Prednisone
Prednisone (prednisone) is a small molecule pharmaceutical. Prednisone was first approved as Paracort on 1982-01-01. It is used to treat adrenal insufficiency, allergic conjunctivitis, allergic rhinitis, ankylosing spondylitis, and asthma amongst others in the USA. The pharmaceutical is active against glucocorticoid receptor.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Prednisone (discontinued: Cortan, Deltasone, Deltome, Fernisone, Liquid pred, Meticorten, Orasone, Paracort, Prednicen, Prednisone, Rayos, Servisone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Prednisone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RAYOS | Horizon Therapeutics Public | N-202020 DISCN | 2012-07-26 | 3 products, RLD |
| PARACORT | Pfizer | N-010962 DISCN | 1982-01-01 | 1 products |
| DELTASONE | Pharmacia & Upjohn | N-009986 DISCN | 1982-01-01 | 5 products, RLD |
| PREDNISONE | Roxane Laboratories | N-017109 DISCN | 1982-01-01 | 1 products |
| METICORTEN | Merck & Co | N-009766 DISCN | 1982-01-01 | 2 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cortane-b | unapproved drug other | 2017-03-20 |
| deltasone | ANDA | 2018-11-02 |
| deltasone 5mg | ANDA | 2020-10-15 |
| p- pack prednisone 20mg, 7- day tapering dose pack | ANDA | 2025-02-11 |
| prednisone | ANDA | 2026-09-03 |
| prednisone d/p | ANDA | 2026-04-09 |
| prednisone delayed release | ANDA | 2026-04-30 |
| prednisone prednisone | ANDA | 2019-05-13 |
| prednisone prednisone intensol | ANDA | 2025-04-22 |
| prednisone tablets, usp, 10 mg | ANDA | 2026-06-04 |
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Indications
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EMA
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Agency Specific
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EMA
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07E: Intestinal antiinflammatory agents
— A07EA: Corticosteroids acting locally
— A07EA03: Prednisone
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H02: Corticosteroids for systemic use
— H02A: Corticosteroids for systemic use, plain
— H02AB: Glucocorticoids, systemic
— H02AB07: Prednisone
HCPCS
Code | Description |
|---|---|
| G2112 | Patient receiving <=5 mg daily prednisone (or equivalent), or ra activity is worsening, or glucocorticoid use is for less than 6 months |
| G2113 | Patient receiving >5 mg daily prednisone (or equivalent) for longer than 6 months, and improvement or no change in disease activity |
| G9468 | Patient not receiving corticosteroids greater than or equal to 10 mg/day of prednisone equivalents for 60 or greater consecutive days or a single prescription equating to 600 mg prednisone or greater for all fills |
| G9470 | Patients not receiving corticosteroids greater than or equal to 10 mg/day of prednisone equivalents for 60 or greater consecutive days or a single prescription equating to 600 mg prednisone or greater for all fills |
| J7512 | Prednisone, immediate release or delayed release, oral, 1 mg |
Clinical
Clinical Trials
2503 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 87 | 267 | 103 | 14 | 27 | 444 |
| Prostatic neoplasms | D011471 | — | C61 | 86 | 228 | 81 | 7 | 16 | 370 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 60 | 151 | 51 | 4 | 11 | 238 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 42 | 93 | 42 | 3 | 8 | 161 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 27 | 78 | 41 | 8 | 18 | 151 |
| B-cell lymphoma | D016393 | — | — | 52 | 93 | 24 | 6 | 6 | 151 |
| Leukemia | D007938 | — | C95 | 27 | 65 | 32 | 6 | 11 | 119 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 28 | 54 | 25 | 2 | 2 | 96 |
| Multiple myeloma | D009101 | — | C90.0 | 21 | 48 | 32 | 3 | 4 | 91 |
| Follicular lymphoma | D008224 | — | C82 | 17 | 33 | 34 | 3 | 7 | 84 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Burkitt lymphoma | D002051 | — | C83.7 | 21 | 32 | 9 | — | — | 55 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | 14 | 18 | 4 | — | — | 26 |
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | 5 | 18 | 7 | — | 1 | 26 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 6 | 11 | 8 | — | 2 | 23 |
| Adenocarcinoma | D000230 | — | — | 3 | 20 | 1 | — | — | 22 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 5 | 7 | 6 | — | 2 | 17 |
| Myelodysplastic syndromes | D009190 | — | D46 | 6 | 13 | 1 | — | — | 17 |
| Biphenotypic leukemia acute | D015456 | — | C95.0 | 5 | 7 | 5 | — | 1 | 16 |
| Membranous glomerulonephritis | D015433 | EFO_0004254 | N03.2 | — | 3 | 6 | — | 9 | 16 |
| Precursor b-cell lymphoblastic leukemia-lymphoma | D015452 | — | — | 6 | 9 | 2 | — | — | 12 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 16 | 2 | — | — | 1 | 19 |
| Hematologic neoplasms | D019337 | — | — | 6 | 7 | — | — | 2 | 11 |
| Non-small-cell lung carcinoma | D002289 | — | — | 8 | 5 | — | — | — | 10 |
| Plasmablastic lymphoma | D000069293 | — | C83.3 | 6 | 6 | — | — | — | 10 |
| Aids-related lymphoma | D016483 | EFO_1001365 | — | 4 | 7 | — | — | — | 10 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 3 | 7 | — | — | — | 9 |
| Primary myelofibrosis | D055728 | — | D47.4 | 2 | 8 | — | — | — | 9 |
| Carcinoma | D002277 | — | C80.0 | 2 | 7 | — | — | — | 8 |
| Proteinuria | D011507 | — | R80 | — | 3 | — | — | 4 | 7 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | 5 | — | — | — | 6 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy rate | D018873 | — | — | 1 | — | — | — | 4 | 5 |
| Pathologic constriction | D003251 | — | — | 1 | — | — | — | 2 | 3 |
| Tinnitus | D014012 | — | H93.1 | 1 | — | — | — | 2 | 3 |
| Gastrointestinal diseases | D005767 | — | — | 2 | — | — | — | 1 | 3 |
| Pathologic complete response | D000095384 | — | — | 1 | — | — | — | 1 | 2 |
| Ataxia | D001259 | — | R27.0 | 1 | — | — | — | 1 | 2 |
| Allergic rhinitis | D065631 | — | J30.9 | 1 | — | — | — | 1 | 2 |
| Mycosis fungoides | D009182 | — | C84.0 | 1 | — | — | — | 1 | 2 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | 1 | — | — | — | 1 | 2 |
| Hepatic insufficiency | D048550 | — | — | 2 | — | — | — | — | 2 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Allergic bronchopulmonary aspergillosis | D001229 | EFO_0007140 | B44.81 | — | — | — | — | 3 | 3 |
| Granulomatous mastitis | D058890 | — | N61.2 | — | — | — | — | 2 | 2 |
| Mastitis | D008413 | EFO_1001034 | N61 | — | — | — | — | 2 | 2 |
| Hepatitis b | D006509 | — | — | — | — | — | — | 2 | 2 |
| Trigger finger disorder | D052582 | — | M65.3 | — | — | — | — | 2 | 2 |
| Pneumocystis | D011010 | — | — | — | — | — | — | 2 | 2 |
| Uveomeningoencephalitic syndrome | D014607 | Orphanet_3437 | H20.82 | — | — | — | — | 2 | 2 |
| Aspergillosis | D001228 | EFO_0007157 | B44 | — | — | — | — | 2 | 2 |
| Pulmonary aspergillosis | D055732 | EFO_1001834 | — | — | — | — | — | 2 | 2 |
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Prednisone |
| INN | prednisone |
| Description | Prednisone is a synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid. It has a role as a prodrug, an anti-inflammatory drug, an antineoplastic agent, an immunosuppressive agent and an adrenergic agent. It is a 20-oxo steroid, an 11-oxo steroid, a 21-hydroxy steroid, a 17alpha-hydroxy steroid, a glucocorticoid, a 3-oxo-Delta(1),Delta(4)-steroid, a primary alpha-hydroxy ketone, a tertiary alpha-hydroxy ketone and a C21-steroid. |
| Classification | Small molecule |
| Drug class | prednisone and prednisolone derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@]12CC(=O)[C@H]3[C@@H](CCC4=CC(=O)C=C[C@@]43C)[C@@H]1CC[C@]2(O)C(=O)CO |
Identifiers
| PDB | — |
| CAS-ID | 53-03-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL635 |
| ChEBI ID | 8382 |
| PubChem CID | 5865 |
| DrugBank | DB00635 |
| UNII ID | VB0R961HZT (ChemIDplus, GSRS) |
Target
Agency Approved
NR3C1
NR3C1
Organism
Homo sapiens
Gene name
NR3C1
Gene synonyms
GRL
NCBI Gene ID
Protein name
glucocorticoid receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 1, nuclear receptor subfamily 3 group C member 1 variant hGR-B(54), nuclear receptor subfamily 3 group C member 1 variant hGR-B(77), nuclear receptor subfamily 3 group C member 1 variant hGR-B(93), nuclear receptor subfamily 3, group C, member 1 (glucocorticoid receptor)
Uniprot ID
Mouse ortholog
Nr3c1 (14815)
glucocorticoid receptor (Q61629)
Alternate
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Financial
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Rayos – Horizon Therapeutics Public
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Prednisone
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Trends
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Safety
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Adverse Events
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211,538 adverse events reported
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