Given the pervasiveness of Pediatric Obesity, it is imperative to understand its pathophysiology and develop alternative strategies to reverse this condition. Herein, investigators propose to elucidate the interaction between colonic fermentation and insulin resistance in modulating metabolism in youth with obesity.

Start Date01 Sep 2025

Sponsor / Collaborator

Yale University

[+1]

CTRI/2025/04/085492

/ Not yet recruitingNot ApplicableIIT

Comparative evaluation of rifaximin and lactulose in combination vs lactulose alone in prevention of constipation in critically ill chronic kidney disease patients; a randomized controlled trial. - nil

Start Date03 May 2025

Sponsor / Collaborator

All India Institute of Medical Sciences

NCT06483737

/ Not yet recruitingNot ApplicableIIT

Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE): an Invesitgator-initiated, Open-label, Multicenter, Randomized Controlled Trial

Hepatic encephalopathy (HE), a severe complication of decompensated cirrhosis, is characterized as neurocognitive dysfunction. Emerging evidence suggests the potential role of human albumin infusion for the treatment of HE, but its optimal dosage remains undefined. Therefore, the investigators planned a randomized controlled trial (RCT) to compare the efficacy of human albumin infusion at different dosages in in patients with liver cirrhosis and overt HE.

Start Date01 May 2025

Sponsor / Collaborator

The General Hospital of Shenyang Military Region

100 Clinical Results associated with Lactulose

100 Translational Medicine associated with Lactulose

100 Patents (Medical) associated with Lactulose

5,748

Literatures (Medical) associated with Lactulose

01 Dec 2025·Current Neurology and Neuroscience Reports

Hepatic Encephalopathy: Current Thoughts on Pathophysiology and Management

Review

Author: Chakravarty, Ambar ; Pan, Kausik ; Sen, Barun Kumar

PURPOSE OF REVIEW:

This review highlights the causes, types and clinical staging of hepatic encephalopathy (HE). Current concepts on the probable pathogenetic mechanisms and currently practiced therapeutic options are discussed.

RECENT FINDINGS:

HE may be covert and overt. Also known as minimal HE. Covert HE, where there are behavioral abnormalities and impairment in activities of daily living with intact sensorium. The pathophysiology of HE remains poorly understood. There is disturbance of the urea cycle due to liver disease leading to increased production of ammonia. The ammonium ion enters the astrocytes along with glutamate (converted to glutamine by ammonia) and myo-inositol, thereby increasing the osmolality of the astrocytic cytoplasm. This osmotic gradient results in accumulation of water inside the astrocytes resulting in cerebral edema and increase in brain volume. Additionally, current research has noted the role of cerebral oxidative/nitrosative stress and the synergistic effects of increased cerebral ammonia and alteration in neurotransmitters, neurometabolites, and cortical excitability due to systemic inflammation. In advanced liver disease with systemic infection or inflammation, neuroinflammatory processes play significant role in the development of HE. Inflammatory cytokines like TNF-α, IL-6, IL-17 in presence of hyperammonemia have been found to induce neurotoxicity of ammonia by passing through the blood brain barrier and causing enlarged/swollen pale astrocytes, resulting in HE. Disrupted enterohepatic circulation in end stage liver disease also causes elevation of bile acids which induces neuroinflammation. Manganese and zinc play as co-factors of enzymatic reaction. These metal deposition causes multiple psychomotor symptoms observed in HE. The gut environment has a major impact on brain function in patients with HE. Toxins such as ammonia and inflammatory cytokines produced by this impaired intestinal flora access the circulation through porto-systemic anastomoses and exacerbate or precipitate HE. Finally, as a result of recurrent cerebral edema from astrocytic dysfunction and neuroinflammation, permanent neurodegeneration occurs with cognitive decline and motor disturbances, especially parkinsonian features and gait disturbances. This is the stage of chronic hepatic encephalopathy. Currently L-ornithine L-aspartate (LOLA) is being used to lower the ammonia level by stimulating the urea cycle. HE comprises a broad spectrum of neurological and/or psychiatric abnormalities caused by hepatic insufficiency and/or portal-systemic shunting in the absence of any other causes of brain dysfunction. HE may be caused or precipitated by several factors like infections, intoxications and drugs. The encephalopathic features may be covert or overt. The pathogenetic mechanisms for HE may be different. In the presence of liver disease, HE primarily results from disturbed urea cycle with hyperammonemia causing astrocytic swelling and cerebral edema. Porto-systemic anastomoses with intact liver function can cause HE by allowing ammonia and other toxins produced by the gut microbial flora and allowing these to bypass detoxification by the liver and exposing the brain to their harmful effects. Principles of therapy are twofold. First protecting the liver and the brain from gut generated ammonia and other toxins by ensuring smooth bowel function and avoiding stagnation with the use of osmotic laxatives like lactulose or lactitol and also reducing the gut microbial load with use of anti-bacterials/bacteriophages like neomycin and rifaximin along with metronidazole. Second, reducing the already generated cerebral edema by use of mannitol and appropriate ventilatory support. Currently L-ornithine L-aspartate (LOLA) is being used to reduce the ammonia load to the liver. LOLA is a stable compound formed from two amino acids. L-ornithine plays a crucial role in stimulating the urea cycle, leading to a reduction in ammonia levels. Both L-ornithine and L-aspartate serve as substrates for the enzyme glutamate transaminase, and their administration results in elevated glutamate concentrations. Ammonia is subsequently utilized in the conversion of glutamate to glutamine through the action of glutamine synthetase. Finally in resistant cases the use of liver transplant needs to be considered. Alternatively extracorporeal liver assist devices may be used like Molecular Adsorbent Recirculating System (MARS) or Single-Pass Albumin Dialysis (SPAD).

01 Dec 2025·Current gastroenterology reports

Gas-tly Interpretations: A Case-Based Approach to the Nuances of SIBO Breath Testing

Review

Author: Damianos, John A ; Matar, Ayah ; Halawi, Houssam

PURPOSE OF REVIEW:

Breath testing to diagnose intestinal microbial overgrowth (MO) is being increasingly utilized, in part due to direct-to-consumer testing modalities. However, the concept of breath testing in the diagnosis of MO is controversial due to numerous limitations regarding optimal substrate, diagnostic thresholds, and confounding variables. We provide seven real-world cases which comprehensively illustrate the principles and nuances of the interpretation of breath testing.

RECENT FINDINGS:

We highlight recent studies which examine the optimal substrate for breath testing (glucose versus lactulose), the subtypes and clinical significance of breath test patterns including hydrogen, methane, and hydrogen-sulfide, elevated baseline gas levels, and confounders to breath test interpretation including transit time and diet. Reviewing the latest evidence, we provide recommendations for a personalized interpretation of breath tests utilizing unique patient factors. We conclude with an algorithm to assist clinicians in providing more accurate diagnoses.

01 Aug 2025·FOOD CHEMISTRY

Engineering the substrate-binding pocket of Cellobiose 2-epimerase for enhancing lactulose biosynthesis

Article

Author: Chen, Qiuming ; He, Zhiyong ; Wang, Zhaojun ; Chen, Jie ; Wu, Junhao ; Zeng, Maomao

Cellobiose 2-epimerase (CE) converts lactose into lactulose and epilactose with high added value and prebiotic benefits. However, the low conversion of lactulose by CsCE limits its industrial application. Inspired by previous work introducing engineered disulfide bonds on the loop of CsCE, we performed saturation mutagenesis and high-throughput screening of all residues within 4 Å of the engineered disulfide bond. The best mutant, CsCE-S173C/F231C/L172S/I178V(M4), showed a 1.3-fold increase in isomerization activity over CsCE-S173C/F231C. Molecular dynamics simulations and binding pocket analysis revealed that mutations reshaped the shape and size of the substrate-binding pocket and increased non-covalent interactions of the protein with the ligand. Binding free energy calculations showed a higher binding affinity of M4 for lactose and lactulose. Therefore, we demonstrated that the catalytic characteristics of CE can be modulated by further manipulating the loop region near the pocket, which is important for improving the catalytic efficiency and promiscuity of the enzyme.

News (Medical) associated with Lactulose

13 May 2025

·investor.cumberlandpharma.com

CUMBERLAND PHARMACEUTICALS PARTNERS WITH QUREIGHT TO ADVANCE INNOVATIVE IDIOPATHIC PULMONARY FIBROSIS TREATMENT RESEARCH

211.1 KB Cumberland leveraging Qureight's deep-learning AI platform for its Phase II FIGHTING FIBROSIS™ clinical trial NASHVILLE, Tenn. and CAMBRIDGE, England, May 13, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company with development efforts focused on new products for rare diseases, today announced a partnership with Qureight, a Core Imaging Laboratory developing deep-learning image analytics, to enhance the outcome and output of data from Cumberland's FIGHTING FIBROSIS™ clinical trial. The Phase II study is evaluating Cumberland's ifetroban product candidate in patients with idiopathic pulmonary fibrosis (IPF), the most common form of progressive fibrosing interstitial lung disease. This collaboration aims to address a critical unmet need for the estimated 2 million IPF patients worldwide, who currently have limited treatment options that can effectively halt disease progression. The partnership will utilize Qureight's advanced, deep-learning image analytics tools for complex lung disease applications to provide deeper insights into treatment efficacy and disease progression in Cumberland's IPF clinical program. Under this partnership, Qureight's AI-driven analytics technologies will be used to quantify changes in multiple imaging biomarkers, using computed tomography (CT) data from FIGHTING FIBROSIS™ study patients. Qureight's quantitative deep learning-based tools will precisely measure changes in the volume of patients' fibrotic, vascular and airway lung compartments, allowing a more detailed investigation of ifetroban's modulation of both lung structure and function. The collaboration leverages Qureight's expertise in IPF and quantitative imaging biomarkers to support Cumberland's evaluation of crucial primary and secondary study endpoints. "We are excited to partner with Qureight as we work to develop a new treatment for patients with IPF – and address that critical unmet medical need," said A.J. Kazimi, Cumberland Pharmaceuticals Chief Executive Officer. "Given ifetroban's promising data demonstrating prevention of lung fibrosis in multiple preclinical models, we believe Qureight's advanced imaging analysis capabilities will provide crucial insights that could help advance understanding and outputs from our IPF clinical program." Cumberland's FIGHTING FIBROSIS™ clinical trial is a multicenter, double-blind, placebo-controlled Phase II study investigating the safety and efficacy of once daily oral ifetroban for 52 weeks in patients with IPF. The study includes both patients on existing antifibrotic therapies and those not currently receiving such treatments, with a primary endpoint focusing on change in forced vital capacity. "We are thrilled to partner with Cumberland Pharmaceuticals on this important clinical trial," said Dr. Muhunthan Thillai, Chief Executive Officer at Qureight. "Their innovative approach in treating IPF patients for 12 months at this development stage, allows for a truly meaningful assessment of ifetroban's efficacy and tolerability – the characteristics of treatment that IPF patients so urgently need. When combined with our AI image analytics technologies, the resulting data has the potential to significantly deepen our understanding of how to quantify treatment effects in this complex and devastating disease." "The application of AI-driven quantitative imaging in IPF clinical research marks a significant step forward in how we evaluate treatment response," said Phil Molyneaux, MD, Professor of Pulmonary Medicine at the Royal Brompton Hospital, London. "By enabling precise measurement of changes in fibrotic, vascular and airway compartments of the lung, this approach offers insights beyond what traditional pulmonary function tests can provide—potentially allowing us to accelerate the development of urgently needed therapies for patients with IPF." Both Cumberland and Qureight will be attending the upcoming American Thoracic Society International Conference in San Francisco, where the FIGHTING FIBROSIS™ study will be featured in the Clinical Trial Awareness area. This collaborative presence at one of the world's premier respiratory medicine gatherings underscores the companies' shared commitment to advancing innovative solutions for patients with pulmonary fibrosis. About Idiopathic Pulmonary Fibrosis Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease marked by inflammation and fibrosis of the lungs, resulting in rapidly declining lung function and reduced survival within five years of diagnosis. IPF is the most common form of interstitial lung disease and affects up to 2 million individuals globally. While FDA-approved antifibrotic therapies have shown efficacy to slow progression of the disease, there is no approved treatment which effectively halts disease progression and improves patients' symptoms. Therefore, an unmet need exists to identify additional treatments which add benefit and provide alternatives to existing therapies. About The FIGHTING FIBROSIS™ Clinical Trial The FIGHTING FIBROSIS™ clinical trial is a double-blind, placebo-controlled Phase II study designed to evaluate 12 months of oral ifetroban and enroll 128 patients in over 20 medical centers of excellence across the U.S. The study is currently actively enrolling at 16 centers. The clinical trial is registered on ClinicalTrials.gov under identifier NCT05571059. For more information about the study, including eligibility criteria and participating sites, please visit https://www.fightingfibrosistrial.com/ or contact Ingrid Anderson, PhD at ianderson@cumberlandpharma.com or 615-556-7188. About Ifetroban Ifetroban is a potent and selective thromboxane-prostanoid receptor (TPr) antagonist. Ifetroban exhibits high affinity for TPr on many cell types including platelets, vascular and airway smooth muscle, and fibroblasts, and lacks agonistic activity. Ifetroban also displays anti-platelet, antivasospastic, antifibrotic, and antibronchospastic activities and is effective in certain preclinical models of vasospasm, thrombosis, reperfusion injury, cardiac fibrosis, lung fibrosis and endothelial dysfunction, including models that are insensitive to aspirin. Cumberland acquired the ifetroban program in collaboration with Vanderbilt University and Cumberland Emerging Technologies (CET). Cumberland is also sponsoring the FIGHT DMD™ trial, a multicenter, randomized, placebo-controlled Phase II study evaluating two doses of oral ifetroban for the treatment of the cardiomyopathy associated with Duchenne muscular dystrophy, and has a Phase II clinical program for Systemic Sclerosis. About Cumberland Pharmaceuticals Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes: Acetadote® (acetylcysteine) injection, for the treatment of acetaminophen poisoning; Caldolor® (ibuprofen) injection, for the treatment of pain and fever; Kristalose® (lactulose) oral, a prescription laxative, for the treatment of constipation; Sancuso® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and Vibativ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections. For more information on Cumberland's approved products, including full prescribing information, please visit the individual product websites, which can be found on the company's website: www.cumberlandpharma.com. About Qureight Founded in 2018 and headquartered in Cambridge, UK, Qureight is a Core Imaging Laboratory, a rapidly-scaling techbio company deploying its technology on a global scale. The cloud-based, vendor-agnostic Core Imaging Platform is GDPR, HIPPA and NHS Digital compliant. The platform has ISO13485 and ISO27001 accreditation to interrogate clinical trial data. The team is led by co-founder & CEO Dr Muhunthan Thillai, a pulmonologist who trained in lung fibrosis. Forward-Looking Statements This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include macroeconomic conditions, including rising interest rates and inflation, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission ("SEC"), as well as the company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. View original content to download multimedia:https://www.prnewswire.com/news-releases/cumberland-pharmaceuticals-partners-with-qureight-to-advance-innovative-idiopathic-pulmonary-fibrosis-treatment-research-302454434.html SOURCE Cumberland Pharmaceuticals Inc. Investor Contact: Shayla Simpson, Cumberland Pharmaceuticals, (615) 255-0068; Media Contact: Molly Aggas, Dalton Agency, (704) 641-6641; Qureight Media Contact: Amy Thomas, SomX, amy@somx.health

Phase 2

06 May 2025

·ir.bauschhealth.com

Xifaxan® (rifaximin) Treatment Following Overt Hepatic Encephalopathy (OHE) Hospitalization Associated with Reduced Risk of 30-Day OHE Rehospitalization

May 06, 2025 New analysis suggests efficacy of Xifaxan to mitigate OHE rehospitalizations irrespective of treatment history LAVAL, Quebec, May 6, 2025 – Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), a global, diversified pharmaceutical company, and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), today announced new data showing that people hospitalized due to overt hepatic encephalopathy (OHE) had a reduced risk of OHE-related rehospitalization within 30 days if treated with Xifaxan® (rifaximin) following hospital discharge regardless of prior treatment. These findings, based on a claims-based analysis, will be presented today at Digestive Disease Week® (DDW) 2025 in San Diego, CA. “This analysis reinforces the use of Xifaxan to help prevent OHE rehospitalizations,” said Arun Jesudian, MD, Director of Inpatient Liver Services at NYPH/Weill Cornell. “Cases of chronic liver disease and cirrhosis are growing, and these conditions can be debilitating for patients and their families. Providing patients with optimal, guideline-based treatment regimens is imperative because preventing recurrence and rehospitalizations not only benefits patients but also helps reduce burden on the broader healthcare system.” In patients with cirrhosis, an occurrence of fully symptomatic overt hepatic encephalopathy (OHE) is one of the key complications that defines the decompensated phase of the disease and is associated with worsening outcomes, morbidity, and mortality.1 Because in cirrhosis a damaged liver does not function normally, toxins from the gut can enter the bloodstream and travel to the brain, where they can affect neurotransmission precipitating OHE episodes. These episodes may present as alterations in consciousness, cognition, and behavior.2,3 Up to 80% of patients with cirrhosis will eventually develop some form of HE.1 American Association for the Study of Liver Diseases (AASLD) treatment guidelines recommend the use of Xifaxan as an add-on treatment to lactulose after a breakthrough OHE episode to prevent further OHE recurrence.1 Results of this claims-based analysis showed that patients who received lactulose only upon hospital discharge had a higher risk of 30-day OHE rehospitalization compared to those who received Xifaxan (adjusted OR: 1.63-2.73, p<0.05) regardless of pre-hospitalization treatment. Additionally, the risk of 30-day OHE rehospitalization increased with descending tiers of quality of care (QoC), defined as high-, intermediate- or low-quality based on AASLD guidelines (intermediate vs. high QoC: OR = 1.44, low vs. high QoC: OR = 2.45, all p<0.05). Results remained consistent for Medicare- and Medicaid-insured patients. “Xifaxan has been proven to effectively reduce the risk of OHE recurrence, so it is concerning to know that some patients leave the hospital without guideline-based treatment recommendations,” said Aimee Lenar, Executive Vice President of US Pharma at Bausch Health. “It is vital to recognize hepatic encephalopathy in people with liver disease in the hospital setting and to ensure they have access to high-quality, holistic care upon discharge.” The analysis used claims data from the Komodo Research Data (January 2016 – September 2023) to identify commercially-insured patients with an initial OHE hospitalization. Of the 7,880 OHE patient claims data analyzed, prior to hospitalization, 27.1 percent (n=2,135) were treated with Xifaxan, 24.1 percent with lactulose and 48.8% (n=3,848) received no treatment. About XIFAXAN INDICATION XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. IMPORTANT SAFETY INFORMATION XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis. Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients. Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin. In clinical studies, the most common adverse reactions for XIFAXAN (alone or in combination with lactulose) were: HE (≥10%): Peripheral edema (17%), constipation (16%), nausea (15%), fatigue (14%), insomnia (14%), ascites (13%), dizziness (13%), urinary tract infection (12%), anemia (10%), and pruritus (10%) IBS-D (≥2%): Nausea (3%), ALT increased (2%) INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required. XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus. HE (≥10%): Peripheral edema (17%), constipation (16%), nausea (15%), fatigue (14%), insomnia (14%), ascites (13%), dizziness (13%), urinary tract infection (12%), anemia (10%), and pruritus (10%) IBS-D (≥2%): Nausea (3%), ALT increased (2%) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please click here for full Prescribing Information. About Bausch Health Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn. References ### ©2025 Salix Pharmaceuticals or its affiliates. << Back to News Releases

Clinical ResultDrug Approval

06 May 2025

·investor.cumberlandpharma.com

Cumberland Pharmaceuticals Reports 38% Revenue Growth in Q1 2025

NASHVILLE, Tenn. , May 6, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, announced today that its product portfolio of FDA-approved brands delivered combined net revenues of $11.7 million during the first quarter of 2025, a 38% increase over the prior year period. As a result the Company generated a net profit of $1.3 million for the quarter, adjusted earnings of $2.4 million , and cash flow from operations of $3.9 million . Cumberland ended the quarter with approximately $70 million in total assets, $41.6 million in liabilities and $28.7 million of shareholders' equity. "We are entering an exciting time for our company, as we continue to build momentum and capitalize on a range of promising opportunities," said Cumberland Pharmaceuticals CEO A.J. Kazimi . "Our optimism is driven by strong performance from our approved brands, the expansion of international partnerships, meaningful progress across our clinical development programs and the potential for strategic acquisitions." RECENT COMPANY DEVELOPMENTS INCLUDE: Top-Line DMD Study Results In February 2025 , Cumberland announced positive top-line results from the Phase II study evaluating its ifetroban product candidate in patients with Duchenne muscular dystrophy (DMD). This marks a breakthrough for these patients, as it's the first successful Phase II study specifically targeting the cardiac complications of their condition. These study results were selected for a late-breaking presentation in March at the Muscular Dystrophy Association 's Clinical & Scientific Conference . That platform allowed Cumberland to share the promising results with the global DMD community, including leading researchers, clinicians and patient advocates who are working tirelessly to improve outcomes for those affected by this devastating disease. Next steps for Cumberland's DMD program include further data analysis and completion of a full study report in preparation for an end-of- Phase-II meeting with the FDA to determine the requirements for the product's approval. Vibativ® Approval in China Cumberland's potent antibiotic, Vibativ®, received approval from the regulatory authorities in China . This provides Cumberland access to the world's second-largest pharmaceutical market. The company expects the product to launch by the end of the year. FINANCIAL RESULTS: Net Revenue: For first quarter of 2025, net revenues were $11.7 million and included $3.5 million for Kristalose®, $2.3 million for Sancuso®, $1.4 million for Vibativ® and $1.3 million for Caldolor®. Operating Expenses: Total operating expenses for the quarter were $10.4 million . Net Income: The net income for the first quarter of 2025 was approximately $1.3 million . Adjusted Earnings: Adjusted earnings for the quarter were $2.4 million , or $0.16 per share. Balance Sheet: At March 31, 2025 , Cumberland had approximately $70 million in total assets, including $15.1 million in cash and cash equivalents. Liabilities totaled $41.6 million , including $5.2 million on the company's credit facility. Total shareholders' equity was $28.7 million on March 31, 2025 . EARNINGS REPORT CALL: A conference call will be held today, May 06, 2025 , at 4:30 p.m. Eastern Time to provide a company update and discuss the financial results. The link to register is: https://register-conf.media-server.com/register/BIea2bc7f82dd24caea135dbe5460d9b6f. Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference. A replay of the call will be available for one year and can be accessed via Cumberland's website or by visiting: https://edge.media-server.com/mmc/p/wost2na9/. ABOUT CUMBERLAND PHARMACEUTICALS : Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes: Acetadote® (acetylcysteine) injection, for the treatment of acetaminophen poisoning; Caldolor® (ibuprofen) injection, for the treatment of pain and fever; Kristalose® (lactulose) oral, a prescription laxative, for the treatment of constipation; Sancuso® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and Vibativ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections. The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with Duchenne Muscular Dystrophy, Systemic Sclerosis and Pulmonary Fibrosis. For more information on Cumberland's approved products, including full prescribing information, please visit the links to the individual product websites, which can be found on the company's website at www.cumberlandpharma.com. About Acetadote® (acetylcysteine) Injection Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter medications. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. For full prescribing and safety information, visit www.acetadote.com. About Caldolor® (ibuprofen) Injection Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) as well as patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit www.caldolor.com. About Kristalose® (lactulose) Oral Solution Kristalose is indicated for the treatment of acute and chronic constipation. It is a unique, proprietary, crystalline form of lactulose, with no restrictions on length of therapy or patient age. Kristalose is contraindicated in patients who require a low-galactose diet. Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. For full prescribing and safety information, visit www.kristalose.com. About Sancuso® (granisetron) Transdermal System Sancuso is the only skin patch approved by the FDA for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy. When applied 24 to 48 hours before receiving chemotherapy, the Sancuso patch slowly and continuously releases the medicine contained in the adhesive through clean and intact skin areas into the patient's bloodstream. It can prevent CINV for chemotherapy regimens of up to five consecutive days. For full prescribing and safety information, visit www.sancuso.com. About Vaprisol® (conivaptan hydrochloride) Injection Vaprisol is an intravenous treatment for hyponatremia used in the critical care setting. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. The product is a vasopressin receptor antagonist that raises serum sodium levels and promotes free water secretion. Vaprisol is contraindicated in patients with hypovolemic hyponatremia. The coadministration of Vaprisol with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir and indinavir, is contraindicated. For full prescribing and safety information, including boxed warning, visit www.vaprisol.com. About Vibativ® (telavancin) for Injection Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. Intravenous unfractionated heparin sodium is contraindicated with Vibativ administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after Vibativ administration. Vibativ is contraindicated in patients with a known hypersensitivity to telavancin. For more information, please visit www.vibativ.com. ABOUT CUMBERLAND EMERGING TECHNOLOGIES: Cumberland Emerging Technologies, Inc. (www.cet-fund.com) is a joint initiative between Cumberland Pharmaceuticals Inc. , Vanderbilt University , LaunchTN and WinHealth. The mission of CET is to advance biomedical technologies and products conceived at Vanderbilt University and other regional research centers towards the marketplace. CET helps manage the development and commercialization process for select projects, and provides expertise on intellectual property, regulatory, manufacturing and marketing issues that are critical to successful new biomedical products. CET's Life Sciences Center provides laboratory space, equipment and infrastructure for CET's activities and other early-stage life sciences ventures. FORWARD LOOKING STATEMENTS: This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the Company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include macroeconomic conditions, including rising interest rates and inflation, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the Company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission (" SEC "), as well as the Company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIESCondensed Consolidated Balance Sheets(Unaudited) March 31, 2025 December 31, 2024 ASSETS Current assets: Cash and cash equivalents $ 15,108,413 $ 17,964,184 Accounts receivable, net 10,487,925 11,701,466 Inventories, net 4,098,859 3,999,995 Prepaid and other current assets 2,181,954 2,786,513 Total current assets 31,877,151 36,452,158 Non-current inventories 9,939,236 11,005,499 Property and equipment, net 298,740 277,365 Intangible assets, net 16,986,962 17,973,449 Goodwill 914,000 914,000 Operating lease right-of-use assets 7,177,490 6,176,923 Other assets 2,742,299 2,784,016 Total assets $ 69,935,878 $ 75,583,410 LIABILITIES AND EQUITY Current liabilities: Accounts payable $ 13,927,623 $ 13,914,266 Operating lease current liabilities 371,094 356,508 Current portion of revolving line of credit — 5,100,000 Other current liabilities 11,220,902 12,250,955 Total current liabilities 25,519,619 31,621,729 Revolving line of credit - long term 5,240,733 10,176,170 Operating lease non-current liabilities 4,829,054 4,939,739 Other long-term liabilities 6,005,853 6,299,795 Total liabilities 41,595,259 53,037,433 Equity: Shareholders' equity: Common stock—no par value; 100,000,000 shares authorized; 14,961,137and 13,952,624 shares issued and outstanding as of March 31, 2025 and December 31, 2024 , respectively 51,367,883 46,821,425 Accumulated deficit (22,710,863) (23,967,931) Total shareholders' equity 28,657,020 22,853,494 Noncontrolling interests (316,401) (307,517) Total equity 28,340,619 22,545,977 Total liabilities and equity $ 69,935,878 $ 75,583,410 CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIESCondensed Consolidated Statements of Operations(Unaudited) Three months ended March 31 , 2025 2024 Net revenues $ 11,713,055 $ 8,497,701 Costs and expenses: Cost of products sold 1,425,714 1,575,542 Selling and marketing 4,231,980 4,154,588 Research and development 1,295,076 1,158,253 General and administrative 2,463,008 2,367,907 Amortization 1,005,330 1,110,661 Total costs and expenses 10,421,108 10,366,951 Operating income (loss) 1,291,947 (1,869,250) Interest income 125,709 96,746 Interest expense (163,802) (118,526) Income (loss) before income taxes 1,253,854 (1,891,030) Income tax expense (5,670) (11,442) Net income (loss) 1,248,184 (1,902,472) Net loss (income) at subsidiary attributable to noncontrolling interests 8,884 (43,791) Net income (loss) attributable to common shareholders $ 1,257,068 $ (1,946,263) Earnings (loss) per share attributable to common shareholders - basic $ 0.08 $ (0.14) - diluted $ 0.08 $ (0.14) Weighted-average shares outstanding - basic 14,942,522 14,098,022 - diluted 15,259,824 14,098,022 CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIESCondensed Consolidated Statements of Cash Flows(Unaudited) Three months ended March 31 , 2025 2024 Cash flows from operating activities: Net income (loss) $ 1,248,184 $ (1,902,472) Adjustments to reconcile net loss to net cash provided by operating activities: Depreciation and amortization expense 1,031,584 1,150,685 Amortization of operating lease right-of-use assets 285,184 285,184 Share-based compensation 74,212 78,754 Increase (decrease) in non-cash contingent consideration 44,976 (230,430) Decrease (increase) in cash surrender value of life insurance policies overpremiums paid 81,182 (129,217) Noncash interest expense 5,362 3,810 Net changes in assets and liabilities affecting operating activities: Accounts receivable 1,213,541 (1,066,410) Inventories, net 967,399 170,469 Other current assets and other assets 60,371 205,619 Operating lease liabilities (219,493) (213,825) Accounts payable and other current liabilities (600,043) (645,542) Other long-term liabilities (293,942) 156,728 Net cash provided by (used in) operating activities 3,898,517 (2,136,647) Cash flows from investing activities: Additions to property and equipment (47,630) (41,621) Net investment in manufacturing facility (1,162,357) — Additions to intangible assets (18,199) (16,565) Net cash used in investing activities (1,228,186) (58,186) Cash flows from financing activities: Proceeds from ATM offering, net 5,266,334 — Borrowings on line of credit — 11,000,000 Payments on line of credit (10,035,437) (7,700,000) Cash settlement of contingent consideration (511,131) (630,701) Payments made in connection with repurchase of common shares (245,868) (247,605) Net cash provided by (used in) financing activities (5,526,102) 2,421,694 Net increase (decrease) in cash and cash equivalents (2,855,771) 226,861 Cash and cash equivalents at beginning of period $ 17,964,184 $ 18,321,624 Cash and cash equivalents at end of period $ 15,108,413 $ 18,548,485 CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIESReconciliation of Net Income (loss) Attributable to Common Shareholders to Adjusted Earnings (loss) andAdjusted Diluted Earnings (loss) Per Share(Unaudited) Three months ended March 31 , Three months ended March 31 , 2025 2025 2024 2024 Earningsimpact Earnings per share impact Earningsimpact Earnings pershare impact Net income (loss) attributable to commonshareholders $ 1,257,068 $ 0.08 $ (1,946,263) $ (0.14) Less: Net (income) loss at subsidiary attributable tononcontrolling interests 8,884 — (43,791) — Net income (loss) 1,248,184 0.08 (1,902,472) (0.13) Adjustments to net income (loss) Income tax expense 5,670 — 11,442 — Depreciation and amortization 1,031,584 0.07 1,150,685 0.08 Share-based compensation (a) 74,212 — 78,754 0.01 Interest income (125,709) (0.01) (96,746) (0.01) Interest expense 163,802 0.01 118,526 0.01 Adjusted earnings (loss) and adjusted diluted earnings (loss) per share $ 2,397,743 $ 0.16 $ (639,811) $ (0.05) Diluted weighted-average common shares outstanding: 15,259,824 14,098,022 The Company provided the above adjusted supplemental financial performance measures, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. These financial measures should be considered supplemental to, and not as a substitute for, financial information prepared in accordance with Generally Accepted Accounting Principles ("GAAP"). The definition of these supplemental measures may differ from similarly titled measures used by others. Because these supplemental financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety. A reconciliation of the supplemental financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release. Cumberland's management believes these supplemental financial performance measures are important as they are used by management, along with financial measures in accordance with GAAP, to evaluate the Company's operating performance. In addition, Cumberland believes that they will be used by certain investors to measure the Company's operating results. Management believes that presenting these supplemental measures provides useful information about the Company's underlying performance across reporting periods on a consistent basis by excluding items that Cumberland does not believe are indicative of its core business performance or reflect long-term strategic activities. Certain of these items are not settled through cash payments and include: depreciation, amortization, share-based compensation expense and income taxes. Cumberland utilizes its net operating loss carryforwards to pay minimal income taxes. In addition, the use of these financial measures provides greater transparency to investors of supplemental information used by management in its financial and operational decision-making, including the evaluation of the Company's operating performance. The Company defines these supplemental financial measures as follows: Adjusted Earnings (loss): net income (loss) adjusted for the impact of income taxes, depreciation and amortization expense, share-based compensation, interest income and interest expense. (a) Represents the share-based compensation of Cumberland. Adjusted Diluted Earnings (loss) Per Share: Adjusted Earnings (loss) divided by diluted weighted-average common shares outstanding. View original content to download multimedia:https://www.prnewswire.com/news-releases/cumberland-pharmaceuticals-reports-38-revenue-growth-in-q1-2025-302447518.html SOURCE Cumberland Pharmaceuticals Inc. Investor Contact: Shayla Simpson, Cumberland Pharmaceuticals Inc., (615) 255-0068; Media Contact: Molly Aggas, Dalton Agency, (704) 641-6641

Drug ApprovalPhase 2Clinical ResultFinancial Statement

100 Deals associated with Lactulose

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KEGG	Wiki	ATC	Drug Bank
D00352	Lactulose	A06AD11	DB00581

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Chronic constipation	Australia	Arrotex Pharmaceuticals Pty Ltd.	13 Feb 2014
Hepatic Encephalopathy	Australia	Arrotex Pharmaceuticals Pty Ltd.	13 Feb 2014
Hyperammonemia	Japan	Maruishi Pharmaceutical Co., Ltd.	15 Jul 1975
Constipation	Netherlands	-	01 May 1964

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Colonic Diseases	Phase 2	United States	Cumberland Pharmaceuticals, Inc.	01 Apr 2014

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05061992 (CTgov)	Phase 2/3	Fibrosis	56	Lactulose (Lactulose)	iudkrwuege(zwdppflucw) = dxcirsttgu qpvjljjpln (wemurbxmdc, ffiognwsxe - jyhjxcigao) View more	-	21 Nov 2023
				placebo (No Treatment)	iudkrwuege(zwdppflucw) = ksnpbecsfm qpvjljjpln (wemurbxmdc, qqedhufifa - bhkvcxwzqh) View more
NCT05687409 (Pubmed \| Front Microbiol)	Phase 4	Fibrosis	-	Synbiotic (lactulose, Clostridium butyricum, Bifidobacterium longum infantis)	medjbvtdcf(fgpylhrotr) = ngmkspffpj fscpxtsygn (fhjytnbxdd )	Positive	01 Jan 2023
EASL2022	Not Applicable	Fibrosis	-	Lactulose	-	-	24 Jun 2022
				Lactulose + Rifaximin-alpha
NCT01842581 (CTgov)	Phase 4	Hepatic Encephalopathy \| Fibrosis	222	Rifaximin (Rifaximin 550 mg BID)	krvumjjrcm = chutxxpfch gqvxcjlljk (ihhkfysnss, ekljudggqj - rlesgrwkcb) View more	-	09 Sep 2019
				Rifaximin+Lactulose (Rifaximin 550 mg BID + Lactulose)	krvumjjrcm = lcrqonpadj gqvxcjlljk (ihhkfysnss, rjhajlswfq - pshowcjrof) View more
Pubmed \| J Gastroenterol Hepatol	Not Applicable	Hepatic Encephalopathy	120	Lactulose plus albumin	gbnmepmdqw(cnvrmyovfh) = solzaeyghd cypbluyywd (mnwrejdorp ) View more	Positive	01 Jun 2017
				Lactulose alone	gbnmepmdqw(cnvrmyovfh) = ulzefftdra cypbluyywd (mnwrejdorp ) View more
NCT02123017 (CTgov)	Phase 2	-	32	90 grams of Crystalline Lactulose (90 Grams of Crystalline Lactulose)	kklwniplpm(nfgwkatedt) = zlkotutbwj ssnhggsuvi (xvygwgxszu, 2.8) View more	-	24 Feb 2016
				135 grams of Crystalline Lactulose (135 Grams of Crystalline Lactulose)	kklwniplpm(nfgwkatedt) = ixfyxtfanj ssnhggsuvi (xvygwgxszu, 0.9) View more
ECCO2016	Not Applicable	Colitis, Ulcerative	96	lactulose (Ulcerative colitis in remission)	gdsgmtkzai(vekpgkvmqr) = hnlgkcaojd ptvefuoeqe (zxrarifcoy )	Positive	12 Feb 2016
				lactulose (Active ulcerative colitis)	gdsgmtkzai(vekpgkvmqr) = gjvklqdvhm ptvefuoeqe (zxrarifcoy )
UEGW2015	Not Applicable	Hepatic Encephalopathy	126	Lactulose	givogwhtou(anerkmjjje) = rrwtcmdzwv babcieajio (sjvjrtrjaa ) View more	Negative	01 Oct 2015
				Rifaximin	givogwhtou(anerkmjjje) = ibzvsesuxa babcieajio (sjvjrtrjaa ) View more
NCT01283152 (HELP, Pubmed \| JAMA Intern Med)	Not Applicable	Hepatic Encephalopathy	50	Polyethylene glycol 3350-electrolyte solution (PEG)	mqyejuonko(vtllzfncrf) = hzilkyavwq uvsjdlpynd (wlstnvwsvs )	Positive	01 Nov 2014
				Lactulose	mqyejuonko(vtllzfncrf) = qlzlbbnngz uvsjdlpynd (wlstnvwsvs )
NCT00712543 (CTgov)	Phase 4	Constipation	50	lactulose (Powder, Then Liquid Lactulose)	ptamaribxa = xpkfhfeyyk fautoxqkiz (fkarntrjxm, ieltodgnnc - ymqjeotlmp) View more	-	27 Sep 2011
				lactulose (Liquid, Then Powder Lactulose)	ptamaribxa = ddecbtbwog fautoxqkiz (fkarntrjxm, hsthxoblek - ngfjwimjbv) View more

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