Product Description
Budesonide is used to treat Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever). Budesonide is in a class of medications called corticosteroids. It works by decreasing inflammation (swelling) in the digestive tract of people who have Crohn's disease.
Mechanisms of Action: GR Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral,Inhalant,Nasal
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Colitis | Colitis, Ulcerative | Colitis | Colitis, Ulcerative | Crohn Disease | IgA Nephropathy | Kidney Diseases | Proteinuria | Chronic Obstructive Pulmonary Disease
Known Adverse Events: Abdominal Pain | Headache | Pain Unspecified | Arthralgia | Constipation | Flatulence | Adrenal Insufficiency | Kidney Diseases | Back Pain | Dizziness | Dyspepsia | Hypertension | Spasm | Dermatitis | Hirsutism | Dyspnea | Edema | Respiratory Tract Infections | Candidiasis | Candidiasis, Oral | Pneumonia | Sinusitis | Diarrhea | Influenza, Human
Company: Calliditas Therapeutics AB
Company Location:
Company CEO:
Additonal Commercial Interests: Everest Medicines
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States, Unknown Location, Vietnam
Active Clinical Trial Count: 54
Highest Development Phases
Phase 3: Asthma|COVID-19|Chronic Obstructive Pulmonary Disease|Colitis, Ulcerative|Conjunctivitis, Allergic|Crohn Disease|Eosinophilic Esophagitis|Glomerulonephritis|IgA Nephropathy|Kidney Diseases|Nasal Polyposis|Pregnancy Outcomes|Rhinitis, Allergic|Severe Acute Respiratory Syndrome|Sinusitis|Spasm
Phase 2: Colitis, Microscopic|Esophageal Cancer|Healthy Volunteers|Mouth Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| D5989C00001 THARROS | P3 |
Unknown Status |
Chronic Obstructive Pulmonary Disease |
2028-03-07 |
|
| ACT18301 | P2 |
Recruiting |
Asthma |
2027-10-12 |
|
| REB22-1240 | P2 |
Not yet recruiting |
Colitis, Microscopic |
2026-09-01 |
|
| BUL-8/EEA | P3 |
Unknown Status |
Eosinophilic Esophagitis |
2025-12-14 |