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Data updated: Jun 17, 2026

PREDNISONE

Immunology Approved 1971-12-23
Jump to: Indications Approvals Trials Competitors Safety Patents
56
Indications
--
Phase 3 Trials
54
Years on Market

Details

Status
Prescription
First Approved
1971-12-23
Routes
ORAL
Dosage Forms
TABLET, TABLET, DELAYED RELEASE, SOLUTION

Companies

CHARTWELL MOLECULAR WATSON LABS DURAMED PHARMS BARR SUPERPHARM Hikma JUBILANT CADISTA IVAX SUB TEVA PHARMS SCHERER LABS MUTUAL PHARM PHOENIX LABS NY RISING Aurobindo Pharma Dr. Reddy's VALEANT INTL WHITEWORTH TOWN PLSN UPSHER SMITH LABS ROXANE AMNEAL PH HEALTH INWOOD LABS CHARTWELL RX KV PHARM VANGARD AM THERAP GENEYORK PHARMS NOVITIUM PHARMA REXALL HALSEY PUREPAC PHARM VITARINE IMPAX LABS XTTRIUM Teva AIPING PHARM INC SPERTI FERRANTE NYLOS ELKINS SINN UDL Sun Pharma AMNEAL PHARMS NY STRIDES PHARMA PANRAY HEATHER MARSHALL PHARMA EVERYLIFE POINTVIEW HLDINGS Viatris CONTRACT PHARMACAL BUNDY PHARMAVITE PVT FORM LEDERLE
Active Ingredient: PREDNISONE

PREDNISONE Approval History

1972
1973
1974
1975
1976
1977
1978
1979
1980
1981
1982
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1984
1985
1986
1987
1988
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1991
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2020
2021
2022
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2025
2026
Original
New Indication
New Form
Label Update
783 FDA actions from 1971 to 2025
Oct 2025 ORIGINAL
Update
Jun 2024 SUPPL
Label · Labeling
Jun 2024 SUPPL
Label · Labeling

What PREDNISONE Treats

56 FDA approvals

Originally approved for its first indication in 1971 . Covers 56 distinct patient populations.

  • Other (56)
📋

Clinical Trial Registry

689 trials
Trial Sponsor ID Phase Status Title
NCT05896839 NCI-2023-04306 NCI-2023-04306, ETCTN10614 Ph 1, Ph 2 recruiting Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
NCT06649812 NCI-2024-08642 NCI-2024-08642, EA4231 Ph 2 recruiting Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
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
NCT04530565 NCI-2020-06381 NCI-2020-06381, EA9181 Ph 3 active not recruiting Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
NCT04301076 NCI-2020-01535 NCI-2020-01535, 10335 Ph 1 suspended Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL)
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
NCT03808610 2016-0629 NCI-2018-03360, 2016-0629 Ph 1, Ph 2 terminated Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia
NCT03984448 NCI-2019-03711 NCI-2019-03711, A051701 Ph 2, Ph 3 active not recruiting Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas
NCT03269669 NCI-2017-00009 NCI-2017-00009, S1608 Ph 2 active not recruiting Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
NCT07444710 NCI-2026-01137 NCI-2026-01137, PHI-158 Ph 1 not yet recruiting Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
NCT04799275 NCI-2020-01256 NCI-2020-01256, S1918 Ph 2, Ph 3 active not recruiting Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma
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
NCT06738368 RG1124788 NCI-2024-09417, FHIRB0020869 Ph 2 recruiting Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia
NCT02784210 160114 16-N-0114 Ph 2 recruiting Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques
NCT07225946 KLK2-PASenger 78278343PCR3003 78278343PCR3003, 2025-522713-29-00 Ph 3 recruiting A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
NCT06635720 RESPONSE 1000081679 Ph 3 active not recruiting REduced-dose Steroid PrOtocol for Childhood Nephrotic SyndromE (RESPONSE)
NCT02257736 results posted CR105505 56021927PCR3001, 2014-001718-25 Ph 3 active not recruiting An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
NCT05453500 RG1122464 NCI-2022-05225, 11008 Ph 2 active not recruiting Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia
NCT04221477 REGENCY results posted CA41705 2019-004034-42, 2023-503628-22-00 Ph 3 active not recruiting A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
NCT05689021 MC210503 21-010477 Ph 2 active not recruiting CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations
NCT04262154 results posted 19-461 Ph 2 active not recruiting Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer
NCT04497844 AMPLITUDE results posted CR108852 67652000PCR3002, 2020-002209-25 Ph 3 active not recruiting A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
NCT06925737 2400-001 U1111-1312-2498, 2024-517423-40-00 Ph 3 recruiting A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
NCT06533098 FREESIA-3 80202135FNAIT3003 2023-509434-19-00 Ph 3 recruiting A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
NCT04662580 ARX517 ARX517-2011 ARX517-2011 Ph 1 active not recruiting ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer
NCT02123758 CR104358 56021927PCR1010, 2014-001426-14 Ph 1 active not recruiting A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
NCT05090384 results posted GCO 21-0541 Ph 2 completed Pediatric GVHD Low Risk Steroid Taper Trial
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)
NCT03748641 MAGNITUDE results posted CR108534 64091742PCR3001, 2017-003364-12 Ph 3 active not recruiting A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
NCT03274492 POLARIX GO39942 2017-002023-21 Ph 3 completed A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma
NCT04577833 CR108783 67652000PCR1001, 2019-000137-39 Ph 1 active not recruiting A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
NCT06043323 2023-0087 NCI-2023-07173 Ph 2 recruiting A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma
NCT06191744 EPCORE™FL-2 M22-003 2023-506906-38-00 Ph 3 recruiting Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma
NCT04872790 STUDY00022691 NCI-2021-01791, STUDY00022691 Ph 1 active not recruiting Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia
NCT04803201 A051902 NCI-2021-01380, U10CA180821 Ph 2 suspended Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma
NCT05283720 M22-132 2023-505347-38, 2023-505347-38-00 Ph 2 recruiting A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
NCT06474273 GWCT051274 Ph 3 recruiting TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients
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)
NCT01920932 results posted HLHR13 NCI-2013-01123 Ph 2 active not recruiting Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma
NCT06045247 2023-0031 NCI-2023-07174 Ph 2 recruiting Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma
NCT04043494 LBL 2018 UKM17_0023 2017-001691-39 Ph 3 recruiting International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
NCT06136624 OMAHA-003 5684-003 2023-504899-25-00, MK-5684-003 Ph 3 recruiting Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
NCT05848765 REFRACT RG_22-020 Ph 2 recruiting Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy
NCT04978584 2021-0046 NCI-2021-04298, 2021-0046 Ph 2 active not recruiting Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Alone and With Combination Chemotherapy for the Treatment of Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma, Smart Stop Study
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
NCT02166463 results posted NCI-2014-01223 NCI-2014-01223, s15-00950 Ph 3 active not recruiting Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
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
NCT02883049 results posted NCI-2011-03797 NCI-2011-03797, S12-01254 Ph 3 completed Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations

Showing 50 of 689 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

PREDNISONE FDA Label Details

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PREDNISONE INTENSOL

Full clinical data, patents, trials, and competitive landscape for prednisone.

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Data Sources

FDA Approval: ANDA084275 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.