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Cortancyl Oral Tablet

Assistance Publique - Hôpitaux de Paris · Phase 3 active Small molecule

Cortancyl Oral Tablet is a Corticosteroid (glucocorticoid) Small molecule drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 3 development for Inflammatory and autoimmune disorders (e.g., rheumatoid arthritis, lupus, vasculitis), Allergic reactions and asthma exacerbations, Hematologic malignancies and lymphomas (as adjunctive therapy). Also known as: immediate release prednisone tablets.

Cortancyl is a corticosteroid that suppresses immune and inflammatory responses by binding to glucocorticoid receptors.

Cortancyl is a corticosteroid that suppresses immune and inflammatory responses by binding to glucocorticoid receptors. Used for Inflammatory and autoimmune disorders (e.g., rheumatoid arthritis, lupus, vasculitis), Allergic reactions and asthma exacerbations, Hematologic malignancies and lymphomas (as adjunctive therapy).

Likelihood of approval
59.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Immunology slight uplift +1.0pp
    Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2028–2030 —
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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 nameCortancyl Oral Tablet
Also known asimmediate release prednisone tablets
SponsorAssistance Publique - Hôpitaux de Paris
Drug classCorticosteroid (glucocorticoid)
TargetGlucocorticoid receptor (GR)
ModalitySmall molecule
Therapeutic areaImmunology / Rheumatology / General Anti-inflammatory
PhasePhase 3

Mechanism of action

Cortancyl (prednisone) is a systemic corticosteroid that acts as a glucocorticoid receptor agonist, reducing the production and activity of inflammatory cytokines and immune cells. It is used to manage various inflammatory and autoimmune conditions by broadly suppressing immune-mediated inflammation. The drug crosses cell membranes and binds intracellular glucocorticoid receptors, modulating gene transcription related to inflammation.

Approved indications

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 Cortancyl Oral Tablet

What is Cortancyl Oral Tablet?

Cortancyl Oral Tablet is a Corticosteroid (glucocorticoid) drug developed by Assistance Publique - Hôpitaux de Paris, indicated for Inflammatory and autoimmune disorders (e.g., rheumatoid arthritis, lupus, vasculitis), Allergic reactions and asthma exacerbations, Hematologic malignancies and lymphomas (as adjunctive therapy).

How does Cortancyl Oral Tablet work?

Cortancyl is a corticosteroid that suppresses immune and inflammatory responses by binding to glucocorticoid receptors.

What is Cortancyl Oral Tablet used for?

Cortancyl Oral Tablet is indicated for Inflammatory and autoimmune disorders (e.g., rheumatoid arthritis, lupus, vasculitis), Allergic reactions and asthma exacerbations, Hematologic malignancies and lymphomas (as adjunctive therapy).

Who makes Cortancyl Oral Tablet?

Cortancyl Oral Tablet is developed by Assistance Publique - Hôpitaux de Paris (see full Assistance Publique - Hôpitaux de Paris pipeline at /company/assistance-publique-h-pitaux-de-paris).

Is Cortancyl Oral Tablet also known as anything else?

Cortancyl Oral Tablet is also known as immediate release prednisone tablets.

What drug class is Cortancyl Oral Tablet in?

Cortancyl Oral Tablet belongs to the Corticosteroid (glucocorticoid) class. See all Corticosteroid (glucocorticoid) drugs at /class/corticosteroid-glucocorticoid.

What development phase is Cortancyl Oral Tablet in?

Cortancyl Oral Tablet is in Phase 3.

What are the side effects of Cortancyl Oral Tablet?

Common side effects of Cortancyl Oral Tablet include Hyperglycemia / glucose intolerance, Hypertension, Osteoporosis / bone loss, Immunosuppression / increased infection risk, Insomnia / mood changes, Gastrointestinal upset.

What does Cortancyl Oral Tablet target?

Cortancyl Oral Tablet targets Glucocorticoid receptor (GR) and is a Corticosteroid (glucocorticoid).

Related

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