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Methylprednisone

Dana-Farber Cancer Institute · Phase 2 active Small molecule ✓ Verified Jun 2026

Methylprednisone is a Small molecule drug developed by Dana-Farber Cancer Institute. It is currently in Phase 2 development. Also known as: Medrol, Depo-Medrol, Solu-Medrol, Urbason®.

Methylprednisolone is a small molecule used in the treatment of various conditions, including kidney transplantation, primary focal segmental glomerulosclerosis, myelodysplastic syndrome, aplastic anemia, and renal transplanted recipients. It is not directly mentioned as an intervention in the provided ClinicalTrials.gov data, but it is a type of corticosteroid, which is often used in conjunction with other medications such as mycophenolate mofetil in clinical trials.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameMethylprednisone
Also known asMedrol, Depo-Medrol, Solu-Medrol, Urbason®
SponsorDana-Farber Cancer Institute
TargetGlucocorticoid receptor
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Methylprednisone

What is Methylprednisone?

Methylprednisone is a Small molecule drug developed by Dana-Farber Cancer Institute.

Who makes Methylprednisone?

Methylprednisone is developed by Dana-Farber Cancer Institute (see full Dana-Farber Cancer Institute pipeline at /company/dana-farber-cancer-institute).

Is Methylprednisone also known as anything else?

Methylprednisone is also known as Medrol, Depo-Medrol, Solu-Medrol, Urbason®.

What development phase is Methylprednisone in?

Methylprednisone is in Phase 2.

What does Methylprednisone target?

Methylprednisone targets Glucocorticoid receptor.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing