Data updated: Jun 28, 2026
PREDNISOLONE · Aurobindo Pharma
Generic · see CORTALONE Corticosteroid Hormone Receptor Agonists
Immunology
Approved 1955-06-21
1. Endocrine disorders . Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic disorders .
NDA
Small Molecule
30
Indications
--
Phase 3 Trials
71
Years on Market
Details
- Status
- Prescription
- First Approved
- 1955-06-21
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION, SYRUP
Companies
Aurobindo Pharma ELKINS SINN WATSON LABS INC PHARMOBEDIENT CNSLTG FOSUN PHARMA FERRANTE Teva Hikma ROXANE BUNDY VALEANT PHARM INTL PUREPAC PHARM PANRAY ZHEJIANG XIANJU TP ANDA HOLDINGS LANNETT CO INC IMPAX LABS EVERYLIFE RISING NESHER PHARMS PHOENIX LABS NY HEATHER WHITEWORTH TOWN PLSN CHARTWELL MOLECULAR UDL PHARM ASSOC PVT FORM SUPERPHARM WE PHARMS MARSHALL PHARMA INWOOD LABS IVAX SUB TEVA PHARMS CHARTWELL RX SPERTI VITARINE TABLICAPS
Active Ingredient: PREDNISOLONE
Website: ↗
PREDNISOLONE Approval History
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Original
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127 FDA actions from 1971 to 2026
Apr 2026 SUPPL
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What PREDNISOLONE Treats
24 indicationsPREDNISOLONE is approved for 24 conditions since its original approval in 1971. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Adrenocortical Insufficiency
- Congenital Adrenal Hyperplasia
- Nonsuppurative Thyroiditis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Juvenile Rheumatoid Arthritis
- Ankylosing Spondylitis
- Bursitis
- Tenosynovitis
- Gouty Arthritis
- Osteoarthritis
- Epicondylitis
- Systemic Lupus Erythematosus
- Rheumatic Carditis
- Dermatomyositis
- Pemphigus
- Dermatitis Herpetiformis
- Stevens-Johnson Syndrome
- Exfoliative Dermatitis
- Mycosis Fungoides
- Psoriasis
- Seborrheic Dermatitis
- Allergic Rhinitis
- Asthma
Source: FDA Label
PREDNISOLONE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 8 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in PREDNISOLONE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PREDNISOLONE treats. First-in-class if their pivotal trials read out positive.
Ianalumab VAY736 ✓ Won — Ph3 readout
Novartis Pharmaceuticals TNFRSF13C · monoclonal antibody (anti-BAFF-R, glycoengineered for ADCC) · 8 Phase 3 trials
Tulisokibart MK-7240 / PRA023
Merck Sharp & Dohme LLC TNFSF15 · monoclonal antibody (anti-TL1A) · 3 Phase 3 trials
Afimkibart RVT-3101 / PF-06480605 / RG6631
Hoffmann-La Roche TNFSF15 · monoclonal antibody (anti-TL1A) · 6 Phase 3 trials
Drugs Similar to PREDNISOLONE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
180 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04759586 | NCI-2021-01071 NCI-2021-01071, ANHL1931 | Ph 3 | active not recruiting | Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma |
| NCT06124157 | NCI-2023-09214 NCI-2023-09214, AALL2131 | Ph 2 | recruiting | A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL) |
| NCT05675410 | NCI-2022-10845 NCI-2022-10845, AHOD2131 | Ph 3 | recruiting | A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab |
| NCT06624670 | 1368-0140 2024-514306-31-00, U1111-1306-8055 | Ph 3 | recruiting | A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum |
| NCT06317662 | NCI-2024-01994 NCI-2024-01994, AALL2321 | Ph 2 | recruiting | Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia |
| NCT02629042 PULPISOLONE | CHUBX 2014/09 2015-002485-24 | Ph 3 | completed | Efficacy of Oral Prednisolone on Pain Reduction in Emergency Care of Acute Irreversible Pulpitis |
| NCT06956482 PROCORNAC | 2024_0476 PHRC-23-0354, 2025-522109-39-00 | Ph 3 | recruiting | PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis |
| NCT03286634 | ASIA-DS-ALL-2016 | Ph 2 | active not recruiting | ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016 |
| NCT06890884 | 2140-011 2024-515526-89-00, U1111-1309-2852 | Ph 2 | recruiting | A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011) |
| NCT07571681 COLTHYR | MU-THY-COL-2026-01 MD-MU-IRB-R.24.11.2879 | Ph 2, Ph 3 | not yet recruiting | Colchicine for Autoimmune and Subacute Thyroiditis |
| NCT06717347 | 2140-010 MK-2140-010, 2024-515566-13-00 | Ph 3 | recruiting | A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010) |
| NCT04043494 LBL 2018 | UKM17_0023 2017-001691-39 | Ph 3 | recruiting | International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma |
| NCT03959085 | AALL1732 NCI-2019-02845, AALL1732 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy |
| NCT03914625 | NCI-2019-02187 NCI-2019-02187, AALL1731 | Ph 3 | active not recruiting | A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia |
| NCT03007147 | AALL1631 NCI-2016-01588, AALL1631 | Ph 3 | active not recruiting | Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia |
| NCT07005154 | 5541-CL-0201 | Ph 2 | recruiting | A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer |
| NCT03206671 B-NHL 2013 | UKM12_0020 2013-003253-21 | Ph 3 | active not recruiting | Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents |
| NCT07553988 | CL01069052 | Ph 2 | active not recruiting | A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer |
| NCT05761171 | AALL2121 NCI-2023-00503, AALL2121 | Ph 2 | active not recruiting | A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia |
| NCT04078568 | KD-3-01 | Ph 3 | completed | Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease |
| NCT07052929 | 2957-CL-0101 2025-523213-29 | Ph 1, Ph 2 | recruiting | Study of ASP2957 in Male Participants With X-linked Myotubular Myopathy Who Need Ventilators |
| NCT01679119 INCA results posted | UCL 11/0475 | Ph 2 | completed | Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy |
| NCT06421597 RIGID | 2023-506949-27-00 | Ph 2 | active not recruiting | Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease |
| NCT04300556 | MORAb-202-G000-201 2019-003600-12, 2023-506868-14 | Ph 1, Ph 2 | recruiting | A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types |
| NCT04862221 TRIUMPH | PALF IRN/TRIUMPH U01DK062436 | Ph 2 | recruiting | TReatment for ImmUne Mediated PathopHysiology |
| NCT04161898 SELECT-TAK | M19-052 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK) |
| NCT06953791 CONSISTENT | CONSISTENT | Ph 2 | recruiting | Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Patients |
| NCT07380152 COPOSTCOVID | 47222421.7.0000.5440 | Ph 1 | completed | Corticosteroid Therapy in Pulmonary Sequelae of Covid-19 |
| NCT05776459 | AC102-201 | Ph 2 | active not recruiting | Efficacy and Safety of AC102 Compared to Steroids in Adults With Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL) |
| NCT06220032 HO170DLBCL | HO170 DLBCL-ANTICIPATE 2023-505377-32 | Ph 3 | recruiting | Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma |
| NCT07072585 | AALL2331 NCI-2025-02230, AALL2331 | Ph 2, Ph 3 | not yet recruiting | Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL) |
| NCT07172659 | MDGH-DOV-2001 | Ph 2 | recruiting | Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction |
| NCT02281929 AntibioCor | 2014_05 2014-002536-13, PHRC-2013-0552 | Ph 3 | completed | Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone |
| NCT02881086 | GMALL08_2013 | Ph 3 | completed | Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment |
| NCT05619653 MYOFLAME-19 | MYOFLAME-19 2022-001682-12 | Ph 3 | active not recruiting | Myocardial Protection in Patients With Post-acute Inflammatory Cardiac Involvement Due to COVID-19 |
| NCT06260904 | AIIMS BBSR/PGThesis/23-24/112 | Ph 4 | completed | Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus |
| NCT07252271 | VlP | Ph 4 | not yet recruiting | Very Low Dose Prednisolone on Newly Diagnosed Rheumatoid Arthritis |
| NCT06483802 | 2016-CL-0101 | Ph 1 | withdrawn | A Study of ASP2016 in Adults Who Have Heart Disease Associated With Friedreich Ataxia |
| NCT03368664 LemKids results posted | EFC13429 U1111-1180-6352, 2016-003100-30 | Ph 3 | terminated | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT |
| NCT07227428 | 2502-080-1613 | Ph 4 | not yet recruiting | Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis |
| NCT04873583 PASTA | 1473_PASTA 2022-500631-36-00, 2021-005571-39 | Ph 3 | recruiting | High Dose Steroids in Children With Stroke |
| NCT03933631 PAACK | 2018-9829 | Ph 3 | recruiting | Pilocarpine Use After Kahook Goniotomy |
| NCT06143891 ROCKnrol-1 | EFC17757 2023-505394-32, U1111-1280-4918 | Ph 3 | active not recruiting | A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease. |
| NCT07210008 RUBY | APHP240908 2025-521591-64-00 | Ph 3 | not yet recruiting | "Randomized Controlled Trial Testing the Efficacy of Corticosteroid Therapy Versus Placebo in Fibrotic Hypersensitivity Pneumonitis" |
| NCT06676579 | 24-005668 | Ph 2 | recruiting | Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN) |
| NCT04479267 | 2019-135 P30CA022453 | Ph 2 | active not recruiting | Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Lymphoma |
| NCT07035379 | TRS00501003 | Ph 1, Ph 2 | not yet recruiting | A Phase I/II Study of TRS005 in Combination With Cyclophosphamide, Doxorubicin, and Prednisone（T-CHP） in Previously Untreated Patients With CD20-positive DLBCL |
| NCT06471465 BRADI | ICO-2023-15 | Ph 3 | recruiting | Corticodependent or Corticoresistant Brain Radionecrosis After Radiotherapy for Brain Metastases |
| NCT05984381 | AIIMS BBSR/PG Thesis/2023-24 | Ph 4 | completed | Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid |
| NCT05412394 | Infant Steroid Phase II | Ph 4 | recruiting | Once Weekly Infant Corticosteroid Trial for DMD |
Showing 50 of 180 trials
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PREDNISOLONE FDA Label Details
Indications & Usage
FDA Label (PDF)1. Endocrine disorders . Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic disorders . As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis; including juvenile rheumatoid arthr...
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CORTALONE
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.