prednisone
Trade name: meticorten
Small moleculeapproved
Approved
Feb 21, 1955
Prednisone is a glucocorticoid medication mostly used to suppress the immune system and decrease inflammation in conditions such as asthma, COPD, and rheumatologic diseases. It is also used to treat high blood calcium due to cancer and adrenal insufficiency along with other steroids. It is taken by mouth. — Wikipedia
Clinical trial activity
2,167 trials · 1,085 clinical orgs · 106 marketing orgs
Phase 1
326
Phase 2
1432
Phase 3
610
Phase 4
313
Earliest trial started Jun 1, 1978 (NCT00000596)
Timeline
1950s
- Feb 21, 1955
Earliest FDA Approval
- Feb 21, 1955
Schering — NDA Secondary Org
- Jun 1, 1955
Schering-Plough — First NDA Organization
- Jun 1, 1955
Schering-Plough — NDA Organization
- Jun 21, 1955
Pharmacia & Upjohn — NDA Secondary Org
- Jul 1, 1955
Pfizer — NDA Secondary Org
1960s
- Sep 18, 1961
Allergan — NDA Secondary Org
1970s
- Nov 24, 1971
Roxane Laboratories — NDA Secondary Org
- Nov 24, 1971
Roxane Laboratories — Marketing Organization
- Dec 23, 1971
Inwood Laboratories — Marketing Organization
- Jan 4, 1972
Perrigo — NDA Secondary Org
- Jan 4, 1972
Padagis Us — Marketing Organization
- Jan 4, 1972
Padagis Us — NDA Secondary Org
- Jan 17, 1972
Watson Pharmaceuticals — Marketing Organization
- Apr 17, 1972
Bayer — Marketing Organization
- Apr 21, 1972
West-Ward Pharmaceutical — Marketing Organization
- Apr 21, 1972
John J. Ferrante — Marketing Organization
- Jul 5, 1972
Contract Pharmacal — Marketing Organization
- Jul 13, 1972
Sandoz — Marketing Organization
- Sep 6, 1972
Fosun — Marketing Organization
- Nov 10, 1972
AbbVie — Marketing Organization
- Nov 10, 1972
AbbVie — NDA Secondary Org
- Nov 14, 1972
Mutual Pharmaceutical — Marketing Organization
- May 1, 1973
Sperti — Marketing Organization
- Jun 20, 1973
Whiteworth Towne Paulsen — Marketing Organization
- Jul 10, 1973
Alcon — NDA Secondary Org
- Jul 10, 1973
Novartis — NDA Secondary Org
- Jul 10, 1973
Eyevance — Marketing Organization
- Jul 10, 1973
Eyevance — NDA Secondary Org
- Jul 13, 1973
Impax Laboratories — Marketing Organization
- Jan 29, 1974
Solvay — Marketing Organization
- Mar 6, 1974
Belmar Pharmacy — Marketing Organization
- Mar 21, 1974
Heather Pharma — Marketing Organization
- May 2, 1974
Lannett Company, Inc. — Marketing Organization
- Feb 25, 1975
Everylife Foundation for Rare Diseases — Marketing Organization
- Jun 12, 1975
Akorn, Inc. — Marketing Organization
- Jun 17, 1975
Barr Laboratories — Marketing Organization
- Dec 9, 1975
Schwarz Pharma — Marketing Organization
- Aug 26, 1976
Mylan — Marketing Organization
- Jan 1, 1978
Earliest Phase 2 Sponsor(trial)
- Feb 21, 1978
Bayer — NDA Secondary Org
- May 31, 1978
Aurobindo Pharma — Marketing Organization
- May 31, 1978
Rising Pharmaceuticals — Marketing Organization
- Jul 13, 1978
Parke-Davis — NDA Secondary Org
- Jul 13, 1978
Warner Lambert — NDA Secondary Org
- Apr 10, 1979
Sun Pharmaceuticals — Marketing Organization
1980s
- Jul 21, 1981
Nestle — Marketing Organization
- Jan 15, 1982
Vanguard — Marketing Organization
- Mar 17, 1982
Muro Pharmaceuticals — Marketing Organization
- Jul 27, 1982
Lederle — Marketing Organization
- Jul 27, 1982
American Cyanamid — Marketing Organization
- Dec 28, 1982
Bausch & Lomb — Marketing Organization
- Apr 19, 1983
Pharmafair — Marketing Organization
- Oct 4, 1983
Duramed Research — Marketing Organization
- Nov 22, 1983
Chartwell Pharmaceuticals — Marketing Organization
- Jun 1, 1984
Hikma — Marketing Organization
- Oct 5, 1984
Novartis — Marketing Organization
- Oct 25, 1984
Superpharm — Marketing Organization
- Dec 14, 1984
Galderma — NDA Secondary Org
- Feb 4, 1986
Teva — Marketing Organization
- Dec 3, 1986
SmithKline Beckman — Marketing Organization
- Jan 1, 1988
Earliest Phase 3 Sponsor(trial)
- Jun 10, 1988
SmithKline Beckman — NDA Secondary Org
- Jun 15, 1988
Galderma — Marketing Organization
- Aug 2, 1988
Wockhardt — Marketing Organization
- Aug 2, 1988
Xttrium Laboratories — Marketing Organization
- Dec 1, 1989
SmithKline Beecham — NDA Secondary Org
1990s
- Jun 30, 1992
Taro Pharmaceuticals — NDA Secondary Org
- Sep 28, 1992
Cosette — Marketing Organization
- Sep 28, 1992
ACP Nimble — Marketing Organization
- Sep 28, 1992
G & W Laboratories Inc. — Marketing Organization
- Jan 1, 1997
Earliest Phase 1 Sponsor(trial)
- May 12, 1998
Pfizer — Marketing Organization
- May 28, 1998
We Pharma Ltd — Marketing Organization
- May 13, 1999
VistaPharm, Inc. — Marketing Organization
2000s
- Mar 12, 2001
Fougera — Marketing Organization
- Aug 29, 2001
Jubilant Innovation Ltd. — Marketing Organization
- Oct 22, 2001
Nesher Pharms — Marketing Organization
- Jul 12, 2002
Vintage — Marketing Organization
- Mar 5, 2003
Pharmaceutical Associates — Marketing Organization
- Aug 25, 2005
Apotex — Marketing Organization
- Sep 19, 2006
Almirall — NDA Secondary Org
- Oct 20, 2006
Leo Pharma — NDA Secondary Org
2010s
- Jul 26, 2012
Horizon Pharma — NDA Secondary Org
- Jul 26, 2012
Horizon Pharma — Marketing Organization
- Oct 31, 2014
Taro Pharmaceuticals — Marketing Organization
- Mar 27, 2017
Hi Tech Pharmaceuticals — Marketing Organization
- Apr 25, 2017
Actavis — Marketing Organization
- Apr 25, 2017
Allergan PLC (2015) — Marketing Organization
- Jul 24, 2017
Glenmark Pharmaceuticals — Marketing Organization
- Sep 28, 2017
Teligent Pharmaceuticals — Marketing Organization
- Dec 4, 2018
Geneyork Pharmaceuticals — Marketing Organization
- Jan 30, 2019
Encube Ethicals Pvt. Ltd. — Marketing Organization
- Oct 23, 2019
Alembic — Marketing Organization
- Nov 15, 2019
Novitium Pharma — Marketing Organization
- Nov 20, 2019
Zydus Discovery DMCC — Marketing Organization
- Nov 20, 2019
Cadila Healthcare — Marketing Organization
2020s
- May 11, 2020
Cintex Services — Marketing Organization
- Jun 16, 2020
Amneal Pharmaceuticals — Marketing Organization
- Sep 2, 2020
Strides Pharma Science — Marketing Organization
- Jul 6, 2021
Ani Pharmaceuticals — Marketing Organization
Indications
Approved for
- Addison Disease
- Adrenal Hyperplasia, Congenital
- Anaphylaxis
- Anemia
- Anemia, Aplastic
- Anemia, Diamond-Blackfan (approved 2012)
- Anemia, Hemolytic
- Arthritis
- Arthritis, Gouty
- Arthritis, Juvenile
- Arthritis, Psoriatic
- Arthritis, Rheumatoid
- Asthma
- Berylliosis
- Brain Edema
- Brain Neoplasms
- Bursitis
- Chorioretinitis
- Choroiditis
- Colitis, Ulcerative
- Conjunctivitis, Allergic
- Corneal Injuries
- Crohn Disease
- Dermatitis, Allergic Contact (approved 1972)
- Dermatitis, Atopic
- Dermatitis, Contact
- Dermatitis, Exfoliative
- Dermatitis Herpetiformis
- Dermatitis, Seborrheic
- Dermatomyositis
- Eczema (approved 1972)
- Endocrine System Diseases
- Erythema Multiforme
- Hematologic Diseases (approved 1955)
- Herpes Zoster Ophthalmicus
- Hypercalcemia
- Hypersensitivity (approved 1955)
- Inflammation
- Iridocyclitis
- Iritis
- Keratitis
- Keratitis, Herpetic (approved 1973)
- Leukemia
- Leukemia, Biphenotypic, Acute (approved 1955)
- Lupus Erythematosus, Systemic
- Lymphoma
- Multiple Sclerosis
- Mycosis Fungoides
- Myocarditis
- Neoplasms
- Nephrotic Syndrome
- Ophthalmia, Sympathetic
- Optic Neuritis
- Osteoarthritis
- Pemphigus
- Peptic Ulcer
- Pneumonia
- Polymyositis
- Psoriasis
- Pulmonary Edema
- Pulmonary Eosinophilia
- Purpura, Thrombocytopenic, Idiopathic
- Rheumatic Diseases (approved 1955)
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Rosacea (approved 1973)
- Sarcoidosis
- Serum Sickness
- Skin Diseases
- Spondylitis
- Spondylitis, Ankylosing
- Stevens-Johnson Syndrome
- Synovitis
- Tennis Elbow
- Tenosynovitis
- Thrombocytopenia
- Thyroiditis, Subacute
- Trichinellosis
- Tuberculosis, Meningeal
- Tuberculosis, Pulmonary
- Uveitis (approved 1955)
- Uveitis, Posterior
Studied for
- Abdominal Wall · Early Phase 1
- Abortion, Habitual · Phase 4
- Abortion, Spontaneous · Phase 4
- Acne Vulgaris · Phase 4
- Adenocarcinoma · Phase 1
- Adipose Tissue, Brown · Phase 4
- Adolescent · Phase 2/Phase 3
- Adrenal Cortex Hormones · Phase 4
- Adrenal Hyperplasia, Congenital · Phase 4
- Adrenal Insufficiency · Phase 4
- Adrenocortical Carcinoma · Phase 1
- Affective Disorders, Psychotic · Phase 4
- AIDS-Associated Nephropathy · Phase 2
- Airway Management · Phase 4
- Allergy and Immunology · Phase 2
- Allografts · Phase 3
- Alveolitis, Extrinsic Allergic · Phase 2
- Alzheimer Disease · Phase 3
- Amyotrophic Lateral Sclerosis · Phase 2
- Analgesics, Opioid · Phase 4
- Anemia · Phase 3
- Anemia, Aplastic · Phase 2
- Anemia, Diamond-Blackfan · Phase 1/Phase 2
- Anemia, Hemolytic · Phase 2
- Anemia, Hemolytic, Autoimmune · Phase 3
- Anemia, Sickle Cell · Phase 3
- Anesthesia · Phase 4
- Aneurysm · Phase 3
- Angioedema · Phase 3
- Antibodies, Antineutrophil Cytoplasmic · Phase 1/Phase 2
- Antibodies, Monoclonal · Phase 2
- Anti-Inflammatory Agents · Phase 2/Phase 3
- Antineoplastic Combined Chemotherapy Protocols · Phase 2
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis · Phase 3
- Arrhythmias, Cardiac · Phase 4
- Arterial Occlusive Diseases · Phase 3
- Arthritis · Phase 2
- Arthritis, Juvenile · Phase 4
- Ascites · Phase 3
- Aspergillosis, Allergic Bronchopulmonary · Phase 2/Phase 3
- Atherosclerosis · Phase 3
- Atrial Fibrillation · Phase 4
- Autism Spectrum Disorder · Early Phase 1
- Autistic Disorder · Early Phase 1
- Autoimmune Diseases · Phase 4
- Autoimmune Diseases of the Nervous System · Phase 2
- Barrett Esophagus · Phase 4
- Bartonella Infections · Phase 4
- Basal Cell Carcinoma · Phase 1/Phase 2
- Behcet Syndrome · Phase 2
- Bell Palsy · Phase 4
- beta-Thalassemia · Phase 2
- Biliary Atresia · Phase 3
- Birdshot Chorioretinopathy · Phase 2
- Bone Marrow Failure Disorders · Phase 2
- Bone Marrow Transplantation · Phase 2
- Brain Injuries · Phase 2
- Brain Neoplasms · Phase 3
- BRCA1 Protein · Phase 2
- Breast Neoplasms · Phase 3
- Brentuximab Vedotin · Phase 2/Phase 3
- Bronchiolitis · Phase 2
- Bronchiolitis Obliterans · Phase 2
- Burkitt Lymphoma · Phase 4
- Carcinoma · Phase 3
- Carcinoma, Giant Cell · Phase 3
- Carcinoma, Hepatocellular · Phase 3
- Carcinoma, Merkel Cell · Phase 1/Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 1
- Carcinoma, Ovarian Epithelial · Phase 1
- Carcinoma, Renal Cell · Phase 2
- Carcinoma, Squamous Cell · Phase 1/Phase 2
- Cardiomegaly · Phase 1
- Cardiomyopathies · Phase 4
- Cardiotoxicity · Phase 3
- Cardiovascular Diseases · Phase 4
- Castleman Disease · Phase 2
- Castration · Phase 3
- Cataract · Phase 4
- Cat-Scratch Disease · Phase 4
- Celiac Disease · Phase 2/Phase 3
- Cellulitis · Phase 2
- Cerebellar Diseases · Phase 2
- Child · Phase 2/Phase 3
- Cholangitis · Phase 2/Phase 3
- Chondrocalcinosis · Phase 4
- Chorioretinitis · Phase 3
- Choroidal Effusions · Phase 4
- Chronic Disease · Phase 4
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Chronic Pain · Phase 3
- Churg-Strauss Syndrome · Phase 4
- Cocaine-Related Disorders · Phase 2
- Cognition Disorders · Phase 2
- Cognitive Dysfunction · Phase 3
- Colitis · Phase 2
- Colorectal Neoplasms · Phase 1
- Community-Acquired Infections · Phase 3
- Comparative Study · Phase 4
- Conjunctivitis · Phase 4
- Connective Tissue Diseases · Phase 4
- Corneal Diseases · Phase 2
- Corneal Edema · Phase 4
- Corneal Transplantation · Phase 4
- Corneal Ulcer · Phase 4
- Coronary Artery Disease · Phase 2/Phase 3
- Coronary Restenosis · Phase 4
- Cough · Phase 4
- COVID-19 · Phase 4
- Cranial Nerve Diseases · Phase 1/Phase 2
- Craniopharyngioma · Phase 4
- Croup · Phase 4
- Cryoglobulinemia · Phase 2
- Cryptogenic Organizing Pneumonia · Phase 2
- Cushing Syndrome · Phase 2
- Cystic Fibrosis · Phase 3
- Cytokines · Phase 2
- Cytomegalovirus · Phase 4
- Cytomegalovirus Infections · Phase 4
- Dapsone · Phase 3
- Deficiency Diseases · Phase 2
- Dermatitis, Allergic Contact · Phase 1/Phase 2
- Dermatitis, Contact · Phase 3
- Dermatitis, Seborrheic · Phase 3
- Desmoplastic Small Round Cell Tumor · Phase 1
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 1 · Phase 1/Phase 2
- Diabetes Mellitus, Type 2 · Phase 4
- Diabetic Retinopathy · Phase 3
- Diagnosis · Phase 3
- Diarrhea · Phase 2
- DiGeorge Syndrome · Phase 1/Phase 2
- DNA Repair-Deficiency Disorders · Phase 2
- Down Syndrome · Phase 3
- Drug Evaluation · Phase 4
- Drug Hypersensitivity Syndrome · Early Phase 1
- Drug Interactions · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Investigational · Phase 4
- Drug Therapy · Phase 1/Phase 2
- Drug Therapy, Combination · Phase 2
- Dry Eye Syndromes · Phase 4
- Dyslipidemias · Early Phase 1
- Eczema · Phase 4
- Edema · Phase 4
- Embolism, Cholesterol · Phase 2
- Encephalitis · Phase 2
- Endocardial Cushion Defects · Phase 3
- Endomyocardial Fibrosis · Phase 1
- Endoscopy · Phase 2
- Enteropathy-Associated T-Cell Lymphoma · Phase 4
- Eosinophilia · Phase 4
- Eosinophils · Phase 4
- Epilepsy · Phase 4
- Epiretinal Membrane · Phase 4
- Erysipelas · Phase 2
- Erythema Multiforme · Phase 3
- Esophageal Achalasia · Phase 4
- Esophageal Diseases · Phase 1
- Esophageal Stenosis · Phase 4
- Esophagogastric Junction · Early Phase 1
- Extranodal Extension · Phase 2
- Eye Infections · Phase 3
- Eye Infections, Bacterial · Phase 4
- Facial Nerve Injuries · Phase 2/Phase 3
- Fanconi Anemia · Phase 1
- Fatigue · Phase 4
- Fecal Microbiota Transplantation · Phase 2/Phase 3
- Friedreich Ataxia · Phase 1
- Fuchs' Endothelial Dystrophy · Phase 4
- Gastrointestinal Neoplasms · Phase 1
- Gaucher Disease · Phase 1/Phase 2
- General Surgery · Phase 4
- Genetic Diseases, Inborn · Early Phase 1
- Geographic Atrophy · Phase 2
- Geriatrics · Phase 3
- Gestational Trophoblastic Disease · Phase 2
- Giant Cell Arteritis · Phase 4
- Glaucoma · Phase 4
- Glomerulonephritis · Phase 3
- Glomerulonephritis, IGA · Phase 4
- Glomerulonephritis, Membranous · Phase 3
- Glomerulosclerosis, Focal Segmental · Phase 3
- Glucocorticoids · Phase 4
- Glucose Intolerance · Phase 1
- Glycogen Storage Disease Type I · Phase 3
- Gout · Phase 2
- Graft Rejection · Phase 4
- Graft vs Host Disease · Phase 4
- Granuloma · Phase 4
- Granulomatosis with Polyangiitis · Phase 4
- Graves Ophthalmopathy · Phase 4
- Headache · Phase 3
- Healthcare-Associated Pneumonia · Phase 4
- Healthy Volunteers · Phase 4
- Hearing Loss · Phase 2/Phase 3
- Hearing Loss, Sensorineural · Phase 3
- Hearing Loss, Sudden · Phase 3
- Heart Diseases · Phase 4
- Heart Failure · Phase 4
- Heart Transplantation · Phase 3
- Hemangioma · Phase 4
- Hematologic Diseases · Phase 4
- Hematologic Neoplasms · Phase 2
- Hematoma · Phase 3
- Hematopoietic Stem Cell Mobilization · Phase 3
- Hematopoietic Stem Cell Transplantation · Phase 2
- Hemoglobinopathies · Phase 2
- Hemoglobin SC Disease · Phase 2
- Hemoglobinuria · Phase 2
- Hemoglobinuria, Paroxysmal · Phase 2
- Hemolysis · Phase 2
- Hemophilia A · Phase 4
- Hepatitis · Phase 2
- Hepatitis, Alcoholic · Phase 4
- Hepatitis, Autoimmune · Phase 4
- Hepatitis B · Phase 2
- Hepatitis B, Chronic · Phase 4
- Hepatitis C · Phase 3
- Hepatitis C, Chronic · Phase 2
- Hepatolenticular Degeneration · Phase 1/Phase 2
- Hermanski-Pudlak Syndrome · Phase 2
- Herpesvirus 8, Human · Phase 2
- Histiocytosis, Langerhans-Cell · Phase 4
- Histiocytosis, Sinus · Phase 4
- Histone Deacetylase Inhibitors · Phase 2
- HIV · Phase 3
- HIV Infections · Phase 4
- Hodgkin Disease · Phase 4
- Homologous Recombination · Phase 2
- Hormones · Phase 2
- HTLV-I Infections · Phase 1
- Hypereosinophilic Syndrome · Phase 4
- Hyperglycemia · Early Phase 1
- Hyperpigmentation · Phase 4
- Hypersensitivity · Phase 3
- Hyperuricemia · Phase 4
- Idiopathic Pulmonary Fibrosis · Phase 3
- IgA Vasculitis · Phase 4
- Immune Checkpoint Inhibitors · Phase 2
- Immune Checkpoint Proteins · Phase 2
- Immune Reconstitution Inflammatory Syndrome · Phase 4
- Immune System Diseases · Phase 2
- Immunoglobulin G4-Related Disease · Phase 4
- Immunoglobulins · Phase 3
- Immunosuppression Therapy · Phase 4
- Immunosuppressive Agents · Phase 4
- Immunotherapy · Phase 2
- Infections · Phase 3
- Infertility · Phase 4
- Inflammatory Bowel Diseases · Phase 2/Phase 3
- Inosine Triphosphate · Phase 2/Phase 3
- Intellectual Disability · Phase 4
- Intestinal Diseases · Phase 4
- Intestinal Neoplasms · Phase 2
- Intraocular Lymphoma · Phase 1/Phase 2
- Iritis · Phase 2
- Ischemic Stroke · Phase 4
- Kasabach-Merritt Syndrome · Phase 2
- Keratitis · Phase 3
- Keratitis, Herpetic · Phase 3
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 4
- Kidney Glomerulus · Phase 4
- Kidney Neoplasms · Phase 2
- Kidney Transplantation · Phase 4
- Lambert-Eaton Myasthenic Syndrome · Phase 2
- Leber Congenital Amaurosis · Phase 1/Phase 2
- Lenalidomide · Phase 2
- Leprosy · Phase 2/Phase 3
- Leukemia, B-Cell · Phase 1/Phase 2
- Leukemia, Hairy Cell · Phase 1/Phase 2
- Leukemia, Large Granular Lymphocytic · Phase 2/Phase 3
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 4
- Leukemia, Lymphoid · Phase 4
- Leukemia-Lymphoma, Adult T-Cell · Phase 4
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 3
- Leukemia, Myeloid, Acute · Phase 3
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative · Phase 3
- Leukemia, Myeloid, Chronic-Phase · Phase 2
- Leukemia, Myelomonocytic, Chronic · Phase 1/Phase 2
- Leukocyte Disorders · Phase 4
- Leukoencephalopathy, Progressive Multifocal · Phase 4
- Lichen Planus, Oral · Phase 4
- Lipoma · Phase 1/Phase 2
- Livedoid Vasculopathy · Phase 4
- Liver Cirrhosis · Phase 3
- Liver Cirrhosis, Biliary · Phase 4
- Liver Diseases · Phase 1
- Liver Diseases, Alcoholic · Phase 3
- Liver Failure · Phase 2
- Liver Failure, Acute · Phase 4
- Liver Transplantation · Phase 4
- Living Donors · Phase 3
- Long QT Syndrome · Phase 4
- Lung Diseases · Phase 4
- Lung Diseases, Interstitial · Phase 4
- Lung Diseases, Obstructive · Phase 4
- Lung Neoplasms · Phase 4
- Lung Transplantation · Phase 2
- Lupus Nephritis · Phase 3
- Lymphadenopathy · Phase 1/Phase 2
- Lymphatic Diseases · Phase 2
- Lymphocytes · Phase 2
- Lymphoma, AIDS-Related · Phase 2
- Lymphoma, B-Cell · Phase 4
- Lymphoma, B-Cell, Marginal Zone · Phase 3
- Lymphoma, Extranodal NK-T-Cell · Phase 3
- Lymphoma, Follicular · Phase 4
- Lymphoma, Large B-Cell, Diffuse · Phase 4
- Lymphoma, Large-Cell, Anaplastic · Phase 4
- Lymphoma, Large-Cell, Immunoblastic · Phase 3
- Lymphoma, Mantle-Cell · Phase 4
- Lymphoma, Non-Hodgkin · Phase 4
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 3
- Lymphoma, Primary Effusion · Phase 1/Phase 2
- Lymphoma, T-Cell · Phase 4
- Lymphoma, T-Cell, Peripheral · Phase 4
- Lymphomatoid Granulomatosis · Phase 2
- Lymphoproliferative Disorders · Phase 2
- Macula Lutea · Phase 4
- Macular Edema · Phase 4
- Malaria · Phase 3
- Mediastinal Neoplasms · Phase 4
- Medulloblastoma · Phase 4
- Meibomian Gland Dysfunction · Phase 4
- Melanoma · Phase 2
- Metabolic Side Effects of Drugs and Substances · Phase 2
- Metabolism · Phase 2/Phase 3
- Microscopic Polyangiitis · Phase 4
- Morals · Phase 4
- Mucocutaneous Lymph Node Syndrome · Phase 3
- Multiple Myeloma · Phase 4
- Multiple Sclerosis, Relapsing-Remitting · Phase 4
- Muscular Dystrophies, Limb-Girdle · Phase 2
- Muscular Dystrophy, Duchenne · Phase 3
- Mutation · Phase 2
- Myasthenia Gravis · Phase 4
- Mycophenolic Acid · Phase 4
- Myelin-Oligodendrocyte Glycoprotein · Phase 2/Phase 3
- Myelodysplastic-Myeloproliferative Diseases · Phase 2
- Myelodysplastic Syndromes · Phase 2
- Myeloproliferative Disorders · Phase 2
- Myocardial Ischemia · Phase 2/Phase 3
- Myocarditis · Phase 4
- Myocardium · Phase 4
- Nasal Polyps · Phase 4
- Nasopharyngeal Carcinoma · Phase 2
- Natural Killer T-Cells · Phase 2/Phase 3
- Neoadjuvant Therapy · Phase 2
- Neoplasm Metastasis · Phase 3
- Neoplasms · Phase 3
- Neoplasms, Germ Cell and Embryonal · Phase 4
- Nephritis · Phase 4
- Nephrosis, Lipoid · Phase 4
- Neuroblastoma · Phase 3
- Neuromyelitis Optica · Phase 4
- Neutropenia · Phase 2
- N-Myc Proto-Oncogene Protein · Phase 1/Phase 2
- Ocular Hypertension · Phase 4
- Only Child · Phase 4
- Opioid-Related Disorders · Phase 2
- Opsoclonus-Myoclonus Syndrome · Phase 2
- Optic Disk · Phase 4
- Optic Neuritis · Phase 3
- Optic Neuropathy, Ischemic · Phase 2
- Oral Ulcer · Phase 2
- Organ Transplantation · Phase 4
- Ornithine Carbamoyltransferase Deficiency Disease · Phase 3
- Oropharyngeal Neoplasms · Phase 1/Phase 2
- Osteoarthritis, Hip · Phase 4
- Osteoarthritis, Knee · Phase 4
- Osteoradionecrosis · Phase 2
- Ovarian Neoplasms · Phase 2
- Pain · Phase 4
- Panuveitis · Phase 4
- Papilledema · Phase 4
- Paranasal Sinus Diseases · Phase 2/Phase 3
- Pathologic Processes · Phase 2
- Pemphigoid, Bullous · Phase 4
- Pericarditis · Phase 3
- Pericarditis, Tuberculous · Phase 3
- Peripheral Arterial Disease · Phase 4
- Peritoneal Neoplasms · Phase 1
- Pharmacokinetics · Phase 1
- Pharmacological and Toxicological Phenomena · Phase 4
- Pharmacology · Early Phase 1
- Philadelphia Chromosome · Phase 2
- Phosphatidylinositol 3-Kinases · Phase 1/Phase 2
- Pituitary Neoplasms · Phase 4
- Plasmablastic Lymphoma · Phase 2
- Plasmacytoma · Phase 2
- Pneumonia, Pneumocystis · Phase 4
- Polyarteritis Nodosa · Phase 4
- Polycystic Ovary Syndrome · Phase 4
- Polycythemia Vera · Phase 2
- Polymorphism, Genetic · Phase 2
- Polymyalgia Rheumatica · Phase 4
- Polyradiculoneuropathy · Phase 3
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · Phase 2
- Positron-Emission Tomography · Phase 2/Phase 3
- Postmenopause · Phase 2
- Postoperative Complications · Phase 3
- Postoperative Nausea and Vomiting · Phase 2
- Postoperative Pain · Phase 3
- Precancerous Conditions · Phase 1
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 4
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 4
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma · Phase 1/Phase 2
- Prednisone · Phase 2
- Pregnancy Complications · Phase 2/Phase 3
- Premature Birth · Phase 2/Phase 3
- Primary Myelofibrosis · Phase 2
- Prognosis · Phase 2
- Prostatectomy · Phase 2
- Prostatic Neoplasms · Phase 4
- Prostatic Neoplasms, Castration-Resistant · Phase 4
- Prostheses and Implants · Phase 4
- Proteinuria · Phase 2
- Pruritus · Phase 2
- Pseudophakia · Phase 4
- Psoriasis · Phase 4
- Psychotic Disorders · Phase 4
- Pulmonary Disease, Chronic Obstructive · Phase 4
- Pulmonary Eosinophilia · Phase 4
- Pulmonary Fibrosis · Phase 2
- Pulpitis · Phase 4
- Purpura · Phase 4
- Purpura, Thrombotic Thrombocytopenic · Phase 3
- Pyoderma Gangrenosum · Phase 3
- Quality of Life · Phase 3
- Radiation Pneumonitis · Phase 2
- Radiotherapy · Phase 2
- Regional Blood Flow · Phase 4
- Renal Dialysis · Phase 4
- Renal Insufficiency · Phase 4
- Renal Insufficiency, Chronic · Phase 4
- Renal Replacement Therapy · Phase 4
- Respiration, Artificial · Phase 4
- Respiratory Distress Syndrome · Phase 4
- Respiratory Sounds · Phase 4
- Respiratory Syncytial Virus Infections · Phase 1
- Respiratory Tract Infections · Phase 4
- Restless Legs Syndrome · Phase 1/Phase 2
- Retina · Early Phase 1
- Retinal Detachment · Early Phase 1
- Retinal Diseases · Phase 4
- Retinal Perforations · Early Phase 1
- Retinal Telangiectasis · Early Phase 1
- Retinal Vein Occlusion · Phase 2/Phase 3
- Retroperitoneal Fibrosis · Phase 4
- Retroperitoneal Neoplasms · Phase 1
- Rhabdomyosarcoma · Phase 1
- Rhinitis · Phase 3
- Rhinitis, Allergic · Phase 3
- Rhinitis, Allergic, Perennial · Phase 3
- Safety · Phase 1
- Sarcoidosis, Pulmonary · Phase 3
- Sarcoma · Phase 2
- Sarcoma, Kaposi · Phase 2
- Schizophrenia · Phase 4
- Sciatica · Phase 3
- Sciatic Neuropathy · Phase 3
- Sclerosis · Phase 2
- Sepsis · Phase 4
- Signs and Symptoms, Respiratory · Phase 4
- Sinusitis · Phase 4
- Sjogren's Syndrome · Phase 4
- Skin Neoplasms · Phase 2
- Sleep Apnea, Obstructive · Phase 4
- Small Cell Lung Carcinoma · Phase 2
- Spasms, Infantile · Phase 3
- Spinal Injuries · Phase 4
- Squamous Cell Carcinoma of Head and Neck · Phase 1/Phase 2
- Status Asthmaticus · Phase 4
- Steroids · Phase 3
- Stiff-Person Syndrome · Phase 2
- Stomatitis · Phase 2
- Stroke · Phase 4
- Survival · Phase 2/Phase 3
- Systemic Vasculitis · Phase 2
- Takayasu Arteritis · Phase 4
- Testicular Neoplasms · Phase 3
- Thalassemia · Phase 2
- Thalidomide · Phase 3
- Therapeutics · Phase 4
- Thrombocythemia, Essential · Phase 2
- Thrombocytopenia · Phase 4
- Thrombocytopenia, Neonatal Alloimmune · Phase 3
- Thrombocytosis · Phase 2
- Thrombosis · Phase 2
- Thymoma · Phase 2
- Thyroid Diseases · Phase 4
- Thyroid Gland · Phase 2/Phase 3
- Thyroiditis, Autoimmune · Phase 4
- Thyroiditis, Subacute · Phase 4
- Tooth · Phase 4
- Tooth Abnormalities · Phase 4
- Tooth Avulsion · Phase 4
- Tooth, Impacted · Phase 4
- Tracheal Stenosis · Phase 4
- Translocation, Genetic · Phase 2
- Transplantation · Phase 1/Phase 2
- Triple Negative Breast Neoplasms · Phase 1
- Tuberculosis · Phase 3
- Tumor Suppressor Protein p53 · Phase 2
- Urination Disorders · Phase 2
- Urologic Neoplasms · Phase 1
- Urticaria · Phase 3
- Uveitis · Phase 4
- Uveitis, Anterior · Phase 3
- Uveitis, Intermediate · Phase 4
- Uveitis, Posterior · Phase 4
- Vasculitis · Phase 4
- Vasculitis, Central Nervous System · Phase 2
- Vasculitis, Leukocytoclastic, Cutaneous · Phase 2
- Vasovasostomy · Phase 4
- Vestibular Diseases · Phase 4
- Vestibular Neuronitis · Phase 4
- Vision Disorders · Phase 2
- Visual Pathways · Phase 4
- Vitamin D Deficiency · Phase 4
- Vitrectomy · Phase 4
- Vitreoretinopathy, Proliferative · Phase 4
- Waldenstrom Macroglobulinemia · Phase 2
- Wilms Tumor · Phase 1
- Young Adult · Phase 2/Phase 3
Mechanism of action
- Glucocorticoid receptorAGONIST
NR3C1 agonist
Combination products
blephamide
with sulfacetamide
Also known as blephamide s.o.p, cetapre, isopto cetapre, metimy, predamide, predsulfair, sulphrin
chloroptic-p s.o.p
with chloramphenicol
neo-delta-cortef
with neomycin
poly-pre
with neomycin, polymyxin b sulfate
pred-g
with gentamicin
tridesilon
with acetic acid
Approval history
- approvedPriority reviewFeb 21, 1955
Chemistry & pharmacology
Loading structure…
SMILES
CC(=O)OCC(=O)[C@@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@@]21C- Mol. weight
- 402.49 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral, Topical
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
Yes
Sources
- WikipediaPrednisone ↗
- ChEMBLCHEMBL131 ↗
- ChEMBLCHEMBL1201109 ↗
- ChEMBLCHEMBL1200909 ↗
- ChEMBLCHEMBL1152 ↗
- NCATSVB0R961HZT ↗
- NCATSJ280872D1O ↗
- ChEMBLCHEMBL635 ↗
- NCATS9PHQ9Y1OLM ↗
Also known as
- (11beta)-11,17,21-trihydroxypregna-1,4-diene-3,20-dione
- (11beta)-11,17,21-trihydroxypregna-1,4-diene-3,20-dione
- 11beta,21-dihydroxy-16alpha,17-[(1-methylethylidene)bis(oxy)]pregna-1,4-diene-3,20-dione
- 11beta,21-dihydroxy-16alpha,17-[(1-methylethylidene)bis(oxy)]pregna-1,4-diene-3,20-dione
- 11beta,21-dihydroxy-16alpha,17alpha-isopropylidenedioxypregna-1,4-diene-3,20-dione
- 11beta,21-dihydroxy-16alpha,17alpha-isopropylidenedioxypregna-1,4-diene-3,20-dione
- 11beta,21-dihydroxy-16alpha,17-isopropylidenedioxypregna-1,4-diene-3,20-dione
- 11beta,21-dihydroxy-16alpha,17-isopropylidenedioxypregna-1,4-diene-3,20-dione
- 1,2-dehydrocortisone
- 1,2-dehydrocortisone
- 1,2-dehydrocortisone
- 1,4-pregnadiene-11beta,17alpha,21-triol-3,20-dione
- 1,4-pregnadiene-11beta,17alpha,21-triol-3,20-dione
- 1,4-pregnadiene-17alpha,21-diol-3,11,20-trione
- 1,4-pregnadiene-17alpha,21-diol-3,11,20-trione
- 1,4-pregnadiene-3,20-dione-11beta,17alpha,21-triol
- 1,4-pregnadiene-3,20-dione-11beta,17alpha,21-triol
- 16alpha,17alpha-isopropylidenedioxyprednisolone
- 16alpha,17alpha-isopropylidenedioxyprednisolone
- 16alpha-hydroxyprednisole-16,17-acetonide
- 16alpha-hydroxyprednisole-16,17-acetonide
- 16alpha-hydroxyprednisolone-16alpha,17-acetonide
- 16alpha-hydroxyprednisolone-16alpha,17-acetonide
- 17,21-dihydroxypregna-1,4-diene-3,11,20-trione
- 17,21-dihydroxypregna-1,4-diene-3,11,20-trione
- 3,20-dioxo-11beta,17alpha,21-trihydroxy-1,4-pregnadiene
- 3,20-dioxo-11beta,17alpha,21-trihydroxy-1,4-pregnadiene
- aprednislone
- budesonide acetonide
- cortalone
- cortalone
- cortan
- cortan
- cortancyl
- cortancyl
- crx-102
- crx-102
- crx-102
- d2083
- d2083
- d-2083
- d-2083
- decortin
- decortin
- decortisyl
- decortisyl
- dehydrocortisone
- dehydrocortisone
- dehydrocortisone
- dekotil
- delta(1)-dehydrocortisol
- delta(1)-dehydrocortisol
- delta(1)-dehydrohydrocortisone
- delta(1)-dehydrohydrocortisone
- delta(1)-hydrocortisone
- delta(1)-hydrocortisone
- delta-cortef
- delta-cortef
- delta-cortef
- deltacortril
- deltacortril
- delta-dehydrocortisol
- delta-dehydrocortisol
- delta-dehydrohydrocortisone
- delta-dehydrohydrocortisone
- delta-dome
- delta-dome
- deltahydrocortisone
- delta-hydrocortisone
- delta-hydrocortisone
- deltalone
- deltalone
- deltasone
- deltasone
- desfluorotriamcinolone acetonide
- desfluorotriamcinolone acetonide
- desonate
- desonate
- desonida
- desonida
- desonide
- desonide
- desonide
- desonide
- desonide
- desonide
- desonide
- desonide
- desonide
- desonide
- desonide
- desonidum
- desonidum
- desowen
- desowen
- desowen
- dilacort
- econopred
- econopred
- fernisolone-p
- fernisolone-p
- fernisone
- fernisone
- flo-pred
- hydeltra
- hydeltra
- hydeltra-tba
- hydeltra-tba
- hydroprednisone acetate
- hydroretrocortin
- hydroretrocortine
- hydroretrocortine
- hydroretrocortine
- liquid pred
- liquid pred
- lodotra
- lodotra
- metacortandralone
- metacortandralone
- metacortandralone
- meticortelone
- meticortelone
- meticortelone acetate
- meticorten
- meticorten
- meticortin
- meticotelone acetate
- meti-derm
- meti-derm
- neo-delta-cortef
- omnipred
- omnipred
- orasone
- orasone
- paracort
- paracort
- pevanti
- poly-pred
- prdl
- prdl
- precortisyl
- precortisyl
- precortisyl fte
- pred forte
- pred forte
- pred forte
- pred fte
- pred-g
- pred-g
- predinsolone
- pred mild
- pred mild
- prednacinolone
- prednicen-m
- prednicen-m
- prednisolona
- prednisolona
- prednisolone
- prednisolone
- prednisolone
- prednisolone
- prednisolone
- prednisolone
- prednisolone
- prednisolone
- prednisolone
- prednisolone
- prednisolone
- prednisolone 21-acetate
- prednisolone acetate
- prednisolone acetate
- prednisolone acetate
- prednisolone acetate
- prednisolone acetate
- prednisolone acetate
- prednisolone acetate
- prednisolonum
- prednisolonum
- prednison
- prednison
- prednisona
- prednisona
- prednisone
- prednisone
- prednisone
- prednisone
- prednisone
- prednisone
- prednisone
- prednisone
- prednisone
- prednisone anhydrous
- prednisone anhydrous
- prednisone anhydrous
- prednisone anhydrous
- prednisone anhydrous
- prednisone anhydrous
- prednisone intensol
- prednisone intensol
- prednisonum
- prednisonum
- prelone
- prelone
- prenisolone
- prenolone
- rayos
- rayos
- scheriproct
- scherisolone-kristall suspension
- servisone
- servisone
- sterane
- sterane
- sterapred
- sterapred
- tridesilon
- tridesilon
- ultracortenol
- ultracortenol
- verdeso
- verdeso
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06934915 | Early Phase 1 (Phase 1) | Nov 30, 2026 | Harvard University |
| NCT07220187 | Phase 3 | May 2, 2026 | National Cancer Institute (NCI), SWOG Cancer Research Network |
| NCT07224100 | Phase 2 | May 1, 2026 | Takeda, University of Washington |
| NCT07278856 | Phase 1 | Apr 27, 2026 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT07072585 | Phase 2/Phase 3 (Phase 3) | Mar 30, 2026 | National Cancer Institute (NCI) |
| NCT06833411 | Phase 3 | Jan 31, 2026 | University of Bern |
| NCT07228052 | Phase 4 | Jan 30, 2026 | Yeshiva University |
| NCT07231250 | Phase 2 | Jan 15, 2026 | Sun Yat-Sen University |
| NCT07225946 | Phase 3 | Jan 15, 2026 | — |
| NCT07097363 | Phase 2 | Jan 1, 2026 | AbbVie, University of Washington |
| NCT07276373 | Phase 1/Phase 2 (Phase 2) | Dec 31, 2025 | Corcept Therapeutics |
| NCT07258771 | Phase 4 | Dec 31, 2025 | AbbVie, University of Michigan |
| NCT07221838 | Phase 4 | Dec 31, 2025 | Alexion |
| NCT07299292 | Phase 2 | Dec 1, 2025 | SMED Clinical Research |
| NCT07067801 | Phase 3 | Nov 30, 2025 | CHU Besançon, University of Burgundy, University of Franche-Comté, University of Reims, University of Strasbourg |
| NCT07168161 | Phase 3 | Nov 10, 2025 | Peking University, Staidson (Beijing) Biopharmaceuticals Co., Ltd |
| NCT07215585 | Phase 3 | Nov 2, 2025 | AstraZeneca, Peter MacCallum Cancer Centre |
| NCT07206277 | N/A | Nov 1, 2025 | University of Alberta |
| NCT07060638 | Phase 2 | Oct 31, 2025 | Indiana University, National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| NCT07207954 | Phase 1 | Oct 6, 2025 | Lifordi Immunotherapeutics, Inc. |
Showing 20 of 2,167 trials
Page 1 / 109
Organizations
Research & Development (1,085)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 279 | 137 | 4 | 1989 |
| Roche | For profit | 71 | 43 | 5 | 1999 |
| University of Texas at Houston | Academic/Hospital | 58 | 49 | 5 | 1989 |
| Johnson and Johnson | For profit | 52 | 36 | 5 | 2004 |
| Jiao Tong University | Academic/Hospital | 51 | 37 | 5 | 2004 |
| Novartis | For profit | 50 | 35 | 4 | 2001 |
| Harvard University | Academic/Hospital | 49 | 32 | 5 | 1993 |
| Genentech | For profit | 41 | 13 | 5 | 1998 |
| Sun Yat-Sen University | Academic/Hospital | 41 | 29 | 5 | 2006 |
| Sanofi | For profit | 39 | 24 | 4 | 2003 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 38 | 28 | 5 | 2008 |
| Merck | For profit | 37 | 28 | 5 | 2003 |
| University of Washington | Academic/Hospital | 36 | 25 | 5 | 1997 |
| Astellas | For profit | 35 | 25 | 5 | 1999 |
| Janssen Pharmaceutica NV | For profit | 35 | 2 | 5 | 2006 |
| Pfizer | For profit | 32 | 21 | 5 | 1998 |
| Cornell University | Academic/Hospital | 31 | 24 | 4 | 1996 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 31 | 28 | 5 | 1990 |
| Celgene | For profit | 30 | 13 | 4 | 2005 |
| Southwest Oncology Group | Academic/Hospital | 30 | 22 | 3 | 1994 |
1,085 organizations
Page 1 / 55
Marketing (134)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACP Nimble | For profit | MKTG | Sep 28, 1992 |
| AbbVie | For profit | MKTG | Nov 10, 1972 |
| AbbVie | For profit | NDA2 | Nov 10, 1972 |
| Actavis | For profit | MKTG | Apr 25, 2017 |
| Akorn, Inc. | For profit | MKTG | Jun 12, 1975 |
| Alcon | For profit | NDA2 | Jul 10, 1973 |
| Alembic | For profit | MKTG | Oct 23, 2019 |
| Alembic | For profit | SYN | Oct 23, 2019 |
| Allergan | For profit | NDA2 | Sep 18, 1961 |
| Allergan | For profit | MKTG | — |
| Allergan PLC (2015) | For profit | MKTG | Apr 25, 2017 |
| Almirall | For profit | NDA2 | Sep 19, 2006 |
| Am Therap | For profit | MKTG | — |
| American Cyanamid | For profit | MKTG | Jul 27, 1982 |
| Amneal Pharmaceuticals | For profit | MKTG | Jun 16, 2020 |
| Ani Pharmaceuticals | For profit | MKTG | Jul 6, 2021 |
| Apotex | For profit | MKTG | Aug 25, 2005 |
| Aurobindo Pharma | For profit | MKTG | May 31, 1978 |
| Aurobindo Pharma | For profit | SYN | Nov 16, 2021 |
| Barr Laboratories | For profit | MKTG | Jun 17, 1975 |
| Bausch & Lomb | For profit | MKTG | Dec 28, 1982 |
| Bausch Health Companies | For profit | MKTG | — |
| Bayer | For profit | MKTG | Apr 17, 1972 |
| Bayer | For profit | NDA2 | Feb 21, 1978 |
| Belmar Pharmacy | For profit | MKTG | Mar 6, 1974 |
| Bundy | For profit | MKTG | — |
| Cadila Healthcare | For profit | MKTG | Nov 20, 2019 |
| Century Pharmaceuticals | For profit | MKTG | — |
| Chartwell Pharmaceuticals | For profit | MKTG | Nov 22, 1983 |
| Chartwell Pharmaceuticals | For profit | SYN | May 2, 1974 |
| Cintex Services | For profit | MKTG | May 11, 2020 |
| Contract Pharmacal | For profit | MKTG | Jul 5, 1972 |
| Cosette | For profit | MKTG | Sep 28, 1992 |
| Cosette | For profit | SYN | Sep 28, 1992 |
| Duramed Research | For profit | MKTG | Oct 4, 1983 |
| Elkins Sinn | For profit | MKTG | — |
| Encube Ethicals Pvt. Ltd. | For profit | MKTG | Jan 30, 2019 |
| Everylife Foundation for Rare Diseases | Academic/Hospital | MKTG | Feb 25, 1975 |
| Eyevance | For profit | MKTG | Jul 10, 1973 |
| Eyevance | For profit | NDA2 | Jul 10, 1973 |
| Ferndale Laboratories, Inc. | For profit | MKTG | — |
| Fosun | For profit | MKTG | Sep 6, 1972 |
| Fougera | For profit | MKTG | Mar 12, 2001 |
| G & W Laboratories Inc. | For profit | MKTG | Sep 28, 1992 |
| Galderma | For profit | NDA2 | Dec 14, 1984 |
| Galderma | For profit | MKTG | Jun 15, 1988 |
| Geneyork Pharmaceuticals | For profit | MKTG | Dec 4, 2018 |
| Glenmark Pharmaceuticals | For profit | SYN | Sep 15, 2017 |
| Glenmark Pharmaceuticals | For profit | MKTG | Jul 24, 2017 |
| Halsey | For profit | MKTG | — |
| Heather Pharma | For profit | MKTG | Mar 21, 1974 |
| Hi Tech Pharmaceuticals | For profit | SYN | Feb 27, 2003 |
| Hi Tech Pharmaceuticals | For profit | MKTG | Mar 27, 2017 |
| Hikma | For profit | MKTG | Jun 1, 1984 |
| Hikma | For profit | SYN | Apr 21, 1972 |
| Horizon Pharma | For profit | NDA2 | Jul 26, 2012 |
| Horizon Pharma | For profit | MKTG | Jul 26, 2012 |
| Impax Laboratories | For profit | MKTG | Jul 13, 1973 |
| Inwood Laboratories | For profit | MKTG | Dec 23, 1971 |
| John J. Ferrante | For profit | MKTG | Apr 21, 1972 |
| Jubilant Innovation Ltd. | For profit | MKTG | Aug 29, 2001 |
| Lannett Company, Inc. | For profit | MKTG | May 2, 1974 |
| Lannett Company, Inc. | For profit | SYN | Sep 21, 2007 |
| Lederle | For profit | MKTG | Jul 27, 1982 |
| Leo Pharma | For profit | NDA2 | Oct 20, 2006 |
| Lumara Health | For profit | MKTG | — |
| Marshall Pharma | For profit | MKTG | — |
| Muro Pharmaceuticals | For profit | MKTG | Mar 17, 1982 |
| Mutual Pharmaceutical | For profit | MKTG | Nov 14, 1972 |
| Mylan | For profit | SYN | May 22, 1972 |
| Mylan | For profit | MKTG | Aug 26, 1976 |
| Mylan | For profit | SYN | May 22, 1972 |
| NYLOS | For profit | MKTG | — |
| Nesher Pharms | For profit | MKTG | Oct 22, 2001 |
| Nestle | For profit | MKTG | Jul 21, 1981 |
| Novartis | For profit | NDA2 | Jul 10, 1973 |
| Novartis | For profit | MKTG | Oct 5, 1984 |
| Novitium Pharma | For profit | MKTG | Nov 15, 2019 |
| Padagis Us | For profit | MKTG | Jan 4, 1972 |
| Padagis Us | For profit | NDA2 | Jan 4, 1972 |
| Panray Corp. | For profit | MKTG | — |
| Parke-Davis | For profit | NDA2 | Jul 13, 1978 |
| Perrigo | For profit | NDA2 | Jan 4, 1972 |
| Pfizer | For profit | MKTG | May 12, 1998 |
| Pfizer | For profit | NDA2 | Jul 1, 1955 |
| Pharmaceutical Associates | For profit | SYN | Sep 28, 2017 |
| Pharmaceutical Associates | For profit | MKTG | Mar 5, 2003 |
| Pharmacia & Upjohn | For profit | NDA2 | Jun 21, 1955 |
| Pharmacia & Upjohn | For profit | MKTG | — |
| Pharmafair | For profit | MKTG | Apr 19, 1983 |
| Pharmavite | For profit | MKTG | — |
| Phoenix Laboratories | For profit | MKTG | — |
| Puracap Pharmaceutical | For profit | MKTG | — |
| R.P. Scherer | For profit | MKTG | — |
| Rexall Drug Company | For profit | MKTG | — |
| Rising Pharmaceuticals | For profit | MKTG | May 31, 1978 |
| Roxane Laboratories | For profit | NDA2 | Nov 24, 1971 |
| Roxane Laboratories | For profit | MKTG | Nov 24, 1971 |
| Sandoz | For profit | MKTG | Jul 13, 1972 |
| Schering | For profit | NDA2 | Feb 21, 1955 |
| Schering-Plough | For profit | NDA | Jun 1, 1955 |
| Schwarz Pharma | For profit | MKTG | Dec 9, 1975 |
| SmithKline Beckman | For profit | NDA2 | Jun 10, 1988 |
| SmithKline Beckman | For profit | MKTG | Dec 3, 1986 |
| SmithKline Beecham | For profit | NDA2 | Dec 1, 1989 |
| Solvay | For profit | MKTG | Jan 29, 1974 |
| Sperti | For profit | MKTG | May 1, 1973 |
| Strides Pharma Science | For profit | MKTG | Sep 2, 2020 |
| Sun Pharmaceuticals | For profit | MKTG | Apr 10, 1979 |
| Superpharm | For profit | MKTG | Oct 25, 1984 |
| Tablicaps | For profit | MKTG | — |
| Taro Pharmaceuticals | For profit | NDA2 | Jun 30, 1992 |
| Taro Pharmaceuticals | For profit | MKTG | Oct 31, 2014 |
| Teligent Pharmaceuticals | For profit | MKTG | Sep 28, 2017 |
| Teligent Pharmaceuticals | For profit | SYN | Sep 28, 2017 |
| Teresina | For profit | SYN | May 11, 2020 |
| Teva | For profit | SYN | May 28, 1999 |
| Teva | For profit | MKTG | Feb 4, 1986 |
| Teva | For profit | SYN | Jan 19, 2000 |
| UDL Laboratories | For profit | MKTG | — |
| Upsher-Smith Laboratories | For profit | MKTG | — |
| Vanguard | For profit | MKTG | Jan 15, 1982 |
| Vintage | For profit | MKTG | Jul 12, 2002 |
| VistaPharm, Inc. | For profit | MKTG | May 13, 1999 |
| Vitarine | For profit | MKTG | — |
| Warner Lambert | For profit | NDA2 | Jul 13, 1978 |
| Watson Pharmaceuticals | For profit | MKTG | Jan 17, 1972 |
| We Pharma Ltd | For profit | MKTG | May 28, 1998 |
| West-Ward Pharmaceutical | For profit | MKTG | Apr 21, 1972 |
| Whiteworth Towne Paulsen | For profit | MKTG | Jun 20, 1973 |
| Wockhardt | For profit | MKTG | Aug 2, 1988 |
| Wockhardt | For profit | SYN | Sep 10, 2003 |
| Xttrium Laboratories | For profit | MKTG | Aug 2, 1988 |
| Zydus Discovery DMCC | For profit | MKTG | Nov 20, 2019 |