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 / 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: Chen, Chongjia C ; Laidlaw, Tanya M ; 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 ; Carrier, Erica J. ; Winters, Nichelle I. ; Chen, Jingyuan ; Gokey, Jason J. ; 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

09 Dec 2024

·investor.cumberlandpharma.com

FDA APPROVES ACETADOTE® sNDA

- New Dosing Regimen Simplifies Administration - NASHVILLE, Tenn., Dec. 9, 2024 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on delivering high-quality products to improve patient care, announced today the FDA has approved a supplemental New Drug Application (sNDA) for its Acetadote® (N-acetylcysteine for injection) product. Acetadote is an intravenous (IV) formulation of N-acetylcysteine (NAC) indicated to prevent or lessen liver injury after ingestion of potentially toxic quantities of acetaminophen1. Acetaminophen, a common over-the-counter pain reliever and fever reducer, is the leading cause of acute liver failure in the United States. Each year, thousands of individuals experience accidental or intentional acetaminophen poisoning, leading to serious liver damage. The newly approved dosing regimen simplifies the administration of Acetadote by combining the first two bags of the standard regimen into a single, slower infusion. This streamlined approach has been implemented in hospitals across multiple countries and demonstrated to reduce the frequency of medication errors and potentially serious non-allergic anaphylactoid reactions (NAARs) without compromising the effectiveness of Acetadote2-6. By simplifying the dosing regimen, health care providers can administer the life-saving treatment more efficiently, potentially improving patient outcomes. "This FDA approval is a significant step forward in the treatment of acetaminophen overdose," said Rick Dart, MD, PhD, Director at the Rocky Mountain Poison and Drug Center. "By streamlining the administration of NAC, we can improve patient outcomes and reduce the risk of adverse events. This simplified dosing regimen is a valuable tool for health care providers in managing this potentially life-threatening condition." "We are thrilled to announce the FDA approval of this simplified dosing regimen for Acetadote," said A.J. Kazimi, Cumberland's Chief Executive Officer. "This important milestone underscores our commitment to improving patient care and providing innovative solutions for urgent medical needs. By streamlining the administration process, we aim to enhance patient outcomes and reduce the burden on health care providers." Key Highlights: FDA-approved sNDA adds a simplified, IV NAC dosing regimen to the product prescribing information. New IV NAC dosing regimen is both safe and effective. New dosing regimen aims to minimize interruptions in care, medication errors and incidence of dose-related reactions. 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 cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis. 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. References: 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/fda-approves-acetadote-snda-302326652.html SOURCE Cumberland Pharmaceuticals Inc. Investor Contact: Shayla Simpson, Cumberland Pharmaceuticals, (615) 255-0068; Media Contact: Molly Aggas, Dalton Agency, (704) 641-6641

Drug ApprovalPhase 2

06 Nov 2024

·www.prnewswire.com

CUMBERLAND PHARMACEUTICALS RECEIVES FDA ORPHAN DRUG AND RARE PEDIATRIC DISEASE DESIGNATIONS FOR NEW TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY

NASHVILLE, Tenn., Nov. 6, 2024 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, announced today that the United States (U.S.) Food and Drug Administration (FDA) granted Orphan Drug Designation and Rare Pediatric Disease Designation to Ifetroban for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). Cumberland is completing the FIGHT DMD™ trial, a multicenter, double-blind, placebo-controlled Phase II study investigating the pharmacokinetics, safety and efficacy of once daily oral Ifetroban in patients with DMD. Results will be announced later this year. "For Duchenne muscular dystrophy, a devastating genetic disorder affecting young boys, securing both Orphan Drug and Rare Pediatric Disease Designations for Ifetroban from the FDA is a critical step forward," said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals. "These designations not only recognize the urgent need for effective treatments but also provide vital support to accelerate research and development. These important regulatory milestones represent hope for families and a pathway to bring transformative medicines to a vulnerable patient population more quickly and efficiently." The U.S. FDA grants Rare Pediatric Disease Designation to incentivize drug development for life-threatening diseases affecting less than 200,000 children in the U.S. As these diseases pose unique challenges to drug development, special focus is needed to provide therapeutic options to these children. Companies that receive approval for a drug or biologic with this designation may be eligible for a voucher which may be redeemed for priority review of a different product. Additionally, this voucher may be transferred or sold to another sponsor. Orphan Drug Designation is granted by the U.S. FDA to encourage development of new therapies for rare diseases or conditions affecting fewer than 200,000 people in the U.S. This designation offers sponsors multiple incentives, which include exemption from user fees, tax credits for qualified clinical trials and potential market exclusivity for seven years following approval of the product. About Duchenne Muscular Dystrophy DMD is a rare and fatal genetic disorder which affects about 1 in every 3,300 male births worldwide. Characterized by mutations in the gene responsible for producing dystrophin, DMD causes damage to the skeletal and cardiac muscle of DMD patients, with cardiomyopathy recognized as the primary cause of death. Ifetroban is being evaluated to treat the heart disease associated with DMD, which has received limited attention with current therapies. About Ifetroban Ifetroban is a potent and selective thromboxane-prostanoid receptor (TPr) antagonist. Ifetroban exhibits high affinity for TPr on many cell types including cardiomyocytes, platelets, vascular and airway smooth muscle, and fibroblasts, and lacks agonistic activity. In several preclinical models of muscular dystrophy, including limb-girdle and Duchenne, ifetroban prevented cardiac fibrosis and cardiac dysfunction and improved mortality. Cumberland previously announced the acquisition of the ifetroban program in collaboration with Vanderbilt University and Cumberland Emerging Technologies. Cumberland is also evaluating ifetroban for systemic sclerosis and pulmonary fibrosis. The ongoing FIGHTING FIBROSIS Trial is a multicenter, randomized placebo-controlled Phase II study in patients with idiopathic pulmonary fibrosis (IPF), a progressive interstitial lung disease. IPF is marked by inflammation and fibrosis of the lungs, resulting in rapidly declining lung function and reduced survival within five years of diagnosis. The study is evaluating the safety and efficacy of once daily oral Ifetroban for 52 weeks. About Cumberland Pharmaceuticals Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the delivery of high-quality prescription brands to improve patient care. The Company develops, acquires, and commercializes brands for the hospital acute care, gastroenterology and rheumatology 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; Vaprisol® (conivaptan) Injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; 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; Kristalose® (lactulose) for Oral Solution, a prescription laxative, for the treatment of chronic and acute constipation; and Sancuso® (granisetron) Transdermal delivery system, for the treatment of nausea and vomiting associated with chemotherapy. For more information on Cumberland's approved products, including full prescribing information, please visit the individual product websites, links to which can be found on the Company's website . About Cumberland Emerging Technologies Cumberland Emerging Technologies, Inc. () is a joint initiative between Cumberland Pharmaceuticals Inc., Vanderbilt University, Launch Tennessee and WinHealth Pharma. The mission of CET is to bring biomedical technologies and products conceived at Vanderbilt and other regional research centers to 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, located in Nashville, Tennessee, provides laboratory space, equipment and infrastructure to early-stage life sciences companies. 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. 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 results of operations. These factors include market conditions, competition, an inability of manufacturers to produce Cumberland's products on a timely basis or failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure, natural disasters, public health epidemics, and other events beyond our control, as more fully discussed in the Company's most recent Form 10-K and subsequent 10-Qs as filed with the SEC. 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. SOURCE Cumberland Pharmaceuticals Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Orphan DrugAcquisitionClinical Result

05 Nov 2024

·www.prnewswire.com

New Study Compares Caldolor® (ibuprofen injection) to ketorolac

– Real World Study Compared Over 150,000 Adult & Pediatric Patients – – Caldolor Associated with Fewer Adverse Drug Reactions – – Caldolor also Improved Healthcare Utilization – NASHVILLE, Tenn., Nov. 5, 2024 /PRNewswire/ -- Specialty pharmaceutical company Cumberland Pharmaceuticals (Nasdaq: CPIX) today announced the publication of new real-world outcomes research demonstrating the safety and healthcare resource advantages of its Caldolor (ibuprofen) injection over ketorolac in both adult and pediatric populations. The study, published in Frontiers of Pain Research, provides compelling evidence that Caldolor is associated with a significantly reduced incidence of adverse drug reactions (ADRs) and improved healthcare utilizations when compared to ketorolac. This extensive, retrospective, payer database analysis evaluated the records of over 17 million patients who had received either ketorolac or Caldolor. Ultimately, 31,046 Caldolor and 124,184 ketorolac adult patients were selected and compared for ADRs and subsequent healthcare resource utilization, which includes inpatient, outpatient and emergency department visits as well as all procedures and prescriptions during the follow up time of 29 days. An additional 5,579 pediatric patients were identified in each arm and compared in a separate claims analysis. Key findings reveal that, in adults, Caldolor was associated with a 45% reduction in renal dysfunction (p<0.001) and a 78% decrease in hematuria rates (p<0.001) when compared to ketorolac. Notably, patients also experienced fewer gastrointestinal complications as well as reduced headaches, nausea and abdominal pain. Among pediatric patients, the results showed Caldolor was associated with a 51-65% lower rate of ADRs, including headache and nausea, with 95% confidence intervals supporting clinical significance. Caldolor also demonstrated a positive impact on healthcare resource utilization (HCRU) when compared to ketorolac, with decreased emergency room and outpatient visits, as well as a shortened hospital length of stay for both adults and children. "These findings underscore Caldolor's potential to improve patient care by reducing their treatment complications, while also delivering potential savings for healthcare systems through decreased hospital readmissions and shortened treatment times," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. About Caldolor® (ibuprofen) Injection Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and 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 NSAIDs, 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 . 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 cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis. For more information on Cumberland's approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the company's website . 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. 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 results of operations. These factors include market conditions, competition, an inability of manufacturers to produce Cumberland's products on a timely basis or failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure, natural disasters, public health epidemics, and other events beyond our control, as more fully discussed in the Company's most recent Form 10-K and subsequent 10-Qs as filed with the SEC. 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. SOURCE Cumberland Pharmaceuticals Inc. 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Clinical ResultDrug ApprovalPhase 2

100 Deals associated with Ifetroban

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KEGG	Wiki	ATC	Drug Bank
D04500	Ifetroban	-	DB12321

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Pulmonary Fibrosis	Phase 2	US	Cumberland Pharmaceuticals, Inc.	31 Jan 2024
Cardiomyopathy, Dilated	Phase 2	US	Cumberland Pharmaceuticals, Inc.	19 Oct 2020
Cardiomyopathy, Dilated	Phase 2	US	Vanderbilt University Medical Center	19 Oct 2020
Muscular Dystrophy, Duchenne	Phase 2	US	Vanderbilt University Medical Center	19 Oct 2020
Muscular Dystrophy, Duchenne	Phase 2	US	Cumberland Pharmaceuticals, Inc.	19 Oct 2020
Malignant Solid Neoplasm	Phase 2	US	Cumberland Pharmaceuticals, Inc.	12 Dec 2018
Asthma, Aspirin-Induced	Phase 2	US	Cumberland Pharmaceuticals, Inc.	17 Jul 2017
Hypertension, Portal	Phase 2	US	Cumberland Pharmaceuticals, Inc.	06 Mar 2017
Liver Cirrhosis	Phase 2	US	Cumberland Pharmaceuticals, Inc.	06 Mar 2017
Associated Pulmonary Arterial Hypertension	Phase 2	US	Cumberland Pharmaceuticals, Inc.	01 Jan 2017

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03962855 (TRAP, CTgov)	Phase 2	Cardiovascular Diseases	57	Ifetroban Sodium (Ifetroban)	wsmfobnjfa(vbjcymxpsm) = ygtodtyhzx pqzovpnvzn (xzrqzqxlsy, qkdhmsdrtw - bnivmuyudb) View more	-	05 Dec 2024
				Placebo (Placebo)	wsmfobnjfa(vbjcymxpsm) = rtsmgdbfpy pqzovpnvzn (xzrqzqxlsy, mcsjrwkdaq - sdsiejtcpy) View more
NCT03028350 (CTgov)	Phase 2	Asthma, Aspirin-Induced \| Respiratory Diseases	54	Ifetroban Oral Capsule (Ifetroban Oral Capsule)	ypnlxkvphz(bhhfiumfyz) = euuyfqgvrx lxhvjkfbkc (cqgvxpskbm, ykrzoxcczt - yaxnztylpu) View more	-	28 Jun 2024
				Placebo Oral Capsule (Placebo Oral Capsule)	ypnlxkvphz(bhhfiumfyz) = redpyuoxax lxhvjkfbkc (cqgvxpskbm, lnzzhhjrbu - xezyfxfgdz) View more
NCT03326063 (CTgov)	Phase 2	Asthma aspirin-sensitive \| Asthma, Aspirin-Induced \| Nasal Polyps	38	Ifetroban (Ifetroban)	jixftrnvzx(ibfcvsswzx) = ooofvwxaqw aleomdygfs (olfjrqrdfz, hwiypzitdi - surubpenuy) View more	-	14 Jul 2023
				Placebo (Placebo)	jixftrnvzx(ibfcvsswzx) = fhisjgfmdd aleomdygfs (olfjrqrdfz, qspyseensx - qjdqcyzyiq) View more
The FIGHT DMD Trial (MDA2022)	Not Applicable	Muscular Dystrophy, Duchenne	-	Ifetroban-treated mice	spsxcjpmdg(hkhwnhyhfk) = mpnvmbzscy eevslqngre (pcwatcvruo )	Positive	13 Mar 2022
				Oral Thromboxane Receptor Antagonist	spsxcjpmdg(hkhwnhyhfk) = vbvtdzberq eevslqngre (pcwatcvruo )
NCT02802228 (CTgov)	Phase 2	Hypertension, Portal \| Liver Cirrhosis	30	Ifetroban (Ifetroban)	ervrrhoydd(orztemnzyl) = gcauvqgtxc xuivoplhhk (nceehwbcpt, jnjmtjhkav - eodcddxame) View more	-	19 Jan 2022
				Placebo (Placebo)	ervrrhoydd(orztemnzyl) = sktsofqlgw xuivoplhhk (nceehwbcpt, ratcgydllo - zenmdmmtll) View more
NCT02216357 (CTgov)	Phase 2	Asthma aspirin-sensitive	19	Ifetroban, Oral Capsule (Ifetroban, Oral Capsule)	npuofbnvxv(cpzimpbppm) = msstommmew ehvsurwfqh (ccpgkkzcma, dfegagoecj - wpzxmmhoil) View more	-	22 Mar 2017
				Placebo, Oral Capsule (Placebo, Oral Capsule)	npuofbnvxv(cpzimpbppm) = nunbxpikjd ehvsurwfqh (ccpgkkzcma, qxphluzeip - qvyiuqijqy) View more

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