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Prednisone 15 mg

Merck Sharp & Dohme LLC · Phase 1 active Small molecule ✓ Verified May 2026 Quality 15/100

Prednisone 15 mg is a Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 1 development. Also known as: Prednisone.

Prednisone 15 mg is a small molecule used to treat various conditions, including Leukemia, Lymphoma, Myelofibrosis, Lupus Erythematosus, and Acute Lymphoblastic Leukemia. It is often used in combination with other medications such as cytarabine, decitabine, and doxorubicin hydrochloride in clinical trials.

Likelihood of approval
12.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Big-pharma sponsor +3.0pp
    Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2033–2036
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +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 namePrednisone 15 mg
Also known asPrednisone
SponsorMerck Sharp & Dohme LLC
ModalitySmall molecule
PhasePhase 1

Approved indications

No approved indications tracked.

Common side effects

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 Prednisone 15 mg

What is Prednisone 15 mg?

Prednisone 15 mg is a Small molecule drug developed by Merck Sharp & Dohme LLC.

Who makes Prednisone 15 mg?

Prednisone 15 mg is developed by Merck Sharp & Dohme LLC (see full Merck Sharp & Dohme LLC pipeline at /company/merck).

Is Prednisone 15 mg also known as anything else?

Prednisone 15 mg is also known as Prednisone.

What development phase is Prednisone 15 mg in?

Prednisone 15 mg is in Phase 1.

What are the side effects of Prednisone 15 mg?

Common side effects of Prednisone 15 mg include INFUSION RELATED REACTION, NAUSEA, NEUTROPENIA, FATIGUE, CONSTIPATION, COUGH.

Related

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