Dr. Falk Pharma GmbH

Address: Leinenweberstrasse 5, Hochdorf

Sponsor Overview

assignment

Specializations

Inflammatory Oesophageal Disorders

Dr. Falk Pharma GmbH is active in eosinophilic esophagitis and in the prevention of oesophageal strictures after endoscopic treatment, with a clear focus on conditions affecting the oesophagus and swallowing function.

Eosinophilic esophagitis
Oesophageal stricture prevention
Budesonide orodispersible tablets

The sponsor also funds work on acute radiation proctitis, extending its interest in gastrointestinal inflammation beyond the upper digestive tract.

Intestinal Autoimmune and Gluten-related Disease

Another major area of interest is celiac disease, particularly persistent symptoms and mucosal injury in patients maintaining a gluten-free diet.

Celiac disease
Symptom control
Mucosal healing

Research in this field includes therapies aimed at reducing ongoing intestinal inflammation and improving disease-related discomfort in adults.

Hepatobiliary Cholestatic Disease

The sponsor shows strong involvement in primary sclerosing cholangitis, including studies addressing disease activity, progression, and treatment tolerability in a chronic cholestatic liver disease.

Primary sclerosing cholangitis
Norursodeoxycholic acid
Norucholic acid

This therapeutic area reflects a sustained interest in bile acid-related approaches for complex hepatobiliary disorders.

Motility and Functional Upper Gastrointestinal Disorders

Dr. Falk Pharma GmbH also funds research in idiopathic and diabetic gastroparesis, focusing on impaired gastric emptying and related symptom burden.

Gastroparesis
Upper gastrointestinal motility
Naronapride

These studies place emphasis on digestive motility disorders that affect meal tolerance, nausea, and postprandial discomfort.

Sponsored Trials

Trial Name	Country	Status
Comparative Bioavailability and Food Effect of Four Norucholic Acid Formulations (tablet, granule, capsule) in Healthy Adult Volunteers	Germany	Recruiting
Efficacy and Safety Evaluation of Naronapride Dihydrochloride Trihydrate in Moderate Idiopathic or Diabetic Gastroparesis: A Randomized, Double-Blind, Placebo-Controlled Study	Austria Belgium France Germany Italy Latvia Poland The Netherlands	Not Recruiting
Efficacy and Tolerability of Budesonide Orodispersible Tablets in Preventing Esophageal Strictures Post-Endoscopic Submucosal Dissection in Adults	France Germany Poland Portugal Spain Sweden The Netherlands	Not Recruiting
Efficacy and Tolerability of Rectal Budesonide Suppositories for Acute Radiation Proctitis in Male Patients with Prostate Carcinoma: A Phase II Randomized Controlled Trial	Austria Germany	Recruiting
Efficacy and Tolerability of ZED1227 in Patients with Celiac Disease Experiencing Symptoms Despite a Gluten-Free Diet: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial	Austria Croatia Finland Germany Ireland Italy Norway Poland Romania Spain Sweden	Recruiting
Evaluation of Norucholic Acid in the Treatment of Primary Sclerosing Cholangitis: An Open-Label Study	Austria Belgium Denmark France Germany Hungary Norway Poland Sweden The Netherlands	Not Recruiting
Non-Inferiority Phase III Trial of Budesonide Orodispersible Tablets for Inducing Histological Remission in Adult Eosinophilic Esophagitis	Austria Germany Portugal Spain	Recruiting
Pharmacokinetic Comparison of Oral Budesonide Formulations With and Without Food in Patients With Acute Eosinophilic Esophagitis	Sweden	Not Yet Recruiting
Pharmacokinetic Interaction Study of Itraconazole, Quinidine, and Rifampicin on Single-Dose ZED1227 in Healthy Subjects	Portugal	Not Recruiting
Pharmacokinetic Interaction Study of Naronapride with Food, Itraconazole, and Rifampicin in Healthy Subjects	Portugal	Not Recruiting