Data updated: Nov 8, 2026
MEDROL (methylprednisolone) · Pfizer
Respiratory
Approved 1957-10-24
2
Indications
--
Phase 3 Trials
69
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1957-10-24
- Revenue
- $76M (Q4-2023)
- Routes
- ORAL, RECTAL
- Dosage Forms
- TABLET, ENEMA
MEDROL Approval History
1958
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2026
Original
New Indication
New Form
Label Update
129 FDA actions from 1957 to 2025
Jul 2013 SUPPL
Mfg
Oct 2002 SUPPL
Mfg
Dec 1999 SUPPL
Mfg
Jan 1993 SUPPL
Mfg
Jan 1989 SUPPL
Mfg
Feb 1987 SUPPL
Mfg
Mar 1983 SUPPL
Label
Nov 1982 SUPPL
Mfg
Apr 1981 SUPPL
Mfg
Oct 1980 SUPPL
Mfg
Apr 1980 SUPPL
Label
May 1979 SUPPL
Mfg
Apr 1979 SUPPL
Mfg
Apr 1978 SUPPL
Label
Dec 1977 ORIGINAL
New Ingredient
Sep 1976 SUPPL
Mfg
Oct 1957 ORIGINAL
New Drug
What MEDROL Treats
2 FDA approvalsOriginally approved for its first indication in 1957 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Oct 1957)
- • Approved indication (Dec 1977)
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📋
Clinical Trial Registry
241 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| 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 |
| NCT02784210 | 160114 16-N-0114 | Ph 2 | recruiting | Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques |
| 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 |
| NCT06970743 CaDAnCe-303 | BGB-16673-303 | Ph 3 | active not recruiting | A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors |
| NCT06670521 COPED | 24-1535 R21AG089278 | Ph 2 | recruiting | Corticosteroids for Post-Extubation Dysphagia |
| NCT06474273 TACKLE-IT | GWCT051274 | Ph 3 | recruiting | A Multicenter Randomized Controlled Trial to Treat Acute T Cell Mediated Rejection in Kidney and Kidney-Pancreas 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) |
| NCT05986422 | PoCoVIT 01EP2201 | Ph 2 | terminated | Methylprednisolone in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS) |
| 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 |
| NCT05039619 POSTERITY | WA42985 2021-000097-29, 2023-505825-15-00 | Ph 2 | recruiting | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants |
| NCT03007147 | AALL1631 NCI-2016-01588, 2024-515499-12-00 | Ph 3 | active not recruiting | Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia |
| NCT04544436 MUSETTE results posted | BN42082 2020-000893-69, 2023-506467-34-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS) |
| NCT03898154 results posted | 2018-0533 | Ph 4 | terminated | Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures |
| NCT04408625 PROCLAIM | J4B-MC-OKAA (PRV-FTD101) | Ph 1, Ph 2 | active not recruiting | Phase 1/2 Clinical Trial of LY3884963 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN) |
| NCT07412470 FREXERA | EFC18554 2025-521521-33-00, 2025 | Ph 2, Ph 3 | recruiting | A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation |
| NCT07070882 | AAAV7426 | Ph 1 | active not recruiting | Oral Steroid Taper After Total Knee Arthroplasty |
| NCT07052929 | 2957-CL-0101 2025-523213-29, 2025 | Ph 1, Ph 2 | recruiting | Study of ASP2957 in Male Participants With X-linked Myotubular Myopathy Who Need Ventilators |
| NCT01624805 | 2012-0334 NCI-2012-01096, 2012-0334 | Ph 2 | recruiting | Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome |
| NCT05097976 | 21090203 | Ph 4 | recruiting | Medrol Dosepak for Outpatient Total Knee Arthroplasty |
| NCT04216524 | 2019-0587 NCI-2019-08358, 2019-0587 | Ph 2 | recruiting | Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm |
| NCT07525466 | TRhos-NKTCL-HLH | Ph 1, Ph 2 | recruiting | Combination of Mitoxantrone Liposome and Etoposide, Dexamethasone, Pegaspargase and Golidocitinib (MEPL-G) in the Treatment of NK/T-cell Lymphoma Associated Hemophagocytic Lymphohistiocytosis (NKTCL-HLH) |
| NCT00792948 results posted | NCI-2009-00800 NCI-2009-00800, S0805 | Ph 2 | active not recruiting | Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia |
| NCT05303792 | A042001 U10CA180821, NCI-2022-01735 | Ph 2 | active not recruiting | Comparing Inotuzumab Combined With Low Intensity Chemotherapy Plus Blinatumomab to Usual Chemotherapy Plus Blinatumomab in Older Adults With CD22+ B-cell Acute Lymphoblastic Leukemia |
| NCT04629248 MAJESTY | WA41937 2020-003233-38, 2023-506525-11-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy |
| NCT04963296 ALLEGORY | CA42750 2020-005760-57, 2023-504774-38-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus |
| NCT07509749 GVHD | S2025-772-01 | Ph 2 | recruiting | Novel Therapies for Severe Acute GVHD (Graft-versus-host Disease) |
| NCT04438382 results posted | EAQ172 NCI-2018-02825, EAQ172 | Ph 2 | terminated | Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis |
| NCT07507643 | 26-077 | Ph 3 | recruiting | A Study of Methylprednisolone in People Having Liver Surgery |
| NCT04411654 | J3Z-MC-OJAB (PRV-GD2-101) | Ph 1, Ph 2 | active not recruiting | Phase 1/2 Clinical Trial of PR001 in Infants With Type 2 Gaucher Disease (PROVIDE) |
| NCT04548999 GAVOTTE results posted | BN42083 2020-000894-26, 2023-506515-18-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS) |
| NCT05462730 PULSE-MI results posted | PULSE-MI 2022-500762-10-00 | Ph 2 | completed | Pulse Glucocorticoid Therapy in Patients With ST-Segment Elevation Myocardial Infarction |
| NCT06936566 MAGIC V | STUDY-24-01656 P01CA039542 | Ph 2 | recruiting | MAGIC Ruxolitinib for aGVHD |
| NCT04127578 | J3Z-MC-OJAA formerly PRV-PD101 | Ph 1, Ph 2 | active not recruiting | Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) |
| NCT04862221 TRIUMPH | PALF IRN/TRIUMPH U01DK062436 | Ph 2 | active not recruiting | TReatment for ImmUne Mediated PathopHysiology |
| NCT07455396 PATCH | IRB00544439 | Ph 2 | recruiting | Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma |
| NCT06356571 SubQSA | LPS18183 U1111-1298-7348 | Ph 2 | active not recruiting | A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma |
| NCT04224558 | Pro00051458 | Ph 1, Ph 2 | recruiting | Stem Cell Transplantation in Crohn's Disease |
| NCT03913559 | INOMRD NCI-2019-01062 | Ph 2 | terminated | Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia |
| NCT07101445 | STUDY00008909 NCI-2025-03018, STUDY00008909 | Ph 4 | recruiting | Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial |
| NCT07394894 | LPC RA VS US steroids | Ph 4 | not yet recruiting | Local Percutaneous Pulsed Radiofrequency Ablation Versus Ultrasound Guided Steroids Injection in Management of Pain in Cases of Chronic Planter Fascitis, Randomised Double Blinded Study |
| NCT04918147 results posted | DAIT AIG01 UM1AI144298, NIAID CRMS ID#: 38708 | Ph 2 | terminated | Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD) |
| NCT04305145 | 19-763 | Ph 2 | active not recruiting | Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis |
| NCT05220319 CORTERAS | Z-2021070 | Ph 4 | completed | CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients |
| NCT07357935 | 2025ZD01902401 | Ph 1, Ph 2 | not yet recruiting | Early Inflammatory-Immune Stratification and Precision Glucocorticoid Intervention in Acute Respiratory Failure Induced by Community-Acquired Pneumonia |
| NCT04151082 | 2019-0207 NCI-2019-06735, 2019-0207 | Ph 1, Ph 2 | recruiting | High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors |
| NCT03229538 STRESS results posted | Pro00078106 1U01TR001803-01 | Ph 3 | completed | STeroids to REduce Systemic Inflammation After Infant Heart Surgery |
| 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) |
| NCT05704049 IZALCO | ACT17453 U1111-1280-5090, 2023-508870-27 | Ph 2 | active not recruiting | A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma |
| NCT05627557 INShore results posted | WA43380 2022-000369-42, 2023-505140-19-00 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome |
| NCT03952637 | 190101 19-HG-0101 | Ph 1, Ph 2 | recruiting | A Phase 1/2 Study of Intravenous Gene Transfer With an AAV9 Vector Expressing Human Beta-galactosidase in Type I and Type II GM1 Gangliosidosis |
Showing 50 of 241 trials
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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.
MEDROL FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.