Prednisolone

Generic Name: Prednisolone

Brand Names: Millipred Dp 6 Day

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₈O_₅

CAS Number: 50-24-8

Unique Ingredient Identifier: 9PHQ9Y1OLM

Background: Prednisolone is a glucocorticoid similar to cortisol used for its anti-inflammatory, immunosuppressive, anti-neoplastic, and vasoconstrictive effects.

Prednisolone was granted FDA approval on 21 June 1955.

Indication: Prednisolone is indicated to treat endocrine, rheumatic, and hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, and gastrointestinal diseases; allergic and edematous states; and other conditions like tuberculous meningitis.

Associated Conditions: Acute Gouty Arthritis, Acute Leukemia, Allergic Bronchopulmonary Aspergillosis, Allergic Conjunctivitis (AC), Allergic Contact Dermatitis, Allergic Skin Reaction, Allergic corneal marginal ulcers, Alveolitis, Extrinsic Allergic, Ankylosing Spondylitis (AS), Aspiration Pneumonia, Aspiration Pneumonitis, Atopic Dermatitis, Bell's Palsy, Berylliosis, Bullous dermatitis herpetiformis, Burns, Chorioretinitis, Choroiditis, Congenital Adrenal Hyperplasia (CAH), Congenital Hypoplastic Anemia, Conjunctivitis, Contact Dermatitis, Corneal injuries, Corneal ulceration, Crohn's Disease (CD), Cyclitis, Dermatomyositis (DM), Dermatosis of the Ear Canal, Drug hypersensitivity reaction, Edema of the cerebrum, Epicondylitis, Erythroblastopenia, Exacerbation of COPD, Exacerbation of asthma, Eye inflammation caused by Cataract Surgery, Eye inflammation caused by Infection, Fissure;Anal, Herpes Zoster Keratitis, Hot Water Burns (Scalds), Hypercalcemia of Malignancy, Idiopathic Pulmonary Fibrosis (IPF), Immune Thrombocytopenia (ITP), Inflamed External Hemorrhoid, Inflamed Hemorrhoids, Internal, Inflammatory Reaction caused by susceptible Bacterial Infections, Iridocyclitis, Iritis, Itching caused by susceptible Bacterial Infections, Keratitis, Loeffler's syndrome, Lymphoma, Metastatic Castration-Resistant Prostate Cancer (mCRPC), Multiple sclerosis exacerbation, Mycosis Fungoides (MF), Ocular Inflammation, Ophthalmia, Sympathetic, Optic Neuritis, Otic Eczema, Pemphigus, Perennial Allergic Rhinitis (PAR), Pericarditis, Pneumocystis Jirovecii Pneumonia, Polymyalgia Rheumatica (PMR), Posterior Uveitis, Posttraumatic Osteoarthritis, Proctitis, Proteinuria, Pruritus, Pruritus Ani, Psoriatic Arthritis, Pulmonary Tuberculosis (TB), Pure Red Cell Aplasia, Rash, Relapsing Polychondritis, Rheumatoid Arthritis, Rheumatoid Arthritis, Juvenile, Rosacea, Seasonal Allergic Rhinitis, Secondary Adrenal Insufficiency, Secondary thrombocytopenia, Serum Sickness, Severe Asthma, Sjogren's Syndrome (SS), Stevens-Johnson Syndrome, Superficial punctate keratitis, Synovitis, Systemic Lupus Erythematosus, Transplanted Organ Rejection, Trichinosis, Tuberculosis (TB), Tuberculous Meningitis, Ulcerative Colitis, Uveitis, Vasculitis, Acquired immune hemolytic anemia, Acute Bursitis, Acute Rheumatic heart disease, unspecified, Acute Tenosynovitis, Anal eczema, Bacterial skin infections, Exfoliative erythroderma, Idiopathic Bronchiolitis obliterans with organizing pneumonia, Idiopathic eosinophilic pneumonias, Non-suppurative Thyroiditis, Primary adrenocoritical insufficiency, Severe Psoriasis, Severe Seborrhoeic dermatitis, Severe alcoholic liver disease, Steroid-responsive inflammation of the eye, Subacute Bursitis, Susceptible Bacterial Infections, Symptomatic Sarcoidosis, Varicella-zoster virus acute retinal necrosis

Associated Therapies: -

Clinical Trials

Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus

Phase 2

Completed

Conditions: Stomatitis
Neoplasm of the Breast
Malignant Tumor of Breast
Oral Mucositis

Interventions: Drug: Miracle Mouthwash Plus Hydrocortisone
Drug: Prednisolone

First Posted Date: 2014-08-29

Last Posted Date: 2022-12-01

Lead Sponsor: US Oncology Research

Target Recruit Count: 104

Registration Number: NCT02229136

Locations: 🇺🇸
12 sites incl Yakima, WA, Boulder, CO, and Austin, TX, US, Texas, United States

Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy

Phase 2

Completed

Conditions: Duchenne Muscular Dystrophy

Interventions: Drug: Prednisolone

First Posted Date: 2014-06-19

Last Posted Date: 2018-12-21

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 25

Registration Number: NCT02167217

Locations: 🇺🇸
Nemours Hospital, Orlando, Florida, United States
🇺🇸
Washington University in Saint Louis, Saint Louis, Missouri, United States
🇺🇸
University of California Davis, Sacramento, California, United States

and more 3 locations

Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair

Not Applicable

Terminated

Conditions: Hypospadias

Interventions: Drug: placebo-controlled
Drug: Prednisolone

First Posted Date: 2014-06-13

Last Posted Date: 2023-12-22

Lead Sponsor: Francis Schneck

Target Recruit Count: 28

Registration Number: NCT02162810

Locations: 🇺🇸
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

Urokinase Plasminogen Activator Receptor in Abiraterone Treated Patients With Castration Resistant Prostate Cancer

Terminated

Conditions: Prostatic Neoplasms

Interventions: Drug: Abiraterone
Drug: Prednisolone

First Posted Date: 2014-04-29

Last Posted Date: 2015-11-20

Lead Sponsor: Kristoffer Staal Rohrberg

Target Recruit Count: 3

Registration Number: NCT02125617

Locations: 🇩🇰
University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark

Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients

Phase 4

Completed

Conditions: Drug Interaction Potentiation

Interventions: Drug: Everolimus
Drug: Mycophenolate mofetil
Drug: Tacrolimus
Drug: Methylprednisolone
Drug: Prednisolone

First Posted Date: 2014-03-04

Last Posted Date: 2019-07-24

Lead Sponsor: National Taiwan University Hospital

Target Recruit Count: 14

Registration Number: NCT02077556

Locations: 🇨🇳
National Taiwan University Hospital, Taipei, Taiwan

Evaluation of Safety of Cabazitaxel (Jevtana) in Patients With Metastatic Hormone Refractory Prostate Cancer

Phase 4

Completed

Conditions: Prostate Cancer Metastatic

Interventions: Drug: CABAZITAXEL XRP6258
Drug: Prednisone
Drug: Prednisolone

First Posted Date: 2014-02-28

Last Posted Date: 2016-06-02

Lead Sponsor: Sanofi

Target Recruit Count: 10

Registration Number: NCT02074137

Locations: 🇮🇳
Investigational Site Number 356003, New Delhi, India
🇮🇳
Investigational Site Number 356005, Kollkata, India
🇮🇳
Investigational Site Number 356002, Trivandrum, India

A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms

Phase 4

Completed

Conditions: Cataract
Dry Eye Syndromes

Interventions: Drug: Sodium Carboxymethylcellulose
Drug: Levofloxacin
Drug: Prednisolone

First Posted Date: 2014-01-07

Last Posted Date: 2014-04-23

Lead Sponsor: Allergan

Target Recruit Count: 180

Registration Number: NCT02028754

Barretts oEsophageal Resection With Steroid Therapy Trial

Phase 4

Withdrawn

Conditions: Esophageal Stenosis
Barrett Esophagus

Interventions: Drug: Placebo Oral Tablet
Drug: Prednisolone

First Posted Date: 2013-12-09

Last Posted Date: 2023-07-03

Lead Sponsor: Professor Michael Bourke

Registration Number: NCT02004782

Locations: 🇦🇺
Westmead Hospital, Westmead, New South Wales, Australia

Comparison of the Effectiveness of Two Different Dosages of Cortisone Compared to Placebo in Rheumatoid Arthritis

Phase 3

Completed

Conditions: Progression of Rheumatoid Arthritis

Interventions: Drug: Placebo
Drug: Prednisolone

First Posted Date: 2013-12-04

Last Posted Date: 2020-04-10

Lead Sponsor: Prof. Dr. rer. nat. H.J. Trampisch

Target Recruit Count: 395

Registration Number: NCT02000336

Locations: 🇩🇪
Rheumapraxis Oberhausen, Oberhausen, Germany
🇩🇪
Rheumatologische Schwerpunktpraxis Bielefeld, Bielefeld, Germany
🇩🇪
Rheumatologische Schwerpunktpraxis Bocholt, Bocholt, Germany

and more 22 locations

A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma

Phase 1

Completed

Conditions: Lymphoma, Non Hodgkin

Interventions: Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Obinutuzumab
Drug: Polatuzumab Vedotin
Drug: Prednisolone
Drug: Prednisone
Drug: Rituximab

First Posted Date: 2013-11-25

Last Posted Date: 2023-03-14

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 85

Registration Number: NCT01992653

Locations: 🇫🇷
Hopital Henri Mondor, Unite Hemopathies lymphoides, Creteil, France
🇺🇸
Banner MD Anderson Cancer Center, Greeley, Colorado, United States
🇺🇸
The University of Alabama at Birmingham, Birmingham, Alabama, United States

and more 8 locations

Drug Development Updates

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