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No Spironolactone
No Spironolactone is a Small molecule drug developed by Piedmont Healthcare. It is currently in Phase 1 development.
Spironolactone is a small molecule that acts as a mineralocorticoid receptor antagonist. It has been studied in various clinical trials for conditions such as cirrhosis, liver disease, and hereditary kidney diseases.
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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).
| 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 name | No Spironolactone |
|---|---|
| Sponsor | Piedmont Healthcare |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne (PHASE4)
- A Study to Evaluate the Effect of Food or no Food on the Bioavailability of an Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Adult Subjects (PHASE3)
- Digoxin In Treatment of Alcohol Associated Hepatitis (PHASE2)
- An Observational Study to Learn More About the Real-world Outcomes in Patients With Heart Failure Who Initiate Treatment With Vericiguat in Japan
- Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation (EARLY_PHASE1)
- Arterial Stiffness and Blood Pressure (NA)
- Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease (PHASE3)
- Alport Therapy Registry - European Initiative Towards Delaying Renal Failure in Alport Syndrome
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial 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:
- No Spironolactone CI brief — competitive landscape report
- No Spironolactone updates RSS · CI watch RSS
- Piedmont Healthcare portfolio CI
Frequently asked questions about No Spironolactone
What is No Spironolactone?
Who makes No Spironolactone?
What development phase is No Spironolactone in?
Related
- Manufacturer: Piedmont Healthcare — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing