Last reviewed · How we verify

spirolactone

Second Xiangya Hospital of Central South University · Phase 1 active Small molecule ✓ Verified May 2026

spirolactone is a Small molecule drug developed by Second Xiangya Hospital of Central South University. It is currently in Phase 1 development for Aldosteronism, Ascites, Chronic heart failure.

Spirolactone is a small molecule with a cyclic ester attached to another ring system, classified as a synthetic steroid. It is an antimineralocorticoid, functioning as an antagonist of the mineralocorticoid receptor.

Likelihood of approval
7.6% 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).
  • Cardiovascular Phase 3 risk -2.0pp
    Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
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 namespirolactone
SponsorSecond Xiangya Hospital of Central South University
TargetCytochrome P450 2C19, Multidrug and toxin extrusion protein 1, Nuclear receptor subfamily 1 group I member 2
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 1

Approved indications

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 spirolactone

What is spirolactone?

spirolactone is a Small molecule drug developed by Second Xiangya Hospital of Central South University, indicated for Aldosteronism, Ascites, Chronic heart failure.

What is spirolactone used for?

spirolactone is indicated for Aldosteronism, Ascites, Chronic heart failure, Diagnostic Test for Primary Aldosteronism, Edema.

Who makes spirolactone?

spirolactone is developed by Second Xiangya Hospital of Central South University (see full Second Xiangya Hospital of Central South University pipeline at /company/second-xiangya-hospital-of-central-south-university).

What development phase is spirolactone in?

spirolactone is in Phase 1.

What does spirolactone target?

spirolactone targets Cytochrome P450 2C19, Multidrug and toxin extrusion protein 1, Nuclear receptor subfamily 1 group I member 2.

Related

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