Data updated: May 26, 2026
PREDNISONE INTENSOL (prednisone)
Corticosteroid Hormone Receptor Agonists
Immunology
Approved 1985-02-20
PREDNISONE INTENSOL is indicated for the treatment of Adrenocortical Insufficiency; Congenital Adrenal Hyperplasia; Hypercalcemia; Thyroiditis; Psoriatic Arthritis; Rheumatoid Arthritis; Ankylosing Spondylitis; Tenosynovitis; Gouty Arthritis.
Source: FDA Label • Hikma
1
Indication
--
Phase 3 Trials
41
Years on Market
Details
- Status
- Prescription
- First Approved
- 1985-02-20
- Routes
- ORAL
- Dosage Forms
- SOLUTION
PREDNISONE INTENSOL Approval History
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Original
New Indication
New Form
Label Update
19 FDA actions from 1985 to 2024
Jun 2024 SUPPL
Label · Labeling
Dec 2020 SUPPL
Mfg · Manufacturing (CMC)
May 2001 SUPPL
Mfg · Manufacturing (CMC)
Jan 2001 SUPPL
Mfg
Aug 1996 SUPPL
Mfg
Jul 1995 SUPPL
Label
Feb 1995 SUPPL
Label
Oct 1994 SUPPL
Label
Mar 1994 SUPPL
Label
Oct 1993 SUPPL
Mfg
Jul 1991 SUPPL
Label
Sep 1990 SUPPL
Mfg
Feb 1990 SUPPL
Label
Oct 1989 SUPPL
Label
Jan 1989 SUPPL
Mfg
Nov 1988 SUPPL
Update
Feb 1985 ORIGINAL
Update
What PREDNISONE INTENSOL Treats
9 indicationsPREDNISONE INTENSOL is approved for 9 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Adrenocortical Insufficiency
- Congenital Adrenal Hyperplasia
- Hypercalcemia
- Thyroiditis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Tenosynovitis
Source: FDA Label
PREDNISONE INTENSOL Competitive Set
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Indication competitors
10
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What's emerging in PREDNISONE INTENSOL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PREDNISONE INTENSOL treats. First-in-class if their pivotal trials read out positive.
Tulisokibart MK-7240 / PRA023
Merck Sharp & Dohme LLC TNFSF15 · monoclonal antibody (anti-TL1A) · 3 Phase 3 trials
Ianalumab VAY736 ✓ Won — Ph3 readout
Novartis Pharmaceuticals TNFRSF13C · monoclonal antibody (anti-BAFF-R, glycoengineered for ADCC) · 8 Phase 3 trials
Afimkibart RVT-3101 / PRA023
Hoffmann-La Roche TNFSF15 · monoclonal antibody (anti-TL1A) · 6 Phase 3 trials
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Clinical Trial Registry
681 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 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 | active not recruiting | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations |
Showing 50 of 681 trials
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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.
PREDNISONE INTENSOL FDA Label Details
Indications & Usage
PREDNISONE INTENSOL is indicated for the treatment of Adrenocortical Insufficiency; Congenital Adrenal Hyperplasia; Hypercalcemia; Thyroiditis; Psoriatic Arthritis; Rheumatoid Arthritis; Ankylosing Spondylitis; Tenosynovitis; Gouty Arthritis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.