A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Determine the Safety and Efficacy of Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Ifetroban prevents and treats lung fibrosis due to multiple causes (bleomycin, genetic, radiation). The safety and efficacy of oral ifetroban will be assessed in patients with IPF.

Start Date31 Jan 2024

Sponsor / Collaborator

Cumberland Pharmaceuticals, Inc.

NCT03340675

/ Active, not recruitingPhase 2

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study With an Open-Label Extension to Determine the Safety, Pharmacokinetics and Efficacy of Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is a devastating X-linked disease which leads to loss of ambulation between ages 7 and 13, respiratory failure and cardiomyopathy (CM) at any age, and inevitably premature death of affected young men in their late twenties. DMD is the most common fatal genetic disorder diagnosed in childhood. It affects approximately 1 in every 3,500 live male births across all races and cultures, and results in 20,000 new cases each year worldwide.Significant advances in respiratory care have unmasked CM as the leading cause of death. As there are yet no specific cardiac treatments to extend life, the current study aims to address this unmet medical need using a new therapeutic strategy for patients with DMD.
Funding Source - FDA OOPD

Start Date19 Oct 2020

Sponsor / Collaborator

Cumberland Pharmaceuticals, Inc.

[+1]

NCT03962855

/ CompletedPhase 2IIT

The Thromboxane Receptor Antagonist to Block the Effects of Non-Platelet Thromboxane Generation and Improve Endothelial Function (TRAP) Trial

This study evaluates whether addition of the thromboxane receptor antagonist to chronic aspirin therapy improves endothelial function and reduces non-platelet thromboxane generation in patients with established cardiovascular disease. Half of participants will receive ifetroban and the other half will receive matching placebo for the 4 week study period.

Start Date20 Sep 2019

Sponsor / Collaborator

American Heart Association, Inc.

[+1]

100 Clinical Results associated with Ifetroban

100 Translational Medicine associated with Ifetroban

100 Patents (Medical) associated with Ifetroban

Literatures (Medical) associated with Ifetroban

01 Sep 2023·The Journal of allergy and clinical immunology

Trial of thromboxane receptor inhibition with ifetroban: TP receptors regulate eicosanoid homeostasis in aspirin-exacerbated respiratory disease

Article

Author: Laidlaw, Tanya M ; Chen, Chongjia C ; Feng, Chunli ; Boyce, Joshua A ; Cho, Laura ; Buchheit, Kathleen M ; Israel, Elliot ; Le, Meghan ; Hacker, Jonathan ; Cahill, Katherine N ; Cui, Jing

BACKGROUND:

Aspirin-exacerbated respiratory disease (AERD) is the triad of asthma, nasal polyposis, and respiratory reactions to COX-1 inhibitors. Overproduction of cysteinyl leukotrienes and underproduction of prostaglandin E₂ (PGE₂) are hallmarks of AERD. A mouse model predicted a key role for the thromboxane-prostanoid (TP) receptor in AERD.

OBJECTIVE:

Our aim was to determine whether ifetroban, a TP receptor antagonist, attenuates aspirin-induced respiratory symptoms in patients with AERD.

METHODS:

A total of 35 patients with AERD completed a 4-week double-blinded, placebo-controlled trial of ifetroban and underwent an oral aspirin challenge. The primary outcome was change in the provocative dose of aspirin that caused a 2-point increase in Total Nasal Symptom Score. Changes in lung function, eicosanoid levels, and platelet and mast cell activation were assessed. Cultured human nasal fibroblasts were stimulated with or without the TP agonist U46619 and assayed for prostanoid production.

RESULTS:

Ifetroban was well tolerated in AERD and did not change the mean 2-point increase in Total Nasal Symptom Score (P = .763). Participants taking ifetroban had greater aspirin-induced nasal symptoms and a greater decline in FEV₁ value than did participants receiving placebo (-18.8% ± 3.6% with ifetroban vs -8.4% ± 2.1% with placebo [P = .017]). Four weeks of ifetroban significantly increased urinary leukotriene E₄ levels and decreased nasal PGE₂ levels compared with placebo. Peak aspirin-induced urinary thromboxane levels correlated with peak urinary leukotriene E₄ and prostaglandin D₂ metabolite levels in participants taking ifetroban. U46119 significantly potentiated the production of PGE₂ by cultured nasal fibroblasts from subjects with AERD but not by cultured nasal fibroblasts from controls without polypoid sinusitis.

CONCLUSION:

Contrary to our hypothesis, TP receptor blockade worsened aspirin-induced reactions in AERD, possibly by exacerbating dysregulation of the eicosanoid system. TP signaling on stromal cells may be critical to maintaining PGE₂ production when COX-2 function is low.

01 Jan 2023·Bio-protocol

Correction Notice: Microscopy and Plate Reader–based Methods for Monitoring the Interaction of Platelets and Tumor Cells in vitro

Article

Author: Hale, Elizabeth J ; Toragall, Veeresh ; Werfel, Thomas A ; Hulugalla, Kenneth R

Platelets and their activation status play an essential role in cancer metastasis. Therefore, the anti-metastatic potential of antiplatelet drugs has been investigated for many years. However, the initial screening of these antiplatelet drugs to determine which agents can inhibit the interactions of platelets and tumor cells is very limited due to reliance upon expensive, time-consuming, and low-throughput animal experiments for screening. In vitro models of the platelet-tumor cell interaction can be a useful tool to rapidly screen multiple antiplatelet drugs and compare their ability to disrupt platelet-tumor cell interactions, while also identifying optimal concentrations to move forward for in vivo validation. Hence, we adopted methods used in platelet activation research to isolate and label platelets before mixing them with tumor cells (MDA-MB-231-RFP cells) in vitro in a static co-culture model. Platelets were isolated from other blood components by centrifugation, followed by fluorescent labeling using the dye CMFDA (CellTrackerTM Green). Labeling platelets allows microscopic observation of the introduced platelets with tumor cells grown in cell culture dishes. These methods have facilitated the study of platelet-tumor cell interactions in tissue culture. Here, we provide details of the methods we have used for platelet isolation from humans and mice and their staining for further interaction with tumor cells by microscopy and plate reader-based quantification. Moreover, we show the utility of this assay by demonstrating decreased platelet-tumor cell interactions in the presence of the T-Prostanoid receptor (TPr) inhibitor ifetroban. The methods described here will aid in the rapid discovery of antiplatelet agents, which have potential as anti-metastatic agents as well. Key features • Analysis of platelet-tumor cell binding dynamics. • In vitro methods developed for measuring platelet-tumor cell binding to enable rapid testing of antiplatelet and other compounds. • Complementary analysis of platelet-tumor cell binding by imaging and fluorimetry-based readings. • Representative results screening the effect of the antiplatelet drug, ifetroban, on platelet-tumor cell binding using the protocol. • Validation results were presented with both a TPr agonist and ifetroban (antagonist).

01 Sep 2022·American journal of respiratory and critical care medicine

Thromboxane–Prostanoid Receptor Signaling Drives Persistent Fibroblast Activation in Pulmonary Fibrosis

Article

Author: Banovich, Nicholas E. ; Rathinasabapathy, Anandharajan ; Gutor, Sergey ; West, James D. ; Sabusap, Carleen ; Sherrill, Taylor P. ; Blackwell, Timothy S. ; Young, Lisa R. ; Han, Wei ; Gulleman, Peter ; Tada, Yuji ; Winters, Nichelle I. ; Carrier, Erica J. ; Gokey, Jason J. ; Chen, Jingyuan ; Freeman, Michael L. ; Camarata, Jane E. ; Kropski, Jonathan A. ; Polosukhin, Vasiliy V. ; Suzuki, Toshio ; Tanjore, Harikrishna ; Chen, Xinping

Rationale: Although persistent fibroblast activation is a hallmark of idiopathic pulmonary fibrosis (IPF), mechanisms regulating persistent fibroblast activation in the lungs have not been fully elucidated. Objectives: On the basis of our observation that lung fibroblasts express TBXA2R (thromboxane-prostanoid receptor) during fibrosis, we investigated the role of TBXA2R signaling in fibrotic remodeling. Methods: We identified TBXA2R expression in lungs of patients with IPF and mice and studied primary mouse and human lung fibroblasts to determine the impact of TBXA2R signaling on fibroblast activation. We used TBXA2R-deficient mice and small-molecule inhibitors to investigate TBXA2R signaling in preclinical lung fibrosis models. Measurements and Main Results: TBXA2R expression was upregulated in fibroblasts in the lungs of patients with IPF and in mouse lungs during experimental lung fibrosis. Genetic deletion of TBXA2R, but not inhibition of thromboxane synthase, protected mice from bleomycin-induced lung fibrosis, thereby suggesting that an alternative ligand activates profibrotic TBXA2R signaling. In contrast to thromboxane, F2-isoprostanes, which are nonenzymatic products of arachidonic acid induced by reactive oxygen species, were persistently elevated during fibrosis. F2-isoprostanes induced TBXA2R signaling in fibroblasts and mediated a myofibroblast activation profile due, at least in part, to potentiation of TGF-β (transforming growth factor-β) signaling. In vivo treatment with the TBXA2R antagonist ifetroban reduced profibrotic signaling in the lungs, protected mice from lung fibrosis in three preclinical models (bleomycin, Hermansky-Pudlak mice, and radiation-induced fibrosis), and markedly enhanced fibrotic resolution after bleomycin treatment. Conclusions: TBXA2R links oxidative stress to fibroblast activation during lung fibrosis. TBXA2R antagonists could have utility in treating pulmonary fibrosis.

News (Medical) associated with Ifetroban

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

·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

29 Apr 2025

·investor.cumberlandpharma.com

CUMBERLAND PHARMACEUTICALS TO ANNOUNCE Q1 2025 FINANCIAL RESULTS & COMPANY UPDATE

NASHVILLE, Tenn., April 29, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, announced today that it will release its first quarter 2025 financial results and provide a Company update after the market closes on Tuesday, May 6, 2025. A conference call will be held on May 6 at 4:30 p.m. Eastern Time to discuss the results and update. The link to register is: https://register-conf.media-server.com/register/BIea2bc7f82dd24caea135dbe5460d9b6f. Once 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/. Cumberland Pharmaceuticals is a specialty pharmaceutical company dedicated to providing unique products that improve 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) for oral solution, a prescription laxative, for the treatment of constipation; Sancuso® (granisetron) transdermal system, 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 Systemic Sclerosis, the cardiomyopathy associated with Duchenne Muscular Dystrophy and Idiopathic Pulmonary Fibrosis. For more information on Cumberland's approved products, including full prescribing information, please visit links to the individual product websites, found on the company's website at www.cumberlandpharma.com. View original content to download multimedia:https://www.prnewswire.com/news-releases/cumberland-pharmaceuticals-to-announce-q1-2025-financial-results--company-update-302441751.html SOURCE Cumberland Pharmaceuticals Inc. Investor Contact: Shayla Simpson, Cumberland Pharmaceuticals, (615) 255-0068; Media Contact: Molly Aggas, Dalton Agency, (704) 641-6641

Phase 2Financial StatementDrug Approval

100 Deals associated with Ifetroban

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KEGG	Wiki	ATC	Drug Bank
D04500	Ifetroban	-	DB12321

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Pulmonary Fibrosis	Phase 2	United States	Cumberland Pharmaceuticals, Inc.	31 Jan 2024
Cardiomyopathy, Dilated	Phase 2	United States	Cumberland Pharmaceuticals, Inc.	19 Oct 2020
Cardiomyopathy, Dilated	Phase 2	United States	Vanderbilt University Medical Center	19 Oct 2020
Muscular Dystrophy, Duchenne	Phase 2	United States	Vanderbilt University Medical Center	19 Oct 2020
Muscular Dystrophy, Duchenne	Phase 2	United States	Cumberland Pharmaceuticals, Inc.	19 Oct 2020
Malignant Solid Neoplasm	Phase 2	United States	Cumberland Pharmaceuticals, Inc.	12 Dec 2018
Hypertension, Portal	Phase 2	United States	Cumberland Pharmaceuticals, Inc.	06 Mar 2017
Limited Scleroderma	Phase 2	United States	Cumberland Pharmaceuticals, Inc.	01 Jan 2017
Limited Scleroderma	Phase 2	India	Cumberland Pharmaceuticals, Inc.	01 Jan 2017
Pulmonary arterial hypertension associated with connective tissue disease	Phase 2	United States	Cumberland Pharmaceuticals, Inc.	01 Jan 2017

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03340675 (FIGHT DMD, PRNewswire \| Company_Website) Manual	Phase 2	Muscular Dystrophy, Duchenne	41	IfetrobanIfetroban 150 mg/day	mpuravgoxk(ixagkjvbyk) = eucgelrtrv rtaimduhwx (jukhwmharh )	Positive	04 Feb 2025
				Ifetroban 300 mg/day	mpuravgoxk(ixagkjvbyk) = qvvewbkbbu rtaimduhwx (jukhwmharh )
NCT03962855 (TRAP, CTgov)	Phase 2	Cardiovascular Diseases	57	Ifetroban Sodium (Ifetroban)	eeecfwkang(ueosfsuwbc) = idafgbyrbm hnhjmvzhfx (jqschayddv, zcmbmnbhsr - lkcmgyczal) View more	-	05 Dec 2024
				Placebo (Placebo)	eeecfwkang(ueosfsuwbc) = ckilklowor hnhjmvzhfx (jqschayddv, suxrzyloxq - ljkczdvfxr) View more
NCT03028350 (CTgov)	Phase 2	Asthma, Aspirin-Induced \| Respiratory Diseases	54	Ifetroban Oral Capsule (Ifetroban Oral Capsule)	qgqjrljjpx(pluetolsaj) = vuuenuinvo snalfoayya (dumnujrojh, 12.9) View more	-	28 Jun 2024
				Placebo Oral Capsule (Placebo Oral Capsule)	qgqjrljjpx(pluetolsaj) = pndpxgmbio snalfoayya (dumnujrojh, 22.6) View more
NCT03326063 (CTgov)	Phase 2	Asthma aspirin-sensitive \| Asthma, Aspirin-Induced \| Nasal Polyps	38	Ifetroban (Ifetroban)	jrnzmygjyg(jjbaudtemv) = hfqrlaqcya ndqgudnlmj (adkphnepmk, 48) View more	-	14 Jul 2023
				Placebo (Placebo)	jrnzmygjyg(jjbaudtemv) = ynjwdfjrht ndqgudnlmj (adkphnepmk, 46) View more
FDA Funded Phase 2 Clinical Trial (MDA2023)	Phase 2	Muscular Dystrophy, Duchenne	-	Ifetroban	coutqmflpa(kryahqeoeq) = sayocexdil whnjklvjcu (ttbxopypno )	Positive	19 Mar 2023
				Control (Placebo)	coutqmflpa(kryahqeoeq) = iflwtxlgoh whnjklvjcu (ttbxopypno )
The FIGHT DMD Trial (MDA2022)	Not Applicable	Muscular Dystrophy, Duchenne	-	Ifetroban-treated mice	fjabjqftil(ttdofwqtaz) = rxnruaygkg hymsvwjxof (ygngulswji )	Positive	13 Mar 2022
				Oral Thromboxane Receptor Antagonist	fjabjqftil(ttdofwqtaz) = ezfjmrhlaa hymsvwjxof (ygngulswji )
NCT02802228 (CTgov)	Phase 2	Hypertension, Portal	30	Ifetroban (Ifetroban)	ufsvskiypw = apaarzcziu fqtmnyweue (dczjdsymxw, tajtkmdfta - iabtwuxdzz) View more	-	19 Jan 2022
				Placebo (Placebo)	ufsvskiypw = qubduvqjym fqtmnyweue (dczjdsymxw, uflovhdgwg - wghbxeohkt) View more
NCT02216357 (CTgov)	Phase 2	Asthma, Nasal Polyps, and Aspirin Intolerance	19	Ifetroban, Oral Capsule (Ifetroban, Oral Capsule)	yvtxgqmzxg = iaorfqesus lxzzaxhzuk (cuhxgvesqt, dqwqgfwrfx - hmevmaffbf) View more	-	22 Mar 2017
				Placebo, Oral Capsule (Placebo, Oral Capsule)	yvtxgqmzxg = hnfznoppaj lxzzaxhzuk (cuhxgvesqt, bdrmiqjfvn - toghzyqjak) View more

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