baricitinib Exhibits Steroid-Sparing Effect in PMR Trial

In coninuation of my update on Baricitinib

Baricitinib had a significant glucocorticoid (GC)-sparing effect in people with newly diagnosed polymyalgia rheumatica (PMR), who participated in the phase 3 JAK-Spare trial, was according to results reported at the European Alliance of Associations for Rheumatology (EULAR) 2026 Annual Meeting.

GC-free remission at week 16 was achieved in nearly two thirds (65.2%) of the 23 people who had received the drug in the trial, as compared to 17.4% of the 23 people who had been treated with placebo (P < .01).

And when participants who had initially been treated with placebo crossed over to treatment with baricitinib, their GC-free remission rate at week 28 increased to 65.2%. The GC-free remission rate in the baricitinib arm also increased to 78.3%.

Study investigator Helga Lechner-Radner, MD, of the Medical University of Vienna in Vienna, Austria, reported the trial’s findings during the late-breaking abstract session. She told Medscape Medical News that the findings were “important because we do still have a lot of patients on steroids, because whenever we try to reduce or taper steroids, they relapse again.”

Baricitinib is a drug that is “efficacious and safe in many of our [rheumatic and musculoskeletal] diseases. We know the mechanism, we know the safety profile, and therefore, it also makes sense to also test this drug in this patient population,” Lechner-Radner added.

The JAK-Spare Study

The JAK-Spare study involved 46 people with recently diagnosed PMR who were recruited between July 2022 and May 2024 across five European centers. The mean age of the recruited participants was 65 years, just over half were men, and all were White.

Crucially, a very early diagnosis (within 3 weeks) was needed for inclusion so that participants had not been taking GCs for very long, Lechner-Radner said. The average disease duration before enrollment was just 16 days, and the average daily oral GC dose was 18 mg.

Participants were randomly allocated to receive baricitinib 4 mg/d or to a placebo. A rapid GC-tapering regimen was used in both arms, which aimed to reduce the dose of GCs to zero within 11 weeks rather than the usual 52 weeks. After the initial 16-week study period, patients in the placebo group crossed over to treatment with baricitinib, while those in the baricitinib arm continued treatment. Then at 28 weeks, participants in GC-free remission were randomly assigned again either to continue baricitinib 4 mg/d through week 44 or lower their dose of baricitinib to 2 mg/d, stopping it altogether from 36 to 44 weeks.

Lechner-Radner said in an interview that GCs were given from the outset in the trial in both treatment arms because the investigators felt that it would not have been ethical to give patients newly diagnosed with PMR no treatment at all.

This is in contrast to the BACHELOR trial in which baricitinib was compared against no treatment initially in the placebo arm, with intravenous (IV) and oral GCs used only as a rescue treatment from week 4 onward. However, IV GCs are not licensed for this purpose in Austria, she said, and “they have a high dropout rate because many of those patients needed to be rescued.”

Lechner-Radner also said that, as an oral tablet, baricitinib is “an easy medication [to take]” when compared to those that require injection.

Reductions in GC Use

Assessment at week 28 showed continued improvement in the baricitinib arm, with 78.3% of participants in GC-free remission, but 65.2% of those originally in the placebo group were also now in GC-free remission, up from 17.4% at 16 weeks.

The time to relapse was significantly longer with baricitinib than placebo (P = .008). Participants in the baricitinib arm also took a lower median cumulative GC dose than those in the placebo group, at 736 mg vs 1065 mg at 16 weeks (P = .015) and 736 mg vs 1086 mg at 28 weeks (P = .013).

After re-randomization of the 33 patients who were in GC-free remission at 28 weeks, GC-free remission continued out to 44 weeks in 93.3% of those still taking baricitinib 4 mg/d and in 72.2% of those who tapered to 2 mg/d and then 0 mg/d (P = .186). Flare-free survival was higher among people who continued to take baricitinib 4 mg/d but was not statistically significant from those who tapered and then stopped baricitinib.

In each phase of the study, the percentages of participants with at least one adverse event were similar between the groups, at 87% in both in the first phase, 60.9% with baricitinib 4 mg/d vs 43.5% in the placebo crossover in the second phase, and 80% with baricitinib 4 mg/d vs 66.7% in those who tapered baricitinib in the third phase.

New Steroid-Sparing Option in PMR?

“With PMR, one wants to get patients off steroids as quickly as possible. Steroid therapy is quite toxic, and this is minimized by short duration of use and at a low dose,” Jonathan Kay, MD, professor of medicine and population and quantitative health sciences and the Timothy S. and Elaine L. Peterson Chair in Rheumatology at the UMass Chan Medical School in Worcester, Massachusetts, told Medscape Medical News. He was not involved in the trial.

But “if you can get someone on a medication that has less likelihood of causing toxicity than the steroid, the better that is going to be for the patient,” he added.

While these were positive data for a JAK inhibitor, Kay wondered whether such a drug would be likely to gain approval for use in this indication from regulatory authorities.

“In the United States, JAK inhibitors are restricted to patients who failed TNF [tumor necrosis factor] inhibitors,” he explained. “So will the FDA allow the label change to allow JAK inhibitors to be used in PMR before TNF inhibition?”

Kay pointed out that the interleukin 6 inhibitor sarilumab, which is given by subcutaneous injection every 2 weeks, is already approved to treat PMR.

https://en.wikipedia.org/wiki/Baricitinib

Baricitinib Exhibits Steroid-Sparing Effect in PMR Trial

Psilocybin linked to reduction in depression

In continuation of my update on Psilocybin  

A study of 19 patients with treatment-resistant depression treated with psilocybin in Switzerland found psilocybin was associated with a significant reduction in depression symptoms. The study is published in The Lancet Regional Health—Europe.

Psilocybin—a naturally occurring psychedelic compound found in some species of mushrooms—has demonstrated promising antidepressant effects in depression and treatment-resistant depression in controlled clinical trials. However, its effectiveness and safety in real-world treatment settings remain largely unknown.

This study analyzed the medical records of 19 patients who received one to four clinical dosing sessions of psilocybin at the Psychiatric University Hospital Zurich as treatment for treatment-resistant mild to severe depression.

On average, the clinician-reported depression rating scores decreased from approximately 31/60 before psilocybin treatment to 20/60 within 42 days after the final dosing session. The patient-reported depression scores decreased from an average of 32/63 to 23/63. Side effects were reported in 30/40 psilocybin dosing sessions, with the most common being fatigue, headache, and tearfulness, but no serious or sustained side effects were documented.

The authors say their findings suggest that results from clinical trials may translate into routine clinical practice, although outcomes appear smaller in scale. They highlight that the small sample size of this study limits generalizability and, as there was no longer-term follow-up, it is not known if the improvements in depression symptoms were maintained. They call for larger real-world studies.

https://en.wikipedia.org/wiki/Psilocybin

Drug duo synergy may help cystic fibrosis patients clear lung mucus, animal tests suggest

Two existing types of drugs synergize to improve the clearing of mucus from the lungs of animals with cystic fibrosis, a Stanford Medicine research team has found. The findings are published in the June 2026 issue of the Journal of Clinical Investigation. If replicated in humans, the discovery may provide a way to reduce chronic lung infections in people with cystic fibrosis.

Methacholine

Formoterol

"I really hope this discovery can help CF patients," said lead author Nam Soo Joo, Ph.D., a senior research scientist at Stanford Medicine. "If these drugs improve mucociliary clearance in people as much as they do in our animal models, we expect this to help remove pathogens from the lungs and reduce patients' airway infections."

The study's senior author is Carlos Milla, MD, a professor of pediatrics at Stanford Medicine and a pulmonologist who treats children with CF at Stanford Medicine Children's Health.

The research team showed that the drug combination—a beta adrenergic agonist, formoterol, and a low-dose cholinergic agonist, methacholine—was safe and well-tolerated in a small group of people, including individuals with CF and healthy volunteers. The drugs are already approved by the U.S. Food and Drug Administration for other uses, and the scientists are now planning a trial of the combination's effectiveness in CF patients.

The finding could be especially beneficial for the 10% to 20% of CF patients who do not respond to targeted medications for cystic fibrosis known as CFTR (cystic fibrosis transmembrane conductance regulator) modulators, Joo noted.

The synergistic medications may also help people with other respiratory conditions, such as chronic obstructive pulmonary disease or bronchiectasis, a chronic lung disease characterized by severe airway scarring, he added.

Cystic fibrosis is a relatively common genetic disease, affecting 1 in every 3,000 to 4,000 babies born in the United States. Patients have mutations in the cystic fibrosis transmembrane conductance regulator gene. In healthy people, the CFTR gene encodes protein channels that let chloride and bicarbonate ions cross cell membranes. But in CF patients, the channels malfunction, causing the lungs and digestive system to produce thick mucus. This sticky mucus harbors bacteria and makes CF patients vulnerable to chronic lung infections.

Drugs called CFTR modulators that restore the chloride channels' function have improved the lives of many CF patients by allowing their bodies to manufacture normal mucus. But up to 20% of patients' gene mutations are incompatible with CFTR modulator drugs, meaning the medications don't help.

That's why Joo's team was excited to find a different approach to the mucus problem.

A fortuitous finding

The researchers' discovery was an accident. They were studying whether various drugs could speed mucociliary clearance, in which the cilia, hairlike projections that line the passages into the lungs, beat in a coordinated way to move mucus and bits of foreign matter, such as bacteria or dust, out of the airways. The process keeps the lungs healthy.

During drug tests on tissue in a dish, the researchers used a combination of a beta adrenergic agonist and a cholinergic agonist to check that the tissues were viable. (Each of the two medication categories includes several drugs; at first, the researchers were not using drugs approved for use in people.) To the scientists' surprise, the drug combination—intended only as an experimental control—sped up mucociliary clearance.

Joo discussed this unexpected observation with study co-author Jeffrey Wine, Ph.D., an emeritus professor of psychology and of human biology.

"Jeff said, 'Do you think this may work in CF?'" Joo recalled. "I said, 'Well, probably not.'"

The combination seemed unpromising because people with CF are already known to have an abnormal response to beta adrenergic agonists. Meanwhile, cholinergic agonists administered alone cause people's airways to constrict in an asthma-like manner, which presents a safety concern.

A counterintuitive result

Even though they suspected the drug combination would fail, Joo's team tested it, first in airway tissue samples from a ferret model of CF, then in tissue and live animals including ferrets, rats, sheep, and pigs with pharmacologically induced or genetic CF.

In the new study, the researchers used formoterol and methacholine, which are a beta adrenergic agonist and a cholinergic agonist, respectively. The scientists chose these specific drugs because they are already approved by the FDA for use as inhaled medications.

Each drug caused a small increase in mucociliary clearance when given alone, but together their effects were far more pronounced. For instance, in rats with CF, the drug combination increased the animals' mucociliary clearance velocity to about 80% of that seen in healthy rats.

Follow-up experiments on tracheal tissue showed that the drugs given together increase fluid secretion, inhibit absorption of fluid, and raise the pH of the secreted fluid. These changes make the mucus less viscous and more mobile.

Furthermore, the researchers showed that when the drug combination was given to ferrets with CF that were also receiving a CFTR modulator drug, the animals could clear mucus more easily than when they received only the CFTR modulator, suggesting that the drug combination may benefit all CF patients.

In a small safety test in humans, as expected, methacholine caused airway constriction when given alone. But the two drugs in combination did not.

The results are exciting both for their implications for cystic fibrosis and for patients with other lung conditions, Joo said.

"Patients with other respiratory disorders like chronic obstructive pulmonary disease or bronchiectasis also have mucociliary clearance impairment, but compared with CF, it's mild," he said. "If we use this drug in other airway diseases, it may improve those patients as well, but we still require large-scale clinical trials to know the optimal combination and concentrations of these drugs."

https://en.wikipedia.org/wiki/Methacholine

https://en.wikipedia.org/wiki/Formoterol

Drug duo synergy may help cystic fibrosis patients clear lung mucus, animal tests suggest

Acetaminophen reaffirmed as first-line medication for treating pain and fever during pregnancy

In continuation of my update on acetaminophen 

Acetaminophen remains the recommended first-line medication to treat pain and fever during pregnancy, according to an updated statement from the Society for Maternal-Fetal Medicine (SMFM). A comprehensive review of the available scientific evidence does not establish a causal relationship between acetaminophen taken during pregnancy and an increased risk of autism spectrum disorders and attention deficit and hyperactivity disorder (ADHD) in children, according to SMFM. The work is published in the journal Pregnancy.

SMFM's statement is based on a thorough review of recent studies and earlier research on acetaminophen during pregnancy. The newest studies vary in their findings on the potential association between prenatal acetaminophen exposure and risk of childhood neurobehavioral issues and have significant limitations in their study design.

"After another careful review of the existing research, we continue recommending acetaminophen as a safe treatment for our pregnant patients who need it for pain relief and to reduce fever," said Judette M. Louis, MD, MPH, chair of the SMFM Publications Committee.

Acetaminophen is a commonly used non-opioid analgesic during pregnancy. An estimated 65% of pregnant women use acetaminophen at some point during pregnancy, mostly to treat headache and fever. Acetaminophen is the active ingredient in many over-the-counter and prescription medications, including Tylenol.

"Both untreated fever and pain during pregnancy carry potential health risks, so you shouldn't just 'tough it out,'" said Louis. "Untreated fever, particularly in the first trimester, is known to be linked to birth defects and miscarriage. We also know that maternal fever during labor can be associated with poor neonatal outcomes."

Along with acetaminophen, SMFM recommends nonpharmacological interventions, including hydration and physical therapy, to help manage pain during pregnancy.

Nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids are not recommended to treat fever and pain during pregnancy. NSAIDs increase the risk of fetal renal impairment, premature closure of the ductus arteriosus, oligohydramnios, and maternal bleeding. Opioid medications taken during pregnancy are associated with neonatal abstinence syndrome, addiction, and sedation, and are also not recommended as first-line treatments for pain during pregnancy.

https://en.wikipedia.org/wiki/Paracetamol

Acetaminophen reaffirmed as first-line medication for treating pain and fever during pregnancy

With trial success, Gilead paves way for broader use of Livdelzi

A phase 3 study of Gilead’s Livdelzi has met its primary endpoint, showing the drug's ability to normalize a key marker of disease progression for those with the rare liver disorder primary biliary cholangitis (PBC). 

In the IDEAL trial, which compared Livdelzi to placebo, Gilead’s pill allowed significantly more patients to gain control of their alkaline phosphatase (ALP) levels, which are a key signal of disease progression. The trial's primary endpoint hinged on the number of patients who achieved ALP levels in the normal range with at least a 15% decrease from baseline, the company said Tuesday. 

The trial included 96 participants ages 18 to 75 who had inadequately controlled PBC. Patients in this group are associated with increased risk of progression to liver transplant or death compared with patients at normalized ALP levels, Gilead explained.

The patient pool in the trial included only those with an incomplete response or intolerance to ursodeoxycholic acid (UDCA), the standard first-line treatment for PBC. UDCA treatments replace bile acids, slowing disease progression and improving liver function. 

“These results extend the evidence base for Livdelzi to a broader population of people living with PBC and support ALP normalization as an achievable therapeutic goal in patients with ALP between 1 to 1.67,” Cynthia Levy, M.D., of the University of Miami Miller School of Medicine, said in a release. 

Gilead said it will provide full results from the trial at a future medical meeting and engage with global regulators on the data. 

https://en.wikipedia.org/wiki/Seladelpar

With trial success, Gilead paves way for broader use of Livdelzi

Chia seeds show promise in supporting heart health, metabolic function

Chia seeds: A superfood for cardiometabolic health

Chia seeds, long a dietary staple in Mesoamerican cultures dating back to the Aztecs and Mayans, have attracted modern scientific scrutiny for their unusually dense nutritional profile. A 28-gram (g) serving—approximately two tablespoons—contains 138 calories, 8.7 g of fat, 11.9 g of carbohydrates, 9.7 g of fiber and 4.7 g of complete protein, according to data from the U.S. Department of Agriculture. Chia seeds also provide significant amounts of calcium, magnesium, iron and potassium.

Heart benefits

The most compelling evidence for chia seeds' cardiovascular benefits comes from studies examining their effect on blood pressure. In a study published in the journal Plant Foods for Human Nutrition, participants who consumed 35 grams of chia flour daily for 12 weeks experienced reduced blood pressure, even among those already taking antihypertensive medication. Researchers noted this effect occurred alongside reductions in inflammatory markers, including C-reactive protein, and improvements in clotting protein profiles.

Additional research has focused on chia seeds' potential to improve cholesterol levels. A meta-analysis of 10 clinical trials reported that regular consumption of chia seeds can reduce total cholesterol, triglycerides and LDL cholesterol while increasing HDL, suggesting a positive effect on lipid profile.

The seeds' high omega-3 fatty acid content appears central to these effects. Chia seeds contain alpha-linolenic acid, a plant-based omega-3 that the human body cannot produce independently. This fatty acid supports heart health, brain function and systemic anti-inflammatory activity. Chia seeds also contain multiple antioxidant compounds, including chlorogenic acid, caffeic acid, myricetin, quercetin and kaempferol, which may protect against oxidative damage linked to heart disease, cancer and aging.

Blood sugar control

For those managing Type 2 diabetes, chia seeds may offer particular value. Studies suggest that daily consumption of chia seeds—either 7-24 g incorporated into white bread or 34 g of whole-grain chia—reduces post-meal blood sugar levels as well as blood pressure in healthy individuals and diabetics alike. As explained by BrightU.AI's Enoch engine, chia seeds help lower blood sugar because their soluble fiber slows the absorption of sugar into the bloodstream, which prevents sharp spikes in glucose levels. This stabilizing effect is especially beneficial for managing diabetes and maintaining steady energy.

Animal studies report similar effects on diabetic rat models fed with chia seeds, suggesting that the seeds not only help with blood sugar control but may also help reduce cardiovascular risk factors in people with Type 2 diabetes.

How to safely incorporate chia seeds into your diet

Despite these promising findings, medical professionals emphasize that chia seeds are not without potential risks. Chia seeds' high oxalate content may increase kidney stone risk in susceptible individuals. Additionally, because chia seeds can lower both blood pressure and blood sugar, they may interact additively with prescription medications for hypertension and diabetes, potentially causing excessive reductions.

Gastrointestinal side effects remain the most common complaint. Chia seeds' high fiber content—nearly 10 grams per serving—can cause bloating, cramping and gas when introduced too quickly to the diet. Experts recommend gradually increasing fiber intake to allow the digestive system to adjust, and always consuming chia seeds with adequate water to prevent bowel obstruction.

The growing body of evidence supporting chia seeds' health benefits coincides with increasing consumer interest in functional foods. Chia seeds can be incorporated into diets through multiple methods: sprinkled on yogurt, salads or cereal; blended into smoothies; used as a thickener for soups and sauces; or soaked in water to form a gel that can substitute for eggs in baking. Ground chia seeds can be added to pancake batter or mixed into hummus and other dips.

Chia seeds represent one of several plant-based foods being studied for their potential to support cardiovascular health through accessible, affordable dietary changes rather than pharmaceutical interventions alone. The seeds join other functional foods, such as oats, flaxseed and fatty fish, in a growing list of whole foods associated with reduced cardiovascular and metabolic risks.

https://en.wikipedia.org/wiki/Chia_seed

China approves fruquintinib combination for kidney cancer

China’s National Medical Products Administration (NMPA) has approved a combination of ELUNATE (fruquintinib) and TYVYT (sintilimab) for patients with advanced renal cell carcinoma whose disease has progressed following prior VEGFR-tyrosine kinase inhibitor (VEGFR-TKI) therapy.

The approval applies to patients with locally advanced or metastatic disease who have not previously received programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor therapy in the first-line setting.

The decision was based on results from the phase 3 FRUSICA-2 study, which evaluated fruquintinib combined with sintilimab against axitinib or everolimus monotherapy in second-line treatment.

The study met its primary endpoint of progression-free survival (PFS), with patients receiving the combination therapy achieving median PFS of 22.2 months compared with 6.9 months in the comparator arm.

Objective response rates were also higher in the combination group, while the safety profile was reported to be consistent with the known effects of each treatment.

Professor Dingwei Ye of Fudan University Shanghai Cancer Center said advances in targeted therapies and immunotherapy combinations were continuing to reshape treatment approaches in advanced renal cell carcinoma.

“The rapid advancements in targeted therapies, immunotherapies and their combination regimens have led to a significant evolution in the treatment landscape for advanced renal cell carcinoma. Optimising the selection of treatment for individual patients is a key focus of clinical interest,” said the professor.

Kidney cancer remains a significant global health burden, with around 435,000 new diagnoses estimated worldwide in 2022. Approximately 90% of kidney tumours are renal cell carcinoma.

The approval represents the latest indication for sintilimab in China and expands use of the combination regimen following earlier approval in advanced endometrial cancer.

https://en.wikipedia.org/wiki/Fruquintinib

FDA Approves Trimbow (beclomethasone/formoterol/glycopyrrolate) Inhaler for the Maintenance Treatment of Asthma

Chiesi USA, Inc. (key-A-zee), a global biopharmaceutical company,   announced   the U.S. Food and Drug Administration   approval of  Trimbow (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; or BDP/FF/G; 86 mcg/4.9 mcg/10.6 mcg and 172 mcg/4.9 mcg/10.6 mcg) for the maintenance treatment of asthma in adults. Trimbow delivers three active ingredients in a single device, referred to as a single inhaler triple therapy (SITT), presenting an option for adults whose asthma may require more than one inhaled medicine for daily maintenance treatment. Trimbow was the first treatment approved in the single inhaler triple therapy class outside of the U.S. and is commercialized in nearly 50 countries, including those within the European Union, the United Kingdom, and China.

                                                      Glycopyrrolate

Trimbow (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; or BDP/FF/G) is the first U.S. FDA-approved product from Chiesi’s respiratory portfolio, bringing with it more than four decades of global expertise in respiratory leadership.

Formoterol

Beclometasone or beclomethasone

Approval was supported by Phase 3 TRIMARAN and TRIGGER studies, which included lung function as a co-primary endpoint in adults with asthma,1 building on its long-standing use as the first therapy in its class approved outside the U.S.

Approximately 27 million people in the U.S. live with asthma, which remains a significant burden to patients, caregivers, and society.2 Roughly 50% to 91% of people across all asthma disease severities show evidence of Small Airway Disease (SAD), which affects the tiny bronchioles deep within the airway tree.3,4

“The approval of Trimbow marks an important milestone as healthcare professionals continue to expand options for individualized care for the millions of people in the U.S. living with asthma, many of whom still struggle with symptoms,”2 said Nicola Hanania, MD, MS, Director, Airways Clinical Research Center, Professor of Medicine, Baylor College of Medicine and Chief, Section of Pulmonary, Critical Care and Sleep Medicine, Ben Taub Hospital, Houston, Texas. “This treatment has demonstrated improvement in lung function in Phase 3 clinical trials.”1

The FDA approval is supported by data from two Phase 3, double-blind, parallel-group, randomized, active-controlled clinical trials, TRIMARAN and TRIGGER, that evaluated the safety and efficacy of Trimbow in more than 2,200 adults with uncontrolled asthma.1 Across studies, Trimbow demonstrated improvements in lung function compared with BDP/FF, an inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) product. Trimbow demonstrated a safety profile comparable with BDP/FF, with common adverse events, occuring at an incident rate greater than or equal to 1%, including bronchitis, hypertension, back pain, blood pressure increase, dysphonia, upper respiratory tract infection, influenza, anemia, muscle spasms, laryngitis, oropharyngeal pain, and sinusitis.1

“This is an important development for the community at a time when access to treatment and the cost of care remain significant challenges for many individuals living with asthma,” said Lynda Mitchell, MA, CAE, CEO of the Allergy & Asthma Network. “There is no cure for asthma, and the condition presents a major burden to patients, caregivers, and society. Patients benefit when they have more options to treat their asthma – we are eager to see continued progress in innovation to address ongoing unmet needs in asthma care.”

https://en.wikipedia.org/wiki/Formoterol

https://en.wikipedia.org/wiki/Beclometasone

FDA Approves Trimbow (beclomethasone/formoterol/glycopyrrolate) Inhaler for the Maintenance Treatment of Asthma

FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List.

The U.S. Food and Drug Administration announced the  proposal  to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances. 

The 503B bulks list identifies bulk drug substances that outsourcing facilities may use in compounding under the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In most cases, outsourcing facilities cannot compound drugs using bulk drug substances unless the substance appears on the 503B bulks list, or the compounded drug is on the FDA’s drug shortage list at the time of compounding, distribution, and dispensing. 

After evaluating the nominations for these three substances, the FDA did not identify a clinical need for outsourcing facilities to compound semaglutide, tirzepatide, and liraglutide from bulk drug substances. 

“When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This action reflects our responsibility to protect patients and preserve the integrity of the drug approval process while continuing to provide a transparent, science-based pathway for public input.”

The FDA carefully reviewed the nominations it received and did not identify sufficient evidence to include semaglutide, tirzepatide and liraglutide on the 503B bulks list. A determination of clinical need is based on patient safety and medical necessity under the law. 

The FDA is now inviting interested parties to submit comments electronically through the docket by June 29, 2026. The agency will consider submitted comments before making a final determination. 

https://en.wikipedia.org/wiki/Liraglutide

https://en.wikipedia.org/wiki/Tirzepatide

https://en.wikipedia.org/wiki/Semaglutide

More : 

FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List | FDA