Vasculan (ifetroban) / Cumberland - LARVOL DELTA

Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (clinicaltrials.gov) - P2 | N=34 | Active, not recruiting | Sponsor: Cumberland Pharmaceuticals | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ May 2026

Enrollment closed • Trial completion date • Cardiovascular • Dermatology • Hypertension • Immunology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Rheumatology • Scleroderma • Systemic Sclerosis

CUMBERLAND PHARMACEUTICALS RECEIVES FDA ORPHAN DRUG AND RARE PEDIATRIC DISEASE DESIGNATIONS FOR NEW TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (PRNewswire) - "Cumberland Pharmaceuticals Inc...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."

FDA event • Orphan drug • Duchenne Muscular Dystrophy • Immunology • Muscular Dystrophy

Cumberland Pharmaceuticals Reports Third Quarter 2023 Financial Results (PRNewswire) - "Patient enrollment is well underway in two company sponsored Phase II clinical programs to evaluate ifetroban in Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs; and the Cardiomyopathy associated with Duchenne Muscular Dystrophy ('DMD'), a rare and fatal genetic neuromuscular disease that results in deterioration of the skeletal, heart and lung muscles."

Enrollment status • Immunology • Systemic Sclerosis

Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (clinicaltrials.gov) - P2 | N=34 | Recruiting | Sponsor: Cumberland Pharmaceuticals | Trial completion date: Dec 2022 ➔ Dec 2025 | Trial primary completion date: Dec 2022 ➔ Dec 2025

Trial completion date • Trial primary completion date • Cardiovascular • Dermatology • Fibrosis • Hypertension • Immunology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Rheumatology • Scleroderma • Systemic Sclerosis

Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (clinicaltrials.gov) - P2; N=34; Recruiting; Sponsor: Cumberland Pharmaceuticals; Trial completion date: Feb 2021 ➔ Dec 2022; Trial primary completion date: Dec 2020 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Dermatology • Fibrosis • Hypertension • Immunology • Pulmonary Arterial Hypertension • Rheumatology • Scleroderma • Systemic Sclerosis

Cumberland Pharmaceuticals Reports Second Quarter 2021 Financial Results & Company Update (PRNewswire) - "Cumberland is sponsoring Phase II clinical programs to evaluate its ifetroban product candidates in...Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs...Enrollment in these clinical studies was interrupted due to the COVID-19 pandemic. While enrollment of new patients has been limited in 2021, many of the clinical study sites have reopened and resumed screening of patients for potential enrollment into the studies."

Enrollment status • Immunology • Systemic Sclerosis

Cumberland Pharmaceuticals Reports Second Quarter 2020 Financial Results & Company Update (Cumberland Press Release) - "Cumberland has completed a pilot Phase II study involving ifetroban in patients suffering from aspirin-exacerbated respiratory disease, a severe form of asthma. A follow-up Phase II study is currently underway for this asthma indication. The Company is also currently evaluating ifetroban in...patients with cardiomyopathy associated with Duchenne Muscular Dystrophy..."

Trial status • Asthma • Duchenne Muscular Dystrophy • Respiratory Diseases

Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (clinicaltrials.gov) - P2; N=34; Recruiting; Sponsor: Cumberland Pharmaceuticals; Trial completion date: Feb 2020 ➔ Feb 2021; Trial primary completion date: Dec 2019 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date

Cumberland Pharmaceuticals announces strategic review (PRNewswire) - "Cumberland Pharmaceuticals Inc....today announced that it has commenced a strategic review of its branded product portfolio, as well as its roster of international partners....Cumberland also continued to advance its Vasculan® and Boxaban® clinical programs, with patient enrollment progressing in each of those Phase II studies."

Enrollment status

Cumberland Pharmaceuticals reports fourth quarter revenue growth of 16% (PRNewswire) - "Cumberland also continued to advance its Vasculan and Boxaban clinical programs, with patient enrollment progressing in each of those Phase II studies."

Enrollment status