This section highlights FDA-related milestones and regulatory updates for drugs developed by Cumberland Pharmaceuticals (CPIX).
Over the past two years, Cumberland Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ifetroban and Vibativ. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ifetroban - FDA Regulatory Timeline and Events
ifetroban is a drug developed by Cumberland Pharmaceuticals for the following indication: In Duchenne Muscular Dystrophy Heart Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ifetroban
- Announced Date:
- June 23, 2025
- Indication:
- In Duchenne Muscular Dystrophy Heart Disease
Announcement
Cumberland Pharmaceuticals shared the latest positive results from its Phase 2 FIGHT DMD trial evaluating ifetroban, a novel oral therapy for Duchenne muscular dystrophy (DMD) heart disease, at the annual Parent Project Muscular Dystrophy (PPMD) conference in Las Vegas
AI Summary
Cumberland Pharmaceuticals recently presented promising Phase 2 FIGHT DMD trial results at the annual Parent Project Muscular Dystrophy conference in Las Vegas. The trial evaluated ifetroban, a novel oral therapy aimed at protecting the heart in Duchenne muscular dystrophy (DMD) patients, a group at high risk for life-threatening cardiac damage. New pharmacokinetic data and reductions in cardiac biomarkers, such as NT-proBNP and cardiac troponin I, indicate that ifetroban may help prevent ongoing heart damage. The study showed that high-dose ifetroban treatment resulted in a significant improvement in left ventricular ejection fraction, suggesting enhanced heart function. These findings provide compelling early evidence of ifetroban’s ability to slow the progression of heart disease in DMD patients, offering hope for a treatment that directly targets the leading cause of death in this vulnerable population.
Read Announcement- Drug:
- ifetroban
- Announced Date:
- February 4, 2025
- Indication:
- In Duchenne Muscular Dystrophy Heart Disease
Announcement
Cumberland Pharmaceuticals announced positive top-line results from its Phase 2 FIGHT DMD trial.
AI Summary
Cumberland Pharmaceuticals recently announced positive top-line results from its Phase 2 FIGHT DMD trial. The study tested ifetroban, a new oral therapy aimed at treating heart disease in patients with Duchenne muscular dystrophy (DMD). DMD leads to progressive muscle weakness and heart complications, making heart failure a leading cause of death. In this 12‑month, double‑blind, placebo‑controlled trial, 41 patients received either a low dose, a high dose of ifetroban, or placebo. The high dose group experienced an overall improvement of about 3.3% in left ventricular ejection fractions (LVEF), while the placebo group showed a decline. These findings suggest that ifetroban may help improve cardiac function in DMD patients, offering new hope where limited treatment options exist. The therapy was well‑tolerated with no serious drug‑related events reported, marking a breakthrough in addressing DMD-related heart disease.
Read Announcement
Vibativ - FDA Regulatory Timeline and Events
Vibativ is a drug developed by Cumberland Pharmaceuticals for the following indication: FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Vibativ
- Announced Date:
- March 4, 2025
- Indication:
- FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)
Announcement
Cumberland Pharmaceuticals announced 2024 highlights include expanded product labeling, key FDA designations and new study publications
AI Summary
Cumberland Pharmaceuticals announced that 2024 was a transformative year marked by important FDA-related milestones. The company expanded its product labeling and earned key FDA designations, including Orphan Drug and Rare Pediatric Disease status for its ifetroban product candidate. These designations target cardiomyopathy in patients with Duchenne muscular dystrophy and provide crucial support to accelerate the development of a much-needed therapy. Additionally, Cumberland shared new study publications that highlight real-world outcomes demonstrating the safety and effectiveness of its products. For example, research comparing Caldolor® to ketorolac emphasized Caldolor’s potential advantages in reducing adverse reactions and improving healthcare resource utilization. These initiatives reinforce Cumberland’s commitment to enhancing patient care, driving growth, and delivering value to stakeholders as the company continues to advance innovative treatments for patients in need.
Read Announcement- Drug:
- Vibativ
- Announced Date:
- February 18, 2025
- Indication:
- FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)
Announcement
Cumberland Pharmaceuticals Inc and SciClone Pharmaceuticals (Holdings) Limited announced the NMPA (National Medical Products Administration) approval of Cumberland's Vibativ® (telavancin) injection in China.
AI Summary
Cumberland Pharmaceuticals Inc. and SciClone Pharmaceuticals have announced that China’s National Medical Products Administration (NMPA) has approved Cumberland’s Vibativ® (telavancin) injection. This approval paves the way for the life-saving antibiotic to be launched in China, the world’s second-largest market. Under the agreement between the two companies, SciClone will have exclusive rights to register, promote, and distribute Vibativ in the country.
Vibativ is designed to treat hospital-acquired and ventilator-associated pneumonia as well as complicated skin infections, particularly those caused by multidrug-resistant Gram-positive bacteria such as MRSA. With its once-daily dosing and proven efficacy against drug-resistant infections, this approval represents a significant advancement in making effective treatment options available to patients in China.
Read Announcement
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