CLINICAL TRIALS PROFILE FOR METHYLPREDNISOLONE

505(b)(2) Clinical Trials for methylprednisolone

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00977444 ↗	Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment	Unknown status	National Council of Science and Technology, Mexico	Phase 2/Phase 3	2007-11-01	Abstract Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of knee. A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8 mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will be the change from baseline to final assessment in the Western Ontario and McMaster University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.
New Formulation	NCT00977444 ↗	Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment	Unknown status	Nucitec	Phase 2/Phase 3	2007-11-01	Abstract Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of knee. A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8 mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will be the change from baseline to final assessment in the Western Ontario and McMaster University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.
New Formulation	NCT01267201 ↗	A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form	Completed	Pfizer	Phase 1	2010-11-01	A new formulation of methylprednisolone is being developed. A study is needed to determine the drug availability using the new formulation, a powder for reconstitution into a suspension, versus the current commercially available tablet formulation in healthy volunteers.
New Formulation	NCT01405131 ↗	A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets	Withdrawn	Pfizer	Phase 1	2012-01-01	A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets.
New Formulation	NCT01405157 ↗	A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions	Withdrawn	Pfizer	Phase 1	2012-01-01	A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fasting conditions.
New Formulation	NCT01405170 ↗	A Bioequivalence Study Comparing Methylprednisolone Suspension to Methylprednisolone Tablets Under Fed Conditions	Withdrawn	Pfizer	Phase 1	2011-10-14	A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fed conditions.
New Combination	NCT02188368 ↗	Pomalidomide for Lenalidomide for Relapsed or Refractory Multiple Myeloma Patients	Active, not recruiting	Celgene Corporation	Phase 2	2014-08-01	The purpose of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of pomalidomide given as part of a combination therapy that include more than just steroids to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not respond to past treatment) multiple myeloma (MM). Pomalidomide (alone or in combination with dexamethasone) has been approved by the United States Food and Drug Administration (FDA) for the treatment of MM patients who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of their last therapy. However, the use of pomalidomide in combination with other drugs used to treat MM, such as chemotherapeutic agents and proteasome inhibitors, is currently being tested and is not approved. Pomalidomide is in the same drug class as thalidomide and lenalidomide. Like lenalidomide, pomalidomide is a drug that alters the immune system and it may also interfere with the development of small blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. The testing done with pomalidomide thus far has shown that it is well-tolerated and effective for subjects with MM both on its own and in combination with dexamethasone. Using another drug class, namely proteasome inhibitors, we have demonstrated that simply replacing a proteasome inhibitor with another in an established anti-myeloma treatment regimen can frequently overcome resistance regardless of the other agents that are part of the anti-myeloma regimen. Importantly, the toxicity profile of the new combinations closely resembled that of the proteasome inhibitor administered as a single agent. Based on this experience, we hypothesize that the replacement of lenalidomide with pomalidomide will yield similar results in a similar relapsed/refractory MM patient population.

All Clinical Trials for methylprednisolone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000146 ↗	Optic Neuritis Treatment Trial (ONTT)	Unknown status	National Eye Institute (NEI)	Phase 3	1988-07-01	To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis. To determine the natural history of vision in patients who suffer optic neuritis. To identify risk factors for the development of multiple sclerosis in patients with optic neuritis.
NCT00000147 ↗	Longitudinal Optic Neuritis Study (LONS)	Unknown status	National Eye Institute (NEI)	N/A	1988-07-01	To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis. To determine the natural history of vision in patients who suffer optic neuritis. To identify risk factors for the development of multiple sclerosis in patients with optic neuritis.
NCT00000579 ↗	Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1994-09-01	The purposes of this study are to assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS and to create a network of interactive Critical Care Treatment Groups (CCTGs) to establish and maintain the required infrastructure to perform multiple therapeutic trials that may involve investigational drugs, approved agents not currently used for treatment of ARDS, or treatments currently used but whose efficacy has not been well documented.
NCT00000596 ↗	Diffuse Fibrotic Lung Disease	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1978-06-01	To determine the effects of cyclophosphamide compared with prednisone, dapsone, or high-dose intermittent 'pulse' therapy with methylprednisolone in patients with idiopathic pulmonary fibrosis. Also, to evaluate the use of intermittent, short-term, high-dose intravenous corticosteroids in patients with sarcoidosis. There were actually four separate clinical trials.
NCT00000730 ↗	Comparison of Three Treatments for Pneumocystis Pneumonia in AIDS Patients	Terminated	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	This study compares three different therapies for treatment of refractory Pneumocystis carinii pneumonia (PCP) in patients with AIDS. "Refractory" means that the patient has failed to respond to at least 4 days of treatment with either of two standard therapies: (1) sulfamethoxazole/trimethoprim (SMX/TMP) or (2) pentamidine (PEN). This study compares therapy with trimetrexate (TMTX) and leucovorin (LCV) to standard therapy and standard therapy plus high-dose steroids (methylprednisolone). The purpose is to find better and safer forms of treatment for PCP in AIDS patients. There is at present no scientific information about the best treatment for an AIDS patient with PCP who is not improving while receiving the standard therapies (SMX/TMP or PEN). New drug treatments are available, including steroid therapy and TMTX, but there is no information proving that these new treatments work better than the standard therapies.
NCT00000741 ↗	The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS	Withdrawn	Upjohn	Phase 3	1969-12-31	To determine the effect of methylprednisolone on respiratory failure in HIV-infected patients with presumed or confirmed pneumocystis carinii pneumonia who are stratified for presence or absence of respiratory failure at the time of randomization to the study.
NCT00000741 ↗	The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To determine the effect of methylprednisolone on respiratory failure in HIV-infected patients with presumed or confirmed pneumocystis carinii pneumonia who are stratified for presence or absence of respiratory failure at the time of randomization to the study.

Clinical Trial Conditions for methylprednisolone

Condition Name

Condition Name for methylprednisolone
Intervention	Trials
Leukemia	59
Lymphoma	47
Myelodysplastic Syndromes	35
Graft Versus Host Disease	27

Condition MeSH

Condition MeSH for methylprednisolone
Intervention	Trials
Leukemia	85
Syndrome	79
Lymphoma	74
Graft vs Host Disease	50

Clinical Trial Locations for methylprednisolone

Trials by Country

Trials by Country for methylprednisolone
Location	Trials
China	191
Canada	160
Spain	85
Italy	76
France	59

Trials by US State

Trials by US State for methylprednisolone
Location	Trials
Texas	103
California	102
New York	92
Ohio	72
Pennsylvania	72

Clinical Trial Progress for methylprednisolone

Clinical Trial Phase

Clinical Trial Phase for methylprednisolone
Clinical Trial Phase	Trials
PHASE4	15
PHASE3	17
PHASE2	23

Clinical Trial Status

Clinical Trial Status for methylprednisolone
Clinical Trial Phase	Trials
Completed	381
Recruiting	167
Terminated	92

Clinical Trial Sponsors for methylprednisolone

Sponsor Name

Sponsor Name for methylprednisolone
Sponsor	Trials
National Cancer Institute (NCI)	71
M.D. Anderson Cancer Center	27
Hoffmann-La Roche	26

Sponsor Type

Sponsor Type for methylprednisolone
Sponsor	Trials
Other	1149
Industry	226
NIH	132

Last updated: May 20, 2026

Methylprednisolone clinical trials update, market analysis, and forecast (2026-2035)

Executive summary: Publicly disclosed clinical-trial activity for methylprednisolone is limited because the molecule is widely marketed as an established corticosteroid across multiple indications and dosage forms, with many current studies focusing on specific delivery systems, dosing regimens, and combination therapies rather than novel methylprednisolone entities. Market growth is driven by (1) chronic and acute inflammatory disease demand, (2) hospital and specialty use, and (3) ongoing replacement of legacy routes and formulations with lower-burden regimens. Near-term exclusivity is not a meaningful constraint for most methylprednisolone presentations due to widespread generic availability in most geographies; the practical competitive barrier is manufacturing, regulatory compliance, and formulation differentiation more than patent moat.

What methylprednisolone clinical trials are ongoing in 2026?

Featured snippet answer: Clinical activity is concentrated in disease-area trials (autoimmune, pulmonary, neurologic, allergy) that test methylprednisolone as part of standardized regimens, assess alternative dosing schedules, or evaluate delivery approaches (for example, steroid-sparing strategies, combination regimens with biologics, or optimized IV-to-oral transitions).

Which trial types dominate methylprednisolone programs

Public trial records for methylprednisolone typically fall into four buckets:

• Regimen optimization: modified dose intensity, taper schedules, timing relative to acute events, and IV-to-oral conversion.
• Combination trials: methylprednisolone with disease-modifying therapies (including biologics and immunomodulators) to improve response kinetics or reduce steroid exposure.
• Delivery and formulation studies: pharmacokinetics (PK), bioequivalence (where applicable), and local delivery approaches.
• Comparative effectiveness: head-to-head comparisons against other corticosteroids (prednisone, dexamethasone) in specific clinical settings.

What endpoints are most common

Trials typically use:

• clinical response scores and relapse-free outcomes for inflammatory/immune diseases
• time-to-improvement or exacerbation rate in pulmonary and neurologic contexts
• safety endpoints centered on infection risk, glucose control, gastrointestinal effects, and steroid-related adverse events

Where the clinical work is most visible

Most activity clusters in:

• hospital-heavy indications (acute exacerbations, severe inflammatory presentations)
• specialty centers running protocolized steroid pathways
• regions with high prevalence of autoimmune and inflammatory disease cohorts

What market does methylprednisolone serve, and how big is it?

Featured snippet answer: Methylprednisolone is a mature systemic corticosteroid used across acute and chronic inflammatory, autoimmune, and allergic conditions. Demand is supported by broad guideline placement in hospital and outpatient settings, but growth is paced by generic penetration and payer pressure.

Demand drivers that keep methylprednisolone stable

• Universal guideline fit for many steroid-responsive conditions (autoimmune flares, severe allergy, acute neurologic inflammation).
• Hospital formularies: methylprednisolone is repeatedly used for acute presentations where rapid anti-inflammatory action matters.
• Switching and conversion protocols: clinicians commonly begin IV dosing and convert to oral steroid tapers, supporting sustained use across disease courses.

Downside drivers

• Generic substitution in most markets reduces pricing power.
• Steroid stewardship initiatives can lower exposure in some chronic pathways via steroid-sparing regimens.
• Safety scrutiny in high-risk populations can affect prescribing patterns.

How does methylprednisolone pricing and generic competition affect revenue?

Featured snippet answer: Revenue growth in methylprednisolone is structurally constrained by widespread generic availability. Value expansion is most likely to come from volume growth, mix shift to higher-cost presentations (for example, IV brands or specialty formulations), and periodic label or protocol shifts that favor methylprednisolone over alternatives.

Implications for business planning

• IP is not typically the limiting factor for most methylprednisolone products because multiple competitors exist.
• Moat is more likely to be built through:
  • manufacturing scale and reliability
  • regulated supply continuity
  • formulation differentiation (bioavailability, stability, usability)
  • contracted access via hospital group purchasing organizations

When does methylprednisolone lose exclusivity, and is exclusivity relevant?

Featured snippet answer: For most methylprednisolone presentations, patent exclusivity is not a reliable driver of near-term commercial differentiation because multiple generic versions exist across major markets.

Why exclusivity timelines are rarely decisive

• Core methylprednisolone API is long off-patent in most jurisdictions.
• Remaining exclusivity tends to be formulation- or product-specific and often does not block generic entry broadly.
• Clinical demand is anchored to guideline use, not to a single branded formulation.

Which methylprednisolone patents protect formulations and manufacturing, and how strong are they?

Featured snippet answer: Where patent coverage remains, it is usually concentrated in formulation-specific compositions, delivery devices (if any), manufacturing process steps, or specific dosing regimens rather than the base molecule.

What a realistic methylprednisolone patent estate looks like

• composition-of-matter or formulation patents for stable salts, specific excipient systems, or solvent systems
• process patents targeting crystallization, particle size, or sterile manufacturing steps
• method-of-use patents tied to specific disease protocols and dose timing
• secondary patents on combination products (when present)

How strength translates into market impact

Even with remaining patents, practical impact depends on:

• whether competitors can design around the claim boundaries
• whether regulators require the patented reference product’s clinical bridge
• whether hospitals and payers keep using the protected formulation due to contracting

What is the Orange Book status of methylprednisolone products?

Featured snippet answer: Methylprednisolone is widely represented in FDA drug listings; Orange Book entries are dominated by multiple approved ANDA products and older NDAs. Product-level exclusivity, where present, tends to be limited and not molecule-level.

What to check for a given methylprednisolone product

• NDA and ANDA listing coverage for the specific dosage form and strength (IV, oral, depot where applicable)
• patent-by-patent listings (active/inactive) and enforcement status
• whether patents are tied to the reference listed drug (RLD) only or extended across equivalents

What generic entry risks exist for methylprednisolone?

Featured snippet answer: Generic entry risks are low in the sense that competition is already entrenched, but supply and formulation-specific regulatory hurdles still create practical barriers to entry for certain dosage forms.

Where entry barriers show up

• sterile injectable manufacturing capacity and batch consistency
• stability and solubility constraints for certain excipient systems
• logistics and cold-chain requirements where relevant
• facility inspections and contamination control

How does methylprednisolone compare with prednisone and dexamethasone on clinical and market use?

Featured snippet answer: Clinical choice is indication- and route-driven. Methylprednisolone is often selected for settings where clinicians want a specific potency profile and IV-to-oral transition protocols; prednisone and dexamethasone are used depending on guideline alignment, half-life considerations, and clinician preference.

Market mix considerations

• neurologic and hospital protocols can favor methylprednisolone in standardized pathways
• chronic regimens can skew to prednisone due to long-standing prescribing patterns and low-cost generics
• dexamethasone selection often depends on specific disease guidance and dosing convenience

What biosimilar risk applies to methylprednisolone?

Featured snippet answer: No biosimilar risk applies because methylprednisolone is a small-molecule corticosteroid, not a biologic.

What does a 2026-2035 market projection for methylprednisolone look like?

Featured snippet answer: The market is expected to grow at a moderate rate globally, with volume-driven expansion offset by pricing pressure from generics. Forecast growth is more likely to track underlying incidence and acute care utilization than to reflect durable branded differentiation.

Projection framework (directional)

• Base case: modest CAGR driven by volume and mix shift within steroid-responsive indications.
• Upside: increases in acute-care throughput, higher adoption of steroid protocols in specific diseases, and successful sales of differentiated formulations.
• Downside: steroid stewardship programs that reduce total steroid exposure, continued aggressive payer substitution across corticosteroids, and supply disruptions.

Key drivers to monitor

• hospital utilization metrics in autoimmune and acute inflammatory pathways
• payer and formulary switching behavior among corticosteroids
• launch success of differentiated presentations (where any formulation differentiation exists)
• manufacturing capacity expansions or outages for sterile injectables

Clinical trial signal map: where new studies are most likely to change prescribing

Featured snippet answer: The highest probability of clinical practice change comes from trials that reduce steroid exposure, improve response speed, or standardize IV-to-oral switching, especially when paired with modern immunomodulators.

High-impact trial categories

• steroid-sparing protocols in chronic autoimmune diseases
• optimized dosing in acute neurologic inflammation
• combination strategies that reduce relapse while managing infection risk
• administration usability improvements in inpatient workflows

Key Takeaways

• Methylprednisolone clinical activity in 2026 is likely dominated by regimen optimization, combination therapy, and delivery/formulation studies rather than new-molecule breakthroughs.
• Market growth is expected to be moderate and volume-led due to entrenched generic competition and limited molecule-level exclusivity.
• Competitive advantage is primarily manufacturing reliability and formulation usability, not patent-driven exclusivity.
• Future prescribing shifts are most likely from trials that reduce total steroid exposure while maintaining clinical efficacy.

FAQs

1. Which diseases most commonly use methylprednisolone in hospital protocols?
2. Do methylprednisolone trials focus more on IV dosing or oral conversion strategies?
3. How does steroid stewardship affect methylprednisolone utilization in chronic care?
4. Are there formulation innovations for methylprednisolone that change pharmacokinetics or usability?
5. What factors determine supply stability for sterile methylprednisolone injectables?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. ClinicalTrials.gov. U.S. National Library of Medicine. https://clinicaltrials.gov/