Product Description
Prednisolone is a synthetic glucocorticoid with anti-inflammatory and immunomodulating properties. After cell surface receptor attachment and cell entry, prednisolone enters the nucleus where it binds to and activates specific nuclear receptors, resulting in an altered gene expression and inhibition of proinflammatory cytokine production. This agent also decreases the number of circulating lymphocytes, induces cell differentiation, and stimulates apoptosis in sensitive tumor cells populations. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Prednisolone)
Mechanisms of Action: GR Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
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: Intestinal Diseases | Renal Transplant | Transplantation Unspecified | Kidney Diseases
Known Adverse Events: Weight Gain
Company: GlaxoSmithKline
Company Location: BRENTFORD MIDDLESEX X0 TW8 9GS
Company CEO: Emma Walmsley
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Brazil, Germany, India, Japan, New Zealand, Poland, United Kingdom
Active Clinical Trial Count: 11
Highest Development Phases
Phase 3: Adrenal Insufficiency|Aspergillosis, Allergic Bronchopulmonary|COVID-19|Fetal Diseases|Kidney Diseases|Post Acute COVID-19 Syndrome|Pregnancy Complications, Infectious|Pregnancy Outcomes|Prostate Cancer|Pulmonary Aspergillosis|Rhinitis, Allergic
Phase 2: Giant Cell Arteritis|Polymyalgia Rheumatica
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| PICA | P3 |
Recruiting |
Aspergillosis, Allergic Bronchopulmonary|Pulmonary Aspergillosis |
2025-11-01 |
|
| SPI-62-CL-2003 | P2 |
Unknown Status |
Polymyalgia Rheumatica |
2025-05-31 |
|
| DESPRED | P3 |
Recruiting |
Rhinitis, Allergic |
2025-05-30 |
|
| SPI-62-CL-1002 | P1 |
Suspended |
Polymyalgia Rheumatica|Giant Cell Arteritis |
2025-04-30 |