Methylprednisolone

Overview

Methylprednisolone is a prednisolone derivative glucocorticoid with higher potency than prednisone. It was first described in the literature in the late 1950s. Methylprednisolone was granted FDA approval on 24 October 1957. In the outbreak of COVID-19, low dose methylprednisolone-based therapy was successful in treating COVID-19-associated pneumonia in one patient with long-term immunosuppression. The efficacy of methylprednisolone in novel coronavirus pneumonia is being investigated further in clinical trials.

Indication

Oral and intramuscular methylprednisolone are indicated for a number of endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, respiratory, hematologic, neoplastic, edematous, gastrointestinal, nervous system, and other disorders. Intra-articular and soft tissue injections are indicated for short term treatment of acute gouty arthritis, acute and subactute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, and synovitis of osteoarthritis. Intralesional injections are indicated for alopecia areata, discoid lupus erythematosus, keloids, lichen planus, lichen simplex chronicus and psoriatic plaques, necrobiosis lipoidica diabeticorum, and localized hypertrophic infiltrated inflammatory lesions of granuloma annulare.

Associated Conditions

Acute Gouty Arthritis
Acute Leukemia
Allergic Conjunctivitis (AC)
Allergic corneal marginal ulcers
Alopecia Areata (AA)
Ankylosing Spondylitis (AS)
Aponeurosis contusion
Aspiration Pneumonitis
Asthma
Atopic Dermatitis
Autoimmune Hemolytic Anemia
Berylliosis
Bronchial Asthma
Bullous dermatitis herpetiformis
Chorioretinitis
Choroiditis
Congenital Adrenal Hyperplasia (CAH)
Congenital Hypoplastic Anemia
Contact Dermatitis
Degenerative Joint Disease
Dermatomyositis (DM)
Discoid Lupus Erythematosus (DLE)
Drug hypersensitivity reaction
Edema of the cerebrum
Epicondylitis
Erythroblastopenia
Gout
Hypercalcemia of Malignancy
Immune Thrombocytopenia (ITP)
Inflammatory Reaction of the Cysts
Iridocyclitis
Iritis
Keloids Scars
Keratitis
Leukemias
Lichen Planus (LP)
Lichen simplex chronicus
Loeffler's syndrome
Lymphoma
Meningitis caused by Mycobacterium Tuberculosis
Mycosis Fungoides (MF)
Necrobiosis lipoidica diabeticorum
Nummular Dermatitis
Ocular Inflammation
Ophthalmia, Sympathetic
Optic Neuritis
Pemphigus
Perennial Allergic Rhinitis (PAR)
Polymyositis
Posttraumatic Osteoarthritis
Primary adrenocortical insufficiency
Psoriatic Arthritis
Psoriatic plaque
Pure Red Cell Aplasia
Regional Enteritis
Rheumatoid Arthritis
Rheumatoid Arthritis, Juvenile
Seasonal Allergic Rhinitis
Seborrheic Dermatitis, Eczematous
Secondary adrenocortical insufficiency
Secondary thrombocytopenia
Serum Sickness
Severe Seborrheic Dermatitis
Stevens-Johnson Syndrome
Systemic Lupus Erythematosus
Temporal Arteritis
Tendonitis exacerbated
Transfusion Reactions
Trichinosis
Ulcerative Colitis
Uveitis
Acute Bursitis
Acute Multiple sclerosis exacerbation
Acute nonspecific tenosynovitis
Acute rheumatic carditis
Anterior eye segment inflammation
Articular inflammation
Cystic tumors of aponeurosis
Cystic tumors of tendon
Disseminated Pulmonary Tuberculosis (TB)
Exfoliative erythroderma
Fulminating Pulmonary Tuberculosis
Idiopathic eosinophilic pneumonias
Inflammatory dermatoses of the scalp
Localized Hypertrophic, Inflammatory, Infiltrated granuloma annulare lesions
Non-suppurative Thyroiditis
Severe Erythema multiforme
Severe Psoriasis
Subacute Bursitis
Symptomatic Sarcoidosis
Synovitis of osteoarthritis
Systemic Dermatomyositis
Varicella-zoster virus acute retinal necrosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder	2025/01/08	NCT06763848	Not Applicable	Recruiting	Third Affiliated Hospital, Sun Yat-Sen University
Multi-center Prospective Clinical Study on Glucocorticoid Pulse Therapy for Graves' Ophthalmopathy (GO)	2024/11/18	NCT06693856	Not Applicable	ENROLLING_BY_INVITATION	Zou Junjie
Corticoid Therapy in Acute Myocarditis	2024/07/26	NCT06522100	Phase 3	Not yet recruiting	Assistance Publique - Hôpitaux de Paris
Steroids for Rhinoplasty: Pain, Nausea, Edema and Ecchymosis	2024/07/03	NCT06483204	Phase 4	Not yet recruiting	Vanderbilt University Medical Center
Efficacy of Methylprednisolone Pulses in Neuroendocrine Celles Hyperplasia of Infancy : An Early Phase Study	2024/06/24	NCT06471556	Phase 2	Not yet recruiting	Assistance Publique - Hôpitaux de Paris
Medrol Dose Packs for Post-Operative Pain Control	2024/06/11	NCT06453083	Early Phase 1	Completed	University of Utah
Improving the Treatment of Acute Relapses in Multiple Sclerosis Through Intranasal Methylprednisolone Administration	2024/01/25	NCT06223074	Phase 2	ENROLLING_BY_INVITATION	Universidad Nacional Autonoma de Mexico
A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD)	2023/09/28	NCT06057012	Phase 2	Completed	Brii Biosciences Limited
Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain	2023/08/02	NCT05971004	Not Applicable	Completed	Tiss'You srl
Depo-Medrol on Psoas After LLIF	2023/07/03	NCT05929755	Phase 4	Recruiting	Hardeep Singh

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
SOLU-MODERIN 40 MG POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Pfizer S.L.	49767	LIOFILIZADO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Not Commercialized
SOLU-MODERIN 1 G POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Pfizer S.L.	53203	LIOFILIZADO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Commercialized
URBASON 8 mg POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Fidia Farmaceutici S.P.A.	34021	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Commercialized
SOLU-MODERIN 500 MG POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Pfizer S.L.	53202	LIOFILIZADO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Commercialized
URBASON 40 mg POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Fidia Farmaceutici S.P.A.	34023	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Commercialized
SOLU-MODERIN 125 MG POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Pfizer S.L.	49768	LIOFILIZADO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Commercialized
URBASON 16 mg COMPRIMIDOS	Fidia Farmaceutici S.P.A.	59123	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
METILPREDNISOLONA ORION 4 MG COMPRIMIDOS EFG	Orion Corporation	89233	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Not Commercialized
URBASON 40 mg COMPRIMIDOS	Fidia Farmaceutici S.P.A.	59124	COMPRIMIDO	Diagnóstico Hospitalario. Tratamiento De Larga Duración.	Commercialized
METILPREDNISOLONA ORION 16 MG COMPRIMIDOS EFG	Orion Corporation	89232	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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