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ciclosporine

Hospices Civils de Lyon · Phase 3 active Small molecule Under review Quality 35/100

ciclosporine is a Small molecule drug developed by Hospices Civils de Lyon. It is currently in Phase 3 development for Kawasaki's disease, Keratoconjunctivitis sicca, Prevention of Cardiac Transplant Rejection.

Ciclosporine is an immunosuppressant medication used to prevent organ rejection in transplant patients, including those receiving kidney, lung, and liver transplants. It works by modulating cyclophilin A, a protein involved in the immune response, and is typically taken orally or intravenously.

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 nameciclosporine
SponsorHospices Civils de Lyon
TargetCalcineurin subunit B type 1, Canalicular multispecific organic anion transporter 1, Canalicular multispecific organic anion transporter 2
ModalitySmall molecule
Therapeutic areaImmunology
PhasePhase 3

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 ciclosporine

What is ciclosporine?

ciclosporine is a Small molecule drug developed by Hospices Civils de Lyon, indicated for Kawasaki's disease, Keratoconjunctivitis sicca, Prevention of Cardiac Transplant Rejection.

What is ciclosporine used for?

ciclosporine is indicated for Kawasaki's disease, Keratoconjunctivitis sicca, Prevention of Cardiac Transplant Rejection, Prevention of Kidney Transplant Rejection, Prevention of Liver Transplant Rejection.

Who makes ciclosporine?

ciclosporine is developed by Hospices Civils de Lyon (see full Hospices Civils de Lyon pipeline at /company/hospices-civils-de-lyon).

What development phase is ciclosporine in?

ciclosporine is in Phase 3.

What are the side effects of ciclosporine?

Common side effects of ciclosporine include Headache, Oedema peripheral, Diarrhoea, Pyrexia, Urinary tract infection, Hypertension.

What does ciclosporine target?

ciclosporine targets Calcineurin subunit B type 1, Canalicular multispecific organic anion transporter 1, Canalicular multispecific organic anion transporter 2.

Related

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