FDA Approves Foundayo (orforglipron), the Only GLP-1 Pill for Weight Loss That Can be Taken Any Time of Day Without Food or Water Restrictions

Eli Lilly and Company (NYSE: LLY)  announced the FDA approval of   Foundayo™ (orforglipron) for adults with obesity, or overweight with weight-related medical problems. When used alongside a reduced-calorie diet and increased physical activity, Foundayo helps individuals lose excess body weight and keep the weight off. Foundayo will be available via LillyDirect®, with prescriptions accepted immediately and shipping beginning April 6, followed shortly after by broad availability through U.S. retail pharmacies and telehealth providers.

Adults taking Foundayo lost an average of 27 pounds on the highest dose in the ATTAIN-1 clinical trial1

Foundayo, Lilly's second FDA-approved obesity medicine, will be available via LillyDirect® with free home delivery, starting at $25 per month with commercial coverage and $149 for self-pay

"People living with obesity need treatment options that meet them where they are – and for many, a once-daily pill that can be taken with no food or water restrictions can offer them greater flexibility in how they approach their treatment," said Deborah Horn, DO, director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston. "With Foundayo, we now have an oral option that delivered an average of 12.4% weight loss at the highest dose in clinical trials – addressing both the clinical realities of obesity and the practical challenges patients face every day."

Supported by the rigorous ATTAIN clinical trial program, Foundayo was proven to help people lose weight and keep it off. In the ATTAIN-1 trial, individuals taking the highest dose of Foundayo and who stayed on treatment lost an average of 27.3 pounds (12.4%) compared to 2.2 pounds (0.9%) with placebo.1 Participants taking Foundayo, regardless of trial completion, lost an average of 25 pounds (11.1%), compared to 5.3 pounds (2.1%) with placebo.2 In the ATTAIN program, Foundayo also led to reductions in many markers of cardiovascular risk, including waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure across all doses.

"Today, fewer than 1 in 10 people who could benefit from a GLP-1 are taking one, held back by access, stigma, perceived complexity or the belief that their condition isn't serious enough for treatment. We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications," said David A. Ricks, chair and CEO of Eli Lilly and Company. "As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world."

Lilly is committed to making Foundayo accessible and affordable. Eligible people with commercial insurance may pay as little as $25 per month with the Foundayo savings card.3 Individuals opting for self-pay can access Foundayo starting at $149 per month for the lowest dose. Additionally, eligible Medicare Part D individuals may be able to get Foundayo for $50 per month, beginning as soon as July 1, 2026.

Use of Foundayo with other GLP-1 receptor agonist medicines is not recommended. It is not known whether Foundayo is safe and effective for use in children. Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath. If you have any of these symptoms, tell your health care provider. The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo.

"There is no single path that works for everyone living with overweight or obesity," said Joe Nadglowski, president and CEO of the Obesity Action Coalition. "New treatment options expand choice and help more people find care that fits their lives, their goals and where they are in their journey – whether they're just starting to explore treatment or looking for a different long-term approach."

Lilly has submitted orforglipron for weight management and/or type 2 diabetes in more than 40 countries and plans to launch in each country shortly after approval

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

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FDA Approves Foundayo (orforglipron), the Only GLP-1 Pill for Weight Loss That Can be Taken Any Time of Day Without Food or Water Restrictions

Vitamin C may reduce cancer-linked digestive chemical reactions

In continuation of my update on Vitamin C

A new study from the University of Waterloo uses mathematical modeling to examine how Vitamin C affects chemical reactions in the digestive system that are linked to cancer development. 

Over the last several decades, North American diets have seen a steady increase in exposure to nitrates and nitrites: compounds found in cured meats as well as fruits and vegetables grown using polluted soil and water. While nitrates and nitrites play important roles in neurological and heart health, in the stomach, they can undergo a chemical reaction known as "nitrosation" and form chemicals that many scientists suspect increase cancer risk. 

Since at least the 90s, researchers have been studying the link between cancer and these compounds, with conflicting results. Our work suggests that the presence of dietary Vitamin C may help explain these inconsistencies." 

Dr. Gordon McNicol, post-doctoral researcher in applied mathematics and first author of the study

The team built a mathematical model of the salivary glands, stomach, small intestine and plasma, and simulated how nitrites and nitrates move through the body and change over time. Their model demonstrated that when Vitamin C is also present in food, such as leafy greens like spinach, which contain both Vitamin C and nitrate, it could decrease cancer risk. 

The study also suggested that taking Vitamin C supplements after each meal could have a moderate positive effect in reducing the formation of nitrosation products associated with cancer risk from dietary nitrites and nitrates, such as those found in foods like bacon and salami. 

The researchers hope these findings will support future nutrition research. 

"This work provides a mechanistic roadmap for future clinical and laboratory studies by identifying the key interacting drivers of these potentially harmful chemical reactions, including nitrite exposure, antioxidant intake, meal timing, gastric conditions and oral microbiome activity," said Dr. Anita Layton, professor of applied mathematics and Canada 150 researcher chair. "This model can help researchers design more targeted experiments and interventions, focusing on when and in whom nitrosation is most likely to occur." 

The research, "Vitamin C as a nitrosation inhibitor: A modelling study across dietary patterns and water quality," appears in the Journal of Theoretical Biology.

https://www.sciencedirect.com/science/article/pii/S002251932600069X?via%3Dihub

Vitamin C may reduce cancer-linked digestive chemical reactions

FDA Approves Lasix ONYU (furosemide) for Treatment of Edema in Heart Failure

SQ Innovation, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its drug-device combination Lasix ONYU (furosemide injection) for the treatment of edema (due to fluid overload) in adult patients with chronic heart failure. Lasix ONYU was developed to enable subcutaneous infusion of furosemide outside the healthcare setting for selected patients, as prescribed by a clinician without the need for a healthcare professional to administer the drug.

About 6.7 million Americans suffer from heart failure, with the prevalence expected to rise to 8.7 million by 2030. Heart failure is a leading cause of hospitalizations for individuals aged 65 and older with approximately 1.2 million hospitalizations per year [1].

Lasix ONYU consists of a novel high-concentration formulation of furosemide combined with a state-of-the-art small Infusor for treatment at home. The innovative design includes a reusable unit that can be used for 48 treatments and a plastic sterile single-use unit that is discarded after treatment. The two-component design reduces manufacturing complexity and cost, allowing the product to be offered at a different, more favorable price point which is expected to reduce barriers to widespread adoption.

“Lasix ONYU has the potential to be transformative in the care of patients experiencing worsening heart failure due to fluid overload,” said Pieter Muntendam, MD, founder, President and CEO of SQ Innovation. “Treating selected patients at home offers important benefits to patients, health systems and payors. We look forward to launching Lasix ONYU with leading health systems in the 4th quarter of 2025.”

Bioavailability and diuretic response were determined in a clinical study in which Lasix ONYU demonstrated complete bioavailability (112%) resulting in similar diuresis (115%) and natriuresis (117%) when compared to the same dose given by IV bolus. The biphasic delivery of furosemide by the Infusor resulted in a tempered diuretic response while IV bolus administration led to a shorter period of more intense diuresis. The results of the study were published in a leading cardiovascular journal [2].

“Heart failure is the most common serious medical condition in the U.S. and affects about one in four Americans during their lifetime. The number of patients affected is expected to double over the next 20 years and we currently already often lack adequate resources to take care of the 6.7 million patients affected presently – there are not enough beds, clinicians and funds”, said Dr. Javed Butler, Professor of Medicine at University of Mississippi and President, Baylor Scott and White Research Institute. “The only two actionable solutions now are more widespread adoption of guideline directed medical therapy (GDMT) and treating more patients at home with products such as subcutaneous diuretics instead of hospitalization for intravenous diuretics.”

“Decongestion through use of IV diuretics has been the cornerstone of treatment for reducing edema and hypervolemia in heart failure patients for over five decades,” stated S. Craig Thomas, Immediate Past President of the American Association of Heart Failure Nurses (AAHFN), an organization dedicated to advancing nursing education, clinical practice, and research to improve outcomes for heart failure patients. “The availability of accessible, affordable, and novel options that do not require the presence of a healthcare professional allows for transformative new clinical care-delivery. This means patients who now would typically need to be hospitalized for several days of IV treatment can instead remain home, supported by periodic or remote monitoring. The significance of this shift away from inpatient care for patients, hospitals, and payers cannot be overstated.”

Starting this quarter, Lasix ONYU will be available from leading pharmaceutical distributors enabling timely availability at participating medical facilities and affiliated retail pharmacies.

SQ Innovation is hosting a Conference Call and Webcast on Thursday October 9, at 4:30pm ET to introduce the product and answer questions from the community. Participating in the conference call will be:

Pieter Muntendam, MD, President and CEO of SQ Innovation

Mustafa M. Ahmed, MD, Professor of Medicine, Section Chief, Heart Failure, University of Florida Health, Gainesville, FL

Craig Thomas, Nurse Practitioner, Advanced Heart Failure Center, University of Virginia Health System, Charlottesville, VA and Immediate Past President American Association of Heart Failure Nurses (AAHFN)

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

FDA Approves Lasix ONYU (furosemide) for Treatment of Edema in Heart Failure

FDA Approves Jascayd (nerandomilast) to Treat Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim’s Jascayd (nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) as an oral treatment option for idiopathic pulmonary fibrosis (IPF) in adult patients.2 Jascayd is the first and only preferential inhibitor of phosphodiesterase 4B (PDE4B) to be approved in this indication. This represents a novel mechanism of action that exerts both antifibrotic and immunomodulatory effects, thereby slowing the decline in lung function in IPF patients.2,3

“This milestone represents a new era in the treatment of IPF, a rare and debilitating chronic condition that worsens lung function. Nerandomilast has proven to slow lung function decline in IPF,” said Toby Maher, M.D., Ph.D., Professor of Clinical Medicine, Keck School of Medicine, USC Los Angeles. “Nerandomilast is a welcome new treatment option with a well-tolerated safety profile for physicians to consider for appropriate patients.”

The FDA approval is based on data from two clinical trials: FIBRONEER™-IPF (NCT05321069) and Trial 2 (NCT04419506). The primary endpoint in FIBRONEER™-IPF was the absolute change from baseline in Forced Vital Capacity (FVC), a measure of lung function,4 in mL at week 52.2,3 Nerandomilast demonstrated a significantly smaller FVC decline compared to placebo.2,3 Specifically, the adjusted mean decline in patients receiving 18 mg or 9 mg nerandomilast was -106 mL and -122 mL, respectively, versus -170 mL in the placebo group.2 Additionally, a treatment effect was shown as early as week two with nerandomilast 18 mg compared to placebo, with changes from baseline in FVC continuing to diverge over time to week 52.2,3

“The FDA approval of nerandomilast is a pivotal moment for people living with IPF as this marks the first time in over 10 years that the treatment landscape is evolving,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “This new step forward, driven by the compelling results of the FIBRONEER™-IPF trial, underscores our unwavering commitment to change the way we treat IPF by delivering innovative therapies like nerandomilast.”

The most common (≥5%) adverse reactions reported in patients treated with nerandomilast and more frequently than the placebo group were as follows for nerandomilast 18 mg, 9 mg and placebo, respectively: diarrhea (42%, 31%, 17%), COVID-19 (13%, 16%, 12%), upper respiratory tract infection (13%, 11%, 10%), depression (12%, 11%, 10%), weight decreased (11%, 10%, 8%), decreased appetite (9%, 9%, 5%), nausea (8%, 9%, 7%), fatigue (7%, 8%, 6%), headache (7%, 6%, 5%), vomiting (6%, 5%, 5%), back pain (6%, 5%, 4%) and dizziness (5%, 6%, 5%).2

Discontinuation due to adverse reactions occurred more frequently in patients treated with nerandomilast (with or without background antifibrotic treatment) 18 mg (15%) and 9 mg (12%) compared to placebo (11%).2 The most frequent adverse reaction leading to discontinuation of nerandomilast 18 mg and 9 mg was diarrhea (6% and 2%, respectively).2

There is no ‘Warnings and Precautions’ section in the FDA approved product label.2

“The FDA approval of nerandomilast is exciting news for people living with idiopathic pulmonary fibrosis and their caregivers,” said Scott Staszak, President and CEO of the Pulmonary Fibrosis Foundation. “There has been a long-standing need for new treatment options for IPF within our community and nerandomilast provides an important addition to the care landscape.”

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

FDA Approves Jascayd (nerandomilast) to Treat Idiopathic Pulmonary Fibrosis

Mavacamten improves obstruction in adolescents with hypertrophic cardiomyopathy

In continuation of my update on Mavacamten

Adolescent patients with obstructive hypertrophic cardiomyopathy (HCM) who received the drug mavacamten saw a significant improvement in left ventricular outflow tract (LVOT) gradient, a measure of blood flow obstruction in the heart, compared with those who received a placebo, according to a small study presented at the American College of Cardiology's Annual Scientific Session (ACC.26). The trial is the first to test mavacamten in patients younger than 18. This study was simultaneously published online in the New England Journal of Medicine at the time of presentation.

"These results are very encouraging," said Joseph William Rossano, MD, chief of cardiology at Children's Hospital of Philadelphia and the study's lead author. "Patients feel better, and their hearts look better."

HCM is a genetic disorder in which the heart muscle thickens, causing the heart chambers to become smaller and potentially reducing its ability to pump blood. In many cases, the thickened muscle blocks or reduces the flow of blood into the aorta from the left ventricle, known as obstructive HCM. Obstructive HCM can cause symptoms such as chest pain, dizziness, shortness of breath and swelling and lead to heart failure and death.

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

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Mavacamten improves obstruction in adolescents with hypertrophic cardiomyopathy

Investigational drug delivers mixed results for uncontrolled blood pressure

The investigational drug tonlamarsen—which is designed to lower blood pressure by reducing the production of angiotensinogen, a protein that turns into the hormone that regulates blood pressure—caused a significant and sustained drop in angiotensinogen but its impact on blood pressure was less clear, according to a study presented. 

https://searchusan.ama-assn.org/usan/documentDownload?uri=/unstructured/binary/usan/tonlamarsen-sodium.pdf

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Investigational drug delivers mixed results for uncontrolled blood pressure

Probing a paradoxical drug response for irregular heartbeat

                                                                               Mexiletine

https://go.drugbank.com/drugs/DB00379

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

Irregular heartbeat, or arrhythmia, can be treated with various procedures or medication, but not all medications work for all patients. In fact, one arrhythmia medication can actually cause arrhythmia in people with a common genetic variant. This problem creates a need for personalized medicine to provide patients with the most beneficial outcome, according to new research from WashU

Jon Silva, a professor of biomedical engineering in the McKelvey School of Engineering at Washington University in St. Louis, and Martina Marras, a doctoral student in his lab, made their discovery by screening four genetic variants to see if any of them altered the effectiveness of the drug mexiletine. The work is published in The Journal of Precision Medicine: Health and Disease.

Probing a paradoxical drug response for irregular heartbeat

https://medicalxpress.com/news/2026-01-stem-cell-expert-qa-pathways.html?utm_source=embeddings&utm_medium=related&utm_campaign=internal

FDA Approves Ferabright (ferumoxytol injection) Contrast Agent for Magnetic Resonance Imaging of the Brain

Azurity Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA)  approval of  Ferabright (ferumoxytol injection), the first and only iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.1

“Ferabright is an advanced superparamagnetic iron oxide nanoparticle contrast agent engineered for high relaxivity,” said Ronald Scarboro, CEO of Azurity Pharmaceuticals. “It significantly enhances image contrast and precision in brain tumor delineation compared to non-contrast MRI, offering clinicians a new tool for diagnostic imaging and improved patient care.”

In a clinical trial, Ferabright-enhanced MRI significantly improved visualization of primary and secondary brain neoplasms compared with pre-contrast imaging.1 In addition to improved imaging, Ferabright offers an extended imaging window due to its long half-life, which may support flexible MRI protocols without the need for multiple contrast administrations.1 As an iron-based agent, Ferabright is processed through the body’s natural iron metabolism pathways,3,6,7 potentially reducing concerns related to long-term retention associated with other contrast agents.2,8 And unlike many other agents, Ferabright is suitable for patients with renal insufficiency,2,3,4 enabling access to contrast-enhanced MRI while reducing exposure to heavy metals found in other contrast agents.5

“Ferumoxytol expands our MRI toolkit and provides an option for patients who are either contraindicated for or decline gadolinium,” said Csanad Varallyay, MD, PhD, Neuroradiologist based in Portland, Oregon, with longstanding research experience in ferumoxytol-enhanced MRI.

Ferabright will be supplied in single-dose vials of 300 mg elemental iron per 10 mL (30 mg/mL) and 510 mg elemental iron per 17 mL (30 mg/mL) for intravenous infusion over at least 15 minutes.1 Ferabright is contraindicated in patients with known hypersensitivity to ferumoxytol, any of Ferabright’s components, or any other intravenous iron products. Reactions have included anaphylaxis.1

https://www.chemicalbook.com/ChemicalProductProperty_EN_CB92493638.htm

FDA Approves Ferabright (ferumoxytol injection) Contrast Agent for Magnetic Resonance Imaging of the Brain

Small molecule could slow or stop progress of Parkinson's disease and related brain disorders, not just treat symptoms

A team of researchers from NYU Abu Dhabi and the University of Denver has identified a promising small molecule that could help slow or halt the progression of serious brain diseases such as Parkinson's disease, offering new hope for treatments that go beyond managing symptoms. These diseases, which also include Lewy body dementia and multiple system atrophy, are caused by aggregation and spread of a neuronal protein, which damages brain cells over time. Currently, there are no approved treatments that can stop or slow this process.

More: 

https://medicalxpress.com/news/2026-03-small-molecule-parkinson-disease-brain.html

Small molecule could slow or stop progress of Parkinson's disease and related brain disorders, not just treat symptoms

Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease,  announced  the U.S. Food and Drug Administration (FDA)  issuing  a CRL for its New Drug Application (NDA) for OLC to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

“We plan to immediately seek a Type A meeting with the Agency to gain alignment on the best strategy to ensure rapid resolution of the CRL,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “With a second manufacturing vendor identified that has produced OLC drug product, we remain optimistic about our ability to bring this promising new treatment option to patients with CKD on dialysis who are managing hyperphosphatemia, and we plan to provide an update as soon as we have additional clarity on next steps from the FDA.”

After submitting the NDA, and as a part of the application review and routine information requests, the FDA notified Unicycive that a third-party manufacturing vendor of its main contract development and manufacturing organization (CDMO) was cited for deficiencies following a cGMP inspection. This citation is unrelated to OLC. Unicycive also notes that as part of the NDA review, the Agency has not highlighted any other technical concerns related to the submitted CMC documentation or testing of OLC itself.

As part of its overall manufacturing strategy, the Company had previously identified a back-up third-party manufacturing vendor to build redundancy into its supply chain. The second vendor has a long history of successful FDA and international regulatory inspections and has already produced OLC drug product, which could also be used to support the resolution of the CMC issues identified in the CRL.

About Oxylanthanum Carbonate (OLC)

OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden.

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.1 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra)  announced   the U.S. Food and Drug Administration (FDA)   acceptance the  review of the resubmitted New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025.

“Based on the FDA’s requirement for an additional clinical trial demonstrating the efficacy of reproxalap in treating the symptoms of dry eye disease, and per agreement with the FDA, the NDA resubmission contained a single clinical trial that achieved the primary endpoint of reducing ocular discomfort relative to the vehicle control,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “We look forward to a productive dialog with the FDA during the NDA review of reproxalap, which, to our knowledge, remains the only dry eye disease investigational therapy to have demonstrated acute activity in reducing ocular discomfort and redness in pivotal trials simulating the disease flares that are likely the most bothersome aspects of dry eye disease.”

About Reproxalap

Reproxalap is an investigational new drug candidate in development for the treatment of dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology. Reproxalap is a first-in-class small-molecule modulator of RASP, which are elevated in ocular and systemic inflammatory diseases. The mechanism of action of reproxalap has been supported by the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap has been studied in more than 2,900 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials.

https://go.drugbank.com/drugs/DB16688

FDA grants speedy approval to Eli Lilly's weight-loss pill for obesity

Federal regulators on Wednesday approved Eli Lilly's new weight-loss pill, a second daily oral medication to treat obesity and other weight-related conditions.

The Food and Drug Administration granted expedited approval to orforglipron, a GLP-1 drug that works like widely used injectable medications to mimic a natural hormone that controls appetite and feelings of fullness.

The drug, which will be branded as Foundayo, is expected to begin shipping Monday. The company said people with insurance may be able to get the drug starting at $25 per month with a Lilly discount card. Prices for people paying cash will range between $149 per month to $349 per month, depending on the dose.

The new pill joins drugmaker Novo Nordisk's oral Wegovy pill, which has spurred more than 600,000 prescriptions in the United States since it was approved in December.

The FDA authorized Eli Lilly's drug as part of a new program aimed at cutting drug approval times. The agency said it reviewed the company's application in 50 days.

More;

FDA grants speedy approval to Eli Lilly's weight-loss pill for obesity

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

Study Details | NCT07506044 | Dexmedetomidine as an Adjuvant During Dural Puncture Epidural

In continuation of my update on Dexmedetomidine

Study Overview

Brief Summary:

The study aimed to determine the effects of using varied doses of DEX on the concentration of bupivacaine injected for epidural labor analgesia, and to assess the benefits of the dural puncture epidural.

Detailed Description

The primary efficacy point is the total dose of bupivacaine administered during labor. The secondary endpoints include the VAS pain scores, number of administered additional doses, incidence of motor block, delivery type (spontaneous vaginal or cesarean), maternal satisfaction, and complications such as hypotension, fetal bradycardia, and epidural-related maternal fever.

Official Title

The Effect of Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine for Parturients Having Dural Puncture Epidural Technique to Elaborate Labor Pain.

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

Read more :

Study Details | NCT07506044 | Dexmedetomidine as an Adjuvant During Dural Puncture Epidural | ClinicalTrials.gov

Study Details | NCT07506395 | Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder

In continuation of my update on Psilocybin

This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD severity.

Detailed Description

This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD severity.

These will be assessed by the following outcome measures:

• Proportion of participants completing the study protocol
• Incidence of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
• Mean change in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and PTSD checklist for DSM-5 (PCL-5). The CAPS-5 and PCL-5 are based on the DSM-5 not the DSM-5-TR.

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

More at : 

Study Details | NCT07506395 | Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder | ClinicalTrials.gov

Finerenone shows superior survival and kidney protection over spironolactone in diabetic kidney disease

In continuation of my update on Finerenone

Researchers from National Taiwan University Hospital and collaborating institutions have demonstrated that finerenone, a new-generation nonsteroidal mineralocorticoid receptor antagonist (MRA), significantly reduces the risk of death and major heart and kidney events compared with spironolactone in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).

The study, published in Nature Communications, analyzed real-world clinical data from over 2,200 patients across global health databases, using an advanced "target trial emulation" framework to mimic randomized clinical trials.

A safer and more effective alternative

Among adults with CKD and T2D, treatment with finerenone led to:

• 69% lower all-cause mortality (adjusted hazard ratio 0.31)
• 53% lower risk of kidney failure or rapid kidney decline (MAKE)
• 26% fewer cardiovascular complications (MACE)
  compared to spironolactone.

Moreover, finerenone users experienced fewer episodes of hyperkalemia (high blood potassium), a common side effect that often limits spironolactone use.

"Finerenone appears not only safer but also more effective in protecting both the heart and kidneys," said Professor Vin-Cent Wu, senior author and nephrologist at National Taiwan University Hospital. "Our findings provide real-world confirmation that this drug may transform care for diabetic kidney disease."

Advanced analytics with real-world evidence

Using the Global Health Network, encompassing over 146 health care systems worldwide, the team applied target trial emulation—a novel data-science approach—to overcome the limitations of traditional observational studies.

This method enabled researchers to simulate the design of a randomized clinical trial using real-world data, yielding robust comparative results that align with previous landmark studies (FIDELIO-DKD and FIGARO-DKD).

"This is the first real-world head-to-head comparison of finerenone and spironolactone," noted Dr. Chung-An Wang, first author. "The results show that finerenone provides meaningful survival benefits even over a relatively short 1.3-year follow-up

Clinical implications

Both finerenone and spironolactone block the effects of the hormone aldosterone, which contributes to inflammation and fibrosis in the kidneys and heart.

However, finerenone's more selective mechanism reduces the risk of electrolyte disturbances while maintaining strong protective effects on organ health.

This study suggests that finerenone could become a preferred treatment for patients with CKD and T2D, particularly those at higher risk of cardiovascular or renal complications.

"These results could help refine international treatment guidelines and improve outcomes for millions of people living with diabetic kidney disease," said Professor Wu.

The study applied a rigorous target trial emulation framework using global real-world data from over 2,000 matched patients across 21 countries, closely mirroring a randomized clinical trial.

By employing propensity score matching to balance key clinical variables, the study minimized bias and produced consistent, statistically robust results showing finerenone's lower risks of death, kidney failure, and cardiovascular events compared with spironolactone.

Supported by strong biological rationale, transparent methodology, and public data sharing, the findings are credible, reproducible, and clinically meaningful for improving outcomes in diabetic kidney disease.

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

Chung-An Wang et al, Finerenone versus spironolactone in patients with chronic kidney disease and type 2 diabetes: a target trial emulation, Nature Communications (2025). DOI: 10.1038/s41467-025-64640-3

Finerenone shows superior survival and kidney protection over spironolactone in diabetic kidney disease