TheraRadar
Data updated: May 26, 2026

METHYLPREDNISOLONE ACETATE

Respiratory Approved 1979-03-14

METHYLPREDNISOLONE ACETATE is indicated for the treatment of Asthma; Atopic Dermatitis; Contact Dermatitis; Drug Hypersensitivity; Serum Sickness; Transfusion Reaction; Bullous Dermatitis Herpetiformis; Exfoliative Dermatitis; Mycosis Fungoides; Pemphigus.

Source: FDA Label • WATSON LABS
14
Indications
--
Phase 3 Trials
47
Years on Market

Details

Status
Discontinued
First Approved
1979-03-14
Routes
INJECTION
Dosage Forms
INJECTABLE

METHYLPREDNISOLONE ACETATE Approval History

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Original
New Indication
New Form
Label Update
143 FDA actions from 1979 to 2026
Apr 2026 SUPPL
Label · Labeling
Jan 2026 ORIGINAL
Update
Jan 2026 SUPPL
Label · Labeling

What METHYLPREDNISOLONE ACETATE Treats

10 indications

METHYLPREDNISOLONE ACETATE is approved for 10 conditions since its original approval in 1979. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Asthma
  • Atopic Dermatitis
  • Contact Dermatitis
  • Drug Hypersensitivity
  • Serum Sickness
  • Transfusion Reaction
  • Bullous Dermatitis Herpetiformis
  • Exfoliative Dermatitis
Source: FDA Label

METHYLPREDNISOLONE ACETATE Competitive Set

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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 METHYLPREDNISOLONE ACETATE's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications METHYLPREDNISOLONE ACETATE treats. First-in-class if their pivotal trials read out positive.

Drugs Similar to METHYLPREDNISOLONE ACETATE

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Clinical Trial Registry

5 trials
Trial Sponsor ID Phase Status Title
NCT03913702 results posted UTMB IRB #: 18-0156 Ph 2 terminated Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement
NCT03794505 F-2018-3401-056 Ph 3 completed Quality of Life and Pain With Infiltration or Suprascapular Nerve Block in Glenohumeral Arthirtis
NCT02847494 results posted 2016-6342 Ph 4 completed Corticosteroids for Acute Migraine in the Emergency Department
NCT02403856 CALCECHO RC15_0019 Ph 4 completed Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection
NCT01652495 TPESP2011-12 results posted 2012-000866-40 Ph 4 completed Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection
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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

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.

METHYLPREDNISOLONE ACETATE FDA Label Details

Indications & Usage

METHYLPREDNISOLONE ACETATE is indicated for the treatment of Asthma; Atopic Dermatitis; Contact Dermatitis; Drug Hypersensitivity; Serum Sickness; Transfusion Reaction; Bullous Dermatitis Herpetiformis; Exfoliative Dermatitis; Mycosis Fungoides; Pemphigus.

Looking for the branded version?

DEPO-MEDROL

Full clinical data, patents, trials, and competitive landscape for methylprednisolone acetate.

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Data Sources

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